Q3 2023 Plus Therapeutics Inc Earnings Call
Okay.
Okay.
Good afternoon, ladies and gentlemen walk me to the plus Therapeutics third quarter 2020, Threep results conference call.
Before we begin we want to advise you that over the course of the call and question and answer session forward looking statements will be made regarding events trends business prospects and financial performance, which may affect plus pet parents, plus therapeutics 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 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.
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 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 wind up good afternoon, everyone. Thank you once again for taking time to join US today as we provide an overview of recent business highlights and discuss our 2023 third quarter financial results.
Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer, and Dr. Norman The France, our Chief Medical Officer.
I'll begin the call by reviewing our recent clinical and regulatory progress with a focus on the third quarter and then turn the call over to Andrew to review our financials.
Dr. <unk> of France will then be joining us for Q&A.
I'll begin with updates on our two lead Radiotherapeutic CNS cancer programs, starting with recurrent glioblastoma or GBM.
I respect GBM trial of Radium, 186, Obispo Meda and patients with GBM funded substantially by the.
It is to enroll as we work to add new sites in order to complete enrollment.
Of the phase III by the end of 2024.
In parallel to the active phase II trial, the phase one dose escalation trial.
10 years to enroll.
Assessing the effects of very high administered radiation dosage and large volumes to bigger size tumors.
On radiation distribution tumor coverage and safety.
We presented an update on the respect GBM trial at the society for Neuro oncology Astro meeting in August.
To summarize the safety data.
A single administration of <unk> 186, Obispo Meda is generally well tolerated with no dose limiting toxicities and minimal systemic radiation exposure across 30 for GBM patients.
In addition, no patient experienced treatment related adverse events with the outcome of deaths and no patients withdrew due to aes, most aes were mild or moderate in intensity and non serious.
The maximum tolerated dose was not reached.
With regard to efficacy as we briefly discussed last quarter. We found that overall survival is highly correlated with absorbed dose and treat a tumor volume.
And the data set presented at snow ASKO immediately absorbed radiation dose to the tumor was 308 great.
When we look at the median overall survival in the phase one trial through cohort six for patients with absorbed doses less than a 100 Gray median overall survival was 22 weeks for about five months.
And in contrast for patients with absorbed doses greater than 100, Great median overall survival was 70 weeks or almost 18 months.
Applying the Cox proportional hazard statistical model, we have found that for each 100 Gray increase in total absorbed dose the risk of death decreased by 45, 6% and for each 10% increase in the ratio of.
I've treated to total tumor volume the risk of death decreased by 66, 9%.
This data can be found in much greater detail on our website.
In addition, we continue to assess data from the ongoing phase II trial.
New safety and efficacy data from the phase II will be presented at snow in November.
Following the snow meeting, we will be hosting a key opinion leader leader webinar of investigators to discuss the data in detail.
This webinar will feature neuro oncology expert Dr. Andrew Brenner, who is the principal investigator on the trial and is presenting the data at snow as well as others will.
We will be sharing the details of this event soon and invite you to join US as we delve into the data with these experts more deeply.
Now let me update you on our respect <unk> phase <unk> dose escalation trial.
For indium of estimated for patients with Leptomeningeal metastases a L M.
This is a trial that is substantially funded by the state of Texas through secret.
Following a successful FDA type C meeting in Q3.
We rapidly completed cohort four and the <unk> trial.
Cohort four is the first of four planned cohorts in part B of the phase one trial complete.
Completing the dosing in cohort four was the fastest enrollment of all the cohorts to date.
And enthusiasm from sites to participate enroll patients remains high.
Prior to our FDA meeting, we completed part a of the phase one trial, specifically cohorts one through three.
This past August we presented the results of these cohorts at the snow Astro meeting and provided further explanation in context at the Kom Roundtable event following the August meeting.
In summary for the first three cohorts the data shows a favorable safety profile and no dose limiting toxicities have been reached.
Pharmacokinetic analysis showed that the drug circulated rapidly throughout the CSF space.
And remain there for at least seven days following single administration.
Using the CMS side tumor cell enumeration assay, we found that an average reduction of tumor cell counts at 28 days post treatment of 53%.
And finally median overall survival was 10 months with five or 10 patients still alive.
We also presented <unk> data at the separate innovations in cancer.
In September.
As mentioned the respect <unk> phase one program continues to be funded in part by secret through a three year $17 6 million dollar product development Research funding Award.
In September we received a planned $1 9 million advanced payment as part of the grant contract Andrew will discuss the forecasted grant revenue going forward for the next couple of years in a moment.
Now I'll provide some further color on the <unk> side assay used in our <unk> trial and the license agreement we negotiated for the assay in August.
Taking a look at the big picture first that the diagnosis of L. M and the monitoring of treatment response are notoriously difficult in L N even with this.
Our state of the art imaging clinical evaluation and traditional cerebral spinal fluid evaluation.
In contrast, the CN side assay is highly specific and sensitive.
As a measure of CSF tumor cell elimination the quantitate the number of tumor cells per ml of CSF.
This technology represents a substantial improvement in assessing CSF tumor cells compared to the standard of care.
Plus although we initially pretty skeptical of the value of the technology and use it as a as a potential <unk>.
