Q4 2023 PolyPid Ltd Earnings Call
Okay.
Operator: Greetings and welcome to the PolyPid fourth quarter and full year 2023 conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is recorded, and I would now like to introduce your host for today's conference, Brian Ritchie from Lifesci Advisors. Mr. Ritchie, you may begin.
Okay.
We can.
Welcome to the party piece fourth quarter and full year 2023 conference call. At this time all participants are in a listen only mode. As a reminder, this call is Rick called it and I would now like to introduce your host for today's conference, Brian Ritchie from lifestyle advisors Mr. Ritchie.
You may begin.
Brian Ritchie: Thank you all for participating in PolyPid's fourth quarter and full year 2023 earnings conference call. Joining me on the call today will be Dikla Chachkis-Oxelbrad, Chief Executive Officer of PolyPid, Johnny Misalawan, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer of PolyPid, earlier today. PolyPid released financial results for the 3 and 12 months ended December 31st, 2023.
Thank you all for participating in <unk> fourth quarter and full year 2023 earnings conference call.
Joining me on the call today will be Dr. <unk>, OXXO, Brad Chief Executive Officer of Polly P. Johnny Michel Aoun, Poly Pizza, Chief Financial Officer, and Ori or shops ski Chief operating officer of Poly Pete earlier.
Earlier today <unk>.
<unk> released financial results for the three and 12 months ended December 31 two.
2023.
Brian Ritchie: A copy of the press release is available in the investor section on the company's website, www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities law. For example, management is making forward-looking statements when it discusses the expected timing for recruitment and top-line results from the SHIELD-2 trial and the unblinded interim analysis, the planned new drug application submission for DPLEX-100, the potential impacts and uses of Oncoplex and the PLEX platform, the company's expected cash runway, and the potential to receive additional funds if warrants are expected. Forward-looking statements are subject to numerous risks and uncertainties, many 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. 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.
A copy of the press release is available in the investors section on the company's website www Dot <unk> dot com.
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 the expected timing for recruitment and topline results from the shield two trial.
The unblinded interim analysis planned new drug application submission for <unk>, 100, and the potential impacts and usage for encore Plex and the flex platform the company's expected cash runway and the potential to receive additional funds if warrants are exercised.
Forward looking statements are subject to numerous risks and uncertainties many 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.
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.
Brian Ritchie: I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement. PolyPid 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 This conference call contains time-sensitive information and speaks only as of the live broadcast today, February 14th, 2024, at the completion of these prepared remarks. It is my pleasure to turn the call over to Dikla Tashkis-Axelrod, CEO of PolyPid. Thank you, Dikla.
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 in the forward looking statements <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 February 14th 2024.
With the completion of these prepared remarks.
It is my pleasure to turn the call over to <unk> fastest actual broad CEO of Polly P equal thank.
Dikla Chachkis-Oxelbrad: Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone, including our new shareholders, to our fourth quarter and full year 2023 results. We are thrilled with the significant progress recently achieved throughout our, As we expected, enrollment in our ongoing SHIELD2 pivotal trial for DIPLEX-100 for the prevention of abdominal colorectal surgical site infection has begun to ramp up. We have also generated some new, highly compelling preclinical data with Oncoplex that demonstrates its potential in oncology.
Thank you on behalf of our teammates colleagues I would like to welcome you.
Including our new shareholders to our fourth quarter and full year 2023 earnings call.
We are thrilled with the significant progress recently achieved throughout our business as we expected enrollment in our ongoing shift to a pivotal trial for <unk> 100 for the prevention of abdominal colorectal surgical site infection has began to ramp up.
We have also generated some new highly compelling preclinical data with uncle Sam.
It demonstrates its potentially in oncology.
Dikla Chachkis-Oxelbrad: Moreover, in order to support our robust clinical development efforts, we successfully completed a $16 million financing that included participation from multiple new U.S. life sciences-focused investors. I will discuss all of this in greater detail shortly, but let's begin with the status of Shield. The study has now enrolled more than 100 subjects, and approximately 40 centers are currently open. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients, a plan total of 600 subjects, complete the 30-day form, which is expected to occur in mid-2020. Top-line results are anticipated in the second half.
