Q2 2020 Advaxis Inc Earnings Call

Greetings and welcome to be adopted Inc. conference call to discuss second quarter 2020 financial result business update.

Hi, all participants are any listen only mode.

Good question and answer session will all the formal presentation. If anyone should require off radar systems. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Mr., Tim Mccarthy of Lifesize, either. Thank you Sir you may begin.

Thank you Michelle Thank you everyone for joining us for today's conference call to discuss the fastest second quarter 2020 financial results in business update.

If you have not seen todays press release, please visit <unk> website at Www Dot Dot dot com.

Before turning the call over to Kimberlin, DOCSIS, President and Chief Executive Officer, I would like to remind you that during this conference call. The company will make projections and forward looking statements regarding future events.

Any statements that are not historical fact, including but not women to.

Statements that contain words, such as well believes plans anticipates expects estimates and similar expressions are forward looking statements.

I heard you to review the companies as you see filings, including without limitation. The Companys forms 10-K, and 10-Q, which identify the specific risk factors that may cause actual results or events to differ materially from those described in these forward looking statements.

Axis expressly disclaims any intention or obligation to update these forward looking statements, except as otherwise may be required under applicable law.

That I'll turn the call over to Kimberlin Ken.

Thank you, Tim and welcome everyone to our conference call couldn't Skus in Black since second quarter 2020 financial results and to provide a business okay.

Joining me on todays call are Dr. Andres good Uris, Chief Medical Officer in Mali, Henderson, Chief Financial Officer.

We will all be available during the question and answer session at the end of our prepared remarks.

To start I'd like to provide an overview of our focused strategy at abaxis centered on our proprietary listeria monocytogenes needs.

<unk> L M based immuno oncology drug candidates.

Our LM immunotherapy platform utilizing live attenuated L M. What your bio engineered to secrete tumor specific antigen attitude that fusion proteins to engage the patients immune system to destroy tumor cells.

Our drug constructs developed from this platform have the potential for comprehensive immune stimulation by harnessing pathogen like response against cancers.

We believe our Ellen based drug cost drugs attack cancer in three distinct ways first our LM drug cost structure alert and trained immune system by activating antigen presenting cells are apc's second our constructs attack the tumor directly by generating strong cancer specific T.

Felt responses.

And third they break down the suppressive tumor microenvironment, enabling activated T cells to directly attack tumor cells.

We've applied or old technology platform across a broad range of clinical programs, well drug cost structure that target certain tumor specific and viral specific outreach as well as neoantigen targeted drug constructs that our personal lives based on an individual specific mutations as well as off the shelf.

Tumor type specific.

Through these diverse approaches nearly 500 patients have been dose across HPV associated cancers, prostate cancer, non small cell lung cancer and other tumor types.

Our results have provided significant learnings in terms of safety efficacy and mechanism of action that help inform our more focused clinical plan, which maximizes the likelihood of success.

We use it we see a significant opportunity to apply our differentiated approach to help a broad range of patients.

Especially those patients where nonres about nonresponsive refractory to currently available treatments such as checkpoint inhibitors.

And we'll continue to exercise strong financial discipline as we pursue this plan.

Later on the call Andreas will provide more detailed clinical updates, but before that I'd like to provide some brief program highlights.

Advaxis has pursued two main approaches with its LNG technology single antigen constructs such as Abaxis P.S.J.

And multiple antigen approaches like R&D on hot programs.

And before I go to discuss our exciting recent results with the Abaxis fiber three drug cost structure more how program.

Likes to remind you of our early results from our taxes P.S.A. and its access Neal programs, which have provided important proof of concept for the hot program.

In the phase one two clinical trial broad access P.S.J. construct studied in combination with Keytruda, leaving checkpoint inhibitor.

We were pleased to see a prolongation of survival in men with late stage prostate cancer with a median overall survival of 33.7 months and 37 patients in the combination arm of the study.

In a subset of these patients those with prior Ddos attacks and visceral metastasis. We observed a median overall survival of 16.4 months, which compares quite favorably to best supportive care on the one hand, and two keytruda alone on the other hand.

In addition, we saw no additive toxicities in this combination.

To put these results in perspective, it's important to note that these meaningful impacts on survival have not been previously observed with immunotherapy MRD batched patient population.