Secondary endpoint our team has seen the value of the assay firsthand in our <unk> trial and to paraphrase one of our <unk> trial investigators see inside assay is a quote unquote game changer for <unk> disease diagnosis and monitoring and therefore, it's obviously quite synergistic with our therapeutic approach.
The company that developed the test <unk>, though it has been in financial of the scrap distress throughout 2023 and declared their insolvency earlier this month.
Make it clear that the company's financial distress was not in any way based on the quality of the utility of the assay.
Upon a variety of unrelated factors.
However, prior to <unk> announcement, and because of this very concern plus successfully completed the transfer of all proprietary material.
And equipment from <unk> to use the CNS see inside assay.
Now as per our plan, where the test to no longer be commercially available to us as it is not now plus can now begin CSF tumor cell enumeration testing.
Limited to the respect <unk> trial patients.
Separately, we will consider whether to exercise the exclusivity option that we have which is exercisable through the end of 2024 under the current license in the meantime, we will monitor the insolvency proceedings closely.
Now back to our <unk> trial, we plan to initiate dosing in cohort five this quarter pending <unk> approval.
In terms of next step for respect L. M. We will continue to focus on enrollment site Onboarding data assessment and planning for next steps, including Phase III.
In terms of our pediatric trial, we continue to make steady progress in initiating our first in child pediatric brain cancer trial trial initiation is behind our original schedule as the FDA has required substantially more supporting data from us, particularly from our ongoing trials.
We had a positive follow up meeting in Q3, and all FTA requests are both reasonable and satisfactorily addressable within the next quarter.
Thereafter, pending IND clearance from the FDA and tips is anticipated to be in early 2024, we plan to initiate the phase one respect pediatric brain cancer trial for pediatric patients with dependent moment high grade Glioma and Larry Children's Hospital in Chicago.
Our other novel Radiotherapeutic Rhenium, 188, nano life persona biodegradable alginate microspheres or band for short continues to make regulatory development progress.
As a reminder, Bam as a radio embolization compound designed to treat a variety of solid organ tumors.
We recently received feedback from the FDA regarding its regulatory designation and the band radio Embolic product will be regulated as a device.
Primarily by CVR H, we view this as very good news is the clinical requirements and timeline for approval will be reduced and existing reimbursement paths are already in place.
Our 2020 for corporate goals for Bam will include specific guidance for development based on FDA, the FDA regulatory decision.
Now in terms of drug production behind the scenes, we continued to expand its shore up existing supply agreements.
And work to build an across the board supply chain redundancy, including as it relates to isotope available mobility.
As we complete new agreements our relationships, we will communicate those.
Yeah.
And with that now I'll turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials Andrew.
Thank you Mark good afternoon, everyone.
These refer to our press release issued earlier today for a summary of our financial results for the third quarter ended September 32023.
As of September 32023, cash and cash equivalents were $11 million, which is in line with the balance at June 32023.
In addition, as of today pluses met the requirements to receive the next cash advance from separate a $3 3 million, which we expect to receive prior to reporting our 2023 full year results.
Plus also remains on track to receive additional advances in 2024 amounting to a first.
So a total of $10 2 million incremental non dilutive cash grant funding is expected between today and December 31, 2024 from secret.
In addition, the company continues to benefit from the 3 million grant from the NIH to support the GBM trial through phase II, which is expected to be fully utilized by the end of 2024 to coincide with the completion of the ongoing phase III trial.
Based on the cash on hand, and committed grant funding our current balance sheet provides runway well into 2025.
In addition, the company continues to be aggressive in the pursuit of additional NIH and separate grants to support both our current and planned future programs. Our practice will be to continue to announce those upon award.
The company recognized $1 2 million of grant revenue in the third quarter of 2023, and $3 6 million year to date 2023.
The company forecast grant revenue of between one to $1 5 million in Q4 2023 and.
And between $6 million to $7 million for calendar year 2024.
Total operating expenses for the third quarter of 2023 decreased by <unk> 7 million to $4 5 million in 2023 compared to total operating expenses of $5 2 million for the same period the prior year.
The decrease is due primarily to the completion of the cgmp drug developments in 2022.
Unknown Executive: Good afternoon ladies and gentlemen, welcome to the Plus Therapeutics Third Quarter 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and question and answer session or look in statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics feature operating results in financial position. All such statements are subject to risk and uncertainties, including the risk and uncertainties described under the risk factors section included in Plus Therapeutics and Report on Form 10K and quarterly reports on Form 10Q filed with the Security and Exchange Commission from time to time.
Other income totaling 32000 for the quarter includes a 119000 of interest income, which fully offset the interest expense on the remaining principal on the Oxford debt.
So with the ground supports our existing go forward ban is close to 500000 to over the next 18 months.
Net loss for the third quarter of 2023 was $3 2 million or $1 per share compared to a net loss of $5 2 million or $2 $85 per share for the same period of the prior year.
Now I'll turn it back to Mark.
Thank you Andrew.
We can move on to Q&A I'll take a moment to provide guidance on anticipated milestones over the next 14 months.
Unknown Executive: 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 circumstances after the date they are made.
First of all.
In Q4, we have multiple presentations accepted at the snow annual meeting November 15% to 19 in Vancouver, We're particularly excited to present the first data cut from the ongoing phase two GBM trial to be a company.