Now all of that.
In order to support our robust clinical development efforts, we successfully completed $16 million financing that included participation from multiple new U S life Sciences focused investors.
I will discuss all of these in greater detail shortly but let's begin with the status of share too.
The study has now enrolled more than 100 subjects in approximately 40 centers our currency.
As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients.
<unk> totaled 600 subjects complete the 30 day follow up which is expected to occur in mid 2024.
Top line results are anticipated in the second half of this year.
Dikla Chachkis-Oxelbrad: With respect to the expected recruitment rate, as we said in our last call, Once the site is fully up and running, which takes several weeks following its being formally opened, we anticipate approximately one and a half patients being recruited into the trial per center per month, and we expect to have overall approximately 60 centers opened and recruiting patients. Moving on, to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for DPLEX-100 in the U.S. Last year, the FDA acknowledged not only that the SHIELD1 result may provide supportive evidence of the safety and efficacy of DTX100 in patients with large surgical incisions, but also that if successful, SHIELD2 is sufficient to support a potential NDA submission.
With respect to the expected recruitment rate as we said on our last call. What society is fully up and running which takes several weeks following its being formally open we anticipate approximately one and a half patients being recruited into the trial first center 10 months.
And we expect to US overall, approximately 60 centers open and recruiting patients moving on to reiterate what we have said previously we have a clear regulatory pathway for the potential NDA submission for <unk> 100 in the U S.
Last year.
The FDA acknowledged knocked on me that the shield one.
<unk> may provide supportive evidence of the safety and the secrecy of steep six 100 in patients with large surgical incision.
But also a concern that if successful she'll too is sufficient to support a potential NDA submission.
Dikla Chachkis-Oxelbrad: We continue to strongly believe that SHIELD 2 is a de-risk phase 3 given the more focused patient population for which we have already generated highly positive data in SHIELD-1 and the fact that it will not be conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD-1. We are also leveraging key learnings from SHIELD-1 related to the sites involved in the study. While we are targeting approximately 60 centers for SHIELD2, around the same number as SHIELD1, we now have firm knowledge of the best performing sites from SHIELD1 in terms of recruitment, patient monitoring, and good clinical practice. We believe this to be essential in the execution of shielding.
We continue to strongly believe that here too is a derisk phase III trial.
Using the most searches patient populations in which we have already generated highly positive data and shows one and the fact that it will not be conducted within the tight corporate related restrictions.
Were in place during the pandemic and throughout the duration of shield one.
We're also leveraging key learning some short one related to the sites involved in the study.
While we are targeting approximately 60 Sanchez Porsche to around the same number achieved one we now have some knowledge of the best performing sites. Some shields one in terms of recruitment patient monetary and good clinical practice, we believe this to be essential index.
<unk> asked you to.
Dikla Chachkis-Oxelbrad: We have also enhanced our clinical operation team, another key step towards supporting a successful study. Moving on, I'm excited to report today some new preclinical data generated with our Oncoplex product kit. We have recently demonstrated the ability of Oncoplex to be injected intratumorally while having an effective and prolonged antitumor impact. A single intratuberal injection of Oncoplasma significantly reduced tumor growth and increased survival in two well-established and commonly used tumor animal models, murine melanoma and murine colon carcinoma.
We have also enhanced our clinical operations team and another key step towards supporting a successful study.
Moving on I am excited to report today, some new preclinical data generated with our own complex product candidate. We have recently demonstrated the ability of <unk> to be injected intra tumoral <unk>, while having effective and prolonged antitumor impact.
<unk> intra tumoral injection of Oncogenex significantly reduced tumor growth and increased survival in two well established and commonly used timber.
Models yearend Melanie.
Melanoma at yearend colon carcinoma.
