Q3 2023 PolyPid Ltd Earnings Call
[music].
Okay.
Speaker 1: Greetings and welcome to the Polypide 3rd quarter, 2023 Conference call. At this time participants are in listen only mode. As a reminder, this call is recorded and I would like now to introduce your host for today's conference, Brian Richie from LifeSight Advisor. Mr. Richie, you may begin.
Greetings and welcome to the Polly P third quarter 2023 conference call.
At this time participants are in listen only mode. As a reminder, this call is recorded and I would like now to introduce your host for today's conference Brian Ritchie from lifestyle advisors. Mr. Ritchie you may begin.
Speaker 2: Thank you all for participating in Polly Peach Dirt Quarter 2023 earnings conference.
Thank you all for participating and poly Peach third quarter 2023 earnings conference call.
Speaker 2: Joining me on the call today will be Declan, Chapskis, Axel Brod, chief executive officer of Polly Pied, Johnny Miss Allowing, Polly Pied's chief financial officer.
Joining me on the call today will be D glad trash cause actual Brian.
<unk> Executive officer of Polly P. Johnny Miss allowance Poly Pizza Chief Financial Officer.
Speaker 2: and Ori Worshawski Chief Operating Officer of Public.
Or eat workshop ski Chief operating officer of Poly Pete.
Speaker 2: Earlier today, Polly Pete released financial results for the three and nine months ended September 30th, 2023. A copy of the press release is available in the Investor section on the company's website, www.pollyp.com.
Earlier today <unk> released financial.
Financial results for the three and nine months ended September 32023.
A copy of the press release is available in the investors section on the company's website Www dot.
Dot com.
Speaker 2: I'd like to remind you that on this call, management will make forward-looking statements within the meeting of the Federal Security's laws. For example, management is making forward-looking statements when it discusses recruitment of additional patients into SHIELD-2.
I'd like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities Laws. For example management is making forward looking statements. When he discusses recruitment of additional patients into shield two.
Speaker 2: total recruitment time into the study and the timing of the top line results therefrom. It's intention to conduct an unblind interim analysis once a total of approximately 400 patients complete their 30 day follow-up. The potential new drug application submission for Dplex 100 in the U.S. and EU marketing authorization application regulatory filings.
Total recruitment time into this study and the timing of the topline results from its intention to conduct an unblinded interim analysis. Once a total of approximately 400 patients complete their 30 day follow up the potential new drug application submission for duplex 100 in the U S and EU market.
Authorization application regulatory filings.
Speaker 2: It's an expectation to have 40 centers open by the end of 2023, factors essential in the execution of CO2, the potential of D-Plex 100 in addressing the persistent challenge of surgical site infections, D-Plex 100's potential to provide both elastic efficacy benefits and patients with increased SSI risk factors.
Expectation to have 40 centers open by the end of 2023 factors are essential in the execution of shield to the potential of duplex 100 in addressing the persistent challenge of surgical site infections duplex, one hundred's potential to provide prophylactic efficacy benefits in patients with increased.
High risk factors.
Speaker 2: The company's competitive advantages, potential clinical evaluation of Dplex 100 and the pediatric population.
<unk> competitive advantages potential clinical evaluation of duplex 100 in the pediatric population.
Speaker 2: potential commercial demand for D-Plex 100 and the company's expectations regarding its cash balance.
Commercial demand for duplex 100, and the company's expectations regarding its cash balance.
Speaker 2: Forward-looking statements are subject to numerous risks in them.
Forward looking statements are subject to numerous risks and uncertainties.
Speaker 2: Many of which are beyond our control, including the risks described from time to time in our SEC file. Our results may differ from a-
Any of which are beyond our control, including the risks described from time to time in our SEC filings.
Our results may differ materially from those projections.
Speaker 2: These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place
These statements involve material risks and uncertainties that could cause actual results or events to materially differ.
Accordingly, you should not place undue reliance on these statements I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation. The Companys form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described.
Speaker 2: I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's Form 20F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking state.
And the forward looking statements poly.
Speaker 2: Polly P. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.
<unk> disclaims any intention or obligation except.
As required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information and speaks only as of the live broadcast today November eight 2023.
Speaker 2: This conference call contains time-sensitive information and speaks only as of the live broadcast today, November 8, 2020.
Speaker 2: with the completion of these prepared remarks. It is my pleasure to turn the call over to Diggler, Chatskis Axelbrot, CEO of PolyP. Diggler.
With the completion of these prepared remarks. It is my pleasure to turn the call over to <unk> <unk> <unk> CEO of Polly P. <unk>.
