Q4 2020 Plus Therapeutics Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the plus therapeutics fourth quarter.
2020 results call.
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We're moving trends business prospects and financial performance, which may affect most of the third.
<unk> future operating results and financial position, all such statements are subject to risks and uncertainties, including the risks and uncertainties described under the risk factors section included and plus Therapeutics annual reports on form 10.
And quarterly reports on form 10-Q filed with the Securities and Exchange Commission from time to time, plus Therapeutics advises you to review these risk factors and considering such statements plus therapeutics assumes no responsibility to update or revise any forward looking statements to reflect events trends or circumstance.
And with the day they are made.
It's now my pleasure to turn the floor over to Dr. Marc Hedrick, plus therapeutics, President and Chief Executive Chief Executive Officer, Sir you may begin.
Thank you Erica and good afternoon, everyone. Thank you for taking the time to join US today as we provide the business update.
State and discuss our 2024th quarter and full year results.
Joining me on the call today is Mr. Andrew Sims, our Chief Financial Officer.
But before it and it provides a brief overview of the financial performance and would like to provide an update on the drug development activities focusing my remarks on two key.
And standards.
First progress from the clinical development of our lead drug Rhenium, Dan of life assumes also called our NL.
Currently being developed for recurrent glioblastoma.
And second an update on additional potential clinical target indications for Oriental.
Key tower apart from the current Glioblastoma.
Yeah.
Now for those of you are new to the company.
Arnelle our lead drug is a unique therapeutic consisting of isotopic rhenium 186, which is made in the fishing reactor.
And its key related with proprietary technology and loaded into 100 nanometer.
<unk> per life assumes.
Arnaud is interesting and <unk>.
Part because it releases to energy types beta energy for cancer, killing and gamma energy for imaging.
Our lead indication for arnel, as recurrent glioblastoma, which affects approximately 12000 patients annually and the U S.
And about the same number of patients and the EU.
It is the most common and lethal form of brain cancer and.
And essentially all primary glioblastoma tumors will recur after initial treatment.
The treatment of this devastating disease remains of significant challenge and.
And of me about a decade since the F T approved of new therapy to treat it.
Not surprisingly then there is really no clear.
Go to standard of care for recurrent glioblastoma and even in the few currently approved treatments.
They provide only marginal survival.
And its benefit for those patients so it's a real true medical unmet medical needs.
Now the external beam radiation therapy is commonly used for glioblastoma.
And its efficacy against GBM is about as good as it gets really better than any other potential treatment used today.
But of compared to external beam radiation therapy, whereby external energy of radiation passes to healthy tissue to reach the tumor.
With our and now it may be possible to deliver of radiation dose only to the tumor.
That is up to 15 to 20 times higher than with external beam radiation.
Therapy as it's used today.
And despite the Super high doses of radiation delivered by our and L. A.
And precisely because of its inherent tumor targeting.
Capability unwanted radiation exposure to nearby healthy tissue is actually reduced.
And I should this well of the gamma energy produced by the Arnelle that I've mentioned previously can actually be visualized and real time during the administration of the drug.
This may allow doctors the ability to better control of the radiation dose and distribution.
In order to more effectively treat both the bulk tumor and.
Concomitantly, the microscopic disease, that's often left and the penumbra of healthy tissue.
And 2020, Arnelle was granted both orphan and fast track designations from the FDA for treatment of patients with recurrent glioblastoma.
And to further assist the.
And key and its efforts to develop arnelle successfully for brain cancer and other cancers, plus formed science scientific and clinical advisory boards.
And 2020.
These experts on our boards are leaders in the fields of neuro oncology neurosurgery preclinical drug development and.
And nanotechnology and will help guide and advise us as we advance our versatile proprietary nanotechnology for it.
The ongoing respect clinical trial is the phase one two design of up to 55 patients to determine the maximum feasible dose and to assess the safety.
The company Tolerability distribution and potential efficacy of 186, Arnelle and are current or progressive malignant glioma funded.
Two of significant degree of the trial is funded to a significant degree by the NIH for National cancer Institutes.
[noise] through 'twenty, and 'twenty and into 2021.
One thus far we remain on track and on plan for our and our development program for Glioblastoma, including winding up the phase one clinical program called respect.
Optimization of the regulatory plan and bringing the manufacturing and supply chain for the industry standards and anticipate.
Safety Asian of the next steps and clinical development.
And 'twenty 'twenty to 'twenty and 'twenty, sorry, the society for Neuro oncology annual meeting that was in November of last year, we provided an update on the respect trial for arnel.
At that time interim data from the first 15.