Dikla Chachkis-Oxelbrad: Archoplex has now shown secrecy in all models tested and across the various therapeutic approaches, either as a neoadjuvant via intra-tumoral injection or as an adjuvant via post-resection application in the tumor patient. To date, Oncoplex has been tested in six different models and applications, all with highly effective results. The effect of Oncoplex is attributable to the Plex technology's unique mechanism of action that allows constant and prolonged release of the therapeutic chemotherapeutic drug. Dose of The locality, combined with the prolonged and constant release rate, can promote deep penetration of the drug into the tumor with minimal systemic exposure to the chemotherapeutic agent. The intratumoral injection of the PLEX platform could enable it to be used as an interventional oncology treatment, not only with dosatexel but also with additional chemotherapeutic agents or other types of molecules, such as antibodies, D-specifics, and nucleic acids.
Complex is now shown as CTC in all models it is being tested and across the various to a classic approaches either as of now adjuvant intra tumoral injection, Oregon Adjuvant <unk> post resection application in the tumor bed.
To date on complex is being tested in six different models and applications all with highly effective result.
The effect of uncle Plex is attributable to the <unk> technologies unique mechanism of action that allows constant it along release of the top variety chemotherapeutic drug docetaxel.
Hello quality combined with the prolonged and constant release rate can promote deep penetration of the drugs into the teal manner with minimal systemic exposure.
The chemotherapeutic agent <unk>.
The intra tumoral injection of the flex platform could enable it to be used as an intervention oncology treatment not only with Tulsa excel, but also with additional key mature aquatics.
Or other types of molecules such as <unk> antibodies.
Specifics and nucleic acid shifting gears, we were pleased to recently significantly profile our balance sheet by successfully closing a private placement financing all pipe for $16 million of gross proceeds.
Dikla Chachkis-Oxelbrad: Shifting gears, we were pleased to recently significantly protify our balance sheet by successfully closing a private placement financing or pipe for 16 million dollars of gross profit. The PIPE syndicate was comprised of new and existing investors, including participation from U.S. life science focused investors, DAFNA, Capital Management, and Rosling & Feinberg. Presented to the PIPE, the investors purchased $3,371,312 of the company's ordinary shares, all pre-funded words in Liadere, at a purchase price of $4.81 per share for gross proceeds of $16 million and received warrants to purchase up to the same amount of shares of common stock with an exercise price of $5.50 per share for a total exercise price of $19 million. The words expired upon the earlier of two years from the date of issuance and 10 trading days following PolyPid's announcement of a positive recommendation by the Data Safety Monitor Board regarding the company's unblinded interim analysis in its SHIELD 2 phase 3 trial of DIBLEX-100, resulting in the stopping of the trial due to positive.
The pipe syndicate was comprised of SKU and existing investors, including participation from U S life Science focused investors, that's not capital management and modeling and sensor.
To the pipe the Investor purchased 3 million 371312 off the company's ordinary shares all pre funded warrants at their house.
And the purchase price of four point H, one dollar per share.
For gross proceeds of $16 million and received warrants to purchase up to the same amount of shares of common stock with an exercise price of 5.5 dollars per share for total exercise price of $19 million.
The warrants expired upon the earlier of two years from the date of issuance and 10 trading days following poly pizza announcement of a positive recommendation by the data safety monitoring board regarding the company's unblinded interim analyses in shell to phase III.
Trial, how steep looks 100, resulting in the stopping of the trial due to positive secrecy.
Dikla Chachkis-Oxelbrad: The initial $16 million extended our cash one way until late in the third quarter of 2024 and behind the anticipated timing of SHIELD 2's planned unblinded entry. If the results of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, the additional $19 million would fund PolyPid until the start of a planned new drug application submission for Diplex 100. I'd like to take the opportunity to thank all of the investors who participated in this financing for their confidence and support. With that, it is my pleasure to turn the call over to Johnny. Johnny?
