Q3 2020 Plus Therapeutics Inc Earnings Call
Good afternoon, ladies and gentlemen, welcome to the past Therapeutics third quarter 2020, earning results call at this.
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And as long as again, we want to advise you that over the course of this call and question and answer session forward looking statements will be made regarding events trends business prospects and financial performance, which may affect plus therapeutics future operating results and financial position.
All such statements are subject to risk and uncertainties, including the risks and uncertainties described under the risk factor section included in plus Therapeutics annual report on form 10-K, and quarterly reports on form 10-Q filed with the Securities and Exchange Commission from time to time.
Yes Therapeutics advises you to review these risk factors in considering such statements plus therapeutics assumes no responsibility to update or revise any forward looking statements to reflect events trends or circumstances. After the date. They are made it is now my pleasure to turn the floor over to Dr., Marc Hedrick, plus therapeutics, President and chief.
Executive Officer, Sir you may begin.
Thank you Catherine good afternoon, and thank you for taking the time to join US today, as we provide a business update and discuss or 2023rd quarter results John.
Joining me on the call today is Mr., Andrew Simms, our Chief Financial Officer.
Before Andrew provides.
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So [laughter] cancer.
Cancer recurred.
Recurrent glioblastoma is the most common and lethal form of brain cancer.
Think about 13000 patients per year in the United States.
Essentially all primary glioblastoma tumors occur after initial treatment.
There are currently few approved treatments in the record setting which.
Which in aggregate provide only marginal survival benefit.
Already know has a number of unique aspects that provide compelling scientific rationale, but it may show improved outcomes overcome we use therapies.
First compared to external beam radiation therapy, whereby high energy radiation passes through and effects healthy tissue to reach the tumor or no.
Earn out was prepared in liquid form.
Just to drill into that.
Tumor.
[laughter] inside out targeted approach with already know may reduce unwanted radiation exposure to nearby healthy tissue.
Furthermore bid.
Because rainy M can be visualized in real time during administration.
Oh, I know, maybe let doctors better control the radiation dose and distribution to more effectively treat not only the bulk tumor but also.
But also the attendant occult microscopic disease device in the surrounding health you help tissue.
Fuels recurrences.
Also it may be possible to deliver radiation dose to the tumor that is up to 50 to 20 times higher with our now then with external beam radiation therapy.
We have yet to determine the maximum tolerated dose in a preclinical or clinical studies.
In addition, with a long half life, namely about 90 hours.
Life is someone capsulation and low clearance rate Arnelle's pharmacokinetic profile allows the drug to stay for a long time, where it's applied maximizing the time on tumor of the radiation and theoretically maximizing the cancer killing effects.
Finally.
Once a patient convenience Arnaud is administered in a single treatment.
The shorter hospital stay compared to external beam radiation therapy that may require 20 or more treatment visits for full therapeutic course.
One of the company's first priorities and advancing the development of our now it's the surrounding support our efforts with a world class expert group, who possess the knowledge and experience in the fields of neurosurgical.
Operations and neuro oncology.
As well as have a clear understanding and appreciation for arnelle's profile and potential.
To that end, we were pleased to announce in October the formation of a clinical advisory board.
To help successfully bring our investigational arnelle drug through the clinical development process.
These five experts are leaders in their fields and will be important to our efforts on behalf of the patients with glioblastoma.
We're on track and making good progress on the important 2020 milestones for this program, including completion of the clinical trial enrollment optums.
Optimization of the regulatory plan and bringing the manufacturing and supply change for the industry standards in anticipation of the next steps in clinical development.
During the third quarter, the FDA granted both orphan designation and fast track designation for Arnelle for their treatment of patients with recurrent glioblastoma.
Now let me just provider.
Update specifically on the respect safety and feasibility trial for our Anil.
The fifth dose escalation cohort is now complete and 15 patients have been treated thus far with our now.
Single treatment radiation dosing with aren't Hill is now above 10 X. The typical dose administered in the recurrent setting.
The increased premium volume and dose in the six cohorts.
Should accommodate tumors up to approximately four and a half centimeters which should include the majority of tumor recurrence.
No treatment related serious adverse events have been observed thus far.
And as previously mentioned there appear to be early signals of efficacy in patients without adequate dosing in tumor coverage, even at the lower volume and dosage levels.
