Q2 2021 Onconova Therapeutics Inc Earnings Call
Thank you for your patience.
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Ladies and gentlemen, thank you for standing by.
Come to the <unk> Therapeutics second quarter, 2021 financial results and business update conference call. At this time, all participants are in a listen only mode.
Following management's prepared remarks.
Hold a question and answer session.
To ask a question at that time. These breakfast star followed by one on your attached on phone.
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As a reminder, this call is being recorded today August 12.20 to anyone at.
At this time I would like to turn the call over to Avi older Senior Vice President of corporate development and General Counsel. Please go ahead.
Thank you good afternoon, everyone and welcome to Harken, all the second quarter in 2021 financial results and business update conference call earlier. This afternoon, we issued a press release reporting our quarterly financial results and business progress. If you have not seen this press release is available at investors <unk> media section of our.
Website at Www Dot Dot com.
On today's call a doctor, Steve Hoffman, our president and CEO will give a high level overview on our recent progress and future outlook and then Doctor Mark Gilbert Our recently appointed Chief Medical Officer will introduce himself and provide a more detailed update on our clinical and scientific progress over the past few.
Months finally, Mark Guerin, our Chief Financial Officer will then review our second quarter financial results and we will move to the Q&A portion of the call.
Before we begin I'd like to remind everyone that statements made during this conference call by management 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 disclaimer in todays press release and the risk factors in the company's essentially filings with that it is my pleasure to turn the call over.
Steve.
Thank you Ravi.
Afternoon, everyone and thank you for joining us.
As the COVID-19, pandemic continues to progress and regions of our country and the world.
We hope you and your loved ones are remaining safe.
As has been the case throughout the pandemic, we remain committed to successfully navigating any challenges that may be pros to execute on our clinical and corporate objectives.
Thanks to the talent.
Dedication of our employees partners and investigators, we recently wrapped up a highly productive quarter.
<unk> achieved both clinical and corporate milestones since our last earnings call.
And our lead program <unk>.
Waiting O N 123, 300 were simply called 123, we began dosing patients in our U S phase one trial evaluating and everyday continuous dosing schedule.
As a reminder, 123.
Okay.
Is there any novel multi kinase inhibitor targeting CDK, four and six and additional kinases involved in tumor Genesis.
Putting all five which is reported to be involved in cancer cell survival and the mechanisms of how cancer cells metastasize.
I'll, let Dr. Mark elder speak in more detail.
Our 123 clinical development program and the importance of the phase one study in a few minutes, but we will say now that the trial is continuing to advance and we remain on track to determine the recommended phase II.
<unk> of one to three by the first half of next year.
The recommended phase II dose will be determined based on data from this clinical trial in the U S as well as the ongoing phase one trial in China.
Valuation there a three weeks art, when we cough dosing schedule of 123.
Both administration schemes under study.
Based on the two different dosing schemes of the FDA approved CDK four and six inhibitors in hormone receptor positive her two negative metastatic breast cancer.
Outside our lead program. We also saw a substantial progress in an investigator initiated programs evaluating rigo surgeon in various indications.
The phase one two trial in Riga asserted in combination with a checkpoint inhibitor the role of Mab all three dose escalation cohorts defined in the current protocol has been completed without the maximum tolerated dose of all rigs started having been reached.
<unk>.
Based on this positive finding.
Regarding safety.
The protocol amendment is being prepared to allow for the evaluation of increased doses.
Regal serving them in combination with all of the map.
Preliminary preliminary data from the trial to date have also shown evidence of the combination anti cancer activity in the trials challenging patient population.
These preliminary data will presume be presented.
Coming toward annual Ras targeted drug development summit.
Place from September 21st through the 23rd of 2021.
Support for this ongoing trial, Riga, assertive and the role of Mat and lung cancer comes from preclinical studies, demonstrating reverse sort of ability.
To reverse the immunosuppressive tumor micro environment, they're frequently hampers the efficacy of checkpoint inhibitors.
These studies are reached recently featured in a peer reviewed publication.
Vanderbilt University.
In the journal molecular cancer.
The published results provide a strong scientific rationale.
Combining riga assertive with checkpoint inhibitors.
Based on these findings and additional investigator initiated trial designed to evaluate a regal sort of checkpoint inhibitor combination in melanoma.
Undergoing final protocol evaluation.
In addition.
