Q2 2022 Onconova Therapeutics Inc Earnings Call
[music].
Ladies and gentlemen, thank you for standing by and welcome to the <unk> Therapeutics second quarter 2022 financial results and business update conference call. At this time all participants are in listen only mode. Following management's prepared remarks, we will hold a question and answer session to ask a question at that time.
I am please press the star key followed by the number one as a reminder, this call is being recorded today August 11th 2022.
At this time I'd like to turn the call over to Bruce Michael of Life Science Affairs. Please go ahead.
Thank you operator, and welcome everyone, who aren't going to the second quarter 2022 financial results and business update conference call.
Earlier this afternoon <unk> issued a press release reporting its financial results and business progress.
If you have not yet seen this press release it is available in the investors and media section of the company's website at www dot onto Nova Dotcom.
Following my introduction I can have a president and CEO , Dr. Steve Fruchtman, who will provide an overview of the company's recent highlights and future outlook.
Followed by Chief Medical Officer, Dr. Mark Gilbert.
We'll discuss progress across our pipeline.
And the last week, Chief operating Officer, and Chief Financial Officer, Mark Garrett will report the company's second quarter financial results.
These prepared remarks, we will then be followed by a question and answer session.
Before turning the call over to Hakan of his management team I'd like to remind everyone that statements made during this conference call will include forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially.
Seriously.
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 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 Bruce.
Good afternoon to all our listeners today.
This past quarter.
It was an important period of execution for us.
As you saw.
Of course.
And then pipeline.
As we advance through the second half of the year.
We remain focused internally.
On the advancement of our lead.
Whereas you're cycling.
Golf and program.
Which as a reminder.
This two phase one all comer solid tumor studies designed primarily to evaluate safety and.
Tolerability.
Our orally.
Ball multi targeted kinase inhibitor.
The two administrations schemes being tested in these trials mirrors. Those currently approved CDK four six inhibitors and will identify the best recommended phase two dose and schedule of administration.
Of note <unk> is frankly going forward.
We have completed four dosing cohorts.
Both phase one studies and the safety data continues to look very favorable to date.
Mirroring our robust preclinical data set.
Key components of this preclinical dataset were featured in an abstract recently published at the American Society of clinical oncology annual meeting.
These days.
Dr. Mark Gallardo will discuss in greater detail.
Whereas as cyclical.
Inhibits CDK, four and six and all other kinases implicated in tumor growth.
Cancer cell survival, and metastasis as well as the immuno module activities.
We believe this inhibitory profile may confer, whereas a cyclic safety.
What you see there.
Vintages over currently available agents highlighting its best in class potential.
As you are aware.
CDK inhibitors, a multibillion dollar franchises to address screening for patients with hormone receptor positive.
<unk> negative metastatic breast cancer.
Looking forward for neuralgia side glib.
The continued advancement of rich phase one trials to allow for the second selection.
Commanded phase II dose.
We anticipate having.
For the end of this year.
We continue to home in on the.
Patients and treatment regimens, we will pursue in later stage studies and we will be informed by the results of the phase one program.
Out this process.
To better enable these efforts.
Recently amended the protocol of our phase one study to allow for the collection of Pharmacodynamic data using the cutting edge <unk> assay.
This assay designed to measure vomiting kinase activity and Mark cell proliferation that is believed to be predictive of CDK, four and six inhibitory activity or target engagement.
This approach of having a biomarker to determine target engagement.
Rather than the classic phase, where an approach of observing clinical toxicity, and then pulling back to a previous and lower dose for future trials.
Methodology.
Yesterday in losses and Dr. Gallagher will give us greater details about this approach.
Well, we of course need to finalize the specifics.
Of our planned future trials before they are announced I reiterate where we are.
We're interested in multiple indications and you are at in the cycle.
Potential.
These include hormone receptor positive her two negative breast cancer that is refractory to the FDA approved drugs.
Myeloma mantle cell lymphoma, and based on the mechanism of action of near as a cyclic.
Other potential indications as well.
Interest drawn from broke both preclinical work and the testing unmet need.
Improved options.
Yes.
In additional indications.
Turning our attention now to Regal assertive.
Our first emphasize that our strategy of utilizing investigator sponsored trials with key opinion leaders to pursue the development of <unk>.
Not sure.