The initial $16 million extended our cash runway until late in the third quarters of 2024 and behind the anticipated timing of <unk> planned on blinded interim analysis is the result of the unblinded interim analysis are positive and all of the warrants issued.
In the financing extra.
Exercise the additional $19 million would fund quality to the start of our planned new drug application submission for duplex 100.
To take the opportunity to thank all the investors who participated in this financing for their confidence and support.
With that it is my pleasure to turn the call over to John Johnny.
Johnny Misalawan: Thank you, Nicola. As of December 31st, 2023, the company had cash and short-term deposits of $5.3 million, which amounted to $12.6 million at the end of 2020. This does not include the net proceeds of approximately $15 million dollars generated from the PIPE financing closed in January 2020.
Thank you Claire.
As of December 31st 2023, the company had cash and short term deposits of $5 $3 million.
Compared to $12.6 million at the end of 2022.
This does not include the net proceeds of approximately $15 million generated from the pipe financing closed in January 2024.
Johnny Misalawan: As Dikla noted, we expect that our Proforma Cash Balance will be sufficient to fund operations into late the third quarter of 2020. Now, let's turn to our income statement. Research and development expenses for the three months ended December 31st, 2023, were $4.6 million, compared to $4.7 million in the same three-month period of 2021. R&D expenses in the most recently completed fourth quarter were driven by the ramp-up of the ongoing SHIELD 2 Phase 3 trial for the full year ended December 31st, 2023 and 2020. R&D expenses were $16.1 million and $28 million, respectively. Marketing and business development expenses for the fourth quarter of 2023 were $193,000 compared to $350,000 during the prior year period. General and administrative expenses for the fourth quarter of 2023 were $1.2 million, compared to $1.6 million recorded in the same three-month period of 2022.
As <expletive> noted, we expect that our pro forma cash balance will be sufficient to fund operations into late third quarter of 'twenty 'twenty four.
Now, let's turn to our income statement.
Research and development expenses for the three months ended December 31 2023.
Our four $6 million compared to $4 $7 million in the same three month period of 2022.
R&D expenses in the most recently completed fourth quarter were driven by the ramp up of the <unk>.
Ongoing shield two phase III trial.
For the full year ended December 31st 2023, and 2022, R&D expenses were $16.1 million and $28 million respectively.
Marketing and business development expenses for the fourth quarter of 2023 were $193000 compared to $350000 during the prior year period.
General and administrative expenses for the fourth quarter of 2023 were $1 $2 million compared to one 6 million recorded in the same three month period of 2022.
Johnny Misalawan: For the fourth quarter of 2023, the company had a net loss of $6.4 million, as compared to $6.6 million in the fourth quarter of 2022. For calendar year 2023, the company had a net loss of $23.9 million, compared to a loss of $39.6 million in the full year 2022. Finally, we continue to execute well on our cost containment initiative. As such, our net cash use in operating activities for full year 2023 decreased by $17 million as compared to calendar year 2021, from $34.3 million to $17.3 million. With that, we will now open the call to your questions, operator. 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.
For the fourth quarter of 2023, the company had a net loss of $6 $4 million as compared to $6 $6 million in the fourth quarter of 2022.
For calendar year 2023, the company had a net loss of $23 $9 million.
Paired to a loss of $39 $6 million and the full year 2022.
Finally, we continue to execute well on our cost containment initiatives.
As such our net cash used in operation operating activities for full year 2023 decreased by $17 million as compared to calendar year 2022.
From $34.3 million to $17 $3 million.
With that we will now open the call to your questions operator.
Thank you as a reminder to ask a question that you would need to press star one on one on your telephone and wait for your name to be announced.
Operator: To withdraw your question, please press star 1 and 1 again. We will take our first question, and your first question comes from the line of Roy Buchanan from JNP. Please go ahead; your line is open. Hey, great, thanks for taking the questions. First, I had a couple on the SHIELD-2 interim.
To withdraw your question. Please press star one and one <unk>.
We will take our first question.
Your first question comes from the line of Roy Buchanan from JMP. Please go ahead. Your line is open.