And patients through cohort five.
And their spec trial were available and that data can be found and detail on our website.
But the interim data and brief showed that intra tumoral RNA L can successfully deliver up to 15 times the absorbed dose of radiation administered by.
Disappeared external.
And the radiation therapy.
Our and L treatment volume and radiation dose were increased successfully from the earlier cohorts to the fifth cohort.
Also <unk> was well tolerated with no dose limiting toxicity observed despite.
The standard we hire absorbed doses of radiation compared to the E. B R T or external beam radiation.
And our view one reason, we've see no systemic.
Serious adverse events or S E such as marrow ablation is that the radiation stays in the brain tumor and the adjacent of tissue and exposure outside the brain.
Mercury low and it was actually about a 3000 and fold difference between those two.
Although the dose escalation part of the respect trial is not decided to show efficacy per se. We have seen two long term survivors greater than 30 months.
And and median and mean survival duration and subjects with.
With tumor coverage greater than 75%, which is currently eight nine months and $13 six months, respectively, and growing with six patients still alive.
And the interim.
We expanded enrollment to a third clinical trial site and the Anderson cancer Center in Houston.
We've completed enrollment of the three required patients and the sixth cohort of the respect trial, increasing both the RNA drug volume and radiation dose once again.
And Additionally, I can tell you that we have treated one of an additional three planned patients at the cohort six dosage of the volume but with more.
More aggressive drug delivery parameters.
So thus far and summary, 19 patients with recurrent GBM and treated and the respect trial.
The latest patient update can actually be found in our February 2021, Bios CEO of corporate presentation, which is now on our website.
The plan, there and and G. B M is to complete enrollment and the phase one trial this year as well as complete critical CMC activities by year end or early 2022, such that we would potentially be ready for a phase III pivotal.
About a year from now.
Of course, depending on the strength of the data.
The a feedback.
Now switching gears and regarding additional clinical development programs for Arnaud.
A priority for us in 'twenty and 'twenty one.
As to move additional indications beyond recurrent glioblastoma.
Forward into clinical trials.
Although we have.
Pharmacy preclinical data for a number of potential indications, we intend to focus our near term efforts of two additional CNS indications.
GAAP them and NGL, Carcinomatosis, which the more modern term that's used as Leptomeningeal metastases.
And also pediatric brain cancer.
And if the two very difficult to treat cancers.
All of them Leptomeningeal metastases affects about 110000 patients and the U S and there was no clear standard of care and.
And these patients die rapidly despite what care, we do provide to them.
[noise] pediatric brain.
Both the answers, though much rarer Kerry and equally poor prognosis.
The anticipated treatment approach for pre the pediatric brain cancer with mirror, our approach and adults with glioblastoma using direct targeting and convection enhanced delivery.
However, L M.
<unk> of the lining of the spinal fluid space and then of life for some seem to circulate freely if objected there and preclinical studies, thus far and look promising.
Therefore, the delivery approach, which would be an L and direct into the CSF for cerebral spinal fluid would go typically.
Is it and dwelling reservoir, which is commonly place to these patients.
Our goal is to have pre and pre IND meetings with the FDA for both indications and the early part of 'twenty 'twenty, one understand any gaps that we may currently have and the preclinical data for.
All of those as needed as rapidly as possible.
And you would and movies into patients hopefully by year end 2021, and if possible.
As the final notes and.
Consistent with our state of philosophy of striving for maximum capital efficiency and minimal shareholder dilution and of drug development activities, we intend to apply for state of Texas funding.
And through its secret C. P. R. I T program whenever possible to help support our development expenditures as we've mentioned previously and other calls so now with that let me turn the call over to Andrew for a review of the financial results Andrew.
Thank you Marc and good afternoon, everyone.
Please refer to our press.
The issued earlier today for a summary of our financial results for the fourth quarter and full year ended December 31 and 2020.
At year end 2020, cash and cash equivalents was $8 3 million compared to $17 6 million as of December 31, 2019.
Debt.
The release of all at December 31, and 2020 was $4 3 million down from $9 3 million at December 31 2019.
And April 'twenty, and 'twenty, we amended our debt with Oxford.
Finding additional flexibility by pushing out the interest only period through may of 2021 at the earliest together.
Prince of million pay down of principal.
And the fourth quarter of 'twenty and 'twenty, we entered into a purchase agreement and registration rights agreement with Lincoln Park Capital Fund the cell to Lincoln Park up to $25 million worth of shares over the 36 month term of the agreement.
Subject to various terms and conditions.
And where the funds.
Plus we'll have the right at its sole discretion to sell the shares.