This enables us to dedicate our primary focus and resources to IL two our lead Erasmus cyclic programs.
As you May recall, Riga assertive can attack cancers, several different mechanisms as it has the ability to modulate.
And over expressed Ras pathway.
The P&L K, one pathway and the tumor immune microenvironment.
Our planned investigator sponsored trial in.
Checkpoint inhibitor refractory metastatic melanoma seeks to leverage regret sort of his role as an immune modulator.
This trial, which will evaluate negotiated.
Combination with the PD, one checkpoint inhibitor <unk> lives and that builds upon published preclinical data presented at prominent meetings, such as the ACR and journals.
Came out of the work at Vanderbilt University that showed we go sort of promoting the infiltration of T cells into the tumor microenvironment.
So of course PD one inhibitors.
Work by stimulating the cancer, killing activity of T cells, increasing.
Number of T cells in tumors is expected to enhance.
Efficacy of these exciting agents.
A key goal of the melanoma trial.
Gavin straight answer anti cancer activity.
The Regal asserted tremble, losing that combination in patients showing resistance to checkpoint blockade.
This is similar to another ongoing investigator sponsored trial, which is evaluating legal assertive.
The PD, one inhibitor and the goal with that caveat.
K Ras mutated non small cell lung cancer.
Preliminary data from this trial.
We support.
Mrs.
Behind the skewing to open.
Now Ms study.
We look forward to the continued progress.
Both investigator sponsored studies.
<unk> Regal circuit with an anti PD one agent.
We anticipate reporting additional data.
From the K Ras mutated non small cell lung cancer.
This quarter, an abstract that has been submitted to the European society of medical oncology or as well.
In addition to these two <unk> studies.
Also seeing extremely encouraging results in the investigator sponsored trial evaluating Regal affordable model therapy.
Squamous cell carcinoma of the skin.
Associated with the ultra rare disease.
Trophic EBITA molasses lowest well odd.
Our debt.
Initial single patient data from this trial showed a sustained complete response.
In this difficult to treat indications when the patient and the patient is still in complete remission today and continuing a single agent. We go service over one year.
This importantly.
Provides clinical proof of concept.
Regal suited ability to inhibit T O K one pathway.
Which is a crucial enzyme theres over expressing odd them associated squamous cell carcinoma, and more prevalent squamous cell catches as well.
As mentioned on our last call. This result is driving conversations with clinicians and scientists interested in potentially pursuing additional investigator sponsored trials.
This highlights.
How a collaborative strategy with regards to them allows us to increase our avenues for value creation.
In a capital efficient manner.
With that I'll pass the call off to Dr. Bob Gallagher to speak more about our clinical programs work.
Thank you Steve.
And welcome again to everyone who has joined us.
As usual I'll begin my portion of the earnings call by reviewing the status of our lead north of cyclic program.
Two complementary phase one dose escalation study.
These include a U S trial.
Uhm continuous daily dosing schedule and the trial in China.
Valuation a three weeks on one week off dosing schedule.
Both studies are enrolling patients with advanced solid.
I would too.
I am pleased to report that since our <unk>.
Last earnings call. The U S study has advanced from the fourth to the fifth dose escalation cohort.
Which is evaluating a 200 milligram oral dose of Niraparib cyclic administered each day.
We have not observed any dose limiting toxicity or clinically meaningful cases of neutropenia in the trials to date.
And continue to see anticipated on target effects of the study drug.
We remain highly encouraged by these data.
As they dose limiting factor and therefore, our ability issue.
Both rival Sideslip, an awful cycle.
The most widely prescribed CDK four and six inhibitors is the bone marrow toxicity or minus suppression associated with these agents.
This necessitates an interrupted dosing schedule with drug given three out of every four weeks, so that the bone marrow and recover.
If data from our U S phase one study.
Continues to mature appraisal well.
We would likely seek to move forward with a continuous daily dosing regimen corridor as the cycle.
This would clearly differentiate our therapeutic candidates and could potentially contribute to an improved efficacy profile as the one week all require for both Pablo cyclic and rival cycling.
Mary permit tumor cell proliferation, and therefore tumor growth.
To better inform our development.
We recently enacted a protocol of men in the U S trial.
That will allow us to assess morass of five clubs biological activity in all cohorts moving forward.
