Q1 2022 Onconova Therapeutics Inc Earnings Call
Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, please stay on the line.
[music].
Ladies and gentlemen, thank you for standing by and welcome to the <unk>.
<unk> Therapeutics first quarter 2022 financial results and business update conference call.
At this time all participants are in a listen only mode. Following management's prepared remarks.
We wanted to ask a question at that time. Please press star followed by one on your Touchtone phone. If anyone has any difficulties hearing the conference. Please press star zero for operator assistance as a reminder, this call is being recorded today may 11 2022.
At this time I would like to turn the call over to Avi Oler Senior Vice President of corporate development and General Counsel.
Thank you operator, and welcome everyone to Hackett Nova's first quarter 2022 financial results and business update conference call earlier. This afternoon, we issued a press release reporting our financial results and business progress. If you have not yet seen this press release. It is available on the investors and media section of our website at.
Ww Duncan over Dot Com today's call will begin with our president and CEO , Dr. Steve Fruchtman.
Riding an overview of our recent progress and corporate strategy. Dr. Frost Manual then ask our Chief Medical Officer, Dr. Mark Gilbert to review, our clinical programs. Our CFO Mark Guerin will then report our first quarter financial results before we move on to a question and answer session.
Turning the call over to Steve I'd like to remind everyone that statements made by management. During this conference call will include forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1095, which involve risks and uncertainties that can cause actual results to differ materially.
Forward looking statements speak only as of the date. They are made as the underlying facts and circumstances may change, except as required by law <unk> disclaims any obligation to update these forward looking statements to reflect future information events or circumstances for more information on forward looking statements. Please review the display.
During today's press release and the risk factors in the company's SEC filings with that it is my pleasure to turn the call over to Steve.
Thank you Avi.
And good afternoon, everyone.
Our clinical programs continue to make strong progress over the past months.
We recently executed on the corporate strategy, we've spoken about on our past earnings calls.
This strategy has us internally focused on on neurologist Franklin program.
Leveraging relationships.
Leaders from industry and academia.
Continue the development of Regal asserted through investigator sponsored studies based on the mechanism of action of <unk> Sirona.
Target.
Indications of interest.
<unk>.
As many listening may recall.
<unk> is an orally available multi target.
<unk> inhibitor.
It has a low nanomole affinity.
For CDK, four and six and other client needs.
Play important roles in tumor cell proliferation.
Past this year.
And survival.
It can also stimulate and cancer immunity.
Through the inhibition of the CSF one receptor.
This struck several pathways linked to the described mechanisms on drug resistance.
For this class of drugs.
We believe this inhibitory profile.
<unk> cycling to be a highly differentiated and potentially a best in class therapy.
And we look forward to the publication of an abstract.
At the upcoming Ash <unk>.
<unk> meeting that describes this topic further.
Currently two ongoing phase one trials are evaluating <unk> cyclin pace.
Patients with solid tumors.
These trials are collectively designed to inform the development.
At this stage studies and also seek to begin clinically demonstrating the advantages of <unk>.
<unk> differentiated pharmacologic profile.
Dr. Mark Gelder will be speaking about these studies in more depth.
So for now just to remind everyone.
Yes.
Both a continuous dosing schedule and a three weeks on one week off schedule.
These dosing regimens mimic drug administration schemes.
No.
<unk> Pru CDK, four and six inhibitors.
I'm pleased to say today.
Each of <unk> phase one trials remains on track.
And that we expect to identify.
<unk> recommended phase two dose.
Can have.
This year.
As these trials continue to progress in.
Indications and treatment regimens.
Plan to pursue.
At this stage studies are coming into focus.
While it would be premature to talk about the specifics of these studies before they are finalized.
We'll say now that indications.
Hormone receptor positive.
<unk>, two <unk> negative breast cancer.
Multiple myeloma and mantle cell lymphoma.
Among those in addition to others that are drawing our interest.
This interest is based both on preclinical data.
And the fact that hormone receptor positive <unk> negative breast cancer.
Oney indication.
H CDK four six inhibitors.
Currently FDA approved.
But with the knowledge and <unk>.
Fortunate reality.
That resistance to the currently approved drugs.
