Q4 2021 PolyPid Ltd Earnings Call
[music].
Greetings and welcome to the Polyped fourth quarter and full year 2021 conference call. At this time 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 Bobby I did from lifestyle advisors. Mr. Yet it you may be.
Speaker 1: Greetings and welcome to the PolyPID fourth quarter and four year 2021 conference call. At this time, 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, Bob Yeddid from Lifeside Advisors. Mr. Yeddid, you may begin.
Again.
Speaker 2: Thank you all for participating in PolyPIV's fourth quarter and full year 2021 conference call. Joining me on the call today will be Amir Royseberg, Chief Executive Officer, and Dikle Chaskis-Aksobrod, Executive Vice President and Chief Financial Officer.
Thank you all for participating in poly peds fourth quarter and full year 2021 conference call.
Joining me on the call today will be a mere weisberg, chief Executive Officer, and <unk> <unk> Oxo Braun Executive Vice President and Chief Financial Officer.
Speaker 2: Earlier today, the company released financial results for the three months and 12 months and December 31st, 2021. A copy of the press release is available in the investors section of the company's website www.polipid.com.
Earlier today, the company released financial results for the three months and 12 months ended December 31, 2021, a copy of the press release is available in the investors section of the company's website www Dot <unk> dot com I'd like to remind you.
Speaker 2: I'd like to remind you that on this call, management will make forward-looking statements within the meeting of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected recruitment for trials, theater analysis, and the
On 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 it discusses the expected of recruitment for trials the interim analysis.
Speaker 2: timing and its potential implications, timing of trials, and release of the results thereof.
Timing and its potential implications timing of trials and release of the results thereof, the capacity of the company's manufacturing facility the company's pipeline the potential benefits of duplex 100.
Speaker 2: capacity of the company's manufacturing facility, the company's pipeline, the potential benefits of Deep Firm 100…
<unk> blocks.
Speaker 2: the company's potential partners and the sufficiency of the company's cash to fund future operations.
The company's potential partners and the sufficiency of the company's cash to fund future operations.
Speaker 2: For the constable, they are subject to numerous risks and uncertainties, many which are beyond our control, including the risks and uncertainties described from time to time in RSCC filings. Our results may differ materially.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.
Our results may differ materially from those projections.
Speaker 2: these statements about material risks and uncertainties that could cause actual results or events to materially differ.
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.
Speaker 2: Accordingly, you should not place a new reliance on these statements.
Speaker 2: I encourage you to review the company's filings with the FCC, including without limitation the company's form 20F, which identifies specific factors, which may cause actual results or events, get from materially, from those described and the four looking statements.
I encourage you to review the company's filings with the SEC, including without limitation, the Companys form 20-F, which identify specific factors, which may cause actual results or events differ materially from those described in the forward looking statements.
Speaker 2: Folly Pidd disclaims any intention or obligation.
<unk> disclaims any intention or obligation except.
Speaker 2: is required by law to update or revise financial projections or for good statements whether because of new information, future events or otherwise. The conference call contains time-sensitive information.
As required by law to update or revise financial projections or forward looking statements, whether because of new information future events or otherwise. The conference call contains time sensitive information and speaks only as of the live broadcast today February nine 2022.
Speaker 2: speaks only as of the live broadcast today February 9, 2022.
Speaker 2: completion of those prepared remarks. It's my pleasure to turn the call over to Mayor Weisberg, CEO . I'm here.
Please turn of those prepared remarks, it's my pleasure to turn the call over to Amir Weisberg CEO Amir.
Thank you Bob.
On behalf of our team at <unk> I would like to welcome everyone to our fourth quarter and full year 2021 earnings call.
Speaker 3: I would like to welcome everyone to our fourth quarter in full year 2021.
I will begin today with some brief comments on the planned transition in our senior leadership team.
Speaker 3: I will begin today with some brief comments on plant transition in our senior leaders.
Speaker 3: The cloud will provide a detailed business update and then she will review our financial results after which we will open the call for you.
I will provide a detailed business update and then she will review our financial results after which we will open the call for your questions.
As you know, we recently announced a plan to CEO transition. This year I will be reaching the formal entitlement age, which typical for a company executive in Israel.
Speaker 3: As you know, we recently announced a plan to see your turn.
Speaker 3: this year I will be reaching the formal retirement age which typical for a company.
Speaker 3: So effective on July 1st, 2022, I will retire as a CEO , a role in which I have fulfilled for over 11 years.