In addition, and the fourth quarter of 2020, the company filed a shelf registration on form S. Three allowing for the sale of securities at the market of up to 10 million.
And as previously discussed a plus.
And then.
Conditions to maintain approximately 12 months of go forward cash or access to cash on the balance sheet such that we can reliably fund key product development efforts.
In addition, we will continue to utilize and non dilutive sources of capital.
Such as the existing NIH grants that's the.
Abstention the offset.
Remain clinical development costs.
We will also continue to be aggressive and seeking further separate and the other.
The grants and partnership dollars we're able.
Cash used in operations for full year, 'twenty and 'twenty was approximately $8 4 million compared to $5 9.002 million 19 reported revenues for full.
That's up 2020, the 303 thousands of compared to 7 million of 2019.
This decrease was due to the closeout of the BARDA contract as previously disclosed.
Research and development expenses were $2 7 million for full year, 'twenty and 'twenty as compared to $5 4 million for 2019.
The.
Yes, which was partly attributed to the completion of the BARDA contract in 2019.
G&A expense was $6 for millions of full year, 'twenty and 'twenty as compared to $5 3 million for 2019.
The increase reflects an increase of professional fees relating to the recent and licensing transaction announced in 'twenty.
The decreasing partially offset by decrease and payroll and related expenses.
Interest expense decreased for a full year 2020 to $1 1 million from $1 9 million for full year of 2019, reflecting the principal pay downs and 2019 and 2020.
Net loss for full year, 'twenty and 'twenty.
And each one was $8 2 million as compared to a net loss of $11 4 million for full year 2019.
Net loss in 2019 was impacted by $7 6 million loss from discontinued operations related to the asset divestiture and the second quarter of 2019.
And now I'll turn it back to you.
And I think he may be on mute mark.
Thank you Andrew.
Regarding our forthcoming milestones and to summarize from the previous tests of the script.
They are complete enrollment of all patients and our respect a phase one trial for our and Eleanor of current G. P M.
Complete.
Mark key CMC activities for our now.
Complete the phase III pivotal trial planning in conjunction with the F D. A.
Conduct IND, enabling studies if needed for follow on R&M indications as mentioned.
Dance Arnelle into phase, one for Leptomeningeal cancer, and pediatric brain cancer assuming.
Complete the we get the thumbs up and go ahead from the F D. A.
Complete additional preclinical studies, both for Ari now and potential enhanced variance of all right now.
Continuing to evaluate potential synergistic acquisitions, and and licenses for new investigational drug candidates and.
And related technology.
We continue to explore new partnering relationships, both for our and now and two of our legacy assets does the plus Indoxyl plus.
So with that Erica, let's turn it over for for Q&A.
The floor is now open for questions.
And if you have a question or comment please press star one.
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Thank you. Our first question is from Jason Mccarthy with Maxim Group.
Everyone. Thanks for taking my questions it's of Dave on the line and for Jason. So I was just wondering if you could perhaps shed some color of them you can expect a full data readout for the phase I trial and of that would include overall overall survival data and then secondly, a mindset of question about just the general.
The risk profile of having patients undergo convection enhanced delivery and I guess I understand the right and.
And using for either of you are able to minimize systemic exposure, but I'm just curious as to how that debt that minimized the risk from that perspective balance of that with the invasive nature of relatively invasive nature of convection enhanced delivery.
Yes.
Hey, Dave Thanks.
Yeah, right now I can't give you specific guidance on.
On the on the Phase one trial data and the reason why is because its a dose escalation trial.
And we really have to sort of play read and react with respect of the data.
And there I'd say there.
To give you an update of what the goals of that trial and I think if you can sort of guide you towards the when that when that may come but.
And not exactly.
So in my mind I think about it.
From my perspective first of all feasibility can we can we get our enel and of the brain and get it to where we want to go and and keep.
Amir.
I think the answer to that is yes, I think the check that box in terms of safety and you brought up convection enhanced delivery and that is also dose related as well and delivery related but so far we've had and OSA and so I think we are.
We were we've made good progress there and I feel we're close there.
The third thing that's important is getting to the recommended phase two dose and I think we're getting towards one of.
Towards the end of that debt.
Derivation.
We're getting now to a point, where with the volume and radiation dose for using we can treat tumors that are roughly golf ball side, it's really getting the majority of the tumors that are out there.
And for close there.
The the fourth issue is delivery optimization and I think we're getting close there and as I mentioned and the phase one we bought the we completed phase are the <unk>.
<unk> cohort and our plan now is to.
And to focus on improving and in fact, making.