Hey, great. Thanks for taking the questions first I had a couple on the shield two.
Dikla Chachkis-Oxelbrad: Just can you remind us the powering of the interim for a successful efficacy outcome, i.e., stopping the trial early for efficacy? And then what is the alpha spend for the interim? So, um, first of all, good morning, and thank you for the call. The alpha depends on the final and on the overall number; in general, in order to get, to an early stop, the power for the interim itself, in order that the committee will tell us that we should stop the trial for robust data, the alpha should be 0.01. The overall penalty of the alpha depends on the overall size of the trial. So if we are sent to 600 or sent to 800, the alpha will be different because it gives you an earlier sort of look into the data. But I can tell you that at the end of the day, in SHIELD-1, the alpha on the interim was very, very minimal. We had the interim on 750, if I recall, and overall, 1,000 patients, and it was very minimal. And the powering is 90%.
Interim just can you remind us the powering of the interim for a successful efficacy outcome E. Stopping the trial early for efficacy and then what is the alpha spend sort of interim.
So.
First of all good morning, and thank you for the call. They also depends on the final on the overall number in general in order to get.
Yes.
Two an early stop the power for the interim itself in order that the committee will tell us that way.
We should stop the trial for robust data.
So it should be 0.01.
But overall the penalty of the IL four depends on the overall size of the trial. So if were sent to 600 or whether we are sent to 800, the alpha will be different because it <unk>.
Gives you an earlier close.
Looking to the date I can tell you that at the end of the day.
In shield one the outbound into it was.
Minimal we had their entry and one 760, <unk>, if I recall and an overall 1000 patient and.
It was very.
Very minimal.
And the powering is 90%.
Dikla Chachkis-Oxelbrad: Okay, great. And then just to be clear on the potential warrant exercise, again, the interim success is considered to be a recommendation to continue the trial unchanged, correct? You don't need to stop early for efficacy to be considered a success. So the 10-day period is only in effect if the study stops with positive data. Overall, at the time, we will have around a year plus for the warrant, and the rest, all others.
Okay, Great and then just to be clear on the.
The potential warrant exercise again for the interim success is considered to be a recommendation to continue the trial unchanged correct you don't need to stop early for efficacy to be considered a success.
A 10 day period is is.
On the <unk>.
Perfect. If this the study it stopped.
With me today.
But overall at this time, we will have around Europe.
Plot for the warrant is that the rest are all other scenarios.
Dikla Chachkis-Oxelbrad: Okay, got it. Thank you. And then, just on the pipeline, can you just discuss a bit the, I guess, partnering outlook or progress for the Plex technology outside of D-Plex 100? And then just what other development activities do you have planned for this year?
Okay got it. Thank you and then just.
On the pipeline can you just discuss a bit.
I guess partnering outlook or or progress for the flex technology outside of the <unk> 100, and I guess, what other development activities do you have planned for this year. Thanks.
Dikla Chachkis-Oxelbrad: Thanks. Sure. So we are continuing and also initiating some additional discussions around the platform. Part of the Oncoplex new data that we published today or referred to today is part of the input that we're getting from some of those discussions. So understanding what should be the next step or what partners would want to see in terms of potential efficacy of the product helps our research and development to direct internal development, obviously, and some of this animal data are part of our understanding from the discussions, And within that, we conclude on COPLEX.
Sure sure. So we are continuing.
And also initiating some additional discussions around the platform part of the Oh complex new data that we published today.
Today or referred to today is part of.
Input that we're getting from some of those discussions so understanding.
What should be the next step of what partners would want to see in terms of potential efficacy of the product helps.
Research and development to direct are they internal development, obviously and and.
Some of this the animal data are part of our understanding from discussion and we are continuing robustly clean.
To discuss both the potential future collaborations of duplex as well as platform related collaboration and within that we conclude on complex. Obviously the timing of the maturity of this discussion is something that we cannot predict and cannot discuss.