We are studying meager assertive and a very rare.
Tragic and invariably fatal condition.
Recessive dystrophic EB epidermolysis below Sir.
Complicated by squamous cell carcinoma of the skin.
There are no curative therapies for these patients.
And more recently the standard of care for squamous cell carcinoma has been immuno oncology agents.
In this setting have yielded disappointing results.
This disease is caused by loss of college, and seven which anchors our skin cells in place.
And due to the lack of collagen seven.
Again, the news and over time, most patients develop squamous cell carcinoma in their early twenty's with overexpression of polo like kinase one.
Based on drug screens for inhibitors, a polo like kinase one or <unk>.
<unk> was found to be the most potent inhibitor of polo like kinase one.
An investigator initiated study, which started with a world expert in this ultra rare disease and Austria.
Second site soon to be opened in the United Kingdom.
The first patient.
It's been dosed at the site in Austria, and we look forward to entering additional patients on the study and giving you follow up.
Alongside our clinical and scientific a complicate accomplishments.
We have also achieved a notable corporate milestone during the second quarter by having Dr. Mark Gelder Joy, knocking over as our Chief Medical Officer.
As Marc will tell you about himself in a few moments our ability to recruit such a well qualified and highly talented talented individual was due in part to the strength of our assets.
And the momentum we've generated in our clinical programs.
So with that I'll now hand, the call over to Dr. Gallagher to provide you with some more detail on our programs.
And our overarching clinical development strategy.
Mark.
So thanks, Steve and thanks to all who are listening as well for joining us here today.
For those of you on the call who don't yet know me.
I joined often Nova as the company's Chief Medical officer in the Middle of June of this year.
I am trained as an academic you want apologist and have more than 35 years of experience in drug development in hematology and oncology as well as medical affairs and medical markets.
I also have a.
Fair degree of expertise in the development of kinase inhibitors as cancer Therapeutics.
One of the primary drivers behind my decision to join acre Nova was indeed, the potential I saw in the company's pipeline.
Yeah.
And in particular, one two threes clear differentiation compared to currently approved CDK four six inhibitors.
123 is the ability to simultaneously inhibit both the cell cycle.
And cellular metabolism.
CDK and arc five respectively.
Positions it as a compelling approach for treating cancer patients.
Factory or have become resistant to current CDK four six inhibitors.
I was also highly impressed by preclinical data showing that 123 exhibits superior CDK four inhibition and improved on target toxicity compared to power cycle, which is currently the most.
Widely prescribed CDK four six inhibitor.
One Q3's potent kinase inhibition profile.
And that's it.
Bruce.
Based on mouse models with less neutropenia observed when directly compared to an approved CDK four and six inhibitor.
May provide single agent efficacy and facilitate continuous daily dose.
This would be a difficult development since pulp a cyclic and another improved CDK four six inhibitor rigor cyclic.
Our prescribed in combination with an anti estrogen and a three weeks on one week off treatment schedule.
Due to a lack of single agent activity.
And issues of Tolerability, including side effects related to neutropenia.
We believe that continuous daily dose.
Combined with one two threes ability to potently inhibit CDK four six and other kinase may lead to improved efficacy compared to other approved CBD.
U K four six inhibitors.
Of note.
To date <unk>.
He started enrollment of the first three cohorts in.
In the phase one study in China.
E 40, 80, and 120 milligrams daily.
Daily <unk> through 'twenty one.
Right three or worse neutropenia has not been reported.
As Steve mentioned.
We are currently evaluating.
<unk> daily dosing.
123 monotherapy.
Ongoing phase one study in the United States.
We are pleased to have dose studies.
First patients this past quarter and have since completed dosing of the trials first cohort.
I E 40 milligrams.
Po daily.
Following review of the safety data from the first cohort.
Safety monitoring committee approved moving to the second dosing cohort at 80 milligrams.
So every day.
Continuous dosing and we are now enrolling patients in this cohort in the U S.
As a reminder.
This trial is expected to include three U S sites and seeks to enroll patients with advanced cancers, including but not limited to hormone receptor positive her two negative metastatic breast cancer, who are refractory to or have progressed.
One of the currently approved CDK four six inhibitors.
Yes.
We are also seeing sustained progress in one two threes other ongoing phase one study, which is being conducted in China in collaboration with our partner.
Alex biopharmaceutical.
To date.