So effective on July one 2022, I will retire as CEO at all.
In which I have a full field for over 11 years. It has been an honor to serve as the CEO of fully paid throughout the development phase of our company.
Speaker 3: It has been an honor to serve as the CEO of Polypied throughout the development phase of our...
Okay.
Our board of directors has appointed decline as policies are Chief Executive Officer effective July 2022.
Speaker 3: Our Board of Directors has appointed the client as a polypids chief executive officer effective July 1st, 2020.
Speaker 3: As we prepare for our next phase of goals, declare each day a dear future leader of the company.
As we prepare for our next phase of goals.
<unk> is the future leader of the company.
Speaker 3: She brings clear focus on operations and proven track record on driving, growth and
She bring clear focus on operations and proven track record on driving growth and innovation. She has also led.
Speaker 3: She has also led our strategic and financial planning and capital raising efforts, including our IPO. As a result of your off-Everything Estate, we remain impactful, not really for you.
<unk> financial planning and capital raising effort, including our IPO in 2020.
I look forward to continuing to work closely with decline in order to ensure a smooth transition.
Speaker 3: I look forward to continuing to work closely with DCLA in order to ensure a smooth transition
Speaker 3: I would also like to take a moment to acknowledge the plan in that retirement of Dr. Schaulmuchter, Chief Operating Officer, who will be retiring from...
I would also like to take a moment to acknowledge the plane that retirement of ductile shoulder more stuff Chief operating officer will be retiring from the company next month.
Speaker 3: We would like to thank Shao for successful leading the scale up of the manufacturing capabilities, which is now complete and advancing our clinical development.
We would like to thank shareholders for successful leading the scale up of the manufacturing capabilities, which is now complete and advancing our clinical development programs.
Speaker 3: We believe that polypide is in the strongness operational position in each history and we are well positioned for long-term
We believe that the policy the easing the strong operational position.
Its history, and we are well positioned for long term success. We continue to strongly believe that our equivalent balance sheet will be sufficient to complete the shield one study and prepare for the submission of an NDA to the FDA as well as further advanced our.
Speaker 3: continue to strongly believe that our current balance sheet will be sufficient to complete the shield one study and prepare for the submission of NMDA to the FDA as well as further advance our on-complex development platform.
On complex development platform.
With that.
Speaker 3: I will now turn the call over to the clerk to provide some further updates on our business.
I will now turn the call over to the cloud to provide some further updates on our business the clock.
Thank you Amit and thank you all for joining us on the call on behalf of the management team, we would like to thank him for his leadership qualities now over a decade.
Speaker 4: Thank you, Amir, and thank you all for joining us on the call. First, on behalf of the management team, we would like to thank Amir for his leadership of polypide for over a decade.
Speaker 4: strong belief in our Plex technology and its potential benefit for patient has been a driving force at our
The leasing our flex technology and its potential benefit for patients has been a driving force.
Speaker 4: He has recruited and built a strong management team established on manufacturing base that lets us control this critical aspect of our business and establish our operation team in Israel and the US. It has been a privilege to work with Amir and we look forward to his continued leadership and active involvement for the next several months.
He has.
Got it and build a strong management team.
Please call manufacturing base.
Yes.
This critical aspect of our business and established our operation team in Israel.
Thank you.
It has been my privilege to work with them and we look forward to you Quintin.
<unk> leadership and expertise in Pos for the next several months.
Nick I would like to express how grateful and proud I am to add.
Speaker 4: Next, I would like to express how grateful and proud I am to have the opportunity to lead polypids at this exciting time in our corporate evolution. You won't find many Israel's
The opportunity to lead quality.
I think time corporate evolution.
One find many Israeli Biopharma company.
Speaker 4: that have reached our current stage. Where we are well on our way to complete a SA3 pivotal trauma with several hundred of patients. And this is a milestone that we are approaching at a steady pace.
<unk> reached could change.
Well on our way to complete our phase III pivotal trial with several hundred locations.
This is a model that we are.
Approaching at a steady pace.
Speaker 4: I'm excited to continue working with our talented and passionate teams to achieve further clinical and operational success.
I'm excited to continue working with our talented and passionate team to achieve clinical and operational success.
Speaker 4: on the many opportunities that lie ahead for us.
Execute on the many opportunities that lie ahead.
Speaker 4: with that, I will now provide a brief update on the status of a
With that I will now provide a brief update on the pipeline.