Unknown Executive: It is now my pleasure to turn to the floor over to Dr. Marc Hedrick plus Therapeutics president and chief executive officers so you may begin. Thank you to on up. Good afternoon everyone.
Goodbye.
At our thought leader panel and we'll put out the specifics about that panel when finalized.
Also at the Snow annual meeting in November we will also have an update on our <unk> trial as well.
Marc Hedrick: Thank you once again for taking time to join us today as we provide an overview of recent business highlights and discuss our 2023 Third Quarter Financial Results. Joining me for the call today are Mr. Andrew Sims, our chief financial officer and Dr. Norman LaFrance, our chief medical officer. I'll begin the call by reviewing our recent clinical and regulatory progress with a focus on the third quarter and then turn the call over to Andrew to review our financials.
Looking beyond the snow meeting it and looking forward into 2024.
We intend to complete enrollment in the phase II respect GBM trial, and finalize a pivotal trial design with the FDA.
We also intend to complete enrollment in the phase one respect Lf trial and begin the phase II trial.
We also intend to complete.
Internal implementation of the <unk> inside cerebral spinal fluid tumor cell and emigration.
Marc Hedrick: Dr. LaFrance will then be joining us for Q&A. I'll begin with updates on our two lead radiotherapy, CNS cancer programs starting with recurrent glioblastoma or GBM. Our respect GBM trial of R&M 186 of Bispamata in patients with GBM funded substantially by the A&U's to enroll as we work to add new sites in order to complete enrollment of the phase two by the end of 2024. In parallel to the active phase two trial the phase one dose escalation trial continues to enroll assessing the effects of very high administered radiation doses in large volumes to bigger sized tumors on radiation distribution, tumor coverage and safety.
Assay.
Has been currency has been currently utilized in the respect <unk> clinical trial.
We intend to obtain FDA approval and initiate the phase one respect pediatric brain cancer trial for pediatric patients with dependent Moma.
And high grade glioma at the Lurie Children's hospital in Chicago.
We also will complete key development milestones for the company's next generation radio Embolic device 188 Arnelle Bam.
At a key second source GNP supply chain partner to support late stage clinical trials and commercial supply and published the respect GBM phase one data it appears you'd publication.
Now with that I'll turn it back to <unk> to the operator for our Q&A session.
Thank you.
Ladies and gentlemen to ask a question. Please press star one on your telephone and then wait to hear your name announced.
Marc Hedrick: We presented an update on the respect GBM trial at the Society for Neurooncology ASCO meeting in August. To summarize the safety data, a single administration of R&M 186 of Bispamata is generally well tolerated with no dose limiting toxicities and minimal systemic radiation exposure across 34 GBM patients. In addition, no patients experience treatment-related adverse events with the outcome of deaths and no patients withdrew due to AEEs. Most AEEs were mild or moderate in intensity and non-serious.
Withdraw your question. Please press star one again.
Please standby, while we compile the Q&A roster.
Okay.
Our first question comes from the line of Justin Walsh with Jones trading your line is open.
Hi, Thanks for taking my questions and congrats on the progress I was wondering if you can.
Provide any color on what we can expect from the presentation Thats now I know you mentioned survival data for 15 patients but.
If theres any other info you cannot close has that release and maybe remind us of how many patients worth of data. We saw last time you guys presented.
Marc Hedrick: The maximum tolerated dose was not reached. With regard to efficacy, as we briefly discussed last quarter, we found that overall survival is highly correlated with absorbed dose and treated tumor volume. In the data set presented at SNOW ASCO, the medium-absorbed radiation dose to the tumor was 308 grade. When we look at the median overall survival in the phase 1 trial through cohort 6, for patients with absorbed doses less than 100 grade, median overall survival was 22 weeks or about 5 months.
Marc Hedrick: And in contrast for patients with absorbed doses greater than 100 grade, median overall survival was 70 weeks or almost 18 months. Applying the COX proportional hazard statistical model, we have found that for each 100 grade increase in total absorbed dose, the risk of death decreased by 45.6% and for each 10% increase in the ratio of treated to total tumor volume, the risk of death decreased by 66.9%. This data can be found in much greater detail on our website.
Hey, Justin.
70% of data there were 34 patients at a high level of 34 total patients treated in the trial. We have we have five abstracts accepted.
Besides presenting the phase two data set from.
From a safety and efficacy perspective, one novel thing will show us some pretty substantial updated imaging data and that will be part of the presentation. So this will be across multiple presentations.
Can't really say any more than that.
As we continue to review the data, but one reason, we're having a thought leader panel will be able to bring a lot of that data that will be novel and put it into context with some of the investigators that are actually involved with patient care.
Great really looking forward to all of that so one more question for me.
Theres been some building momentum in the radio pharma field with M&A activity and some some key data releases I was wondering if <unk> seen an increase in interest in your ongoing trials from perspective of patients physicians and investors.
Marc Hedrick: In addition, we continue to assess data from the ongoing phase 2 trial. New safety and efficacy data from the phase 2 will be presented at SNOW in November. Following the SNOW meeting, we will be hosting a key opinion leader webinar of investigators to discuss the data in detail. This webinar will feature neuro-oncology expert, Dr. Andrew Brenner, who is a principal investigator on the trial and is presenting the data at SNOW as well as others.