First three dosing cohorts in the Chinese trial have been accrued.
Based on the data we have seen to date 123 appears to be well tolerated as no dose limiting toxicities have been observed.
We expect findings from the ongoing trial in China too.
To complement those from the U S trial, I mentioned earlier as the Chinese trial is dosing patients with one to three days one through 21 of a 28 day cycle.
Based on the findings from these two studies our aim is to establish the recommended dose and treatment regimen for future phase two.
Basket trial that will enroll patients with several different types of cancer that over express the tyrosine kinase targeted by 123. In addition to CDK four and six.
Based on preclinical models, we have thus far identified at least two potential target indications for this future basket study.
We plan to enroll approximately 36.
<unk> receptor positive her two negative metastatic breast cancer patients who are resistant to approved second generation CDK four six inhibitors as well as patients diagnosed with advanced non Hodgkin's lymphoma with a special interest.
And mantle cell lymphoma.
As well as studying indications with apparent clinical benefit demonstrated in the phase one trial.
I should also point out that while the focus of the 123 program will be a CDK four six inhibitor refractory patients.
We do believe that there may be an opportunity.
To move to first line therapy in the future.
Given one two threes best in class potential.
Yeah.
Looking forward, we will continue to be guided by the results of clinical and preclinical studies as we finalize the design of our future basket trial.
Based on the data we've seen to date, we are particularly excited about one two threes potential to address unmet needs.
In hormone receptor positive <unk> negative breast cancer. We believe this indication also represents a large commercial opportunity as total worldwide sales of the three currently marketed CDK four six inhibitors exceeded $6 billion.
In 2019.
Shifting gears a bit.
I would now like to discuss some progress being made with regard to <unk>, which is being advanced in multiple investigator initiated program.
<unk> is a ras pathway modulator that has been shown to synergize with checkpoint inhibitors in preclinical studies.
These studies were recently featured in a peer reviewed publication out of Vanderbilt University.
Data presented in the paper demonstrated the ability of <unk> to reverse the immunosuppressive tumor microenvironment and promote the activation and tumor infiltration of anti cancer immune cells by creating novel antigens such as <unk>.
<unk> 40 to be expressed on the tumor cells.
This is an important findings as immunosuppressive tumor microenvironment and the lack of immune cell infiltration.
Often leads to checkpoint inhibitor resistance in patients.
When tested in combination with immune checkpoint blockade Rico assertive demonstrated synergistic.
In fact cancer activity and lead to improved tumor growth inhibition and survival in a murine melanoma model that did not respond to immune checkpoint blockade alone.
Or a clinically used combination of immune checkpoint blockade plus a b RAF mec.
<unk> inhibitor.
These data demonstrate <unk> potential to address a critical unmet need by increasing the proportion of patients who respond to checkpoint inhibitor therapies.
Based on these promising findings an investigator initiated study of <unk>.
<unk> <unk> in combination with the checkpoint inhibitor <unk> more commonly known as Keytruda in patients with advanced malignant melanoma.
He is currently under active review for Finalization.
Yes.
In addition to forming the basis for a potential melanoma trial. The recently published data also provide strong mechanistic support for the ongoing K Ras mutated non small cell lung cancer trial.
<unk> in combination with the checkpoint inhibitor devoted a map.
Which is provided by Bristol Myers Squibb, and more commonly referred to as Opdivo.
Through this trial, we are aiming to address a critical unmet need.
K Ras mutations are the predominant genetic driver of non small cell lung cancer and there is currently a lack of effective treatment options for patients who fail to adequately respond to checkpoint inhibitor therapy.
The objectives of this trial are to identify the recommended phase two dose.
Of this novel Regal Circuit, <unk> doublet and to characterize its safety profile.
Secondary objectives include the preliminary evaluation of efficacy.
Assessments of overall response rate for.
Gretchen free survival and overall survival.
Preliminary clinical efficacy and scientific correlates such as the genotype of the various possible K Ras mutations and the immune status of the tumors are also being investigated.
I am pleased to say that we continue to see steady progress in the study.
Clinical data to date provide preliminary evidence of potential anti cancer activity of the <unk> combination.
And as Steve mentioned earlier.
Showed that the maximum tolerated dose of <unk> in combination with <unk> was not reached in the three cohorts of the trials.
Escalation phase.