Very commonly seen.
Shifting gears.
Now briefly mentioned.
High level updates R&D we've asserted.
Which targets <unk> and <unk> pathways.
Regal assertive also acts as an immune modulator due to its ability.
To generate novel antigens in cancer cell membranes, which promotes.
<unk>.
Paul I guess T cells into the tumor micro environment.
Thus recognized the cancer cells as foreign.
And they have the opportunity to.
Thus control their proliferation.
There are currently two investigator sponsored studies.
<unk> ongoing with.
A third expected to begin by the <unk>.
End of June .
Two of these studies seek to leverage regus or immuno module toy effects.
By examining it.
In combination with a PD one checkpoint inhibitor.
Last year, we reported preliminary data.
First on the studies, which is K Ras mutated non small cell lung cancer.
These data were highly encouraging.
We have observed responses with different K, Ras mutations who had failed prior checkpoint inhibitor therapies.
This finding differentiates Regal surrogate.
Oliver through payer as.
Targeted agents.
Since responses.
As seen in different K, Ras mutations and thus demonstrates <unk> potential to be the K Ras mutation independent and two also overcome the mechanisms driving checkpoint inhibitor resist.
Vince.
K Ras mutated non small cell lung cancer.
We look forward to the continued progress of this trial.
And we expect to report additional data.
At a major medical meeting by the end of this year.
We expect the second trial.
We go through the checkpoint inhibitor combination.
To begin later this quarter.
This study will enroll patients with metastatic melanoma, who.
Who are refractory to checkpoint blockade.
I'm pleased to report today.
The FDA recently approved this trial to proceed after reviewing its design, which Dr. Mark <unk>.
Speak about shortly.
In addition to the ongoing and planned investigator sponsored studies.
Just mentioned.
<unk> is also being evaluated as a mono therapy.
In an investigator sponsored study.
Recessive dystrophic Epidermolysis <unk>.
Also known as our debt.
Complicated by squamous cell carcinoma of the skin.
Unlike two combination studies I mentioned.
This trial seeks to take advantage a rigorous search ability.
To potently inhibit the P or K one pathway.
On our last earnings call.
Discuss some very exciting initial data from the trial.
It showed a durable.
Pete response.
Over a year and then extensively pre treated patients with are dead and the metastatic refractory squamous cell carcinoma, who were.
Mains and complete remission today.
Those single patient data.
Always be viewed with caution.
It's important to realize that our deb associated squamous cell carcinoma is an ultra rare disease.
Tragically invariably fatal.
Additionally, rethink.
These initial data could have an important read.
Through into several more prevalent squamous cell indications, which is a concept that mark will discuss in a few moments.
However.
Before Mark begins his contribution to todays call.
I'd like to first.
Again, my thanks to those responsible.
The progress we will be discussing.
This includes all of our shareholders.
Employees partners and investigators.
Of course, most importantly, this list also includes the brave patients who participated in our clinical trials as well as their families.
The unmet needs of patients that inspire I can no routine as we work to develop our clinical programs based on expert science.
With that now.
Ill turn the call over to Marc Kelvin.
Mark.
Thank you, Steve and good afternoon, everyone.
It is my pleasure to provide an update on our recent clinical progress and future plans.
Starting with a discussion of our lead <unk> cyclic program.
As Steve mentioned <unk> is currently being advanced in two complementary phase one dose escalation studies in patients with solid tumors.
One in the United States and one in China, where we are collaborating with headaches biopharmaceutical.
The U S trial.
<unk>, a continuous daily dosing schedule in patients with advanced solid tumors enrollment remains ongoing in this trials fourth cohort, which is evaluating a 160 milligram dose of <unk> the cyclic administered orally.
Each day.
The safety findings coming out of the study continue to be very promising.
We have not observed any dose limiting toxicities or clinically meaningful cases of neutropenia.
Although we are beginning to see anticipated on target effects.
If the final data from our U S study confirmed a RASM cycle favorable safety profile with daily dose.
It will provide an important point of differentiation between nor as the cyclical and the approved CDK four six inhibitors cabos cycle and rifle shot.
Due to their associated bone marrow toxicity that leads to neutropenia. These.