The rest of the delivery parameters, specifically the rate of conviction, which correlates to.
The pressure had behind the conduct of drug and.
So I think we're getting close there and then finally with respect to efficacy signal. That's the one that quickly of the trial is not powered for.
And because of this dose escalation.
It's really that the patients at the end of the escalation period that are really going to drive that efficacy signal, which is going to inform powering decisions going forward. So the way I the way I'd sort of guide you is debt.
We feel pretty confident that we can get through the 2021.
And have the trial fully enrolled.
We can answer I think the majority of those five factors that I mentioned before the one and we can't answer really is efficacy and so that really drives and what we what we do next and it.
The sort of a long answer, but I'm going to I'm going to hit and a couple of things here. So.
So regarding the next clinical step there.
A couple of options one is to go directly from phase one into phase III.
Wanted to do and interim phase two for a.
Well recall of sort of a.
The expansion cohort.
To help nail down.
Those five features and so.
Our goal is to be ready with.
Pivotal ready drug by approximately the end of the year and we're on track for that.
The wind up the phase one trial and enrollment of 2021, playing out that next step whether its directly to phase III or the interim.
Ah trial of some sort of and then lay all of that out two of them.
The shareholders and the community as soon as possible. So 'twenty 'twenty, one will be a really important year for winding down the phase one.
Defining the what interim step there might be going into the pivotal and what the pivotal looks like.
So long winded answer.
To try and cover a lot of ground and their hope I did that on the second question regarding the risk profile of CBD.
So.
It's.
It has been remarkable that we've had no treatment related SAE ease and the adverse events that we've had have been things related to.
So that's a lot.
For minting, the skin and and developing.
Developing per holes into the skull.
That is includes up to kind of more recently, putting for catheters into the brain to get off the mark tumor coverage.
So with respect to the surgery and the instrumentation.
Yeah.
And very safe.
With respect to the conviction.
We are now increasing the rate, we think that we might be able to do a better job conducting out beyond the tumor and get it to the rim of the cells that are responsible for their current where were doing a great job when we deliver.
And over 75%.
Absorbed dose to the tumor volume of really creating a cavity avoid where the tumor was you really just see.
Empty space there once the Arenella's had the chance to do its thing so really we're now becoming.
For a more sophisticated where we're actually focusing on the sales those pesky cells that we know that are there that are potentially responsible for occurrences and trying to address those by optimizing the delivery parameters, we may run into the safety issues, but thus far I think it's been remarkably safe given.
And I think I can think about what we're actually doing.
Great.
Really informative and I really appreciate it thanks a lot.
And that's sorry for being so long winded.
That's helpful. Thank you.
Yeah.
Your next question is from.
And stuff.
Okay.
Hello, gentlemen, and thank you for taking the call and I just have a question on.
I think Andrew you mentioned.
Non dilutive funding from the state of Texas, and the secret I know of previous calls.
Debt, you've stated that that the.
That's the.
Some of the companies based in Texas could receive up to $20 million and non dilutive funding from Texas or up to phase II trials. So I was just wondering if we could get a status update and the and.
And the sort of the the grant cycle of round in Texas and.
And any sort of color and visibility you can care for them all on the plus therapeutics.
Therapeutics qualifying for cheaper funding now that you have.
Youre closer to the Haynesville.
The phase one.
You know me too much of it to the.
Yeah, Yeah, Andrew address you go ahead, and then and then I may have some.
And of that afterwards.
Sure. Thanks.
Thanks, So much for the question. So you know obviously one of the underlying reasons for the moves of Texas was to become eligible for the separate grants.
And at this point, we have submitted an application and the and the last.
Month two.
To.
To help assist us funding Leptomeningeal metastases indication.
And that the.
The deadline for the application was the end of January and now we're at we're waiting on the the separate process.
So you know realistically over the next.
The process runs over the next 60 to 90 days and then the goal is type of decision sometime late summer and the August September timeframe.
Yeah.
Yeah Yeah.
Yeah, I would just to reiterate what Andrew said I.
And I think you said the and his remarks.
And then I mentioned as well our goal is to maximize leverage the.
The unique opportunity that being an oncology company and Texas provides.
And our plan is not to let the specifically guide towards the grant funding.
Because.
There's just these are these are can be hard to get.
And.
Can be fraught with the bureaucratic requirements and so forth it debt.
And that make it hard to.
And the forecast until you actually sign the paperwork and it gets approved.
I think the the key piece of guidance here is we're going to continue the aggressively seek for.
Lending like that.
Like the NIH like other things that we think is our technology warrants that we think there's a lot of interest and people wanting to see the successful and and.