Speaker 3: Thank you, Ron. On behalf of our team at PolyPid, I would like to welcome everyone to our third quarter, 2023 early...
Thank you Brian.
I would like to welcome everyone to our third quarter 2023.
Speaker 3: To begin, I would like to extend our gratitude to so many of you who have continued to reach out to us to express your concern regarding the health and safety of our employees and their families, giving the horrible acts of violence that took place in Israel on October
To begin <unk>.
I would like to extend our gratitude to <unk>.
So many of you who have continued to reach out to us to express your concern.
The health and safety of our employees and their fans.
Emily.
Do you think the horrible act of violence that took place in Israel on October 7th.
Speaker 3: Despite the terrible news over the last few weeks, we at PolyPD remained focused on ensuring the uninterrupted progress of our ongoing shield to pivotal trials for D-Prix-100 for the prevention of abdominal colorectal surgical sites.
Despite the terrible news over the last few weeks, we had RFP to remain focused on ensuring the other interaction progress of our ongoing.
Pivotal trials for <unk> 100 for the prevention of abdominal colorectal surgical site infection are at this time.
Speaker 3: or SSI. Today, there has been no material impact on our operations and specifically on shield 2. In fact, as we said would be the case by this time, we currently have approximately 20 centers open, the majority of which are outside of...
To date, there has been no material impact on our operations.
Just quickly on ship to in fact, as we said would be the case by this time. We currently have approximately 20 centers open the majority of which are outside of Israel.
Speaker 3: The best majority of these 20 centers have opened only in the last few weeks.
Majority of these 20 centers have opened only in the last few weeks.
Speaker 3: Therefore, while we currently have approximately 50 patients recruited into the shield to a trial, we expect enrollment to ramp up.
Therefore, while we currently have approximately 50 patients recruited into the trial, we expect enrollment to wrap up shortly.
Speaker 3: To this end, we anticipate having approximately 4th-piece centers open by the end of 2020.
And we anticipate having approximately 40 centers open by the end of 2023.
Speaker 3: To give you a better sense of the expected pace of enrollment.
To give you a better sense.
Expected pace of enrollment.
Speaker 3: One society is fully up and running, which takes several weeks following its being formally open, we expect approximately 1.5 patients to be recruited into the trial per centur per...
One society is fully up and running which takes several weeks following its being formed and open we expect approximately 1.5 patients to be recruited into the trial per center.
Speaker 3: We intend to conduct an unblinded entry analysis. Once a total of approximately 400 patients complete their 30-day follow-up, and top-line results are expected in the second half of 2020.
We intend to conduct an unblinded interim analysis once it totaled approximately 400 patients complete the 30 day follow up.
And topline results are expected in the second half of 2024.
Speaker 3: I should also add that while surgical incision links is widely known independent procedural risk factor for SSI and abdominal surgeries, it is not the only...
I would also add that while surgical incision length is widely known independent procedure, a risk factor for our society in abdominal surgeries. It is not the only one.
Speaker 3: In the Shield 1 study, we also observed a positive effect of DeepVux 100 in post-alcanalysis of subgroup of patients with patient-specific...
In the shield one study we also observed a positive effect of duplex 100 post Doc analysis subgroup of patients, which patients specific risk factors, such as obesity diabetes hypertension and COPD.
Speaker 3: such as obesity, diabetes, hypertension, and CO.
Speaker 3: Based on these results, we believe DIPLEX100 has the potential to provide prophylactic secrecy benefits in patients with increased SSI risk factors, both procedural and patient.
Based on these results. We believe duplex 100 has the potential to provide to selected secrecy benefits in patients with increased <unk>.
Risk factors, both procedural and patient specific patient in either of these categories are relatively easily identified baidu search and in the pre and in trial terrorist experience and could be ideal candidates multiplex 100 at the time of infusion.
Speaker 3: Patient in either of these risk categories are relatively easily identified by the surgeon in the pre and intraoperative periods and could be ideal candidates for duplex 100 at the time of incision.
Speaker 3: particularly when there is a need for enhanced SSI antimicrobial.
Yes.
Particularly when there is a need for enhanced Ssi antimicrobial prophylaxis.
Speaker 3: Moving on, as you know, we have a clear regulatory pathway for the potential NDA submission for for the clicks 100 in the year.
Moving on as you know we have a clear regulatory pathway for the potential NDA submission for <unk> 100 in the U S.
Speaker 3: Earlier this year, the FDA acknowledged not only that the shield one result may provide support
Earlier this year DSD.
It's not only the shield. One result may provide supportive evidence of the safety and efficacy of duplex 100 patient with large surgical incisions with OXXO concern. This is successful.