These are intriguing results and we are assessing next steps for the Abaxis P.S.A. program. We will keep you updated as we have more clarity on our path forward with this program.

The Abaxis Neal approach on the other hand was designed to present, a large payload of neo antigens to stimulate a targeted patient specific T cell response against cancer cells.

The Abaxis Neal Phase one study provided us with Immunogenicity data, which showed that neoantigen approach delivered through our LM platform was capable of generating specific T cell responses against hotspot mutations as well as other personal neo antigens and demonstrated the potential to come.

Troll tumor growth with our first multi antigen drunk constructs.

Well, we ultimately decided not to pursue the Advaxis Neal program due to the limitations associated with truly personalize neoantigen therapies and Neil study results provided valuable insights and proof of mechanism for how we could apply neoantigen based therapies to a broad patient population.

With a particular tumor type using an off the shelf approach.

The results from a P.S., saying you know studies have laid a strong foundation for our Hot program first the P. S. A study demonstrated safety and clinical activity of one of our Ellen based drugs when combined with the checkpoint inhibitor.

Second the Neo study demonstrated strong and rapid immunogenicity with multiple neoantigens, including hotspot mutations.

Well immunotherapy, specifically checkpoint inhibitors have changed the treatment landscape for some solid tumors.

Back remains the vast majority of patients will not respond to these therapies or will eventually develop resistance to treatment and ultimately progress.

There is a tremendous opportunity to both improved the proportion of patients who may benefit from these treatments and also increased the durability of responses to these treatments.

We believe the drug cost structure in our hot program have the potential to help address this large unmet need.

Our Hot program consists of more than 10 different drug constructs using a cancer types specific off the shelf neoantigen based approach.

The drug cost structure in the Hot program target somatic mutations are hot spots that commonly occur in the cancer types, we're targeting and added to these hot spots are tumor specific uncle feet Atlanta, Jims earlier phase and cancer tests, These antigens, where CTO case, which had been modified.

With this broad and diverse number of targets in each hot drug construct the constructs have a greater likelihood britt to generate potent tumor specific and high strength killer T cells in nearly all patients with the tumor type being targeted by that specific hot construct.

Because hotspot mutations and Oh, they see a proteins play critical critical roles in Oncogenic says we believe targeting all of these are the same timber at the same time provide the best opportunity to kill tumor cells and improved clinical responses.

A real differentiator of our approach is that we combine hi ability targets that are expressed in all or most patients with specific cancer type into an off the shelf treatment that can be readily available to a broad patient population.

Essentially we can provide the benefits of a neoantigen targeted therapy without the manufacturing challenges and long treatment wait times associated with personal lives Neoantigen approaches.

And now I will discuss why we're excited about the early results we have seen in our hot program.

Our ongoing phase one two study investigating advaxis five oethree, our first hot candidate in the clinic in patients with non small cell lung cancer.

Is evaluating abaxis fiber three both as monotherapy and in combination with Mercks anti PD one therapy keytruda.

In May we report updated data from the trial, which showed sustained clinical benefit in patients in the first two evaluable patients treated with Abaxis fiber three in combination with keytruda, including one partial response with tumor reduction of approximately 60%.

And the other patients achieving stable disease with a 25% reduction in a target lesion.

While we were encouraged with a monotherapy data, which showed three out of six a valuable patients achieving stable disease. The dose escalation part of the study our combination arm results are particularly exciting.

These results have been sustained now out to 26 weeks excuse me now out to 16 weeks and 25 weeks, respectively, and these were achieved with a manageable safety and Tolerability profile.

Most importantly, the responses seen in the combination arm were achieved in patients who had recently progressed after two years of therapy with Keytruda and who had achieved only stable disease as their best response, while on Keytruda.

These data suggest that the addition of advanced fiber three to Keytruda has the potential to restore or even enhance sensitivity to checkpoint inhibitors.

In order to understand the mechanism of action brought vaccines five or three drug cost structure, we're doing comprehensive immune and biomarker profiling.

The early results of this work thus far support the clinical results, we have seen to date.

From an Immunogenicity perspective, we have observed activation of cytotoxic and memory CDAV positive and CD for positive T cells.

Specifically in each of the first six patients evaluated in part D and in one patient evaluated in part B of this study.