These two drugs are administered with a three week on one week off dosing schedule to allow time for bone marrow recovery.
We believe that avoiding an interrupted dosing schedule with the RASM cycling.
Could potentially contribute to enhanced efficacy.
Alongside our progress in the U S. We have also seen neurons the cycle phase one trial in China proceeding as planned.
The study continues to enroll patients into its fifth cohort, which is evaluating <unk> 200 milligram oral dose of niraparib the cyclic administered each day.
<unk> lease on one week off dosing schedule.
Given the favorable safety data as seen in this trial to date Panic is currently preparing a protocol amendment that will allow for continued dose escalation.
Yes.
Thanks to the progress we've made in both of <unk> cycle phase one dose escalation programs we.
We remain on track to identify a recommended phase II dose later this year.
Looking ahead.
We expect to utilize this dose in future trials, including a phase II basket study enrolling patients with various cancers, such as CDK four six inhibitor refractory hormone receptor positive her two negative metastatic breast cancer.
Our planned future trials also include studies that will be designed to evaluate <unk> alone.
And in combination with other anti cancer agents in indications, where CDK four six inhibitors are not currently approved.
Before moving on from our discussion of <unk>.
I'd like to briefly highlight the robust preclinical data set supporting our development plan.
Some key aspects of this <unk>.
Include results, suggesting la Raza cycle, Potently inhibits CDK too, which is essential to DNA replication and one of several reported drivers of resistance to the currently available CDK four six inhibitor therapies.
Additionally, the RASM cyclic has been shown to inhibit arc five also known as <unk> one.
Would you say kinase that promote cancer cell survival in hypoxic microenvironment and serves an important role in <unk>.
Adhesion and metastasis.
As Steve mentioned, nor as the cycle also has strong affinity for.
The CSF one receptor inhibition of width.
Leads to activation of an anti cancer immune response.
Beyond data on neurologist cycles inhibitory activities. Our preclinical data set also includes results, indicating that it can suppress the growth of cancer cell lines that are resistant to powerful cyclical which is currently the most widely prescribed <unk>.
K four six inhibitor.
Additionally.
We are also highly encouraged by more recently generated in vitro data, which shows <unk> cyclic killing breast cancer cells that lack the retinoblastoma G.
This is a significant finding SCE expression of retinoblastoma protein is critical to the anti cancer activity of the current CDK four six inhibitors.
Of the Retinoblastoma gene is another resistance pathway.
Therefore.
We believe these results further positioned <unk> to be studied in areas beyond.
Those were power both cycling and other anti CDK four six therapies are currently approved as well as in patients resistant.
Currently approved CDK four six inhibitors.
I also mentioned that <unk> will show cause less bone marrow toxicity powerboat cyclic in mirroring studies.
As mentioned earlier.
Cyclops associated with bone marrow toxicity that necessitates three week on one.
One week dosing schedule.
Collectively these preclinical findings support our enthusiasm for neurosis cycle development. Following the identification of the recommended phase two dose.
Through the progression of our ongoing and planned trials, we aim to show how <unk> differentiated pharmacologic profile.
They lead to improved patient outcomes, we look forward to the program's continued advancement and to providing more details on our future clinical plans once they have been finalized.
Moving on.
I'd now like to speak about <unk> investigator sponsored program, starting with the anti PD one combination studies.
<unk> mentioned earlier.
These include an ongoing phase one two trial evaluating <unk> and the volatile map in combination in K Ras mutated non small cell lung cancer and a planned study designed to evaluate <unk>.
In combination with <unk> and.
In patients with refractory metastatic melanoma.
An important point to note about each of these trials is that.
The inclusion criteria limits their respective patient populations to those have previously failed therapy with a checkpoint inhibitor.
<unk> potential to overcome checkpoint inhibitor resistance is supported by previously reported preclinical data highlighting its immuno module inventory effects.
Data show Rico circuit reversing.
Cold immunosuppressive tumor microenvironment that often underlie checkpoint inhibitor resistance.
By promoting the expression of novel antigens, such as CD 40 on cancer cells.