Speaker 3: of the safety and the secrecy of Dibblax 100 in patient with large surgical incision, but also confirmed that is successful, should do is sufficient to support a potential NDA submission.
Sure.
Fishing to support a potential NDA submission.
Speaker 3: We continue to strongly believe that shield 2 is a de-risk phase 3.
We continue to strongly believe that Q2 is a derisk phase III trial.
Speaker 3: Giving the more focus patient population in which we have already generated highly positive data in shape.
Given the more focused patient population in which we have already generated highly positive data in Q1.
Speaker 3: And the fact that it will not be conducted within the tight coffee-related restrictions that were in place during the pandemic and throughout the duration.
And the fact that it will not be conducted within the tight coffee related restrictions that were in place during the pandemic and throughout the duration of she is what we.
Speaker 3: We are also leveraging key learnings from shield one related to the site involved in the
We are also leveraging key learnings from shield one related to the sites involved in the study.
Speaker 3: While we are targeting approximately 50 centers for SHIELD 2, around the same number as SHIELD 1, we now have firm knowledge of the best performing sites and countries from SHIELD 1, in terms of recruitment, patient monitoring, and good clinical.
We are targeting approximately 50 centers for <unk> around the same numbers showed one we now have firm knowledge of the best performing sites and countries. Some shields one in terms of equipment patient monitoring and good clinical practice.
Speaker 3: We believe this to be essential in the execution of...
We believe this to be essential in the execution.
Speaker 3: We have also enhanced our clinical operations team, another key step towards supporting the successful
We have also enhanced our clinical operations team and another key step towards supporting a successful study.
Speaker 3: While we focus on enrollment into SHIL2, we have also recently achieved several key deep-press 100 manufacturing-related milestones that have helped evolve polypid into a fully integrated biopharmacy.
While we focus on enrollment interfere too. We have also recently achieved several key duplex 100 manufacturing related milestone that have helped us false policies into a fully integrated biopharmaceutical company.
Speaker 3: First, we successfully completed the production and release of three process validation ventures of Duplex 1.
First we successfully completed the production and release of three process validation batches of duplex 100.
Speaker 3: This significant accomplishment completes a substantial requirement towards a planned submission of the Plan X100 NDA and EU Marketing Authorization application regulatory files.
This significant accomplishment complete a substantial requirement towards our planned submission of duplex 100, NDA and EU marketing authorization application regulatory filing.
Speaker 3: I should highlight that the successful validation of the production process at commercial scale is the result of a significant flexibility extension and scale up that more than triple the company's capacity to manufacture the FJX100 for the US, EU and global market.
I should highlight that the successful validation of the production process at commercial scale is the result of the significant facility expansion and scale up it's more than tripled the company's capacity to manufacture Gtx 100 for the U S EU and global markets.
Speaker 3: Our in-house state of the art's good manufacturing practice or a GMP sterile production facility provides us with full control of DIPLEX 100 manufacturing from clinical stage to commercial supply and serve as a key competitive advantage going forward.
In our state of the art.
Factoring practices or GMP scale production facility provides us with full control of duplex 100 manufacturing from clinical stage to commercial supply and serve as a key competitive advantage going forward.
Speaker 3: Most recently we completed a successful GMP audit by the Israeli Ministry of Self of our Manufacturing Facility without any critical or major findings. This audit is also valid for European regulatory...
Most recently, we completed a successful GMP audits by the Israeli Ministry of health of our manufacturing facility without any treaty called major findings.
It is also valid for European regulators.
Speaker 3: importantly, we can now produce different 100 at scale in order to fulfill the expected commercial demand.
Importantly, we can now produce X 100 at scale in order to fulfill the expected commercial demand for the product.
Speaker 3: Moving on, we also continue to augment the published and presented research in support of the Plex1.
Moving on we also continue to augment the published and presented research in support of Gtx 100.
Speaker 3: To this end, a paper highlighting positive pre-clinical result that demonstrated for the first time the safety profile of D-Plex 100 and the Plex technology platform in juvenile animals.
To this end our paper highlighting positive preclinical results that demonstrated for the first time the safety profile of duplex 100, and duplex technology platform in juvenile animals.
Speaker 3: was published in the peer-reviewed journal International Journal of the...
It was published in the peer reviewed journal International Journal of Toxicology. This result has the potential to support the clinical evaluation of duplex 100 in the Physiatrics population.
Speaker 3: These results have the potential to support the clinical evaluation of the Plex 100 in the radiiatric population.
Speaker 3: In addition, we recently presented the result of the Shield 1 Phase Retrial for the first time at a medical meeting the American College of Surgeons, Clinical Congress, 2023, which took place last month in bus.