He had positive T cells were generated.

In addition, antigen spreading was confirmed in five and seven evaluating patients meaning that for the vast majority of patients tested thus far we were able to generate CD eight positive T cells against epitopes that were not incorporated in abaxis by about three.

This is important because antigen spreading improves the potential for killing tumor cells.

These results taken together demonstrate on mechanism activity of Abaxis fiber three and are therefore very encouraging.

We were looking forward to exploring this further through our relationship with personalities announcing February under which we will utilize person analysis and you know I'd be next platform to conduct comprehensive tumor genomic profiling to enable the identification of predictive composite biomarkers and or signatures of response as.

Well as the broad evaluation of potential mechanisms of therapy resistance within the tumor cells.

[noise]. These initial clinical and biomarker data had enhance our confidence in our strategy to focus on drug candidates within our hot program.

We look forward to moving our next hot drug construct Abaxis Bible five ofour in prostate cancer into the clinic.

Hi, Andy for Abaxis Fireboat for was cleared earlier this year and we expect the dose our first patient in this study in the fourth quarter of this year.

Before I turn the call over to Andres I'd like to express my gratitude to the Abaxis team, our partners and trial investigators and especially our patients who are at the very hard of our mission that abaxis, which is to improve the lives of people with cancer and their loved ones.

The dedication of our team and collaborators to this caused has allowed us to build some very nice momentum in our clinical programs and we look forward to providing our shareholders with timely updates as we continued to execute on realizing the potential of our LM platform.

Andres.

Thanks, Ken Thank you all for joining us today.

Ken described we are encouraged by the results from our first programming to Clinique the ongoing phase one two a buck these five will eat that aisle in non small cell lung cancer.

Yeah, I would like to provide you with an overview of that drive our results I know what path forward, where we that program.

It Tonight seeking to establish the recommended dose safety Tolerability and any color CBD all thought bikinis five will be administered alone and in combination with keytruda.

They do hypothesis in this study our first that the addition of about five will be good read resistance in patients with metastatic non small cell lung cancer Feeney <unk> through the last bit up.

Second the bikinis fiber threed prolonged if or when issuing equity and well get all sort of vibe that he said keep we'd get to a alone US first line therapy in non small cell lung cancer.

Based on our historical results without bucket, you say equal me nature, we keytruda as well I would it be results without lucky side with the incoming national Keytruda from Bob Vill decent study.

Well see bowls that the additional five will be making proof the clinical outcomes.

Those patients who would otherwise risky to the alone if they have a PDL one school, how you would equal to 50% or they will enable to on their goal. This thunder over can't combination therapy, we keep through the platinum based chemotherapy in first line.

Going back to the study design, what a bucky fiber to the bottom eight of the study was the monotherapy arm, we evaluated do those level in patients who got refractory metastatic non small cell lung cancer.

He spot eight has been completed seven patients treated with a buck these why we'll see alone.

On the indeed see a then throw has been safe unbelievable, how that fits that doses.

I'm not skin mention three you'll be seeks evaluable patients in bought eight so stable disease, one dose level, one and two in dose level.

I suspect that a bucket fiber to the mono therapy induced specific T cell Directv deal in older patients who need it both levels as willa antigen spinning in 83% of them impart eight.

But to be yield. This study is examining a buckets Bible treme combination with Keytruda in patients who have made a study non small cell lung cancer I'm, a little bit AC DC why is receiving keytruda I've locked up.

In this particular 15 I bought these five will you added on to Keytruda in order to revisit assistance to the trick Pony Hebei door on to once again achieved the he's come toward.

Ought to be what the sign to explore two dose levels about Bucks you spoke with that in combination with keytruda.

The personal which has been recently completed we treat patients enrolled and treated.

We did preliminary encouraging safety and if he could see results in the first do we valuable patients you bought a b, including a bunch of response on a stable the heat for 16, and 24 weeks, respectively. We have decided to expand but to be a dispersals level to enroll up to 15 a decent.

Patients in the first is stage well thought Simon two stage study design.

In both patients previous best responses, we do let alone what is they will be seen during the two years treatment period disposables that the clinical then if you a cheap we the addition of up succeed by both the after that immediate prior progression on Keytruda, maybe who reversing persistent.

