Q1 2020 Earnings Call
Ladies and gentlemen, today's conference is scheduled to begin shortly please continue to standby. Thanks for your patience.
Ladies and gentlemen, today's conference is scheduled to begin shortly we've continued to standby take their patients.
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Ladies and gentlemen, thank you for standby and welcome to the Onconova Terpene weeks versus 420, 2036, and called Swayed Conference call. At this time all participants are in listen only been in later, we will conduct a question and answer session and instructions will follow at that time, if and when should you courts assistant lead the company.
We supposed to explore since you're right on your Touchtone Colton as a reminder, this conference call is being recorded I would now like to tend to come French how big your host Mr., Abby Olin Senior Vice President corporate development and General Counsel. Thank you Sir Please go ahead.
Thank you operator, good afternoon, and welcome talk and all those first quarter 2020, corporate update and financial results Conference call earlier. This afternoon, we issued a press release outlining our financial results and business progress during the quarter. If you have not seen this press release. It is available on the Investor Relations page of our website.
Right.
You W.W. that Onconova dotcom off today's call Dr., Steve for Smith, President and CEO will discuss the company's recent highlights and anticipated clinical one business milestones after Steve completes his opening remarks, Mark Aaron Our Chief Financial Officer will review first quarter financial results.
Following March report will move to the Q when a portion of the pool, which will be joined by Dr., Rick Woodman, Our Chief Medical Officer Lastly, Steve will come back with some final comment in a review of our upcoming milestones before we begin I remind everyone that statements made today. During this conference call will include forward looking.
These statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995, which involve risk and uncertainties that can cause actual results could differ materially forward looking statements speak only as of the date. They are made I see underlying facts and circumstances may change, except as required by law Onconova.
Disclaims any obligation to update these forward looking statements to reflect future information events or circumstances, we see the forward looking statements disclaimer in the press release issued this afternoon and the risk factors and the company's current and future filings with the FCC with that it's my pleasure to now turn the call over to Steve.
Thank you Bobby [laughter] good afternoon, everyone.
Thank you joining todays call.
First.
Our hearts go out to the many individuals.
Holdings.
Impacted by the devastating coal bid.
My team and Denver.
The world has truly changed.
Now, we hope that brilliant scientists from around the world.
Can bring new therapies and prevention.
Sure this devastating played.
Okay, no over demonstrated significant progress.
During their first quarter of Twentytwenty.
Hi, David why the completion of enrollment.
How about pivotal phase three inspired trial.
Higher risk.
Well just plastic syndrome.
We are fortunate.
To have achieved full enrollment.
Prior to the profound impact.
A world wide Colgate 19 pandemic.
Which has forced to Swaptions to research studies at many hospitals and cancer centers across our global.
With enrollment now completed.
I'm getting over his pivotal phase three inspire trial is advancing to the next pivotal catalyst.
Based on historical survival trends.
The inspired trial.
We continue to anticipate.
Porting topline survival data in the second half.
2020.
And we expect to presents the results.
The inspired trial at a major medical meeting later this year.
It was inspired enrollment now complete.
Well, you're not preparing for when we reach 288 survival events before analyzing I read anything topline survival God.
To shorten time.
For our anticipated and be a mixture.
To the F D right.
We have already begun M.D.A. work prior data readout.
We are working regulatory consultancy experts on our N D a document.
The U.S.F.D.A. as well that's all I am a document for the yen day.
In addition to expedite health system already applications when God.
Available.
We are also advancing our plans to be ready for commercialization.
And to develop internal I can know <unk> expertise, we have now Canadian commercial expert.
This is Terry Shoemaker, QL boy, who was instrumental in the commercialization of either side of me.
The most frequently prescribed pharmaceutical agent.
Hi, or risk and yes.
As you recall.
Oh boy.
An open label randomized controlled international study.
Designed to determine.
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Safety.
And Tolerability of single agent intravenous Regensburg Kid in the treatment of patients, which second line high risk Mds.
Patients in this study well less than 80 to use an age and have progressed odd.
Relapsed or failed to respond.
Previous treatment with the standard of care I, Oh, that's already agent therapy.
The study randomized patients to receive either intravenous rigosertib with best supportive care.
For the physicians choice.
I would bet supportive care.
The primary end point of this study.