We will do this using the <unk> assay, Steve referenced earlier.
Which is a clinically validated.
<unk> based tests measuring the presence of thymidine kinase one.
<unk> kinase, one or TK warm.
He's a well known cell cycle regulated enzyme that is important for me.
Clear.
<unk> during DNA synthesis.
T K one catalyzes the conversion of Diamidine, two deoxythymidine model phosphate, which is the further phosphorylated to die and price cost states prior to its incorporation into DNA.
Uh huh.
The activity.
Teekay want.
He is very low or absence in resting cells.
And peaks in the expertise.
And then disappears during my toes.
Serum CK one activity is.
Elevated in cancer patients compared with healthy individuals.
It has been referred to as a liquid.
Lisa.
Prior clinical trials have shown that thymidine kinase, one or TK one activity.
Currently reflects the biologic effect of CDK four six inhibitors.
Incorporating assessment of CK, one into our phase one program.
Is therefore expected to provide valuable data that will enable us to move towards later stage studies with a more thorough understanding of Nebraska side Matt.
Small biologically effective dose and the.
Optimal dose for achieving its maximal pharmacologic effect.
This will allow us to further de risk the rest of the site clubs clinical development.
Is clearly in line with the Fda's project Optimists initiative, which focuses on improving the dose finding and dose optimization paradigm in oncology.
In parallel with our efforts in the United States.
Our partner panics biopharmaceutical.
10 news to advance the phase one trial of <unk> in China.
This study is currently in its fifth dose escalation cohort, which is evaluating <unk> 200 milligrams of oral <unk> at.
Administered each day with a three weeks on one week off dosing schedule.
As mentioned on our last earnings call Alex is working.
On a protocol amendment.
Allow for further dose escalation in this study given the favorable safety data for the phase one program.
Has been generated to date.
Continued progress in Nebraska psychosis phase one trials.
To allow for the identification of a recommended phase two dose in the near future.
Before the end of the year.
Once identified we.
We plan to utilize this dose in plan later stage.
As we've stated consistently in the past. These trials will include a phase two multi indication basket trial designed to evaluate an arrival cycle alone.
<unk> in combination with other anti cancer agents.
Okay.
To expand on a point that Steve made earlier.
One indication that we intend to evaluate and our planned basket trial.
As CDK four six refractory.
Our mone receptor causes in her two negative metastatic breast cancer.
Though CDK four six inhibitors are currently approved and generate billions of dollars in annual sales in this indication.
Virtually all of these patients eventually develop cruises.
This leaves a pressing unmet need we believe <unk> side club kind of address.
We also plan to study <unk> indications.
We're.
CDK four six inhibitors are not approved.
Both as part of the basket trial.
And in the additional preclinical studies.
Our plans to develop <unk> cyclin across multiple indications.
Supported by a robust preclinical data set.
Which include state of publish this past may at the American Society of clinical oncology or <unk> annual meeting.
These data, which come from cell base and in vitro assays.
I like the RASM Cyclops differentiated inhibitory profile.
In cell based assays neurosis cycle with demonstrated potent inhibitory activity.
Again arc five.
Ann.
CSF one receptor.
Two kinases.
They're not targeted by any of the three approved CDK four six.
We believe this finding is significant.
Sebastian.
CSF one off leads to the activation of anti cancer immunity.
While our five.
Placed important roles in carrots yourself survival is hypoxic environments as well as metastasis.
The preclinical studies feature to that though.
Also compared morass of cyclists to Apple massage.
Which is the third approved CDK four 6%.
Unlike our sizable and dry bulk side.
<unk> is administered on a daily dosing schedule.
As neutropenia is not primary dose limiting toxicity.
For Adenoma, Cyprus diarrhea is the primary DLT.
Due to its affinity for the kinase GSK GSK rebate.
<unk> inhibitory activity against GSK.
<unk> data was found to be approximately 29 times less than that of albums cycling.
Indicating that this may be I E. A RASM cycle. It may be we administered at higher more effective doses before causing any problems with diarrhea.
As I've said before to date, we have not seen any dose limiting toxicities in our phase one dose.
Dose escalation trial here in the U S.
I can tell you that in terms of adverse events, we have not seen any high grade diarrhea.
Collectively the results presented at Astro.
Suggests no rashes spikelet.
Inventory profile.