Complement study of TV to Keytruda weren't getting the expansion we evaluate additional patients in this part of the study.

We will provide additional clinical an immunogenicity updates on patients from bought a b as they become available in the fourth what it'll be here.

In addition to our recently announced data in part B. We also shared over plans to begin part C. O. This study, which we evaluate bucky specialty in combination with Keytruda, a softer just like the payment for patients with metastatic non small cell lung cancer, either have a high PDL one expression.

School.

Kindred keep you drew let alone.

Well, we're basis, what ineligible to receive the standard of care regimen of Keytruda in combination with platinum based chemotherapy in first line.

As previously mentioned the this usual to evaluate it could be neutral abridgement about bucky side with the with Keytruda I'll start first line Threed. Many patients you said you get the Csfone driven by yet what results from Bobby.

I'm from dating the keynote 40 seeks to study with Abaxis be estate blocks keytruda prolong survival in patients with metastatic castration resistant prostate cancer.

The encouraging safety Tolerability immunogenic profile and any color you from Bobby over what about five will three study, we no dose limiting toxicities absurd.

Just the our combination immunotherapy regimen may represent an important new option for patients that are ineligible to receive chemotherapy income beat the nation Keytruda.

Well us for those patients will ultimately have received keytruda alone Im personally.

It's important to note that the to evaluate patients treated in part to be what is going to leave with video Ponzi, He and steel that he can vinnie feet with the combination therapy.

Last but up to six months, while also being well tolerated.

No based on the well characterized to fix some of the Ilim Victor on innate and adaptive immunity and within the tumor micro environment.

Well results are suggesting that a bikinis Bible three maybe restoring sensitivity to keytruda in basins refractory to diesel on me also enhance responses in patients undergoing therapy with Keytruda in first line there.

Offsetting these potentially have meant in a patient population buddy ineligible for standard chemotherapy or older whatever CP through let alone in the first line therapy, a logical next step that also brings the potential to improve outcomes in these patients without adding significant books <unk>.

Okay.

Oh it has been absurd, we the cooling dwell immunotherapy combinations.

Therefore, we've got a decision on the immunogenic and genomic profile of our patients will fuel that help us understand the resource bickering decent quarter edging out outcomes.

I'm pleased to know stubs posses currently open to enroll patients and we're looking for work to evaluating a button. So I will leave with Keytruda I saw new regiment that may have a baby positive benefit risk grade youre in the speed particular population.

I will now provide some information on the Immunogenicity data, we hosting from both I would have nuance Jim programs Neil on books.

Buckets, Neil personalized Ilim based immunotherapy sub value engineer about eating a victim that secrease seeking an antigen I'd you lung fusion protein consisting of 240 unique personality you want to Jim I'm not through cater to treatment will be sit on lighting old which has actually been properties.

Did you mean, nobody immunogenicity results from a phase one trial exporting to dose levels about Bucky Neil.

On the regardless of the dose level is that a bucket Neil induced in older patients. One activation approved you fit eternal CD for TD eight positive diesel to nuances in specific T cell responses. After only one week over they need help priming dose and three.

And begin spending we de said responses to neoantigen not selected to be will be part of the new accounts broke a skin mentioned before.

Biopsy sticking a baseline on on therapy into patients in the newest study.

Also documented increased pcps today's from in the tumor micro environment.

So just being the induction of Oh, you more penal type we did that.

So this is study provided strong evidence that the new antigen in Elon victors induce a robust and weaker specific immune response on favorable changes in the tumor micro environment for on did you want on defect.

In that bucket is publicly program in non small cell lung cancer, where approach using the new equipment at the pretty soles already documented gross older clinical studies, we then in Victoria, including dose in the new approach.

So far as Ken mentioned, I talked a little seven out of nine patients how being evaluated.

Next in monotherapy and one partially evaluated in combination therapy.

In all patients we have documented that I'm seeing increasing additional side to kind of scheme occurring.

Okay, seven hours up getting fusion consistent with immune activation.

You are there more the activation of cytotoxic and memory T cell.

Hi, it's been documented in patients treated with monotherapy as well I see the first patient receiving community that up be without bikinis title to the Yankee through that.

So far there has been infusion priming for antigens in a bikinis Bible three in Olson and patients.