In addition, we recently presented the results of the shield one phase III trial for the first time at a medical meeting the American College of Surgeons clinical Congress 2000, Twenty's suites, which took place last month in Boston.
Speaker 3: I am pleased to report that Polypitch Provost in the advancement of Stipex 100 has not gone unknown.
I am pleased to report positive progress in the advancement of <unk> 100 has not gone unnoticed.
Speaker 3: Last month, Deeplex 100 was selected as the winner of the 2023 overall biopharmate solution of the year as part of the third annual biogic breakthrough awards, which recognized the world's best biogic and life science companies, products and...
Last month duplex 100 was selected as the winner after 'twenty two 'twenty three optimal biopharma solution of the year as part of the third annual biotech breakthrough awards, which recognizes the world's best biotech and life science companies products and services.
Speaker 3: shifting gear. I'd like to highlight that we recently regained compliance with NUSDX minimum closing bid price roll. Also, while joining the review are current financials momentarily, I'd like to emphasize the ongoing cost containment efforts towards our
Shifting gears I'd like to highlight that we recently regained compliance with nasdaq's minimum closing bid price also while Johnny will give you our current financials momentarily.
Like to emphasize the ongoing cost containment efforts towards our business.
Speaker 3: including in clinical operations, GNA and manufacturing. For the first nine months of 2023, our net cash used in operating activities decreased by 56% has compared to the first nine months of 20 years.
Including in our clinical operations G&A and manufacturing for the first nine months of 2023, our net cash used in operating activities decreased by 56% as compared to the first nine months of 2022.
Speaker 3: Finally, I would like to take this opportunity to welcome Dr. Nouit, to his or her sex, who was recently appointed to Polypids Board of Dure.
Finally, I would like to take this opportunity to welcome Tocqueville wheat tweezers sacks.
He was recently appointed to polyp. Its board of directors took so Twitter Saks is a biopharmaceutical industry veteran with extensive executive business development clinical and R&D expenditure.
Speaker 3: Dr. Twizel-Zach is a bio pharmaceutical industry veteran with extensive executive business development, clinical and R&D experts.
Speaker 3: She is an experienced sector investor and was a practising physician for nearly 15 years.
She is an experienced sector investor and it was a practicing physician for nearly 15 years.
Speaker 3: We look forward to leveraging her best expertise across the PD, clinical, R&D, and financial funds.
We look forward to leveraging our vast expertise across the PD clinical R&D and financial assumptions.
Speaker 3: as we approach critical clinical and regulatory milestones, as well as potential commercialization.
As we approached critical clinical and regulatory milestones as well as potential commercialization of <unk> 100.
Speaker 3: On behalf of everyone as polypide, I would also like to express my thanks to Anatsur Segal, who is retiring from our board following 15 years of distinguished service. Mr Segal has provided critical counsel over the years that has helped grow and advance out.
On behalf of everyone at Poly Pete I would also like to express my thanks to our nuts or single who is retiring from our board following 15 years of Distinguished service.
Sure Jacob.
As provided critical counsel over the years that has helped grow and advance our business and we wish her the best in all of our future initiative.
Speaker 3: We will show the best in all of future initiatives.
Speaker 3: With that, I am pleased to turn the call over to Johnny.
With that I am pleased to turn the call over to John Johnny.
Speaker 4: Thank you, Degla. As of September 30th, 2023, the company had cash and short-term deposits of $10.2 million.
Thank you the color as of September 32023, the company had cash and short term deposits of $10 $2 million.
Speaker 4: We continue to expect that our cash balance will be sufficient to fund operations in 2.8-1st quarter of 2024.
We continue to expect that our cash balance will be sufficient to fund operations into the first quarter of 2024.
Now, let's turn to our income statement.
Speaker 4: Research and development expenses for the three months ended September 30, 2023 were $3.8 million compared to $6.2 million in the same three month period of 2020.
Research and development expenses for the three months ended September 32023 was three $8 million compared to $6 2 million in the same three month period of 2022.
Speaker 4: The decrease in R&D expenses resulted primarily from the completion of the Shield 1 phase 3 clinical trial and reflect.
The decrease in R&D expenses resulted primarily from the completion of the shield, one phase III clinical trial and reflect.
Speaker 4: the impact of the cost reduction plan that was executed in the fourth quarter of 2020.
The impact of the cost reduction plan that was executed in the fourth quarter of 2022.
Speaker 4: Marketing and business development expenses for the third quarter of 2023 were $261,000, a decrease from the $840,000 during the prior year of three months period.
Marketing and business development expenses for the third quarter of 2023.
$261000 a decrease from the $840000 during the prior year three month period.