Yes so.
We've seen a lot of interest in our CNS radiotherapeutic assets.
There are several reasons for that.
You mentioned, one which is there is there's a renewed interest.
Marc Hedrick: We'll be sharing the details of this event soon and invite you to join us as we delve into the data with these experts more deeply.
Generally speaking in the radio therapeutic space and the Dr of France is sitting with me today.
Has has been been in this space for a while and I think what would tell you that.
Marc Hedrick: Now, let me update you on our respect L.M, phase 1 to a dose-escalation trial of RINIUM of this PMATA for patients with let-demonential metastasis or L.M. This is a trial that is substantially funded by the state of Texas through secret. Following a successful FDA type C meeting in 2003, we rapidly completed cohort 4 in the L.M, trial. Cohort 4 is the first of four planned cohorts in part B of the phase 1 trial.
It's been a remarkable increase in interest over the last.
Last few years that he has seen.
The second thing is the radiotherapy radio therapeutic space.
There is there is a lot of work at preclinical there are a number of very successful products and deals that have been announced but there is a.
There is a relative dearth of mid stage assets and I think that's one reason we've seen a lot of interest in our technology and that we have a.
Marc Hedrick: Completing the dosing in cohort 4 was the fastest enrollment of all the cohorts to date and enthusiasm from sites to participate in role patients remains high. Prior to our FDA meeting, we completed part A of the phase 1 trial, specifically cohorts 1 through 3. This past August, we presented the results of these cohorts at the SNOW ASCO meeting and provided further explanation and context at the KOL Roundtable event following the August meeting.
And ongoing phase III and GBM.
A very big indication and also <unk>, which is rapidly getting through the phase I to phase II. So that's.
That's I think that's created a lot of interest in it and then finally, just the data itself.
These are.
<unk> medical needs.
That carry a very high levels of mortality.
Marc Hedrick: In summary, for the first three cohorts, the data shows a favorable safety profile and no-dose limiting toxicities have been reached. Pharmacokinetic analysis showed that the drug circulated rapidly throughout the CFSF space and remained there for at least seven days following single administration. Using the CN side tumor cell enumeration assay, we found that in average reduction in tumor cell counts at 28 days post-treatment of 53 percent, and finally, median overall survival was 10 months with 5 of 10 patients still alive.
There is nothing approved for <unk> and Theres only been one approved drug for GBM and the last 10 years, which doesn't improve survival, which is <unk>.
The symptomatology, so I think the combination of those three things.
Has really created a lot of renewed interest in this space.
Great. Thanks for taking my question.
Thank you.
Please standby for our next question.
Our next question comes from the line of Sean Lee with H C. Wainwright. Your line is open.
Marc Hedrick: We also presented LM data at the secret innovations in September. As mentioned, the respect LM phase 1 program continues to be funded in part by secret through a 3-year, $17.6 million product development research funding award. In September, we received a plan 1.9 million advanced payment as part of the grant contract. Andrew will discuss the forecasted grant revenue going forward for the next couple of years in a moment. Now it provides some further color on the C inside assay used in our LM trial and the license agreement we negotiated for the assay in August.
Good afternoon, guys and thanks for taking my questions.
First one doing the prepared remarks, you mentioned that the FTE requesting additional info from both existing studies and also for the pediatric study.
Could you provide.
Provided more information on what was requested.
Normally just to take that hi, Sean Thanks for the question.
The FDA has always liked our approach for the dose escalation in pediatric tumors.
Which as everyone knows are not the same as adult tumors and our plan is to do a dose escalation not only an administered dose.
Button volume, but as part of that and as folks know FDA.
Marc Hedrick: Taking a look at the big picture first, the diagnosis of LM and the monitoring of treatment response are notoriously difficult in LM even with the state of the art imaging, clinical evaluation and traditional cerebral spinal fluid evaluation. In contrast, the C inside assay is highly specific and sensitive as a measure of CSF tumor cell enumeration that quantitates the number of tumor cells per ML of CSF. This technology represents a substantial improvement in assessing CSF tumor cells compared to the standard of care.
It's very conservative, particularly around pediatric dosimetry and radiation treatment.
As Mark has mentioned we have a very well established preliminary database in the GBM adult trial and what we did with FDA is review the adult dosimetry trial.
Review, the adult safety data, which is.
Very well tolerated and quite benign.
And pointing out to FDA.
<unk>.
There will be an identical product.
Administered an identical way with the CEB catheters.
It's been quite a success story in adults.
Marc Hedrick: At plus, although we initially pretty skeptical the value of the technology and used it as a potential secondary end point, our team has seen the value of the assay first hand in our LM trial and the paraphrase one of our LM trial investigators, the C inside assay is a quote-unquote game changer for LM disease diagnosis and monitoring and therefore it's obviously quite synergistic with our therapeutic approach.
When they got that information they were very satisfied we have an agreement to move forward in the protocol design and are just finishing up some.
Minor clarifications with them, which we'll do this quarter.
To that point, we expect to start the pediatric trial early next year.
Great. Thank you that makes it a much clearer.