<unk> provides safety and efficacy advantages over currently approved CDK four six inhibitors and complement data discussed on prior earnings call.
These include varying data, showing nebraska, sizable, causing less bone marrow toxicity compared to portable side.
And in vitro data showing the RASM cycle suppressing the growth of Castro cell lines resistant to Paul will cycle in.
Clothing, both lapping the retinoblastoma or RPG.
Looking ahead, we are eager to continue our work aimed at translating our promising preclinical findings completion.
We believe in a RASM sideslip has special to significantly improve the therapeutic paradigm.
Several prevalent cancers and look forward to outlining the specifics of our future clinical plans once final.
Moving on I'd like to briefly discuss progress and Rico circuits investigator sponsored program.
I will focus exclusively on the ongoing <unk>.
Studying.
Outcome of upcoming melanoma study.
Steve has already provided an update on our debt associated squamous cell carcinoma trial.
The first study I'll say is the ongoing phase one trial evaluating <unk> plus the PD one inhibitor in Nevada, Mab NK Ras mutated non small cell lung cancer.
Like the melanoma study this.
This trial exclusively enroll patients who have failed prior checkpoint inhibitor therapy.
A preliminary readout from the study provided encouraging evidence of Regal circuit its ability to overcome checkpoint inhibitor resistance as we observed two partial responses and one is stable disease.
Seven evaluable patients.
As the mechanism of action of <unk> to predict.
System Moy is not dependent on any one specific.
Mutation rigo search of attacks responses were seen across multiple K, Ras mutation variants, which differentiates perrigo Sir.
From agents exclusively focused on patients with specific K Ras mutations such as GE clubs.
We view this preliminary data readout as highly encouraging as it supports our efforts both in this trial and the melanoma study given the similarities between the study combinations and patient populations.
Looking forward to additional data from the non small cell lung cancer trial, we expect to report an updated data.
Abstract submitted to the 2020 to ESMO meeting, which will take place in Paris, France in September 2022.
Our goal with this data readout is to see further evidence.
Of the study doublets anti cancer activity.
And favorable safety profile in this indication.
A key point to note about the ongoing Favre asked mutated non small cell lung cancer trial.
So we have yet to reach the maximum tolerated dose of Regal circuit for the combination with the goal of that.
Therefore, we may have the opportunity to potentially study increased doses of rig of circa combined with the ball on that in a future trial in this indication.
Which remains under consideration.
Ultimately a decision on this front will be based on the final data from the ongoing trial as well as conversations with experts and key opinion leaders in the field.
The second key investigator sponsored study I'll discuss is our planned phase II trial of <unk> plus the PD, one checkpoint inhibitor <unk> in patients with checkpoint blockade.
<unk> III metastatic melanoma.
This trial is supported.
As Steve mentioned by the preclinical data.
Richards group at Vanderbilt University.
The trial seeks to address it.
<unk> in metastatic melanoma.
Eric.
Uh huh.
As roughly half of these patients lack an effective treatment option after progressing on a checkpoint inhibitor.
Primary or acquired resistance.
With PD one inhibition.
No.
To occur in 40% to 60% of patients with metastatic melanoma, leaving mainly in urgent need of a novel therapeutic approach.
Turning now to the trial design.
It will be a single arm.
Say study with stage one expected to include approximately 10 patients.
Yes pre specified response criteria are met.
The study will be cleared proceed stage two.
Where we expect to enroll an additional 19 patients.
The trials treatment regimen will consist of Regal circuit.
500 milligrams orally administered twice daily.
Days, one through 21 raised 28 day treatment cycle.
Plus.
The health authority approved dose of <unk> 400 milligrams.
Administered intravenously every six weeks.
The primary endpoint of the study is overall response rate while key secondary endpoints include progression free survival overall survival as well as safety and Tolerability assessment.
We also intend to collect pre and post treatment biomarker data to better understand Regal Sir.
I'm the tumor immune microenvironment.
While it's too early to know when we can expect some early interim data from the study.
We look forward to providing that guidance in the future as this trial progresses.
With that I would like to introduce our chief operating.
And Chief Financial Officer, Mark Guerin to report, our second quarter financial results.
<unk>.
Okay.
Thank you Mark it's my pleasure to be speaking on the call today.