Overall survival.
All randomized patients in the intent to treat population.
There's also.
That you're not Judy toy F.D.A. approval, which is the sequential analysis of the overall survival Oh, the very high risk.
As defined by the revised international prognostic, scoring system.
Should we go through to prolong survival Indian sponsored trial and they statistically significant manner, we believe rigosertib could be the first new treatment.
Higher risk Mds in more than 15 years.
Today, we disclosed but at the European Hematology logic associations upcoming virtual Congress.
I couldn't over.
Collaborators at MD Anderson cancer center or the centers participating on the inspired trial have an accepted presentation.
The presentation, which was just posted to the European Hematology associations website.
Detail.
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Selling eases side.
Hi isn't high heeled mutations in rats pathway jeans correlate with type of failure to aid decided game.
Genomic analysis at randomization onto the inspire trial.
Hey, you know.
Advances in the understanding of genome.
Have revolutionize cancer care.
Participants on the used by a trial received deep you know make sequencing well their blood or bone marrow at randomization.
At both double time points in their treatment during the study.
Did you know my data.
On the in spite of trial identifiable identifies.
The most common mutations in high risk Mds.
Following he decided then failure.
Including those of the route pathway that may be targeted by Vigo searches.
We believe this data presentation will further advance learnings about Mds.
The important role of genomics and the possible place I've read go sort of treatment for M.D.S. and Oliver Ras driven cancers.
We have made important progress with our additional pipeline programs as well.
In addition to the inspired trial.
Well, that's the plan right pivotal phase two.
Gosh, three combination trial of oral Rigosertib and they decided D. In adult patients with H. your main naive higher risk Mds.
We received feedback from the you see a and 29 team.
And are preparing a phase two slashed reap protocol for submission based on their guidance.
We anticipate meeting with the F.D.A. in the third quarter up this year after submitting a type C meeting request to consult with SK.
We anticipate this new registration trial will begin later this year.
Following yes, yes feedback I'm following the survival pivotal data readout from our inspire study.
We have also received notification that the phase one trial, which forms the basis for this new pivotal trial with oral rigosertib combined with age decided they.
And it can may naive.
Hi risk Mds patients has been accepted for publication in leukemia research and anticipate it's publication in the upcoming months.
In addition to studying the goes through to in Mds.
We are applying for additional legal sort of development progress, including the to be initiated phase one slash two eight study.
Regal surely plus nivolumab in stage for K, Ras mutated lung adenocarcinoma patients.
Moving to re opening.
Well look cool cancer research programs post the coal mandated stoppage.
As well additional plans indications for legal sure there.
Oh, okay less mutated cancers.
And our pipeline programs.
The study in Ken, Yes, mutated lung adenocarcinoma.
We're being investigator sponsored trial.
And we anticipate the first patient real being rolled following the mitigation of the burden of the poll. The pandemic that has been placed on our academic medical centers.
Well checkpoint inhibitors represents a significant advancement.
In the standard of care in treating lung cancer.
I'd have achieved.
Buster status many times over.
Men this unmet medical need continues to exist following disease progression.
In our view this make our novel combination approach rich regus or Ted.
Very attractive option to pursue.
In lung cancer.
And potentially be on.
And beyond Riegert assertive.
Oh win 123 300.
As our investigational first in class.
Dual inhibitor, she DKK four six and arc five.
We believe Oh, when 123 300.
Has the potential.
To treat numerous cancers.
Including refractory metastatic breast cancer.
CDK for six inhibitors, well already commercially available.
For those who are not familiar with this field.
CDK inhibitors have emerged as promising compounds targeting very large cancer indications such as well known receptor positive metastatic breast cancer.
Due to its unique targeting of arc five as well as CDK four and six.
We believe Oh in 123 300.
Has the potential to overcome many of the existing agents limitation.
Making good potential oblique potentially suitable.
There are certain cancers that may not be responsive to the current generation of commercially available CDK Foursix inhibitors.
If successful.
We believe Oh in 123 300 could address this very large market opportunity.
Remain Kane global right Oh in one to treat 300 outside of China.
Our partner in China for this compound is panic biopharmaceuticals, who funded the Chinese I, Andy enabling studies.
The Chinese R&D was approved in January of Twentytwenty.
By the Chinese Health authority.