Marc Hedrick: The company that developed the test biosept those been in financial distress throughout 2023 and declared their insolvency earlier this month. I want to make it clear that the company's financial distress was not in any way based on the quality of the utility of the assay but on a upon a variety of unrelated factors. However, prior to bioseps announcement and because of this very concern, plus successfully completed the transfer of all proprietary materials and equipment from biosept to use the C inside assay.
My second question is on the funding side, you mentioned that Pos.
From a $10 million additional for US Tom simply next year as well as $3 million from NIH.
Would that cover the majority of the expected phase II study expenses for next year.
Thanks, Sean so the so the short answer is yes. So separate funds. So let me let me just kind of give you a background of <unk> and the timing so separate funds two thirds of all costs relating to the study.
Marc Hedrick: And now, as per our plan, we're the test to no longer be commercially available to us as it is not now, plus can now begin CSF tumor cell enemoration testing limited to the respect LM trial patients. Separately, we will consider whether to exercise the exclusivity option that we have, which is exercisable through the end of 2024 under the current license. In the meantime, we'll monitor the insolvency proceedings closely.
No.
Which which makes the grants extremely attractive obviously.
Currently.
They cover effectively the majority of the third party development costs of patient cost drug cost site initiation fees et cetera regulatory costs and then they also cover <unk>.
Significant internal costs salaries, and other overhead rent et cetera.
Marc Hedrick: Now back to our LM trial. We plan to initiate those singing cohort 5 this quarter pending DSMB approval. In terms of next step for respect LM, we will continue to focus on enrollment, site onboarding, data assessment and planning for next steps, including phase 2.
And we so as we as we look forward and I had kind of mentioned we would.
Which we should receive.
Over $10 2 million over the next 15 months.
That will cover.
Just under 70% of the total costs.
Great.
My last question just on the dose escalation study I know previously you guys.
Marc Hedrick: In terms of our pediatric trial, we continue to make steady progress in initiating our first in-child pediatric brain cancer trial. Tribal initiation is behind our original schedule, as the FDA has required substantially more supporting data from us, particularly from our ongoing trials. We had a positive follow-up meeting in Q3, and all FDA requests are both reasonable, and it's satisfactorily addressable within the next quarter. Thereafter pending IED clearance from the FDA anticipated to be in early 2024, we plan to initiate the Phase I respect pediatric brain cancer trial for pediatric patients with the pin-a-moment high-grade glioma at Lurie Children's Hospital in Chicago.
<unk> sure whether the current enrollment the current cohort will be the highest cohorts. So I was wondering.
Would you go.
So even higher than that study and also.
Remember you guys also mentioned.
Had a protocol for retreating patients was that also planned for a different cohort.
Hi, Sean its mark.
On the first question.
We've got another couple of patients to complete six and cohort eight were at very high radiation doses in volumes.
We'll have to look at the data, but my guess is we won't get to a maximum tolerated dose, but we very likely we will get to a maximum feasible dose and.
Marc Hedrick: Our other novel, radiotherapeutic Rhinium-188 Nanoliposome biodegradable Alginate Microsphere or BAM for short, continues to make regulatory development progress. As a reminder, BAM is a radioembolization compound designed to treat a variety of solid organ tumors. We recently received feedback from the FDA regarding its regulatory designation, and the BAM radio-embolic product will be regulated as a device, primarily by CDRH. Review this as very good news as the clinical requirements and timeline for approval will be reduced in existing reimbursement paths are already in place.
And so that data will be analyzed.
Primarily for safety.
And.
And distribution.
So anyway, that's ongoing.
As it relates to re treatments.
So we're in the process of putting a re treatment arm in all of our GBM sites with the idea that and.
I don't want to say too much and preempt some of the data at snow, but we're going to show imaging data.
That I think will be it'd be very interesting and we will look at.
Help help provide a road map.
Marc Hedrick: Our 2024 corporate goals for BAM will include specific guidance for development based on FDA regulatory decision. In terms of drug production, behind the scenes we continue to expand its short, existing supply agreements, and work to build in across the board supply chain redundancy, including as it relates to isotope available ability. As we complete new agreements or relationships, we will communicate those.
For achieving what is our primary corporate goal and Thats the term CNS cancers into a chronic disease.
I will say that as it relates to the phase II, if I can just editorialize a minute.
I think we are on track to complete the single administration.
Phase II by the end of 2024.
As that data continues to look positive.
Andrew Sims: With that now, I'll turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials. Andrew? Thank you, Mark. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the third quarter-ended September 30, 2023. As of September 30, 2023, cash and cash equivalents were $11 million, which is in line with the balance of June 30, 2023. In addition, as of today, plus has met the requirements to receive the next cash advance and secret of $3.3 million, which we expect to receive prior to reporting our 2023 full-year results.
We will present that data in the first pass of that it snow.
We may actually seek pre end of phase II meeting with the FDA to discuss options for.
Great.
All I have and thanks again for taking my questions.
Thank you.
Please standby for our next question.
Our next question comes from the line of Atwood move with Cindy Capital. Your line is open.
Yes, congratulations on the progress.
To clarify you said that cohort four Alan trial was the fastest that you were able to get a.
Andrew Sims: Plus, it also remains on track to receive additional advances in 2024, amounting to a further limit. So, a total of $10.2 million incremental non-dilutive cash grant funding is expected between today and December 31, 2024 from secret. In addition, the company continues to benefit from the $3 million grant from the NIH to support the GBM trial through Phase 2, which is expected to be fully utilized by the end of 2024, to coincide with the completion of the ongoing Phase 2 trial.