We see the a positive T cells generated against hotspot mutations on or other tumor associated antigens from India bikinis fiber to the victim.

Additionally, antigen spending was look meant that im 507 patients.

Suggesting induction of a specific pieces of activity against a secondary it'd be too.

Nope Inc. Buxton cyber threed.

Which maybe an advantage in inducing a very strong on did you want to response.

We will continue to advance or whatever bucky side with the program in non small cell lung cancer. When you finally, moving I would mix cultural cone stroke that bikinis five will fall into the clinic in the sitting on every prostate cancer.

In this study a bikinis fiber report will be administered in the I've just been sitting for patients with prostate cancer, who have experienced biochemical recurrence of stuff radical prostatectomy or regions that up.

We will be looking to provide long term disease control, we'd only a few doses. So what bikinis fiber cool in these patients are the tumor burden in the I've just been sitting is lower than in the advanced metastatic setting the sitting in which I Bucks is be assaying was it study.

We will provide updates on the state of so if I were tonight as they become available.

So we throw constructs from our quote program. We are hopeful that these novel approach will provide off the shelf neoantigens. They therapies that can be applied broccoli grow slowly Jules.

With that I'll turn the call over to more do you put out review over cutting matches only.

Thanks Andre.

Before getting to our financial results for the second quarter ended April Thirtyth I'd like to make a couple of comments in our capital market strategy for 2020.

We started the year in a seller note by strengthening our balance sheet with the completion of a $10 million public offering of common shares in January.

We have also continued efforts to reduce operating expenses the increase fiscal responsibility in support of our focus clinical strategy as outlined by Ken Amanda.

To further and flexibility and Optionality for financing I clinical programs, you put in place and aftermarket or ATM in may of this year. We believe this would mean efficient cost effective solution for issue issuing equity over time.

Turning to our financial results for the second quarter 2020, R&D expenses were 3.9 million compared to 5.9 million for the same carried in 2018.

Decreasing research and development expenses, mostly attributable to the winding down over HPV associated cancer and personalized nilanjan clinical programs.

General and administrative costs for the second quarter, two were 2.6 million, that's compared to 3.1 million for the same period in 2019.

This decrease in expenses as a chip jump to the lower legal fees reduced employee and business development cost in support of our title tighter Cisco fiscal oversight or.

Our net loss for the first quarter second quarter, 2020 was 6.3 million or 10 cents per share compared to net loss of 9.4 million or dollar 59 per share the same period of 2019.

As of April 320, 20, we had approximately 28.2 million cash cash equivalents on hand.

With our continued reduction in operating expenses, including the winding down of nonstrategic clinical programs, our current cash without taking into consideration any potential cash inflows for the company will provide runway till at least August of next year.

Now I'd like to provide an update on our contract dispute initiated by spend though one of our partners in our former phase three inch stretched into their study as noted in our public filings in September 2018 through demand of arbitration Stendal allege that index reached our agreement when they made certain statements regarding the potential winding down about.

Just their program.

The evidentiary hearing of the arbitration withheld in October 2019, and on April 1st of this year. The arbitrator issued a final award denying stendals claim and felt.

The arbitrator found that we had not repudiated the agreement on Donato stendal damages fees or interest associated with the arbitration.

The party in order to bear, they're only attorney's fees evenly split the costs and then straight cost of the arbitration.

We are glad that this matter husband satellite and that no payments are at Stendal as a result.

Before we turn it over to question I'd like to take a moment technology ongoing covert 19 pandemic.

So far we've been fortunate to have expense minimal impact on our personnel and clinical progress, but are aware that there may be potential delays in patient enrollment in our 80 access by those three clinical program as we expand into part D and begin to enroll patients and part C.

Our top priority of safety, we're working closely with our clinical sites as well as evaluating potential new sites to ensure that our work continues with minimal disruptions.

And lastly, I'd like to thank our investors for their continued support and confidence in their programs I also want and thank the entire back team for their hard work and dedication during mission. We look forward to continued momentum in private to 2020.

Thank you and with that we will now open the call up for questions.

Thank you will now be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad. It confirmation tone one indicate your line is in the question Q. You May proceed start to see that your with your question from the Q for participants you think speaker equipment, maybe necessary to pick up your hands.