We anticipate a phase one study may begin in China in the second half of 2020.
We also intend.
Chinese I N b, enabling studies to comply with our F.D.A. standards.
For the U.S. and the rest of the world outside of China.
Oh manufacturer for Oh, and 123 300 is now qualified.
We plan to file a U.S. I envy in the fourth quarter of Twentytwenty.
After obtaining required manufacturing data.
With regard to business development.
During the first quarter re read acquired Regal short could rise in greater China.
As a result.
Good Nova controls the rights for Rigosertib in the U.S. Europe and China.
<unk> among the largest pharmaceutical markets in the world.
Last year, we announced plans to launch early access program with Incept Your medicines group.
We anticipate launching this program in select countries in the second half.
This year.
We expect to continue to evaluate opportunities as we progress.
More than milestones to the next milestone.
As a reminder.
<unk> upcoming annual general meeting of stockholders is coming up I may 27.
I encourage stockholders to vote.
Upcoming annual General meeting.
Our proxy materials are available on our website.
I am very exciting.
I want to know there's board of directors has dominated life science industry veteran Terry Schumacher to join the board at this time.
As mentioned Kerry highly relevant experience.
The Mds space.
Terry was a key executive in the launch of Asia decided they in Mds and will be a very valuable addition.
To all board of directors, we believe her experience in developing and managing commercial organizations in a life science industry will be instrumental in our efforts moving forward.
As we prepare for potential commercialization of Regus circuit.
And now I like to turn the call over to Mark during our Chief Financial Officer.
For a discussion about financial results for first quarter 2020.
Mark.
Thanks, Steve and good afternoon, everyone.
Cash and cash equivalents as of March 31st 2020 totaled $31 million compared to $22.7 million as of December 31st 2019.
As previously noted common stock warrant exercises since our financing transaction in November 2019, how about a $10.6 million of cash to our balance sheet.
Also I would be almost 29 million stock warrants outstanding as of March 31st 2020 over 80% of them where in the money as it may 13th.
Based on our current projections, we expect that our cash and cash equivalence will be sufficient to fund our ongoing trials in operations into the third quarter of 2021.
Our net loss was $5.1 million for the quarter ended March 31st 2020.
Compared to $7.6 million for the comparable period in 2019.
Research and development expenses were $3.4 million for the quarter ended March 31st 2020, and $4.1 million for the comparable period in 2019.
General and administrative expenses were $1.8 million for the quarter ended March 31st 20 $23.2 million, but a comparable period in 2019.
This completes my financial review I'll now turn the call back to speed.
Thank you so much box.
With that we like to open the call for questions.
After the Q Nay I'll finish with some final closing remarks.
Operator, please open the call to cure in a session and thank you.
Sure so ladies and gentlemen, if he would like to that's a question at this time. Please press the star didn't the number one key ongoing touchtone telephone. If your question has been answered or you wish to remove yourself from the keys Reisterstown keep our first question comes from the line Chill pack Guinness with H.C. Wainwright Your line.
Hey, guys. Good afternoon, thanks for taking the questions ledger, all doing well so I've three questions two of which I think are pretty much logistical. The first one is with regard to inspire it's great that you enrolled every one right now and things are progressing and the timelines are still on track. So I was just curious.
As part of your I guess call. It your statistical assumptions now with Cove. It is there potential for any loss to follow up for any of these patients that you might not hear about some of these events or where is it not a concern.
[noise] I'll ask Rick you take that question. Thank you Joe.
Yes, Joe Thank you.
The mean challenge with the coal did pandemic for our global study.
Has been monitoring of the sites.
Fortunately.
The number of patients in which we're not able to confirm survival advance is extremely small.
And we anticipate that continuing.
In part due to the efforts of our see our old and the.
Clinical research assistance in the field and the the team in Onconova.
As well some good luck and I think that we anticipate for the remainder of the collection of survival events that we will be able to continue.
Doing that monitoring, but it is a challenge and the monitors and the team have.
Had to develop unique ways in which to interact with the sites because of the pandemic.
Got it Rick Thank you for that and then my second the logistical question. If you will I know we discussed this in the past, but you know sometimes a lots and I just want to make sure if you're thinking it's still the same with regard to communication strategy around communicate.