Bill is that.
Something that you should expect going forward and does that speed up your timeline at all with Alan trial.
Hi, Ed This is Norman.
Great question and.
As I think we've discussed previously.
Our protocol defined option.
Sure that we agreed to with FDA. Because this is first in man inter fecal administration of of obviously the radioactivity.
Given the interest that Mark alluded to earlier in a question on.
Andrew Sims: Based on the cash on hand and committed grant funding, our current balance sheet provides runway well into 2025. In addition, the company continues to be aggressive in the pursuit of additional NIH and separate grants to support both our current and planned future programs. Our practice will be to continue to announce those upon award. The company recognized 1.2 million of grant revenue in the third quarter of 2023 and 3.6 million year-to-date 2023.
An earlier Q&A question, we're getting a lot of interest on folks for the exact reason Mark mentioned that first of all there are really no treatment for this devastating complication.
And there really are no.
Significant active investigative trials other than ours, and we've gotten a very promising provocative efficacy signal in addition to being a very well tolerated.
Andrew Sims: The company forecasts grant revenue of between 1 to 1.5 million in Q4 2023 and between 6 to 7 million for calendar year 2024. Total operating expenses for the third quarter of 2023 decreased by 0.7 million to 4.5 million in 2023 compared to total operating expenses to 5.2 million for the same period the prior year. The decrease is due primarily to the completion of the CGMP drug development in 2022. Other income totaling 32,000 for the quarter includes 119,000 of interest income which fully offsets the interest expense on remaining principal on the Oxford debt.
Outpatient treatment.
So the short of it for the.
Cohorts now five through seven to be continued we'd expect to enroll.
At the same rate.
With that we'd expect if there are no DLT or other safety observations that that.
May.
Call the decision to end it in earlier cohorts a.
Cohort six.
We will complete the full dose escalation.
Probably by June of next year.
With that we will go to FDA and.
Have a prepay in the phase one dose escalation and pre phase.
Andrew Sims: So with the grant support our existing go-forward burn is close to 500,000 over the next 18 months. Net loss for the third quarter of 2023 was 3.2 million or $1 per share compared to a net loss of 5.2 million or $2.85 per share for the same period of the prior year.
To meet.
Meeting and I don't want to get too forward looking but.
Given the current trend of both the safety Tolerability and preliminary efficacy.
We'll be in a position to talk to FDA about a phase two.
Trial that will include it being.
Perhaps leading to accelerated approval.
Marc Hedrick: Now I'll turn it back to you Mark. Thank you Andrew.
All because.
<unk> has no treatment options is a devastating complication.
Marc Hedrick: Before we move on to Q&A I'll take a moment to provide guidance on anticipated milestones over the next 14 months. First of all in Q4 we have multiple presentations accepted at the snow annual meeting November 15 to 19 in Vancouver. We're particularly excited to present the first data cut from the ongoing phase 2 GBM trial to be accompanied at our thought leader panel and we'll put out the specifics about that panel when finalized.
And not a lot of investigators.
At this point I'll stop there and see if you have any other questions.
Thank you very much that was very helpful. I wish you guys. Good luck. Thank you.
Thank you.
Please standby for our next question.
Our next question comes from the line of Jason Jason Mccarthy with Maxim Group. Your line is open.
Marc Hedrick: Also at the snow annual meeting in November we will also have an update on our LM trial as well. Looking beyond the snow meeting and looking forward into 2024 we intend to complete enrollment in the phase 2 respect GBM trial and finalize the pivotal trial design with the FDA. We also intend to complete enrollment in the phase 1 respect LM trial and begin the phase 2 trial. We also intend to complete internal implementation of the C-inside cerebral spinal fluid tumor cell enumeration assay that has been currently utilized in the respect LM clinical trial.
Hi, guys chat on for Jason.
<unk> already covered but I was just wondering what the plans are for implementing CNS side.
The <unk> study given the buyout <unk> declared bankruptcy will you still be able to use the platform.
Hi, Chad.
Yes, so youre right they declared bankruptcy.
We've been using the test for over a year.
And I didn't mention a bit in my prepared remarks, but I'll expand on those.
We didn't really know what to expect we started using the trial.
Marc Hedrick: We intend to obtain FDA I&D approval and initiate the phase 1 respect pediatric brain cancer trial for pediatric patients with a pinnumoma and high grade glioma at the Lurie Children's Hospital in Chicago. We also will complete key development milestones for the company's next generation radial and volic device 180 RNL BAM. At a key second source DNP supply chain partner to support late-stage clinical trials of commercial supply and publish the respect GBM phase 1 data in a peer review. Publication.
Test, but.
For a year or so of experience, both with our technology and our trial and talking to the investigators.
We think theres a real opportunity.
With this with this test we were concerned about them their solvency.
Over the past year and Thats, why we frankly licensed and transfer the technology.
Two.
To ourselves.
And the in the weeks before they declared insolvency so we wait.
We essentially have.
Unknown Executive: Now with that, I'll turn it back to Tuwanda, the operator for Q&A sessions.
Non exclusive right to use the test for or.