This recruits immune effector cells into the tumor, which can then be stimulated by checkpoint inhibitors to mediate cancer cells.
Yeah.
We also have early clinical evidence of <unk> ability to overcome checkpoint inhibitor resistance.
Thanks to preliminary data from the non small cell lung cancer trial I just mentioned.
A preliminary update from the trial.
Ported last September showed.
Showed a 29% overall response rate and a 43% disease control.
Given that all of the patients enrolled in this trial had previously failed treatment with the standard of care PD. One checkpoint inhibitor. These data suggest that Rico Sheraton may enhance the efficacy of anti PD, one therapy and strong support.
Activity of the study doublet.
I should also emphasize a point made earlier, which is that responses were observed in patients with different K Ras mutation.
This sets <unk> apart.
Approved.
Agents designed to only target patients with a particular, a ras mutation such as <unk> 12.
Since our last update.
Trials dose expansion phase has continued to enroll patients.
While data from prior patients has been mature.
We expect to provide updated results from the trial later this year.
And the additional study that will evaluate the same rigor asserted <unk> doublet.
Potentially higher doses of <unk> is also being considered since we have yet to reach a maximum tolerated dose tolerated dose in the current trial.
Moving on the second investigator sponsored trial I'll speak about today is the upcoming study designed to evaluate <unk> in combination with the anti PD one antibody <unk> in advanced metastatic melanoma.
As mentioned earlier this trial will also exclusively enroll patients who have failed prior checkpoint inhibitor therapy.
There is a pressing unmet need.
<unk> is approximately half of metastatic melanoma patients lack effective treatment options after progressing on a checkpoint inhibitor.
This is a quite frequent occurrence in the syndication as 40% to 60% of metastatic melanoma patients will show acquired or primary resistance to PD one inhibition.
To attempt to address this need.
And the investigators sponsoring a trial will be collaborating on an open label two stage single arm phase II study.
The primary endpoint the trial will be overall response rate while key secondary endpoints will include progression free survival overall survival.
And biomarker assessments intended to shed light on Rico, Sir ability to remodel the tumor microenvironment.
If pre specified response criteria are met during the first stage of the trial. The study will proceed to stage two.
Additional patients will be enrolled.
The design of the study was recently approved by the FDA and is now awaiting IRB approval at the academic Center Center, where it will be conducted.
We expect this to occur later this quarter.
Which will allow the trial to open for enrollment.
The last investigator sponsored study I'll mention today is the ongoing trial evaluating <unk> monotherapy.
In the R Deb associated squamous cell carcinoma.
Which has shown a durable complete response in a heavily pre treated patients.
Since we spoke about the background of this trial and its initial data on our last earnings call today I will focus on what we believe these did mean from a broader perspective.
Let me start by quickly recapping the scientific rationale behind this trial.
Deb is caused by a lack of seven collagen protein, which leads to extreme skin fragility and chronic wound formation.
Over time, many are that patients develop squamous cell carcinoma.
The overexpression of <unk> protein P. L K one.
This led the trials investigator, who is one of the worlds leading experts on our debt.
To run the drug screening for inhibitors.
Okay one.
Of all of the agents tested in this extensive screening.
<unk> was found to be the most potent inhibitor.
Hey, Juan.
Suggesting it may have activity against cancer is driven by <unk> one over expression.
With the observed complete response and the ongoing investigator sponsored trial, we now have clinical proof of concept supporting this hypothesis.
Given the wide array of cancers with <unk> one over expression.
Believe these recent recent proof of concept data highlight rico surface potential to address unmet needs beyond just our deb associated squamous cell carcinoma.
Recent data is now driving conversations with key opinion leaders interested in additional investigator sponsored studies and more prevalent indications such as other subtypes of squamous cell carcinoma.
In parallel the ongoing trial in our Deb patients continues to advance.
Lastly, I'd like to once again emphasize that Rico certain clinical development.
We will be pursued primarily through investigator sponsored studies.
We plan to continue dedicating our internal resources primarily.
Sorry.
Yes.
Okay.
Now, let mark began his discussion of our recent financial results.
Thank you Mark and thanks to everyone, who has joined today's call.