Speaker 4: General and administrative expenses for the third quarter of 2023 were $1.2 million compared to $1.7 million recorded in the same three months period of 2020.
General and administrative expenses for the third quarter of 2023 were $1 $2 million compared to $1 $7 million recorded in the same three month period of 2022.
Speaker 4: For the third quarter of 2023, the company had a net loss of $5.6 million as compared to $9.3 million in the third quarter of 2020.
For the third quarter of 2023, the company had a net loss of $5 $6 million as compared to $93 million in the third quarter of 2022.
Speaker 4: Finally, as the cloud noted, we continue to execute well on our cost containment initials.
Finally ethics I noted, we continue to execute well on our cost containment initiatives.
Speaker 4: As such, our net cash to use and operating activities for the first nine months of 2020.
Such our net cash used in operating activities for the first nine months of 2023 decreased by $16 $1 million as compared to the same period in 2022.
Speaker 4: decreased by $16.1 million as compared to the same period in 2020.
Speaker 4: from 28.9 million dollars to 12.8 million dollars.
$28 $9 million to 12 $8 million.
Speaker 4: With that, we will now open the cold tier question. Operator.
With that we will now open the call to your questions operator.
Speaker 1: Thank you. As a reminder to ask a question you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 and 1 again.
Thank you.
I'd like to ask a question you would need to press star one and one on your telephone.
Wait for your name to be announced to.
To withdraw your question. Please press star one again.
Yeah.
Speaker 1: We will take our first question. And our first question comes from the line of Balaji Passad from Barkas. Please go ahead, your line is open.
We will take our first question.
First question comes from the line of Philosophy Prasad from Barclays. Please go ahead. Your line is open.
Speaker 5: Good morning, this is Xiao An for biology. Thanks for taking our questions. As we are going into 2024, could you highlight the key upcoming milestone events and catalysts down the road so that we should be mindful of those events? Thank you.
Hey, Good morning. This is Michelle pole kolache, thanks for taking our question.
We are going into 'twenty before could you highlight the key upcoming milestone events and catalysts down the road. So that we should be mindful of those events. Thank you.
Speaker 3: Thank you, so good morning. Yes, sure. So I think that obviously looking at our clinical trial, our shields to Phase 3 trial, the first milestone will be a completion of recruitment for the Intriminalis, 430, almost 430 patients. And this will be expected towards the end of the first quarter, early second quarter.
Thank you Darla and good morning.
Yes, sure. So I think that the obviously looking at a clinical trial or shelters.
Two phase III trial, the first milestone will be complete.
Completion of recruitment for the interim analysis for 130, almost 430 patients and this will be expected towards the end of the first quarter early second quarter.
Speaker 3: And two months after that, we should have the feedback from the DMC committee on the entry analysis. So we're talking about around July .
And two months after that we should have the feedback from the DNC Committee on the interim analysis. So we're talking about around July.
Speaker 3: human continuum of recruitment, a quarter post last patient for the interim, we should have last patient in.
Human continue recruitment quarter post the last patient for the interim we should have last patient in.
Speaker 3: and shortly after that the top line from the
And.
Shortly after that the top line for from the <unk>.
Speaker 3: last patient from the top line actually. And obviously this is our main focus today and our main...
Last patient from the top client actually and obviously this is our main focus today and our main.
Speaker 3: investment in the company, all the companies targeted towards the clinical trial and everything that is associated with that.
That meant in the company all the company is targeted towards the clinical trial and everything that is associated with that in parallel to that as we previously said we are in different discussions on commercializing duplex in different geographies and we would expect as we get.
Speaker 3: In parallel to that, as we previously said,
Speaker 3: We are in different discussions on commercializing deeply.
Speaker 3: indifference geographies and we would expect as we get closer to the interim, similar to what we had we chilled one. As we were getting closer to top line and interim
Closer to the injury similar to what we had we chilled one as we were getting closer to topline and entry discussions were much more robust and shortly before publishing the data we signed our European licensing deal. So we would expect to see this also.
Speaker 3: discussions were much more robust and shortly before publishing the data we signed our European licensing deal. So we would expect to see this also in the front of other geographies. And obviously lastly, we're looking on our platform related deal, our own complex.
In the front of other geographies and obviously lastly, we're looking on our platform related deal our own complex.
Speaker 3: These are also discussions that are ongoing. There is work that is done there. Obviously, at this stage, investor are less exposed to everything that is done. But once we do have what to share, we will share. So this is mainly the main.
These are also discussions that are ongoing there is work that is done there. Obviously at this stage investor are less exposed to everything that is done but once we do have that what what to share. We will share. So this is mainly the main <unk>.