Unknown Executive: Thank you. Ladies and gentlemen, to ask the question, please first start 1-1 on your telephone and then wait to hear your name announce.
For our in our trials with our technology and then we have a option exercisable.
Unknown Executive: To withdraw your question, please first start 1-1 again. Please stand by while we compile the Q&A roster.
Extra sizeable through the end of next year.
To gain exclusivity in the area of radio Therapeutics for for this test so.
Now that they are now that they're gone and they are gone and there are no longer operating.
We will be well.
Justin Walsh: Our first question comes from the line of Justin Walsh with Jones Trading. Your line is open. Hi, thanks for kicking the questions and congrats on the progress.
We'll be taking the.
The protocols the information and the testing kits that we have already acquired and are now in Texas and will begin using the test not in a clear fashion, but just as a research tool. So we can use.
Marc Hedrick: I wonder if you can provide any color on what we can expect from the presentations that snow. I know you mentioned survival data for 15 patients, but if there's any other info, you can go ahead of the release and maybe remind us of how many patients worth of data we saw last time you guys presented. Hey, Justin. Last time we presented data, there were 34 patients at a high level, 34 total patients treated in the trial.
In the context of of our trial now with our option.
Based on.
And kind of our ongoing experience we will actually.
Consider whether we want to exercise that and maybe maybe expand that but but right. Now I think the plan is just to implement it use it in our trial and frankly <unk> to pay for that as well.
Marc Hedrick: We have five abstracts accepted. Besides presenting the phase two data sets from a safety and efficacy perspective, one novel thing we'll show is some pretty substantial updated imaging data. And that will be part of the presentation. So this will be across multiple presentations. Can't really say any more than that as we continue to review the data. But one reason we're having a thought leader panel is we'll be able to bring a lot of that data that will be novel and put it into context with some of the investigators that are actually involved with patient care.
Justin Walsh: Great, really looking forward to all that. So one more question for me.
Okay, great. Thanks for taking my question and congrats on the progress.
Thank you.
Thank you.
I'm showing no further questions in the queue I would now like to turn the call back over to Mark for closing remarks.
Thank you to Rhonda thanks, everyone for joining us thanks for the good questions. Thanks for your interest in the company.
And.
We will we will be talking to you soon and have a nice evening.
Goodbye.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Marc Hedrick: Obviously there's been some building momentum in the radio form of field with M&A activity and some key data releases. I wonder if you've seen an increase in interest in your ongoing trials from perspective of patient physicians and investors? Yes, so we've seen a lot of interest in our CNS radio therapeutic assets. And I think there are several reasons for that. You mentioned one, which is there's a renewed interest generally speaking in the radio therapeutic space.
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Marc Hedrick: And the doctor of France is sitting with me today has been in the space for a while. And I think we would tell you that it's been a remarkable increase in interest over the last few years that he's seen. The second thing is in the radio therapeutic space, there's a lot of work preclinical. There are a number of very successful products and deals that have been announced. But there is a there's a relative dearth of mid stage assets.
Marc Hedrick: And I think that's one reason we've seen a lot of interest in our technology. And then we have an ongoing phase two in GBM. A very big indication. And also LM, which is rapidly getting through the phase one to phase two. So that's. That's, I think that's created a lot of interest. And then finally, just the data itself, these are unmet medical needs that carry very high levels of mortality. There's nothing approved for LM and there's only been one approved drug for GBM in the last 10 years, which doesn't improve survival, it just improves the symptomatology. So I think the combination of those three things has really created a lot of renewed interest in the space. Great, thanks for taking the questions. Thank you.
Unknown Executive: Please stand by for our next question.
Sean Lee: Our next question comes from the line of Sean Lee with H.C. Wayne Wright. Your line is open. Good afternoon, guys. And thanks for taking my questions. First of all, doing the preparing marks, you mentioned that the FDA requested additional info from both your existing studies and also for the FM pediatric study. Could you provide a bit more information on what was requested? No, I'm just going to take that. Hi, Sean. Thanks for the question.
Sean Lee: The FDA has always liked our approach for the dose escalation and pediatric tumors, which is everyone knows are not the same as adult tumors and our plan is to do a dose escalation, not only at a minister dose, the button volume, but as part of that and as folks know, FDA is very conservative, particularly around pediatric dose symmetry and radiation treatment. As Mark has mentioned, we have a very well-established pulmonary database in the GBM adult trial.
Sean Lee: And what we did with FDA is review the adult dose symmetry trial, review the adult safety data, which is, you know, very well tolerated and quite benign and pointing out to FDA that the product will be an identical product administered in an identical way with the CED catheters has been quite a success story of adults. When they got that information, they were very satisfied. We have an agreement to move forward in the protocol design and are just finishing up some minor clarifications with them, which will do this quarter.
Andrew Sims: And to that point, we expect to start the pediatric trial early next year. Great. Thank you. That makes it much clearer. My second question is on the funding site. You mentioned that the possibly 10 million dollars additional for us from Cypher next year as well, $3 million of NIH. Would that cover the majority of the expected phase two study expenses for next year? Thanks, Sean. So the short answer is yes. So separate funds, so let me just give you a background of separate and then the timing.