Putting out the data for inspire so since you're looking to present them at a major medical meeting in the second half I'll, just say, presumably ash you would you look too.
And have a one of those typical topline press releases to say, okay. It it hit and we'll give them further data at an upcoming conference.
We're not hit so Uh huh.
The RV water and I'll ask obviously take that one if I may go ahead I'm sure sure thing in terms of communication Joe. Thanks for the question, but you're exactly right that we would anticipate.
Announcing the data when it is ready at the top line level and presenting full day that an upcoming a major medical meetings, such as Asher quite another major medical meeting.
Got it and then my question is are my third and last question with regard to the upcoming type C. Meeting, obviously, you've already had a lot of productive discussions with the FDA around the study design. So I guess I would ask it two ways. What's your wish list of what what you want to get out of there and what are the key outstanding things that you need to get solidified.
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Oh Rick.
Yes, Joe So I think I'm. The first part to your question is that.
We want to get agreement from the FDA on a novel unique adaptive design combination of the phase two three.
And this adaptive design, we presented at Ash and some of the unique features a we feel this design is particularly advantageous for us.
In a variety of ways as well as the medical community in health authorities.
And I think it to the the additional challenge that we have is developing a particularly as we indicated the abstract at ash, a very rigorous and robust interim analysis that allows us to move forward into the phase.
Three parts of the study.
Got it. Thank you very very helpful guys and stay well.
Thank you Joe.
Your next question comes from the lined up you know in Colombia with Maxim Group Your line smelting.
Hi, Thanks for taking the questions. So first I guess, starting first with a inspire can you remind us or are you able to disclose what the current event rate is right now and is there an average number then say you're seen per month are you able to discuss that in any detail.
I think I'll try my head at that and thank you very much. So we did.
Reveal I believe mid March that we have over 85%.
Survival events that we require.
288, and the reality is that it's quite variable we do monitored by not every.
The survival events that we see it is very involved but based on what we are observing we anticipate.
Reaching pivotal data second half of 2020, some before the end of yeah. It's harder, it's very hard to make it more accurate prediction that back.
Got it that makes sense and so I have a really broad sort of theoretical question that my next one and that's rig and regarding you know your second study would be conservative you know a the treatment regimen in Mds high risk Mds landscape seems to parallel data van now and in AML.
Well you know the combination with Venetoclax in a hypomethylating agent is part of the treatment paradigm and at least as as a treatment of choice for select group of patients now looking at the data at Ash last year and there was a study that posted positive response rates in high risk Mds with banana class that is.
Society, but we got 31 days, a actually posted numerical high response rate in the same patient type if I recall correctly and that was also at ash since doctors are familiar with phonetic lax and and since that data was positive what are your thoughts about where you think Rigosertib me.
Be placed in this patient type and you know in terms of strategy is it safe banana KLAX gains approval well in advance you know would that out to your current strategy.
Rick.
Well. Thank you for your question I think that there's a couple of aspects to that question and I'll I'll do a feature them individually first and foremost.
Is that the.
The net clocks is ineffective as a single agent.
In AML or Mds.
And so venetoclax needs a partner compounds.
I think it's clear the field is looking for doublet therapy and to really effectively cheese that they need.
Agents that have differing mechanisms of action and in fact can be administered easily for patients.
So we are looking at you know the potential and I think the field would look at the potential for any agent that can be combined orally.
And this is why our phase two data with already go search it is so important because it satisfies that lease.
Many of the features you would look for in in a doublet combination novel mechanism of action.
Oral formulation and non overlapping toxicity.
And so I think the field is advancing I think both banana Clarkson Regal searches.
Well off for new therapeutic options for patients and I think this is the real highlight.
A bold phonetic clackson rigosertib in the area of Mds.
I think that in terms of the future I think that its unlikely.
That vannatter clocks will precede.
Rigosertib I think that they have yet to demonstrate or any randomized data.
And I think that that clearly needs to be demonstrated for scientific community to evaluate banana clocks appropriately. So I anticipate that these agents potentially would be at their timing be such that they could be combined together in around the same.
Same time and they would offer.
The advantages I mentioned a moment ago.
Got it that's really really helpful. Thank you and just one last question with regard to the plan study with the CDK for six in the U.S. you mentioned that the I need will be filed on or submitted in the fourth quarter. I was just curious has a study design been formalized you know.