Speaker 6: catalyst that we will be looking for. And as we get the interim data, obviously there will be other catalysts that are related to commercialization. Thank you.
Catalyst that we were looking for and as we get the interim data obviously, there will be other catalysts that are related to commercialization.
Thank you.
Thank you.
Thank you.
We will take our next question.
Speaker 1: Your next question comes from the line of Roy Buchanan from JMP. Please go ahead, your line is open.
Your next.
Comes from the line of Voip Mackinnon from JMP. Please go ahead. Your line is open.
Speaker 7: Hi, great. Thanks for hosting the call and thanks for taking the question. I guess the first one and thanks for providing the timelines for the potential timelines for the interim. Does can you remind us the potential outcomes for the interim and again is the potential for resizing the trial as was the case with shield one of potential in shield two.
Hi, great. Thanks for hosting the call and thanks for taking the question.
The first one.
Thanks for providing the timelines for the potential timeline for the interim but can you remind us.
Our comments for the interim and again is that potential for Refis and the trial as was the case with shield, one potential and shield two.
So.
Speaker 3: Good morning, Roy and thank you. So the potential outcome of the interim could be, and I would want to remind everyone that if you remember, in shield one, at 423 patients on the same focus patient population, we had 54% reduction of infection with p-value of 0.0032.
Morning Glory in 10-Q.
So the potential outcome of the interim could be and I would want to remind everyone that if you remember in shield one at 423 patient on the same focused patient population, we had 54% reduction of infection with P value of zero point.
032, so very much in line with what the FDA would want to see and with the potential early stop for efficacy. So the first option.
Speaker 3: So very much in line of what the FDA would want to see with the potential early stop for efficacy. So the first option is obviously early stop for efficacy if the data and the statistics.
Obviously early stop for efficacy if the data and the statistic called planning is robust enough.
Speaker 3: Coal plan is robust enough. If we are mimicking what we saw in shield one, this should be more than sufficient for an early stop first.
If we are mimicking what we saw in shield one this should be more than sufficient for an early stop first you can see.
Speaker 3: As always with clinical trial, the other option is that the DMC will tell us that the trial is fatal, and there's no chance to succeed. And there is also room for recive.
As always with clinical trials. The other option is that the DMC will tell us that the trial is.
They told Fettle and there's no chance to succeeding and there is also room for sizing.
Yes.
Speaker 3: And as we get that also data and understanding the overall infection rate, we can start showing that as well.
Okay and then.
And not and understanding the overall infection rate, we can start sharing that as well.
Speaker 7: Okay, that's actually my next question that blinded infection rate. Just wondering if you had a sense of it, it didn't line with your expectations going into the trial.
Okay that was actually my next question.
Blinded infection rate just wondering if you had it.
Is it in line with your expectations going into the trial.
Speaker 3: So it is in line, but I think that, you know, saying that from our experience, we need to have the first 100 patients to see a train.
So it is in line, but I think that you know.
Now, saying that from our experience we need to have the first 100 patient to see a trend.
Speaker 3: because as you can imagine, as we start recruiting, patients are coming from...
Because as you can imagine as we start recruiting patients are coming.
Hum.
Speaker 3: Hand full of centers and as we start opening the centers we now have 20 by the end of the year We will have 40 and beginning of 2024. We expect to have another 10 And with an average recruitment rate of 1 and a half patients per center We will start seeing recruitment rate rumping up pretty quickly and at that point where patients are more spread Geographically and center-wide
A handful of centers and as we start opening the centers. We now have 20 by the end of the year. We will have 40 and beginning of 2024, we expect to have another 10.
And we then average recruitment rate of one and a half patient per center, we will start seeing equipment trade ramping up pretty quickly and at that point, where a patient on most spread geographically and center wide.
Speaker 3: We believe the trend will be much more visible and much more indicative. But for now, we definitely see the infection rate in line with our expectations.
We believe the trend will be a much more.
Feasible and much more indicative, but for now we definitely see the infection rate in line with expectation.
Speaker 7: Great. And maybe can you just elaborate a little bit on the, I guess, K, of the potential partnering discussions. And you mentioned oncoplex. Are you actively, if they're looking to partner oncoplex or doing internal work with it to be able to present a potential partner as a bit unclear on that? And then just more broadly, just how are you thinking about your capital runway and addressing the need to get to the data? You know?
Okay, great. Thanks, and then maybe can you get to elaborate a little bit on that.
I guess cadence of the potential partnering discussions and you mentioned also plaques are you actively out there looking to partner on <unk> sorry.
Are doing internal work with it too.
Yes.
All right.
Clear on that and then just more broadly just how are you thinking about your capital runway in.