We have also expanded enrollment to a second site and we intend to have a third side on board soon.
Finally, as recently announced by the company are abstract on the clinical experience, thus far with regard to our now will be.
It will be presented at the 25th annual 2020 Society for Neuro oncology held November 19 through 22nd.
And that's actually going to be a virtual meeting did COVID-19, but it's being held in Austin, Texas.
Regarding additional clinical development programs for Arnelle outside of recurrent glioblastoma.
We intend to provide an update.
An update and discuss concrete next steps sometime in Q4.
As previously mentioned.
Not coming into your carcinoma, ptosis care deal carcinoma, ptosis, recurrence head and neck cancer therapies.
Represent three promising potential indications based on existing preclinical data that we have generated thus far.
Regarding our out licensing activities, we're having discussions with potential partners regarding opportunities to help us expand our infill development internationally well the company focus his efforts primarily on the U.S. development for already now.
Regarding our two other clinical stage assets dose it plus doxil plus we continued global partnering discussions well.
While remaining focused primarily on our now in its development and the U.S.
So now let me turn the call over to Andrew for review of the third quarter financial results Andrew.
Thank you Mark and good afternoon, everyone.
Please refer to our press release issued earlier today for a summary of our financial results for the third quarter and nine months ended September 2020.
At September 32020, cash and cash equivalents was 7.6 million compared to 17.6 million as of the summer.
About 31st 2019.
Principal at September 32000, 24.3 million.
In April 2020, we amended our Oxford, providing additional flexibility by pushing out the interest only period through May 2021, together with a pay down to 5 million principal.
Cash used in operations was approximately 5.2 for the nine months ended September 30, Twentytwenty compared to 6.9 million for the same period last year.
There were no reported revenues in the third quarter 2020, as compared to 4.8 million in the same period last year. The decrease in both periods was due to the close out of the BARDA contracts, we mentioned last quarter.
Research and development expenses 0.3 million in the third quarter 2020, as compared to 0.9 million this quarter last year.
Months ended September 2020, R&D expenses of 1.6 million compared to 3.6 million in the same period in 2019.
This decrease was partly attributed to the completion of the BARDA contract and 29 team.
Approximately zero point Eightmillion was incurred in Q2 2020 relating to the in license agreement with no T X zero.
<unk> 0.4 was paid in cash.
And any closed in early may with a balance and stock in a day.
In addition, all grown from and covers a clinical costs on the respect.
Animal trial.
Our sales and marketing expenses were approximately 0.1 million in the third quarter of 2020.
<unk> point Threemillion for the nine months ended September 32020, essentially unchanged compared to the respective periods last year.
[noise] Gina expenses 1 million for the third quarter 2020 unchanged from the same period last year.
For the nine months ended September 32020, Gionee was 3.8 million as compared to 3.3 million in the same period of 29 team.
The slight year over year increase reflects an increase in professional fees in Q2.
Twentytwenty relating to the recent in licensing transaction. This increase was partially offset by decrease in payroll and related expenses.
Interest expense decreased to nine months to September 32020, 0.9 million from 1.5 million in the nine months to September 32019, reflecting the principal pay downs in 2019 and 2020.
Net loss for the third quarter of 2020 was 1.7 million as compared to a net income of <unk> point 5 million in the same quarter last year.
<unk>. This change is primarily due to the approximately 7 million loss from discontinued operations in 2019.
That is related to the Q2 2019 asset divestiture.
And now I'll turn it back to you Mark.
Great Andrew. Thank you. So just before we we finish up and have Q and a.
Regarding previously announced forthcoming milestones in short we are on track.
Sure primary your end goal completion of enrollment in respect we kind of believe currently believe the cohort six will be the final dosing cohorts and still intend to complete that by year end.
To that end active patient screening is ongoing now at site two that's at U.T. southwestern Dallas, Texas, and MD Anderson Houston is on track to begin screening soon and that will be site three.
As recently announced we plan to report the up to date dataset enrollment progress on respect.
At the society for Neuro oncology meeting in mid November of this year.
Informed by the data from the final cohort, which as I mentioned, we presumed to be cohort six.
I'll take that data optimize the regulatory and clinical plan for Arnelle for recurrent glioblastoma.
Then seek FDA guidance on next steps, which will likely fall sometime in the second half of 2021.