I'm happy to report that <unk> maintained its strong financial position over the last quarter with cash and cash equivalents of $46 5 million as of June 32022.
This compares 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 enable the completion of key value, creating milestones across our pipeline.
Our research and development expenses for the second quarter of 2022 were $2 million compared to $1 9 million for the second quarter of 2021.
General and administrative expenses for the second quarter of 2022 were $2 1 million.
Compared with $2 9 million for the second quarter of 2021.
We reported a net loss for the second quarter of 2022 of $4 million or <unk> 19 per share on 29 million weighted average shares outstanding.
This compared with a net loss for the second quarter of 2021 of $4 2 million or <unk> 27 per share $15 8 million weighted average shares outstanding.
With my financial review complete I will now hand, the call off to Steve to summarize our anticipated milestones before transitioning to question and answer.
Thank you Mark.
Before running through our upcoming milestones.
Like to congratulate both Marc and head of corporate development.
Koskey Silverstein.
On their recent and very well deserved promotions.
They each have transitioned.
Into their expanded roles seamlessly.
And I look forward to our continued working together.
Turning now to anticipated milestones.
We expect to identify neuralgia site optimal phase two dose in the second half of the year.
This will inform the design of subsequent studies.
Excluding a phase II basket trial.
Notable indications and doublets.
With regards to Regal.
We plan to announce additional data from the phase.
<unk>, one slash two K Ras mutated non small cell lung cancer trial.
An abstract submitted to the upcoming ESMO meeting in September .
Alongside our <unk> negotiated programs.
We continue to evaluate business development opportunities.
That could potentially expand.
Our pipeline.
Our guiding principles in this area.
That change.
As we were making assessments based on scientific merit.
And the size of it.
Need each potential candidate.
Seeks to address.
Many companies that we interact with are having problems.
Alright financial climate to have adequate resources to develop.
One new molecular entities.
On the financial assessment.
<unk> shared with you.
We are confident we have the required financial resources to continue our important work to develop efficacious and safe drugs.
Patients in need.
With that Ah 90 to conclude the formal portion of today's call.
My thanking all goes well played a role in the progress we have discussed today.
This includes <unk> employees collaborators.
<unk> and most important role.
Great clinical trial patients.
I'll now open the call for questions.
Operator.
Yeah.
Ladies and gentlemen, if you'd like to register for a question for todays question and answer session. You will need to press Star 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 Star then the number two.
If youre using a speakerphone please pick up here handset before entering your request.
One moment. Please first question.
And we will take our first question from the line of Charles <unk> with Guggenheim Securities. Please go ahead. Your line is now open.
Hey, good afternoon, everyone and thanks for taking my questions.
Given it sounds like Youre on track to identify a potential recommended phase II dose for Norad cyclic as early as the end of this year and also it looks like Youre enrolling dose cohort five for both of the phase one study should we interpret that as potentially dose cohorts six to seven is being likely maximum tullow.
Re rated dose doses. Thanks.
Mark would you like to answer that.
So thank you Steve.
As I said, so far to date.
Peru cohort four we have not seen any dose limiting toxicity or DLT.
We are beginning to see some anticipated expected on target activity.
We have incorporated the <unk> assay.
Into this into the phase one study.
We have a good PD marker.
With all of that said.
I have no idea.
At what point, we might reach our quote unquote dose limiting toxicity or MTV maximal tolerated dose.
What I do know is that.
We will continue to dose escalate.
Until we do reach the maximum tolerated dose or.
A dose at which based on the PD marker, we have clear evidence of Max mobile logical effect.
Whether that this dose cohort I E. The fifth whether thats the six of the seven.
I have no way of predicting but based on the.
Quote on quote on target activity.
We are beginning to see.
I I think that we probably are getting reasonably close, but what exactly that will be what dose that exactly will be and exactly when we will get there I can't say I am very hopeful it's before the end of the year because we have some other studies that.
We would like to start moving forward.
Great. Thanks for taking thank you Mark.
Yeah.
Yeah.
We will take our next question is from the line of <unk> with Ladenburg Thalmann. Please go ahead. Your line is now open.
Hello, Thank you for taking my question.
This is Tony I'll sort of I'll call demand. My question is since Mark talk about future phase II basket trial, if possible could you. Please give us more color on the company's plan.
Alright, sorry clip any plan to combine with other drugs and other indications besides breast cancer.