That we have seen some preliminary evidence of anti cancer activity as well as an acceptable safety profile is highly encouraging, particularly when you consider that patients enrolled in this trial have failed.
<unk> therapy with checkpoint inhibitors, cytotoxic et cetera, making this an extremely challenging patient population.
Based on these positive preliminary findings a protocol amendment is currently being prepared that will allow for the evaluation of increased Rico, Sir to doses in combination with the full dose of Nevada Mab recommended on the product label I E.
240 milligrams IV.
Two weeks.
In parallel the trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigo start to define in the current protocol.
Looking ahead, we expect preliminary data from the expansion cohort to be presented in late September.
And hope that the continued progression of this program will offer non small cell lung cancer patients who have progressed. Following first line therapy with a potential efficacious second line treatment.
Moving on I'd like to speak very briefly about the investigator initiated trial evaluating <unk> monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic Epidermolysis <unk>.
I'm pleased to say that this trial continues to progress as planned following the dosing our first patient earlier in the second quarter.
We look forward to its continued progress and hope that <unk> will prove beneficial to this patient population, who suffer with a tremendous unmet medical need.
Lastly.
Before handing the call off to Mark to talk about our financials I'd like to emphasize that while we are very interested in the outcomes of the ongoing and potential investigator initiated studies.
We remain committed to preserving our primary focus and resources on our lead.
123.300 program.
And with that I will now turn the call over to Mark Guerin for a discussion of our second quarter financial results Mark.
Thanks, Mark and good afternoon, everyone.
I'll begin with a quick review of our second quarter expenses, and then I'll discuss our cash position and runway.
Research and development expenses for the second quarter of 2021 were $1.9 million compared to $4.8 million for the second quarter of 2020.
The decrease was primarily related to clinical development and consulting expenses related to our inspire study in the 2020 period.
General and administrative expenses for the second quarter of 2021 were $2.9 million compared to $2.6 million for the second quarter of 2020.
The increase here was primarily related to expenses for Investor relations proxy solicitation fees related to our special meeting by proxy and the 2021 period.
We reported a net loss for the second quarter of 2021 of $4.2 million or <unk> 27 per share on $15.8 million weighted average shares outstanding. This compares with a net loss for the second quarter of 2020 of $7.4 million or 65 per share an $11.3 million weighted shares.
Fanning.
Cash and cash equivalents as of June 32021 were $43.7 million.
<unk> to $19 million as of December 31, 2020.
We believe that this cash position will be sufficient to fund our ongoing clinical trials and business operations for more than 18 months and really a team and a significant milestones, including pursuing corporate development opportunities.
This completes my financial review I'll now turn the call back to speak.
Thank you very much mark.
In summary, we have multiple key near term milestones and value drivers ahead of us.
One.
The continued progression of our O N 123, 300 studies in the U S and China and the anticipated selection.
Recommended phase two dose in the first half of next year.
Two.
Presentation.
The M&A data from the investigator initiated phase one two study.
The <unk> <unk> combination therapy.
And refractory K Ras mutated non small cell lung cancer trial to be presented in late September.
Three.
Finally, we continue to actively evaluate strategic licensing opportunities to enhance our product portfolio.
As with all of our decisions.
Any decision we make on this front will be driven by science and the potential for clinical benefit.
And then the indication.
Unmet medical need.
So with that review of our clinical progress and our financial results, we'd like to open up the call now to questions.
Operator.
Thank you, ladies and gentlemen, if you wish to register for a question for todays question and answer session. You will need the breakfast part then the number one on your telephone.
If your question has been answered and you wish to withdraw your question you may do so by pressing the pound key.
If you are you seeing a speakerphone please pick up your handset before entering your request one.
One moment please for the first question.
We have your first question from Doctor Edzard their route with Guggenheim Securities. Your line is open.
Great. Thanks for taking my questions and congrats on the progress here. So the first question for me just wondered if you could provide any additional color on the ongoing China's study for 123.
Maybe the types of patients being enrolled so far and anything differentiating about the data beyond the lack of grade III plus neutropenia that you highlighted and then I guess secondly, you know anything further on the protocol amendment for Veeco sort of the volume up.
Trial, that's being prepared you know maybe what doses may be explored and any other changes that you may be making to the study design. Thank you.
Thank you Ed.
The gallons or would you like to take those two questions.
Sure Steve no. Thank you.
So.
The study with 123 in China.
Mentioned.