Andrew Sims: So separate funds, two thirds of all costs relating to the study, which makes the grant extremely attractive obviously. Currently, they cover effectively the majority of the third-party development costs, the patient costs, drug costs, site initiation fees, et cetera, regulatory costs. And then they also cover significant internal costs, salaries, and other overhead rent, IT, et cetera. And as we look forward and I can mention, we should receive over 10.2 million over the next 15 months that that will cover just under 70% of the total cost. Great.
Marc Hedrick: My last question is just on the dose escalation study. I know previously you guys weren't sure whether the current cohort will be the highest cohort. Would you go even higher in that study? And also, remember you guys also mentioned they had a protocol for retreating patients. Is that also planned for a different cohort? Sean Smark. On the first question, we've got another couple of patients to complete six in cohort eight. We're at very high radiation doses and volumes and we'll have to look at the data, but my guess is we won't get to a maximum tolerated dose, but we very likely will get to a maximum feasible dose.
Marc Hedrick: And so that data will be analyzed primarily for safety and distribution. So anyway, that's ongoing. As it relates to retreatment, so we're in the process of putting a retreatment arm in all of our GBM sites with the idea that, and I don't want to say too much and preempt some of the data as snow, but we're going to show imaging data that I think will be very interesting and will help provide a roadmap for achieving what is our primary corporate goal, and that's to turn CNS cancers into a chronic disease.
Marc Hedrick: I will say that as it relates to the phase two, if I can just editorialize a minute, that I think we're on track to complete the single administration phase two by the end of 2024. Is that data continues to look positive? We'll present that data in the first pass of that. It's snow. We may actually seek a pre-end of phase two meeting with the FDA to discuss options for great. That's all I have and thank you again for taking my questions.
Unknown Executive: Thank you.
Edward Woo: Please stand by for our next question. Our next question comes from the line of Edward Moove with the Senate Capitol. Your line is open. Congratulations on the progress. To clarify, you said that cohort 4 in the Allen trial was the fastest that you were able to get it built. Is that something that you should expect going forward, and does that speed up your timeline at all with the Allen trial? Hi, this is Norman.
Edward Woo: Great question. As I think we've discussed previously, there are protocol defined options that we agreed to with FDA because this is first and inter-fecal administration of obviously the radioactivity, and Dr. Lee. Given the interest that Marc alluded to earlier in a question on, you know, an earlier Q&A question, we're getting a lot of interest on folks for the exact reason Marc mentioned that, you know, first of all, there are really no treatments for this devastating complication and there really are no significant active investigative trials other than ours.
Edward Woo: And we've gotten a very promising provocative efficacy signal in addition to being a very well tolerated outpatient treatment. So the short of it for the cohorts now five through seven be continued, we'd expect to enroll at the same rate. With that, we'd expect if there are no DLTs or other safety observations that that may call the decision to ended an earlier cohort safe, you know, cohort six will complete the full dose escalation, probably by June of next year.
Edward Woo: With that, we'll go to FDA and have a pre and a phase one dose escalation and pre phase two meeting. And I don't want to get too forward looking, but given the current trend of both the safety tower ability and preliminary efficacy will be in a position to talk to FDA about a phase two. A trial that will include it being just leading to an accelerator approval, all because LM has no treatment options is a devastating complication and not a lot of investigative. At this point, I'll stop there and see if you have any other questions. Thank you very much. That was very helpful. I wish you guys good luck. Thank you.
Unknown Executive: Please stand by for our next question.
Jason Mccarthy: Our next question comes from the line of Jason McCarty with maximum group, the line is open. Hi guys, chat on for Jason.
Marc Hedrick: I'm sorry, this is already covered, but I was just wondering what the plans are for implementing CNS side in the LM study, given a bioseptus declared bankruptcy, will you still be able to use the platform? Hi Chad. Yeah, so you're right, they declared bankruptcy. We've been using the tests for over a year, and I didn't mention a bit of my prepared remarks, but I'll expand on those. You know, we didn't really know what to expect.
Marc Hedrick: We started using the trial, the test, but you know, over a year or so of experience, both with our technology and our trial and talking to the investigators. We think there's a real opportunity with this with this test. We were concerned about them, their solvency over the past year, and that's why we frankly licensed and transferred the technology, to ourselves in the weeks before they declared insolvency. So we essentially have a non-exclusive right to use the test for in our trials, with our technology, and then we have an option that's exercisable through the end of next year to gain exclusivity in the area of radiotherapy for this test.
Marc Hedrick: So now that they're gone and they're gone and no longer operating, we'll be taking the protocols, the information, and the testing kits that we have already acquired and are now in in Texas, and we'll begin using the test, not in a Clia fashion, but just as a research tool so we can use in the context of our trial. Now with our option based on our ongoing experience, we will actually consider whether we want to exercise that and maybe expand that, but right now I think the plan is just to implement it and use it in our trial, and frankly, see Prada to pay for that as well. Okay, great. Thanks for taking the question and I can grab some progress. Thank you. I'm showing no further questions in the queue.
Marc Hedrick: I would now like to turn the call back over to Mark for close and remarks. Thank you, Twanda. Thanks everyone for joining us. Thanks for the good questions.
Unknown Executive: Thanks for your interest in the company, and we will be talking to you soon. Have a nice evening. Goodbye.
Unknown Executive: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.