I am pleased to say that all kind of remains in a strong financial position as of March 31, 2022, the company had cash and cash equivalents of $50 8 million compared to $55 1 million as of December 31, 2021.
Based on our current projections, we believe our current cash position will be sufficient to fund our ongoing clinical trials and business operations, including the pursuit of corporate development opportunities for more than 18 months.
Runway is expected to take us through the achievement of multiple important milestones.
Turning now to a review of our first quarter financial results research and development expenses for the first quarter of 2022 were $2 million compared to $1 9 million for the first quarter of 2021.
General and administrative expenses for the first quarter of 2022 were $2 2 million and this compares with $2 2 million for the first quarter of 2021.
We reported a net loss for the first quarter of 2022, a $4 1 million or <unk> 20 per share on 29 million weighted average shares outstanding.
This compares with a net loss for the first quarter of 2021 of $4 7 million or <unk> 32 per share on $14 6 million weighted common shares outstanding.
This completes my financial review I'll now turn the call back over to Steve to provide a summary of our anticipated milestones before we move on to Q&A.
As always thank you Mark.
We expect to achieve several important clinical milestones.
In the upcoming months.
Starting with <unk>, we remain on track to established its recommended phase II dose in the second half of this year.
This would then enable the subsequent initiation.
Okay.
Two basket trial and a number of.
Indications, including hormone receptor positive <unk>.
Two negative.
<unk> metastatic breast cancer.
Beyond <unk> we.
Expect the invest investigator sponsored trial.
Valuation Vega asserted primarily meso mad combination therapy in melanoma.
Open for enrollment later this quarter.
We also expect.
Can you advancement.
The ongoing phase one slash two a trial.
<unk> started plus new role in that.
In advance K, Ras mutated non small cell lung cancer.
Updated data from this study are expected with great anticipation by year's end.
Finally, we continue to assess opportunities to potentially expand our pipeline.
The strategic licensing.
And collaboration.
With regards to these assets.
Ill emphasize two points.
First.
Any action here will be data driven.
On the science and market size.
Underlying the opportunity.
Second.
We intend to take a highly selective approach in these accurate.
As we continue to have very strong conviction around the therapeutic and commercial potential of our current asset.
With that we will now.
Now open the call for questions.
Operator.
Ladies and gentlemen, if you wish to register Eric If you wish to register for a question for todays question and answer session, you'll need by Star then the number one on your telephone.
If your question has been answered or you wish to withdraw your request made by pressing the pound key if youre using a speakerphone. Please pick up a handset before entering your request.
For our first question.
Our first question comes from Charles <unk> with Guggenheim.
Good evening, everyone and thanks for taking the question regarding CDK <unk> inhibition to what extent is neutropenia, an on target effect and do you need to observe neutropenia in order to also see a.
<unk> effect associated with your inhibitor. Thank you.
Mark Al Dor would you like to take that.
Sure.
For the question so.
Neutropenia is quote unquote arent on target effect.
CDK four six particularly CDK six inhibitors.
If you look at the <unk>.
Phase one data from Pablo rival and Adam cycling.
You'll see that neutropenia was the dose limiting toxicity or DLT associated with both paabo cyclic and rival cyclic and it was really the neutropenia.
<unk>.
Was responsible for the ultimate dose selected to move forward in their phase II and III clinical trials and it was also responsible for the necessity of a three week on one week off schedule.
Schedule.
<unk> also a very potent CDK <unk> inhibitor also has some associated Campania.
But if you look at the phase one data.
Adam Cyclin diarrhea was their primary DLT.
And because they had some neutropenia, but it was not actually the dose limiting toxicity and the neutropenia that was observed did not necessitate a three week on one week off dose schedule, Adam cycle has a continuous daily dosing.
So do we anticipate.
<unk> some neutropenia as we continue with our dose escalation absolutely. We do we will not be surprised at all.
<unk>.
We expect it.
Based on our preclinical data do we think that.
The neutropenia associated with the router cycle will be as severe or profound as that with Pablo cyclic arrival cyclic no we do not.
And.
What do we anticipate will be the DLP associated with neurosis cyclic.
We don't really know yet what are quote unquote DLT will be we have not.