Any specific marker to use thanks.
Mark.
Hi.
So.
All I can say for certain at this point is that we.
We are putting together a a.
Panel a slate.
Studies that we are very interested in moving forward with.
<unk>.
Some of them are single agent neurosis cyclic others are <unk> cycle in combination.
With other anti cancer therapies.
What I can say is that in the breast cancer space.
If you look at the three approved CDK <unk> inhibitors.
<unk>.
Most all of their approvals are in combination with an anti gen. Whether that's an aromatase inhibitor such as let's resolve our served or.
Firm et cetera.
<unk>.
As we've said we are clearly going to move forward in the <unk>.
CDK four six refractory hormone receptor positive her two negative metastatic breast cancer space.
That will likely be in combination with <unk>.
And anti estrogen.
The exact final decisions on the design of that trial have not yet been made but we're 99, 9% of the way there.
<unk>.
Trial.
Design win mantle cell lymphoma, as we've talked about again that has not been absolutely finalized so I don't want to say much more about that.
And.
We're looking at some other trials so until we get.
Absolutely final submitted in written in stone trial designs with various combinations I hate to say anything about it publically, but that's really all I can say.
Steve you may or may not say anything more.
Well. Thank you Bob I think you are comprehensive.
Clearly that these drugs are approved in.
Metastatic breast cancer as Mark mentioned eventually.
All patients will become refractory.
Just on a mechanism of action presented at <unk>, We believe we have.
Sure.
Evidence as well cancer cell breast cancer.
We are active in situations with Powerbar cycle is not so clearly refractory breast cancer population is a major interest.
Also have data in mantle cell.
I suggest this data in myeloma pre clinically so we have a number of indications that we can study as mark mentioned.
Some of the combinations with <unk> clearly.
Some of the indications additional may include.
Checkpoint inhibitors PTK inhibitors, if you think about mantle cell. So we have a number of possible studies, we believe the cycling great benefit to patients that need to show that in the phase II bucket trials implants.
Initiate.
We know the recommended phase two dose.
That's great. Thank you so much.
Thank you.
Once again, if you'd like to ask a question Thats Star one.
We will take our next question is from the line of Robert <unk> with Noble capital markets. Please go ahead. Your line is now open.
Good afternoon.
Just wanted a little clarification on something that you touched on a little earlier.
And with the new.
Cyclic trial.
I understand that your cohorts, thus far looking very good with no dose limiting toxicity and you're enrolling more cohorts.
Is there.
Any timeframe you kind of touched on the idea of of.
Year end.
But in terms of.
The next cohorts.
Do you have any expectation of.
Sure.
Do you have more.
Guidance on when phase two would start.
So I'll take that to give mark.
Yes.
We can't predict when phase two will start till.
We know the recommended phase two dose reason, we're suggesting we may.
No the recommended phase two just before the end of the year, even though we're not seeing as mark highlighted the U S study any dose limiting toxicities were beginning to see engagement of our targets.
As you know the CDK <unk> inhibitors.
The bush rapidly.
Piddly proliferating cell population body, that's the Boeing Max.
We are seeing some decrease in the Wildcat and the patients treated in the current cohort with neurology cyclic, but Matt anything that approaches the serious adverse events since we are engaging the target in the marrow.
Have an active drug the Wildcats have gotten to know and as we continue to dose escalate, we may see more of that but it is hard to predict exactly when the white count or some other toxicity will be observed severe enough to call that we have reached.
Certainly taxes, so they need to pull back without pharmacodynamic marker that Mark described in depth and also help us determine the optimal phase two dose. So it is hard to predict what.
We did try to give some guidance or we suspect perhaps by the end of this year, we will be able to ignore the recommended phase II dose and once we do that we will rapidly move on to what we really wanted deal which has opened the bucket trials for the various indications that we described.
Okay, great. Thank you very much.
Thank you Robert.
Okay.
I am showing no further questions in queue at this time I would like to turn the conference back to the speakers for any closing remarks.
Okay.
Thank you operator, and thanks again to all for listening and for your Saiful questions.
We have enjoyed updating you on our recent progress.
We continue to look forward to making even more progress.
Wish everyone a very.
Lovely evening and thank you again.
Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event you may now disconnect.
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Yeah.
Okay.
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