We are currently enrolling.
The third cohort.
So the first cohort was at 40 milligrams a day days one through 21 of a 28 day cycle second was it 80 and this third cohort is that 120 milligrams.
I can tell you is that.
All three patients in the third cohort.
Have been enroll the Dl key period for the third patient has not yet.
We did.
Yeah.
In terms of the tumor types that we're seeing it's open to us.
All solid tumors.
They have seen a fair amount of.
Well, there's been a variety of different tumors, but have seen.
Breast cancer have seen.
I believe colorectal cancer have seen prostate cancer. So they are seeing the usual types of patients that you would expect in a phase one trial that is open to all solid tumors.
In terms of the safety profile and what we're seeing the tolerability. So far seems to be very very good we have not seen any DLT.
And we have not seen it.
Any grade three or beyond neutropenia, we've seen a couple of patients who have had grade one or grade two neutropenia.
The other side effects that we've seen have been low grade fatigue weakness that sort of thing, but we have not seen anything to date.
That is a strike.
Is there anything else.
But the study is done.
No maybe if we could talk a little bit about the rig or start to.
A protocol amendment.
And any changes there that you could kind of provide incremental color on.
Sure.
<unk>.
As you know the.
Regal surface trial.
That's ongoing.
And this is a combination studying with Regal circuit and the role of the map.
In stage four.
<unk>.
Non small cell lung cancer with K, Ras mutations who have progressed on quote unquote standard of care.
The.
The original protocol called for three.
Dose escalation cohorts.
And the first cohort was <unk> 280 milligrams.
Ah.
Twice, a day or B I D.
The second dosing cohort was 560 milligrams of <unk> in the morning, 280 milligram mid afternoon, and the third dosing cohort was 560 milligrams twice a day.
And what I can tell you is that.
In the first and the second cohort there were no DLT observed I should also mention that in all of these cohorts. In addition to the Regal started patients received <unk>.
240 milligrams IV every two weeks.
In the first two cohorts there were no DLT observed.
In the third dosing cohort there was one DLT observed it was grade three <unk> trillion.
As you know.
HEICO in a premier is commonly observed in patients with non small cell lung cancer, but has also been seen with regus certain and so.
Based on a variety of data I think appropriately a decision was made that this was due to the <unk> circuit.
But there was one DLT and additional three patients were enrolled because a three plus three design and.
There were no further DLT observed so the investigator went on and started rolling six more patients at that dose level.
And because this is an ISS an investigator initiated study.
The.
The investigator really makes.
Decisions in terms of what he wants to do next in discussions with us and in discussions with the folks at Bristol Myer, because remember Bristol Myers squibb's, providing them the Volvo Mack.
All of the parties concerned I've said, they would be interested in seeing further dose escalation.
Have we seen the protocol amendment, yet no I have personally not seen a final coffee or in writing that.
That will be up to the.
The pilot.
Study when he presents that to us what do I anticipate.
My suspicion is that this dose level four will probably be.
It will be an escalation of the REO sales from $5.60.
Two.
667.60, probably.
840 milligrams in the morning, and 560 milligrams in the afternoon in combination within the role of map and if he wants to go to a dose level five that would then probably be.
No.
Uh huh.
Eight 840.
Twice a day.
In combination within Diebold map, but again I have not seen this yet there have been some discussions.
But but I haven't seen it in right.
But do we anticipate that we are going to get an amendment or further dose escalation, yes, we do but Steve Fruchtman did you have anything to add to that.
No Marc Thank you answered frankly, you know I think that.
The anticipated based on the.
The <unk>. We are currently using this 280 milligrams at 560 to 80, that's how we came up with the 840 numbers are probably next dosing escalation and four in the morning five ships in the afternoon.
No additional <unk> in the next would be probably 840.
<unk> 40 in the afternoon.
That amendment being completed.
That makes sense. Thank you.
Thank you.
We have your next question from Joe <unk> with H C. Wainwright Your line is open.
Hi, This is Sarah on for Joe. Thanks for taking the question. My first question is I'm. Just wondering how is the screening process currently going for your spanning cell carcinoma study in the recessive dystrophic epidermolysis.
At the German legislation that you can just provide any color on.
How that process has been handled.
Mark.
Yes. So again this is they are invested.
The investigator initiated study.
That is currently open.
Austria.
What I can tell you is that a second site.