Operator: Obviously, the timing of the maturity of this discussion is something that we cannot predict and cannot discuss, but we are very pleased with the kind of companies that are discussing with us. The level of companies that are discussing and showing interest in our approach is encouraging. Okay, thanks for taking the question. Thank you. We will take our next question. Your next question comes from the line of Balaji Prasad from Barker's. Please go ahead. Your line is open. Hi, good morning. This is Shell on for Balaji.
But we are very pleased with them.
The kinds of companies that are discussing with us the level of the company.
That are discussing and showing interest in <unk>.
Our coach is encouraging.
Great. Thanks for taking the questions.
Thank you Ray.
Thank you.
We will take our next question.
Your next question comes from the line of <unk> Prasad from Barclays. Please go ahead. Your line is open.
Hi, Good morning. This is Michel apologies, thanks for taking our question.
Dikla Chachkis-Oxelbrad: Thanks for taking our question. I'm wondering if it is possible for you to provide an update on the number of patients who have completed their 30-day follow-up at this time. Thank you.
Wondering if it's possible for you to provide an update on the number of patients who have completed their follow up at this time. Thank you.
Sure. So so first of all good morning, Sharon. Thank you for your question.
Dikla Chachkis-Oxelbrad: Thank you for your question. We recently announced that we recruited the 100th patient and, you noticed, in today's press release, we've already indicated that we have more than 100 patients, although only a few days have passed, I think two or three days. So things are progressing, and we started to see we obviously had some slowdown around the end of the year and the beginning of the year due to the holidays and the winter break, but we do start to see the similar trend that we saw in SHIELD1 of ramping up.
We recently announced that we recruited 100 patient.
And.
You noticed in our in today's press release, we've already indicated that our we have more than 100 patient although on the.
Few days have passed.
I think a two or three days so things are progressing and we started to see we obviously had.
Some slow down around the end of the year beginning of the year due to the holidays and the winter break, but we do start to see the similar trend that we saw in shield one of ramping up most of the patient that.
Dikla Chachkis-Oxelbrad: Most of the patients that finish the follow-up. Most of the 100 patients finish the 31-day follow-up. We did not go into specific numbers, but I can tell you that we expect to see recruitment significantly ramp up if we're looking at the next quarter, both in terms of having sent additional centers open and some of the centers that were open but only recently started to recruit patients, but most of the 100 have finalized the surgery and called it very helpful.
Finish the follow up most of that 100 patient finished at 30 why they follow up.
Okay.
It did not go into specific.
Numbers, but I can tell you that we expect to see.
Recruitment if we're.
We're looking at the next quarter.
Significantly ramping up both in terms of having said additional centers open and some of the centers that were open but only recently started to recruit patients at most of the 100 is finalized.
Finalize the 30 days.
Got it very helpful. Thank you.
Operator: Thank you. Thank you. Thank you. Once again, if you wish to ask a question, please press star one and one on your telephone. We will take our next question. Your next question comes from the line of Bublan Pesce-Yapin from HC Wainwright. Please go ahead. Your line is open. Good morning, Tim. Thanks for taking my questions.
Yes.
Yeah.
Okay.
Once again, if you wish to ask a question. Please press star one.
One on your telephone.
We will take our next question.
Your next question comes from the line of the plan.
Yeah Finn from H C. Wainwright. Please go ahead your line is open.
Good morning, Thanks for taking my questions.
Dikla Chachkis-Oxelbrad: First, as we think about commercial batch production, I'm curious how the expected COGs of DPLX-100 compare to other platform technologies involving polymers or lipids attached to small molecules. Uh, yes. As we see things now and for a long time, you know, because we've built our own manufacturer facility and we have full control of the manufacturing, we actually just a few months ago passed a GMP review by the Israeli Ministry of Health that is also applicable for the European Authority for the commercial stage. So our facility is now approved for the GMP commercial stage, and we have all the indications that the COGS will be less than 5%. Again, it's a bit early to be very specific because we do not know exactly the final price of the product, the selling price of the product.