Going on in back in the background in parallel to the current respect clinical trial and our regulatory efforts as I mentioned before our CMC team is now actively manufacturing the drug for respect so we brought that in house.
As well we are putting in place the proper manufacturing controls and capabilities appropriate to provide drug for late stage clinical trial.
And that we anticipate to also be a second half 2021 event.
In Q4 this year as I meant.
As I mentioned Bill will discuss more publicly what we plan to move into the clinic.
As it relates to the Arnaud pipeline and then we're going to continue to push forward on the Arnelle disciplined doxil plus partnering discussions and we'll discuss that further when and if those discussions merit the discussion.
So with that Katherine alternately the acuity over to you and be happy to answer one with Andrew any questions.
Uh huh.
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And we will pause for just a moment.
Your first question comes from the line of Jason Mccarthy with Maxim Group.
Hi, guys. Thanks for taking the question a couple of questions first as far as the data that we could expect to see yet no in November will we be seeing overall survival data.
So.
Will that data be compared to some sort of historical control.
And if so that historical controlled would it be kind of matched in terms of the disease state that these patients are in.
Hey, Jason will provide a survival.
Data.
The caveat there is.
The hope they'll be paid patients that had been recently treated and still alive. So.
We won't we'll be able to draw.
Meaningful conclusions on overall survival.
Only in so much as you know that we can you can take a look at the patients that are both have expired or are still alive. So that will be sort of a blend there.
And then well we'll discuss historical.
Overall survival, we don't intend to have an age man or a specific disease.
Disease matched control.
But I think the overall survival in their current setting, it's pretty well known to be in that six to nine month range.
Great and as you start thinking about meeting with FDA, and then phase two or phase three registration study, however, you're going to.
Map it out yeah, we found that a lot has changed in the space just in the last 12 to 24 months and now we're seeing.
Smaller trials.
With external controls are the synthetic control arm or that the FDA seems to be open to and also the GE car. The agile program for Glioblastoma, that's using a very large groups control for all the drugs that they're testing are these different avenues that you are looking.
Yeah.
When you're thinking about getting already now towards a registration study and how to actually.
Frame that study.
Yes, they are.
As you know that there hasn't been anything approved in recurrent setting since I think going back maybe almost a decade. So it's a it's a tough problem.
We've we've obtained orphan drug status fast track status breakthrough status is not out of the question is depending on the.
On the.
On the clinical data that comes for the other respect trial and then are you seeing a synthetic control or or what.
Or looking at other trial approaches will definitely be something that will incorporate into our discussions with the FDA. I think there are a lot of alternatives here based on the severity of this disease and the paucity of good therapies.
Got you and then just last question on the pipeline from explore expanding all right now I know you haven't specifically said, which indications, but there are certain indications like.
A prostate cancer there are varying cancer kind of on your on your shortlist areas, where bracken therapy and radiation implants.
Or more widely used where these physicians would be comfortable using an isotope like Randy m. and could make that switch and do those trials.
So I would say those are the ones. You mentioned are probably second tier first here are going to be those indications where we have.
Preclinical data that we think is suggestive of potential clinic.
Clinical success.
No comments, you'll carcinoma ptosis of which there's nothing approved for that the only approved drug people site was taken off the market in the last couple of years.
And Port Neal.
And port Neal carcinoma, TOSA similar both both indications like about 100000 patients in the US every year late.
Late stage or current head and neck cancer is also an area, where there's promising preclinical data and not a lot to offer. These patients are usually been maxed out on surgery radiation and chemotherapy in.
Anything that goes much beyond those will acquire additional preclinical studies doesn't mean, we're not interested in or.
Who knows but those three I mentioned before things that we think are things. We're looking at most closely potentially there are also some other areas in the in the CNS in the brain or the.
Or be related structures.
It might be useful that aren't specifically recurrent glioblastoma, but might provide.
Some indications, where we can leverage existing clinical dataset to get into the clinic more rapidly.
Great. Thank you Mark for taking all the questions. Good luck.
Thank you Jason.
I appreciate you being on the call.
Your next question comes from the line of Edwin with Ascendiant capital.
Yes. Thank you for taking my question. My question is on cohort six do you expect a timeline on that to be similar to the cohorts as you've done before or have there been.
Other increases speed or delays in speed, particularly with what's been going on with the aim of the pandemic.