A DLT in our study here in the U S.
But do we anticipate we will see some.
Neutropenia, Yes, we do.
Two am I hopeful.
Are we all hopeful that.
The neutropenia will not.
A three week on one week off schedule.
But the jury is still out.
Yes.
Got it great thanks for that color and detail.
Our next question comes from <unk> <unk> with Ladenburg.
Hello team. Thank you very much for taking my question.
My question will be on there is a cyclical as well Im curious to hear what is the extent of preclinical models. We are expecting to see at <unk> any additional color would be much I appreciate it.
Okay.
I'll ask Scott to Gallagher again to take that Mark.
So.
<unk>.
We submitted an abstract to <unk>.
Describing the.
<unk> kinase inhibitory profile associated with.
Neurosis cycle.
We did not.
Submit an abstract.
That describes any of it.
Activity in terms of.
Preclinical models, such as pdx or xenograft data.
That's helpful. My follow up question will be again on there is a sickness. How many active site is currently open and do you plan to open additional sites curious on the enrollment status.
Sorry, I joined late I hope I'm, not asking something you already covered.
Okay.
Mark.
Yes so.
Again, thank you for the questions in our phase one study here in the U S. We have three active phase one sites.
Who have all been enrolling very well.
And do we anticipate opening additional sites for the dose escalation with phase one dose escalation study no we do not.
As we open.
Additional studies that part of the basket trial once we achieve the recommended phase two dose will we opened additional sites for the basket studies.
Absolutely we will yes.
Yeah.
That's helpful. My last question will be are there any rational combination of strategies you could use to pair it with Laura Sutcliffe are you considering any of those.
Given the safety profile Huston, which of course, but just curious if there are any rational market lets take that.
Mark.
Yeah. So.
Again, thank you for your question Great question, and I think that.
If you look at where the currently approved CDK four six.
Where their approval as I E homeowners sector positive her two negative metastatic breast cancer.
And you look at the combination therapies employed with the three approved agents I E either aromatase inhibitors.
Words et cetera.
We'll be doing combination studies.
With.
One or more aromatase inhibitors will be doing combination studies with one or more surge.
We will.
We are also planning some additional.
Combination studies that we think make a very good <unk>.
<unk>.
And we will be.
<unk>.
Outlining those.
In the future but.
Yes, we are planning.
Combination studies with at least two other if not more anti cancer agents.
Thank you.
And just to give mark Gallagher a break.
As you know mantle cell based on the mechanism of action of <unk> cycle and as we mentioned is a great interest to us.
And based on the anticipated profile and perhaps some preclinical studies plan.
Drugs like Ibrutinib in mantle cell.
<unk> got enough cash that we could anticipate looking at combinations with <unk>.
The typical anti mantle cell drug use such as Ibrutinib as well.
Very helpful. Thank you very much I appreciate you taking my questions.
Okay.
Our next question comes from Joe and get Us where basically we're in right.
Hey, guys. Good afternoon, thanks for taking the question and the details today.
So sticking with the rise a little bit obviously everything we're discussing today is the completely classical route.
Identify the RP to D. In the second half so I wanted to ask my question. This way with all the initiatives that FDA. How are you going to look to reconcile if thats the right word the initiatives with the FDA to identify the minimal effective dose.
I tried to give mark or Greg, but I can't that can Dell do would you like to handle that.
Sure.
<unk>.
What I can tell you is that we have recently.
Completed and finalized a protocol amendment for the ongoing phase one dose escalation study, where we are going to incorporate a PD pharmacodynamic marker. So that we will not only be looking at.
The.
The safety profile with each dose escalation, but we will also be looking.
With the PD marker.
And this will allow us not only to identify the quote unquote MTV or maximally tolerated dose, but also a dose where we achieved maximal biological effect based on the PD marker.
Got it.
That.
That.
Protocol Amendment has been finalized so that's been signed and the amendment has been sent to the three sites for submission to the IRB.
<unk> submitted to the FDA as well.
Okay and then so we're talking about Mark or is that's a good segue for my next question I guess earlier in your prepared comments when you talked about on target effects that you're seeing already and of course, you already had the discussion about neutropenia any other details about what other on target effects, you are seeing and how you're measuring them.