Couple of it from our side first as we think.
Think about commercial batch production. So I'm curious how the expected Cogs of duplex 100, compared to other platform technologies in welding polymers or lipids attached to small molecules.
So.
As we see things now and for a long time, you know because we've built our own manufacture facility.
And we have full control of the manufacturing, we actually just a few months ago cast at G. M P.
The review by the Ministry Israeli Ministry of Health that is also applicable for the European authority for the commercial stage.
Facilities now.
Approved for GMP commercial stage.
And.
We have all the indication that the Cogs will be less than 5% again, it's a bit early to be very specific because we do not know exactly the final.
Price of the product the selling of the price of the product, but all indications shows that it should be the cogs should be less than 5% of them.
Dikla Chachkis-Oxelbrad: But all indication shows that it should be; the COGS should be less than 5%. Great. Thanks for the clarity. And then you mentioned positive pre-clinical data in melanoma and colon carcinoma animal models. So I'm just curious, can you discuss the rationale behind choosing these tumor indications and also potential commercial opportunities associated with Dflex 100? So, it's not that these are the only indications that we are pursuing for clinical. But the idea was to look at because this is an intratumoral approach, we are injecting our oncoplex directly into the tumor, and the chemotherapy is released within the tumor environment for three weeks. The idea was to look at models that have fast-growing cells and look at the approach, the local approach, and the prolonged local approach in the tumor and see the effect.
Yes.
Great. Thanks for the clarity and then you mentioned about positive preclinical data in.
<unk> melanoma and colon carcinoma animal models, so I'm just curious.
Can you discuss the rational behind choosing these tumor indications.
Also our potential commercial opportunities associated with duplex 100.
So so it's not that these are.
Absolutely.
Yes.
That we are pursuing for clinical but the idea was to look at.
Because this is an intra tumoral approach we are injection injecting.
Our own complex directly into the tumor.
And the chemotherapy is released within the tumor environment for three weeks.
The idea was here to look at models that have fast growing sales.
Look at the approach the local approach to prolong local approach in the tumor and see the effect and we were very pleased.
Dikla Chachkis-Oxelbrad: And we were very pleased with the result. They also repeated a similar result that we saw as an adjuvant. This was a narrow adjuvant approach.
Uh huh.
Walt if they repeated also the similar result that we saw as an as an adjuvant. This was a neo adjuvant approach we saw similar.
Dikla Chachkis-Oxelbrad: We saw a similar effect as an adjuvant, that is, applied to the tumor bed post resection, also in an animal model. So the idea was here to expand our preclinical data into a neoadjuvant approach in a fast-growing cell model. All right. Thank you so much for taking our question. Thank you. Thank you. Good day. Thank you. There seems to be no further questions.
Effect as an adjuvant that is.
Applied into the tumor bed post resection also in an animal model. So the idea was to expand.
We're pre clinical data into and no adjuvant approach in a fast growing sales model.
Alright. Thank you so much for taking our questions.
Thank you. Thank you good day.
Thank you so it seems to be no further questions I would like to hand back for closing remarks.
Operator: I would like to hand back for closing remarks. Thank you for joining PolyPid's fourth quarter and year-end 2023 Earnings Conference call. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, Deeplex 100. As always, we are grateful to our team members, existing and new shareholders, and all our external partners for their commitment to our mission and their support in continuing to advance towards our goal of bringing Deeplex 100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call. This concludes today's conference call. Thank you for participating. You may now disconnect.
Thank you for joining quality fourth quarter and year end 2020, see earning conference call. We remain highly confident in our long term prospects, especially the potential of a promising late stage product candidate <unk> 100, as always we are grateful to our team members.
Existing and new shareholders and all our external partners for their commitment to our mission and their support and continuing to advance towards our goal of bringing apex 100 to health care providers and patients as quickly as possible. We look forward to speaking with you again on our.
Next conference call.
This concludes today's conference call. Thank you for participating you may now disconnect.
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