Yeah, it's mark.
You know.
So well.
Well, well well well we enrolled the first patient in cohort six will.
We'll announce that.
We'll have a 30 day review period will increase the dose.
The dose of the drug and the volume.
The volume of the drug so we're obligated to wait 30 days.
Go back to that the SMB.
Before we can go back and complete that.
Cohorts.
So that cohort will likely be a total of six patients.
The I would say the enrollment pace is accelerating.
Bill just having having corporate resources.
Behind the trial as opposed to this being purely academic trial.
And also having the NC I behind the trial, which is new to 2020, I think all those things together, knowing us to move more quickly.
Adding additional sites also is important as you know UTI southwestern has now onboard MD Anderson, we hope to be a third site. So that's why we were still cautiously optimistic we could complete enrollment by the end of the year.
It still be a push but we think we can we can get there.
Then we'll have to let Doug the last patient the trial play out six months before we're ready to proceed to the next step but.
He has mentioned we're roughly on track with that that timeline.
Great and then has there been any update on funding from the state cancer fun and also how would that funding affect your decision to move.
Moving onto other cancer indications.
So.
Secret has.
Cove. It Didnt answer your question that covered in the trial Kuvan hasn't really hurt our efforts in a meaningful way with respect to enrollment where cobot has made an impact is on the availability of secret grandson in fact, we were just alerted.
I think in the last week or so that there is likely.
An RFP coming that we might be able to.
Go to to seek funding for either or an l. for recurrent glioblastoma or for additional indications. So we're waiting for specifics around that but it looks like now.
That is separate is no back open for for business.
Well, there historically have been to funding periods one.
The one in the.
One of the.
This is the December January February timeframe and one in August.
Yes September timeframe. So it's our it's our plan to submit at each cycle and.
And we hope that they're getting back to a normal cycle, which will be to grant submission opportunities.
On a yearly basis in our plan would be to use that both for these new indications or potentially.
A follow on trials with our Anil for example in the diffuse into putting glioma.
Non operable glioblastoma in particular potentially some other areas that we're not currently treating are addressing.
Great well. Thank you I wish you guys. Good luck.
Thanks, Ed which had been a call.
Your next question comes from the line of Sean Lee with H.C. Wainwright.
Oh, Hi, guys. Thanks for taking my question most of my questions have been.
I just had a quick one.
The prepared remarks, you mentioned that.
The CMC work I think are doing I think completed and preparing the GMP batch for that little study. So I was wondering whether there is any additional work left to be done in the manufacturing side.
We intend to produce all the drugs yourself going forward for the at least for the study needs and when do you expect the GMP batch will be ready. Thanks.
Thanks, Ed.
Yeah. So so right now as I mentioned, we are manufacturing the drug.
Along with our radio nucleotide manufacturing partner and San Antonio for the Phase Phase one trial, we make the lysosomes that we work with them to to load them and make them available to the to the three clinical trial sites in the background.
Working on the validation verification studies as it relates to the drug to move its kind of out of phase one.
Drug readiness into a potential pivotal trial, that's going to require not only the the.
The VNB work that I mentioned before but also the scale up too so that we can get roughly.
10%.
Commercial scale. So all that's going on in the background that will largely be outsourced, even though we have a.
Fully capitalized clinical.
Stage, and even commercial stage manufacturing facility in San Antonio Our plan is to because of the unique nature of this drug the fact that Theres a radio nucleotide that the life systems have to be loaded.
We'll likely outsource a lot of that CMO work and then and then you know.
Once we get approved then we'll we'll decide whether to completely outsource that or bring that in house, we have the capability to bring in house, but.
The supply chain and logistics are such that the can so too early to tell whether that will make sense at this point.
Okay. Thanks, that's all I have.
Okay. Thank you Sean appreciate it.
And there are no further questions at this time I'd like to turn the call back over to Dr. Hedrick.
Great. Thank you Catherine.
I appreciate everyone that joined in and participate in the call just to close I'd like to.
I think the.
I think the.
The employees of the company and the patients involved the trials and the physicians that are.
Increasingly excited about the opportunity to potentially work with us and helping to bring this to.
Through the approval process, so have a good evening and.
And again I appreciate you being on the call.
Ladies and gentlemen this.
This concludes today's conference call. Please disconnect your lines at this time and have a wonderful day.
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