Addressing the need to get to that to the data. Thanks.
Speaker 3: So obviously I can't say much on the partnering, but maybe to give a bit of coloring on that. So we are, and we said before, we are in discussions on both fronts, the diplox front, as well as the platform-related slash oncology program. And we are also doing internal work that is not at this stage.
So obviously I can't say much on the partnering but maybe to give a bit of.
Colouring on that so we are and and we said before we are in discussions on both.
Both fronts.
Duplex front as well as the platform related slash oncology program.
And we are also doing internal work.
That is not at this stage.
Speaker 3: Requiring heavy investment because obviously our cash is all
Requiring heavy investment because obviously with our cash is all.
Speaker 3: focused on SHIL2 and getting the program to top line, but we do have an internal program that is more targeting supporting potential collaboration. What we believe will be needed or what we are hearing from those discussions that is needed in order to...
Focused on tier two and getting the program to topline that we do.
Have an internal program.
That is more targeting supporting potential.
Collaboration what we believe will be needed or what we are hearing from those discussion that is needed in order to.
Hum.
Speaker 3: promote a potential partner.
Promote a potential partnership.
Speaker 3: And you were also asking about our financial runway. So as we've indicated, our cash, you've seen that we've entered the quarter with over $10 million and we've indicated that this is sufficient to take us all the way through the end of the first quarter.
And you were also asking about our financial runway so as we've indicated.
Cachet, you've seen that we've ended the quarter with over $10 million and we've indicated that this is sufficient to take us all the way through the.
Towards the end of the first quarter.
Speaker 3: Uh, with, uh, the, uh.
Okay.
The.
Speaker 3: Obviously with running the trial force be the head full recruitment rate so it takes all
Obviously with running the trial full speed ahead full recruitment rate. So it takes all that into consideration I should remind everyone that once we have the top line result from our phase III trial, we have a potential milestone from it.
Speaker 3: I should remind everyone that once we have the top line result
Speaker 3: From our phase 3 trial, we have a potential milestone from a transformer.
Speaker 3: So this is an immediate milestone that is expected once we have phase three data. And obviously, we are looking at different alternatives on financing the trial. And I must say that what makes us very encouraged is the level of support.
<unk> pharma. So this is a an immediate milestones that is expected once we have phase III data.
And obviously, we are looking at different alternatives on.
Financing the trial and I must say that the what makes US very encouraged is the level of support that our largest shareholder.
Speaker 8: that our largest shareholder have shown in the past and are showing now. Great.
Shown in the past and are are showing now.
Great. Thank you.
Thank you.
Thank you.
We will take our next question.
Speaker 1: Your next question comes from the line of Raguran, Selva Raju, from HC, Wayne Wright, please go ahead, your line is open.
Your next question comes from the line of Mike around self erosion from H C. Wainwright. Please go ahead. Your line is open.
Speaker 5: Thanks very much for taking my questions. Firstly, I was just wondering if it would be possible at all for you to give us an update on the number of patients in shield two who have completed their 30-day follow-up at this time.
Thanks, very much for taking my questions. Firstly I was just wondering if it would be possible at all for you to give us an update on the number of patients in shield two who have completed their 30 day follow up at this time.
Speaker 3: Right. So, yeah, sure, we could do that. As I said, we've been in the pre-purdermy mark. We have about 50 patients already enrolled. And I would say that around 40 has been...
Right. So yes, sure we could do that.
As I've said in the prepared remark, we have about a 50 50.
<unk> patient already enrolled and I would say that around them.
<unk> has finished its 30 days.
Speaker 5: Also, in the context of partnering discussions, maybe you can just comment a little bit on the extent to which the fact that you have commercial scale up work already significantly accomplished. Play the role in...
Also in the context of partnering discussions maybe you can just.
Comment a little bit on the extent to which the fact that you have commercial scale up work.
Already significantly accomplished.
Plays a role.
Speaker 5: increasing the attractiveness of this asset for potential partners. And if you could give us a sense of what your preferred working arrangement might be in the future with a potential licensee partner or distributor with respect to the manufacturing, if this is something that you would like to continue to maintain in-house, or if it's something that you anticipate potentially doing tech transfer on in the future.
Increasing the attractiveness of this asset for potential partners and if you could give us a sense of what your preferred working arrangement might be in the future with a potential licensee partner or a distributor with respect to the manufacturing. If this is something that you would like to continue.
To maintain in house or is it something that you anticipate potentially.
Doing tech transfer onto the future.
Speaker 3: So first of all, thank you for this question, because
So first of all thank you for this question.
Because.