Growth from patient related groups to scientific groups that have access to capital and we're gonna be aggressive there but.
But we'll be we'll be careful about the not guiding towards.
Any particular grantor of grant funding and and if we get a great. If we don't we're going to keep trying and and we think that's a good use of our the time and the talent of our team.
Yeah no. Thank you for that I think it's the unique.
The unique opportunity for Texas based biotech company and so I always just want to sort of see what the current guidance.
On that and whether you get it or not if it's great to be able to leverage your status of the Texas company to take advantage of that so it's always just the top of mind when and when we're talking about these programs. So thank you so much for for for the information and the update.
You bet. Thank you for the question the model.
[laughter].
Your next question.
And is from Ed woo with of Cindy of capital.
Yes. Thank you for taking my question going back to the funding question how much of the phase one has currently been funded through grants.
Yeah.
Andrew do you and take that or shall I.
Yeah.
You want and you want to take it and then I'll yes.
And then yeah, you cannot you can hum.
Filling any gaps yeah. Thanks, Ed so.
So I'll take it back to the the timing of the grant because it may be and maybe a lesser debt. So.
When we are when we.
Shortly after signing the.
The agreement with Nana, TX, two and license the R and El product the grant and really just been fun and it's a it's a five year of grants.
Of.
Approximately just north of 3 million.
To cover the hard costs of the clinical trial.
So and it's and again, it's phase one and phase two up to 55 patients.
So of the of the.
We closed the deal I think and Q.
Q2 to Q3 so.
It's it's covering us.
Substantial amount of the clinical trial costs.
Probably on the order of.
80% or more.
The funding debt were actually contributing to the trial beyond.
Our time and the overhead that comes it comes with that the hard costs.
And really related to a.
Drug availability and and.
Why that's important is that investment that we're making in terms of drug availability helps us transition this to a registrational drug supply downstream. So we're kind of investing and what we think is.
It's one of the really difficult.
<unk> parts of the transitioning of Phase one program to a later stage clinical program is scared of the CMC right. So that's really.
And where.
We've kind of picking up the the ball from the Nanos, TX team and really try to nail down the CMC component of that so the gating twenty's probably the.
A good number.
And with most of that 20% being and CMC.
Great and then my last question is in terms of timing you said you hope to have most of the study wrapped up by the end of the year is there any possible delays either with COVID-19 or any other external factors.
Yeah.
Yeah. So.
Additionally, we.
We had concerns about the impact from Covid.
Those those fears have largely been unfounded.
These are sick patients and they are they get it.
Preferential.
Of treatment and the health care system, because of the the acuity and life threatening nature of.
Of the disease.
The the so sort.
So direct answer you. The question is really no we haven't seen any impact of Covid per se.
Indirectly we.
We do see.
A.
Our fight for resources within the academic institutions, where they are running various trials people may be sick or out of working from home or working different schedules and then and then frankly kind of unrelated to COVID-19.
There's a lot of competition and the workforce for.
And called trial resources, and so to the degree that.
And could take the academic institutions are involved and the clinical trial execution day there's.
Competition for those resources from from pharma. So so so I would say debt on the whole we really.
And we're putting a meaningful delay don't anticipate any meaningful delay the things that we're seeing are sort of at the margin and the things that we can all of that we've been able to successfully manage through.
Great well, thank you and good luck.
Thank you.
Thanks.
And there are no further questions.
Sure.
I'll turn the call back over to you for.
Closing remarks.
Yeah.
Great. Thank you very much Erica and the.
The half of our team. We appreciate everyone that joined in and participated in the call and ask questions.
And Furthermore, I would like to really think of plus team for their dedication.
We haven't hard work it was very productive 2020 and.
As it relates to the <unk>.
<unk> therapeutics like the also thank the patients that have been involved and our trials and and participated in the and the communication effort related to the potential for <unk>.
And these tough diseases, and then also the physicians and providers.
The care for these patients.
If you'd like to learn more about what we're doing please go to our website. There are a lot of resources there including.
Presentations videos.
Interviews with patients.
And are available to you and then we post.
On many of the social media.
<unk> and Wilson debt to help educate and you and keep you aware of what's going on we are truly excited about the progress thus far I hope you can see that and what we're doing what we say and we were very Uh huh.
We're very excited also about the vision, we have for helping these patients not all of these very difficult rare cancers. So once again.
And I, Thank you and have a good evening.
Yeah.
Thank you. This does conclude today's conference call. Please disconnect your lines at this time and have a wonderful day.
Okay.
[music].
Again thanks.
[music].
And then.