Well you start with the monotherapy and then a combination would say leventhal on it can you discuss a bit more about that program.
Rick.
Yes, so I am I think first of all.
We anticipate that all in 123 300 will pretend potentially has the mechanism of action that could be affected.
In multiple tumors it may be affected in the current conventional CDK foursix inhibitors or patients that are resistant to those agents.
It will most likely need to be combined with some sort of hormonal therapy.
As as is currently given particularly if it were to be moved to earlier lines of therapy.
Got it okay. Thank you that's helpful. That's it for me.
Thank you.
Your next question comes from the lined up [laughter] demure with noble capital Your line family.
Hello, everyone. Thank you very much for taking my question My question will be on.
So we should not be good started and we go trying to ask for what do you plan to do when you think initiate and what do you think the financial impact would be on that front.
Mark I heard the word financial who'd like to take that.
[noise], yes, the banks I'll be happy to and Oh, Thanks for the question.
Well, we're not able to provide any specific information about what we have spent so far are precisely what we plan to spend between now and topline data and then afterwards.
I can't tell you that we started our pre commercialization readiness activities earlier this year.
And as you might expect our initial focus was on a longer timeline Act precommercial activities.
So once we got to full enrollment we undertook that initiative with the focused on a long time line. Thanks.
Hi, Mike I hope that that answer your question if it doesn't yeah. Please feel free to follow up and I can try to answer a follow up question.
Sure It does that pets, and I think very much.
My question would be on the ran well Gran <unk>, Oh, Oh, they seem to open clinical trials. They do you imagine the that lung cancer trials will initiate right again any other things that you need to accomplish prior to starting.
Yes.
No I heard thank you for that.
The site is ready to go meaning this is true.
The improved.
And we decided is ready to put patients onto this phase one all new clinical research is on hold.
The pandemic impact on academic medical centers, how Foley is reduced to a mitigated.
We hope that cancer research clinical cancer research will be restarted our once that happens we anticipate a patients who already being screened for this study will be put on to this new study.
Let's say thinking the lean and whatnot, but soon will.
He does something to say.
No just saying.
Obviously very eager to get it started so.
I think it's all its all ready to go.
Okay. That's great. My last question on the TDK program. So considering you expect you did a submission into fourth quarter do you expect any delayed driven by cool they.
And manufacturing issues or any other delays we expect so is it still on track to be on Q4 2020.
So so I'll take that we don't expect.
And he ever manufacturer identified they have to do you know validation of the manufacturing processes, we don't expect any delays regarding that.
From a come from the covered pandemic.
Already have a phase one site identified again, that's a bit of an unknown because.
We don't know what's gonna happens at the hospital system and the real restarting though.
Nicole cancer research, we hope.
And pray by the end of this year, when we anticipate possibly the phase one trial at all and 123 300 being started that clinical cancer research will be open again and that our trial will be one of the studies across the U.S. that gets restarted.
Okay, great. Thank you very much for taking my question.
Thank you out.
Your next question comes from the line to Yale Jen with Labor and company. Your line is now open.
Good afternoon, and thanks for taking the questions.
My first question is regarding the Kogan 19 impact.
First of all or does that happen impact regard for the inspires study in terms so.
Patients receiving treatment, so any interruption or any impact on that even though they all have seen road.
Rick.
Thank you for your questions, So first and foremost that.
We do not anticipate.
Any differences in the impact of coded related illness on the investigational arm patients treated with rigosertib versus the physician's choice arm.
At the present time, and we've been monitoring very carefully.
The Cove, it impacts on our global sites and centers or.
And to date, we've not seen any real dramatic impact on anything other than collection of data and monitoring.
And that's more due to.
The the impact of coal that on the care that's happening at the various sites site staff in some places site staff, who are involved who studies.
And do not have access to the hospital, Miss obviously impacts our ability to work with them collecting data. We are finding novel ways as permitted by local health the summer cheese to do that.
To date, we've been very successful in doing that.
And as Steve mentioned in his outset, we achieved enrollment.
Of the 360 is patient in our target enrollment on March 17, So everyone's enrolled it's now a matter of following all of these patients.
Okay, Great that's very helpful and.
That's very good.
If the fusion.
The next question I have probably just love to sort of fortune situations that just curious.