Speaker 3: We believe that it is essential. And it's not just a belief we've seen that in our discussions with our European partner advanced farmer. It was essential to the discussion and it was essential to their due diligence. They obviously came to Israel, reviewed the facility, reviewed the process, reviewed the line of approval that the facility has.
We believe that it is essential and and it's not just I believe we've seen that in our discussions with our European partner advanced pharma. It was essential to the discussion and it was essential to their due diligence. They obviously came to Israel with you.
The facility with you the process review the line of approval that the facility has.
Speaker 3: The manufacturing is not trivial. It's not trivial and this was the trigger.
The manufacturing is not trivial, it's not trivial and this was.
The triggering for us going into this that adventure of building our own manufacturing facility, because we understood that we're not going to get a good enough solution from a CR or our CMO and this was the motivation to make the investment five years six years.
Speaker 3: going into this adventure of building on one manufacturing facility, because we understood that we're not going to get a good enough solution from a CRO or a CMO. And this was the motivation to make the investment five, six years ago and build our own manufacturing facility. And we believe it is essential.
Does that go and build our own manufacturing facility and we believe it is essential.
Speaker 3: Going forward to and we see that in all of our discussion our ability to
Going forward too and we see that in all of our discussion our ability to do.
B.
Speaker 3: a fully integrated bio from a surgical partner of the big farmer is really important.
A fully integrated biopharmaceutical partner off the big pharma is really important.
Speaker 3: And looking forward an additional partnering, I think it's something that we would suggest, obviously to maintain. I think it's an added value that we are bringing and the facility that we have is sufficient for the first several.
And looking forward on additional partnering I think it's a it's something that we would suggest obviously to maintain I think it's an added value that we are thinking and the facility that we have is sufficient for the first several years of well.
Speaker 3: years of full commercialization so we are on a solid ground there.
Full commercialization. So we are on a solid ground there.
Speaker 3: saying that if in some different geography, the margin will motivate us and the partner to have a...
Correct.
I think that if in some different geographies the margin will motivate us and the partner to have a dip.
Speaker 3: different facility, we are open to that. I can tell you that our full control of the manufacturer gives us obviously a larger portion of the end cell and this is something that we would want to maintain.
A different facility. We are open to that I can tell you that or full control of the manufacture keeps.
It gives us obviously, a larger portion of debt and sale and this is something that.
We would want to maintain.
Speaker 5: And lastly, outside of the US and Europe , can you just enumerate for us again, which other non-core territories might be economically interesting from a partnering perspective with regard to the broader global commercial opportunity for a deep life?
And lastly outside of the U S and Europe can you just and Numerate for us again.
Other non core territories might be economically interesting from a partnering perspective.
With regard to the broader global commercial opportunity.
For duplex.
Speaker 3: So obviously there are the obvious countries there.
So obviously there are the obvious countries there.
Speaker 3: Western type of countries, Canada, Australia, Japan, South Korea. This is obviously an obvious market opportunity, but we are also seeing that looking on margin and level of infection and
Western type of countries, Canada, Australia, Japan.
Both Korea this is August.
And obvious market opportunity, but we are also seeing that looking on margin and level of infection and.
Structural.
Speaker 3: payment or repayment South America is a definite opportunity China India so obviously Middle East here, but those those are all potential Territories we've seen some
Hey, mental repayment South America is a definite opportunity China, India, So obviously middle east here, but.
Those are all potential.
Territories, we've seen some.
Reports on that.
Speaker 3: Also as part of our discussions with the potential cost and margin there. So it's really
Also as part of our discussions with the with the potential cost and margin there.
So it's really.
Globally.
Thank you.
Thank you.
Speaker 1: Thank you. There seems to be no further questions that I would like to hand back for closing remarks.
Thank you that seems to be no further questions I would like to hand back for closing remarks.
Okay.
Speaker 3: Thank you for joining Polypiz Third Quargeur 2023 Erning Conference Call. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, Deeplex 100.
Thank you for joining polyp is third quarter 2023, earning conference call. We remain highly confident in our long term prospects, especially the potential of a promising late stage product candidate <unk> 100.
Speaker 3: As always, we are grateful to our team members, shareholders and all our external partners for their commitment to our mission and their support in continuing to advance toward our goal of bringing the PLAX100 to healthcare providers and patients as quickly as possible.
As always we are grateful to our team members shareholder and all our external partners for their commitment to our mission and their support and continuing to advance toward our goal of drinking duplex 100 to health care providers and patients as quickly as possible.
Speaker 3: We look forward to speaking with you again on our next conference.
We look forward to speaking with you again on our next on our next conference call.
Speaker 1: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
[music].
Yes.
Okay.
[music].