Go ahead Mark.
So.
<unk>.
The other on target effects that we're seeing are again, primarily related to bone marrow and bone marrow precursors and so looking at.
Adequate hemoglobin levels looking at platelet counts.
Again, looking at white blood cell counts et cetera.
So we are this is primarily through looking at different different.
Laboratory values and the.
The CBC is the most sensitive indicator of CDK six inhibition.
Got it and then.
My last question just switching gears thanks for the patients.
When you look at the potential for a phase two in <unk>.
Deb.
Obviously, there is no standard of care really and I was just wondering at this point could you take any broad strokes as to the designer size of this study one would guess that it wouldn't be that big.
I'll take that I think actually Joe it can be tightening. This is such an ultra rare disease 100 patients new patients per year in the U S.
Most of them die Unfortunately, a wound.
Injections before they developed squamous cell carcinoma.
The fact that we have one complete remission rate in M&A.
Step in my view is to get more patients because of the nature of the disease I don't think we would have to deal with.
A controlled.
A phase II trial, I think we have a few more patients may have the dose the dose for a few more patients on the current trial.
Sponsors are seeing.
That would be to go directly to the FDA to ash were approved in this rare indication.
Based on the response rate observed and how durable response has been to date.
That would be our plan.
More patients home.
As you know, but the response that we've seen to date and then go to the FDA with data and have a discussion with the FDA.
And the approval what next steps would it take to get such a big player.
Got it thanks, a lot and looking forward to the updates later this year.
Our next question comes from Robert Leboyer with Noble capital markets.
I am opposed to giving Dr. Gilbert break so I'd like to ask a question.
About the <unk> trial, that's coming up.
Based on on the discussion earlier it sounds as if youre thinking with your company can trial rig assertive with Keytruda in metastatic melanoma and this is going to start with a phase using a single arm.
<unk> Center.
And then go to a second stage with additional patients.
Could you elaborate as much as you could on the number of patients treatment time.
And time for data or starting in the second phase.
Sure.
Steve do you want me to handle that or do you want to go do enhance now put in place Rob. It has good taste and it sounds like he prefers you go ahead. Please.
So.
The study is going to be conducted.
Great.
Phase two study of phase one two study.
It's going to be conducted at a single.
Academic center that has a very high volume Mel.
Melanoma patient population.
It will.
X.
The.
Inclusion criteria are such that all patients will have been required to have failed.
Prior.
Checkpoint inhibitor therapy.
And by.
I mean progress.
Prior therapy, it's not going to include patients who are intolerant.
Because this is a combination of <unk> and <unk>.
And in stage one.
There will be 10 patients enrolled.
If a certain response rate Smith as defined in the protocol.
It will then progress to stage two.
Currently.
Stage, two will take place at the same institution.
They feel confident.
That they have.
A.
A very adequate patient population to enroll this trial quickly.
The stage two will enroll an additional approximately 20 patients.
And.
If all goes well and as planned.
Looking at the volumes that they do have we do believe that they can meet the.
Enrollment targets.
But if all goes well.
We should have data from.
The first.
First stage.
By the first part of next year.
We believe that we will have stage one fully enrolled by.
By the end of the year and that we should have some response data.
The first part of next year remember the primary endpoint is response rate per resist.
And so.
It's going to take a minimum two cycles.
Some patients.
May have responses early I after one or two cycles.
But it may be that we don't see responses in other patients so till three or four cycles. So we.
We won't we don't anticipate having results of the first stage until the first part of next year.
Okay.
Great. Thank you very much.
But this is a this is going to be conducted at a.
In academic center with a very high volume of melanoma.
I'm showing no further questions in the queue at this time I'd like to turn the call back to the speakers for any closing remarks.
Thank you operator.
I'd like to once again, thank all of those participating today.
For your very insightful questions.
We are excited about our recent progress.
And look forward to the continued execution of our corporate and clinical plans as outlined today.
Please stay safe and have a nice evening.
Take care.
Ladies and gentlemen, thank you for your participation in today's conference call. This concludes the event you may now disconnect.
Okay.
Okay.
Okay.
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