In the U K, we anticipate we'll be opening.
Air future, but.
The exact timing of that.
I can't tell you for certain today. Additionally.
Additionally.
A very similar study but separate.
ISS in the same population will open here in the United States shortly.
And the screening is.
I mean I can go through the.
Screening criteria inclusion exclusion criteria et cetera are for you.
But the.
This is a population of <unk>.
With this very unfortunate disease, who have developed biopsy proven squamous cell carcinomas and who have been refractory to standard of care.
And as.
As you may or may not be aware of.
Multiple different therapies have been tried over the ages.
For these patients none of them to date have been very successful.
Because of the fact that.
They have large areas of skin that are denuded.
As toxic therapy is very risky in this population.
Because of the.
Fibrosis and webs in the esophagus and.
Limited ability to swallow pills and take things orally.
Many of these patients have to receive medications integrate display.
And the checkpoint inhibitors have not proven to be.
Very effective in this population there are no large series with the checkpoint inhibitors. In these populations. There are just some isolated case reports, but in talking with the investigators.
The results have generally been somewhat discouraged so.
They are very hopeful.
Just on the preclinical work that they have done and the <unk> one over expression seen in.
Many if not most or all of these tumors.
They are very hopeful that they will see some activities with reed.
Yeah.
I'm not sure but.
Yeah.
Criteria I can.
But I don't think there yes.
Yes, very very rare.
Yeah.
I think the answer to your question is we're in a patients identified there'll be put on the study is a very rare patients as mark was saying nothing works actually its probably I shouldn't finish and I will.
Anybody want to go on a weight loss program. After eating you can do pitches are these patients it's very tragic we hope to be able to help them.
Okay. Yes, that's very helpful. Thank you and then I had one quick follow up question and you kind of touched on this briefly before but regarding your 123 program. What's your communication strategy for this study in China.
You have a certain number of patients.
That you don't enroll first before like fully disclosing our dataset or Canada early responses.
And limited number also.
Shared or what's your what's the strategy.
This program in general.
Yes, sure I'll take that one so we have standing joint development meetings between our anchor now over at <unk> to make sure that all the data both for the U S patients.
We review that data with them and we review that data.
One two or three protocol in China.
<unk>.
My approach my vote I will do this as a consensus is probably two ways.
For the.
Recommended phase II dose to be determined and then and then at a major medical meeting to present the data from the phase one and you do it that way as a priority. If we get a response to you know just toward now should we probably would prefer.
In this study.
Seeing what patients because as mark that Gil just said we have diverse patient populations. It's all there's many different cancer indications, we probably will do it.
The data at a major medical meeting.
Okay. Thank you.
Thank you.
We have your next question from Doctor Robert Lebel here with Noble capital. Your line is open.
Good afternoon, just had a quick question about the second cohort in the one to three to 300 trial.
If you could just discuss how many patients and.
What's the timing of that data would be you mentioned selection of dose in the second half, but can happen. If there is any.
Any data presentation or or any other details you can give that would be helpful.
So I'll take that one as well so under the SEC.
Second cohort as Mark said as a team.
I'm, just making sure you're asking about OLED went to treat 300 to the second cohort is treated 80 milligrams three out of four weeks.
And that's the only thing we revealed in the public domain, so far and as I already said rather than doing it per cohort.
The third cohort has already been fully accrued, but we anticipate reviewing the data from the entire study at a major medical meeting when we following reaching the recommended phase two dose.
Okay.
Okay, Great and did you mention when the trial with route is sort of <unk> and keytruda might start accruing patients.
Yeah.
Oh that trial, the protocol is being finalized or needs to usual IRB approval.
Once the protocol is finalized.
<unk> quite soon it will be submitted to the IRB Vanderbilt idea I don't know if they meet every two weeks every month. So following IRB approval I think we can we look forward to the initiation of patients being put on to the protocol, it's hard to predict precisely.
I would guess.
The next few months as.
As a guest okay.
Okay, great. Thank you very much.
Got it.
I am showing no further questions at this time.
I'd like to turn it back to Steve Fruchtman for any closing remarks.
Okay.
Yes.
Thank you everybody for participating on today's update call.
Look forward to executing on our business plan.
And to keep you appraised of all of our progress.
We appreciate your continued interest in our programs. Thank you again and have a great evening.
So long.
Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event you may now disconnect.
Okay.
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