Given that most of the patient L. B and you say the average age it was a mediates 82.
Do you anticipate or speculate I should say.
ER Doc.
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<unk> two mobility, the cold mill, but he will play into this and.
The timeline, unfortunately, or Fortunately in this case, though.
Might be shortened will or will you guys do too to get to the 388 number.
So I'll take that one so I just want to correct yeah.
Eligibility criteria and under the age of into its kind of median age related to the median age of and the S is late 16.
So.
With that said, we don't anticipate any impact.
Colin Reed 19, because it's a well powered trial.
We're also at a major medical centers across the globe and Mds patients, obviously do dissolved ammonia, but Rick and his team are monitoring and the sensors are checking for patients with Mds on its fire has an ammonia they are checking.
For the evidence of coal Goodnight.
So that is continuing and then well powered trial since covert 19 may impact on both bond, we don't believe that it and should impact on the final outcome of the trial.
Interest and I can't I understand that.
Cash just published their survey.
Hi, good and 11.
Patients will.
Hematological malignancies, who had Colgate 19 and cores bad debt.
And despite.
All the pension 111, having hematological malignancies, there was no mds patients.
Identified in that cohort I can't I understand that data, but that's the data for Nash and we don't.
To summarize that covert 19 should impact on the pivotal data that we anticipate a from the inspired trial in the second half of 20 Twond.
Okay, great that Oh I appreciate the color.
The nation and maybe the last one.
ER.
Given I mean should the de that'd be positive and ER.
First of all.
Do you didn't get what time, you might be able to filed that would that be in 2021 or even late or maybe second half of 20.1. Secondly is that in terms of Mick manufactured particularly the CMC. All these are aspect or how is the company intend to manage that.
At this moment.
Regarding I did you know what you're asking about timelines for R. and D.A. application. So we anticipate once.
Once we flipped cod.
And hopefully have positive data, we anticipate it'll take us.
Because we already mentioned that we're doing not pre M.D.A. work already we're not waiting flip to caught a lot of C.M.C. materials toxicology matured as good or bad Daddys thought to be writ. Once we flipped to cards have hopefully positive data we anticipate.
Timeline of seven to nine months to submit R. and D.A. application for Ivy We go circuit.
And the CMC caught up that you'd you'd mentioned that the it's already in the process of.
Checking dumb and making repeat it batches or intend to make a repeated.
As you still to come from the uniformity of the product.
That is correct. We have just in case you did know a full time CMC expert on our staff that I can over who is leading those efforts to make sure that us CMC is.
We saw regulatory requirements and looking into initiating the writing of that part of the NDRC. There's no reason weights.
For the pivotal data to be read out we can start that work already and we have.
Okay, great. Thanks, a lot and.
Everybody keeps safe and we look forward to.
See the data system.
That concludes yeah.
That concludes our kids a session for today I will now turn the call that back to Mr., Steven Brooklyn for closing remarks.
Thank you so much.
Thanks to all of you for participating on today's update call.
We're obviously very excited about the progress we have made with Ivy rigosertib.
Our pipeline programs overall.
I hope you feel and share our enthusiasm.
Important milestones, we look for in the near and medium term include.
And this listing is no particular order.
First our E H a presentation.
Based on did you know movies data from the inspire trial.
Second.
Initiating enrollment of the phase one slash two a trial of Rigosertib plus the roll a mad in Tehran mutated advanced non small cell lung cancer as an investigator initiated study.
Third beginning a phase two slash three.
Combination study.
Oh oral rigosertib plus is inside indeed.
Hey, Joe may not be higher risk Mds patients.
Following the inspired data readout.
For.
USA I N D submission.
Oh in 123 300 during the fourth quarter of 2025.
Followed by clinical trial initiation.
And number five.
Most importantly, which gives us great enthusiasm.
During the second half of this year the release of topline survival data from the inspire trial after reaching 288 survival events.
In closing I encourage all of our stockholders to virtually attend our up cat upcoming annual general meeting of stockholders. Later this month on May 27.
We truly appreciate your continued interest in all of our programs at anchor Nova.
Should you have any additional questions.
Please feel free to contact us.
Please stay safe and thank you all for your participation.
Operator, you may now end the call.
Ladies and gentlemen, this concludes our conference for today. Thank you for participating you may now disconnect.
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