Before passing the Starkey one moment please state your question.

[noise] I first question comes from the line of Gen. Malloy with Alliance. Please proceed with your question.

Hi, good morning, Thanks for taking my question.

I had a question on the how long the part a b C. Given its hard to know for certain on how the travel going obviously the patient surviving longer pushes out the trials, but that's part informed where you guys think part D might run until the timelines or not and then sort of how part C. My my current role as well going forward.

Good morning, Jim. Thanks for your question, Oh, I'll give some preliminary responses and then I'll turn it over to Andres. So a part a was important in that it demonstrated that there was clinical activity. We've had some stable disease in some very fast progressing heavily.

Pre treated patients with late stage lung cancer.

The other important part of part a was that we're able to get a clean look at the immune corrective and biomarker data.

In these monotherapy patients see exactly how Advaxis Bible three was engaging the immune system and we're still collecting that data, but as Andres detailed in his comments, it's clear that the construct in acting on the immune system as it from tended to do and it supports the Clint.

Nickel data that we see both from part a in part B.

In terms of timing Yeah, you know I think it really depends on the data that we see we were very excited and are very excited to continue to see these first two patients from part B. The combination arm a doing well on treatment remember. These are these two patients had progressed previously.

Just before getting on fiber three they have progressed previously on Keytruda ethic after having been on Keytruda for two years with best response being stable disease, and so to actually have achieved a partial response in the second patient, which which has been sustained now onto a greater than 16 weeks, who these signals.

So that we are adding something to the mix now we not you need to make sure. We can demonstrate that over a larger patient population. So as Andres outlined we plan to expand part b odd to add an additional 15 patients and obviously timing on that comes down to enrollment and any potential impacts.

That coal that 19, you might have on our enrollment. We currently have five very high caliber sites that were part of the initial program and now we're adding sites and so we are looking at concerted efforts to accelerate enrollment to see if these data hold up over a larger and we expect to have some additional data from.

Be by the ended the year.

And then as it relates to part C. We expect to have some some data from our part C patients towards the end of this year and into the following year.

The answer your question Jim.

It does thank you and I guess, what the partially answered as well what is the the three patients enrolled as to the two are valuable as a third probably hasn't been in long enough are there any similarities between the third and the first two that.

Give hope that a you know perhaps when it when they are valuable we'll see some some something similar.

So we know we are continuing to evaluate all aspects of these patients to try to understand you know who and how and why certain patients are responding. So it's still early days and we still are assimilating all the data that we're collecting both from an immune grow the front end and a biomarker from now.

Hope it has impacted that a little bit as one of our collaborators has been shut down until recently so we're looking forward to getting data from them and we expect to have some additional data on the biomarker punk from the combo arm by the end of July early August if things go well I'm. So it's too early to tell.

What similar what's different between the different patients. So we want to enroll more patients gather more data understand a bit more as to the mechanism and why we're seeing the responses that we're seeing a we're pleasantly responding to these responses really part b was a means to get the part C. Initially right. So initially the plan was lets show that the.

The combination of Abaxis fiber, three which hadn't been in patients before.

Was safe in combination with Keytruda, we've done that and that we've seen clinical activity, which merits further investigation.

And that's what we're doing with the expansion of part B by adding the additional 15 patients and they were moving to part C, which as first line, which is very intriguing interest the word on part D.

So what did they give some color to the data that we have today, it's important to note that when people progress on checkpoint members people with late stage lung cancer like the patients we have in our in part B of our study only 10 to 15 per se.

And able to recover if you will respond again to some new therapy right. So the fact that we're seeing the stabilization of disease, which was door bubble in the first patient and now the sustained partial response in the second patient is meaningful. So if we can establish that we have a 20.

25% response rate in these patients who fail Keytruda, we think that's a pathway towards a potential approval down the road I want to get ahead of ourselves. It's still early days, but that's why we're very excited right because really nothing is help these patients once they progress on Keytruda every little rights only 10% to 15% of patients are able to.

He helped by other treatments other experimental treatments and other things that are available. So we believe that the bar that's achievable again, if these data hold up over the larger dataset. So we'll have much better information about the potential for our ability to lose sensitize patients to keytruda through this combination arm and.

Part b by the end anywhere.

Thank you that actually leads into the next question is going to asking them. So hard to answer to it. So it seems that's what's the sort of hard data points.

Well that you need and it seems like if you can maintain the 20, 25% response rate in these failures.

Year to failures, that's that's really where you need to need to be finding writer that are better.

Right. So as Andres mentioned, we've done a lot of modeling so and through our modeling what we what we need to see in the next 15 patients is our our two more partial responses to give us a high level of confidence that this thing. The response that we're seeing is real to move.

To the next phase, which be the which would be the second stage of the Simon two stage design that Andres mentioned in his comments I'll. Just you can you elaborate.

Yes. So that's that's what we're gonna say so once we get the the 15 additional patients do we get study should not responses. Then we're confident that we can move onto stage two of the Simon a two stage design and again the them target rates of response is 25%.

In both bought so but there's a go no go crazy PD up very hot solely to go no go criteria from stage one two stage, two which is three or more partial response you thought it's a very high bar at going seeing us a skin was mentioning what we have seen with other immunotherapy strength to rescue chip.

He was sort of failures the responses automobile centered on 10 12, 15% that's what we get to see we the trying to rescue these kind of about patients on other expense of a high took CCT what does he here from what we have seen in the if they program, but if they save on Targetable to combine them Elon Victorian.

On the Keytruda. So now we're not expecting to see any kind of a major safety concerns either as we have not been seen that we have not seen about in the first three patients in part to be a decent study so.

We are hoping to really progress we clean been holding off lease additional 15 patients. The environment is not the best environment. So it's a very competitive landscape on Colby you social kind of a slowing down a TV de seen some sites Ali we get to see that there's starting sites are starting to.

Works.

Again back to normal speed.

Okay got it okay.

Okay, well, let me last question from all the a and what the spin came down pretty dramatically.

But the with the exiting of as other programs.

As you ramp it up into the second half part being a part C and and I guess whatever happens with.

I would appear say or is this the level, we should expect through the rest of years, we should see that sort of move up or down.

Yeah, we've been opening and giving guidance as far as what we expect this the 12 month spend to be kind of around that 25, 23 25 million, but as Andres just said some sites and pulling back other sites are ramping back up. So we're looking to increase the amount of sites to be able to pull in more patients. So.

Well, we're assessing that now right now I'm still confident that we're still you know in August of next year timeframe from a run by and you know certainly we'll be opportunistic and look for other sources of non dilutive financing in the meantime, but at this point, yes, I think that's probably a safe assumption based on run rate we're seeing.

For the rest of them this year and.

Early next year.

Great thing in this last question I guess for Ken are you sort of hinted at the start of the call. The PEO say stay tuned for clarity on a path for us any any timeline or potential guidance or what sort of pet for that might be anticipating that non dilutive financing that was just alluded to potentially.

Right Jim.

Good question. So I know a number of folks are certainly interested to hear a what's going to happen with that program a yet. So the next the next study which would be a randomized control study to generate proof of concept data from your requires about $20 million to $25 million to complete and we are look.

Moving onto the bank financing to help on that in other words partner funding and partnerships take time, and we had hoped to be at a place now to announce that but we're not so there's still some work to do I can't give you a timetable, but we continue to look at potential opportunities. The funds that's that study through non dilutive finance.

Thank you partner funding.

And like I said these things take time, it's hard to predict when we're going to reach a conclusion on that but the data are intriguing.

But when you think about five or three versus P.S.J.

We believe five or three because we're seeing already a partial response in the calm arm is a quicker path to proof of concept and a less expensive path of proof of concept and potentially to an accelerated approval right. When you think about those two programs you can get an accelerated approval based on response rates in non small cell lung cancer.

Whereas in prostate cancer, we didnt see response rates, but we didn't see this nice survival benefit so survival studies by the very nature take longer and therefore more expensive so right now.

For our prioritizing fiber three over P.S.J.

If we can get some more funding non dilutive funding around PSC, we'd like to embark on that next study.

Great. Thank you very much taking the questions.

Thanks, Jim.

Thank you there no further questions at this time I'd like turn the call back over to Mr. Berlin for any closing remarks.

Thank you all again for joining our call today, we're proud of our momentum and confident about the path forward with our hot program and look forward to providing clinical updates in the coming months.

Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation have a wonderful day.