Pipeline.
Speaker 4: Most importantly, a few days ago the FDA agreed
Most importantly, a few days ago, the FDA agreed.
Speaker 4: The complete piece requires for the addition of an unblinded intermenorcy in shield 1. Our base 3 study evaluating the PLA-100 for the prevention of abdominal soft tissue surgical site insects.
Request for the addition, often on blinded interim analysis and shared one.
His III study evaluating <unk> 100 for the.
Convention of Darwin for soft tissue surgical site infection.
Speaker 4: A request was based on the FDA recently established guidance for pharmaceutical companies to address the impact of COVID-19 on meeting, involvement and study of
Request was based on the FDA recently established guideline.
Political company to address the impact of COVID-19 on meeting enrollment in study objectives well.
Speaker 4: for clinical trials conducted during the ongoing pandemic.
Clinical trial conducted during the ongoing pandemic.
The interim analysis is expected during the second quarter of 2021 750 patients completed the 30 day follow up and will allow for early trials starting.
Speaker 4: The entry analysis is expected during the second quarter of 2022, 1,750 patients complete their 30 days follow-up and will allow for early trial stopping due to a frequency, fertility, or for sample size.
Due to efficacy fertility, all four sample size of Esa and.
Speaker 4: and early stop to the trial will occur if there's sicker series of on the SSI rate is better than...
An early stop to the trial will occur.
So you could see result.
<unk> is better than expected.
Speaker 4: This entry analysis is an exceptional opportunity for polypies to more precisely define the targeted patient enrollment range for the Shield 1 study. Also as planned, a recent blinded sample size reassessment was conducted following the completion of the 30-day follow-up period for the 500 patient enroll and it supports the continuation of Shield 1.
Interim analysis is an exceptional opportunity for quality to more precisely define the targeted patient enrollment range of a shield one study.
As planned our recent blinded sample size reassessment.
<unk> conducted following the completion of the 30 day follow up period for the fifth Congress patient enrolled and it supports the continuation of shield one trial.
Speaker 4: Looking forward, the pace of enrollment in the Shield 1 trial continues to be robust. And we expect this trend to continue in 2022, targeting 200 to 250 enrolled patients per
Looking forward the pace of enrollment in the shield one trial continues to be robust.
We expect this trend.
To continue in 2022 targeting 200 to 250 in one patient.
Speaker 4: We now have approximately 680 patients involved into the study across approximately 60 centers in the United States, Europe , and Israel. As such, we expect to reach the 750-n-voltation for the inter-monialysis by the end of the first course.
We now have approximately 680 patients.
Into the study across approximately 60 centers.
United States, Europe and Israel.
We expect to reach the 750 enrolled patients for the <unk>.
Interim analysis by the end of the first quarter, we are very pleased with the rate of.
Speaker 4: We are very pleased with the rate of involvement, especially considering the holiday season and the disruption to hospitals caused by the surge of COVID-19 infection driven by the OmriCon variant.
Especially considering the holiday season.
Construction to hospital caused by the surge of COVID-19 infection, driven by their own recon volumes.
So the financial standpoint as these costs.
Speaker 4: for the financial standpoint, as discussed on our last call, because we only need to conduct SHIELD-1 to potentially receive FDA approval and do not need to run that enrollment in SHIELD-2, we continue to expect that our cash runway will be extended to the end of the...
Because we only need to conduct shield, one to potentially receive FDA approval.
Without the need to ramp up enrollment.
Two we continue to expect cash runway will be extended to the end of this year.
Speaker 4: Shield 2 has currently over 200 patients and more, and as a reminder, it includes broader eligibility criteria including minimally invasive procedure. Now let's switch gear to this.
Q2 is currently over 200 patients to goal and as a reminder, it includes <unk>.
Legibility criteria, including minimally invasive procedure.
Now, let's switch gears to discuss commercialization.
Speaker 4: In terms of potential collaboration for the future commercialization of SIPLEC 100 in the US, Europe and Asia, we remain in dialogue with several large and mid-sized pharmaceuticals.
In terms of potential collaborations for the future commercialization of <unk> 100 in the U S Europe and Asia, we remain in dialogue with several large and midsize pharmaceutical companies that we believe would be ideal commercial partner with Eplex 100.
Speaker 4: that we believe would be ideal commercial partners for Dplex 100.
Yeah.
As we have said previously these companies are leaders in selling pharmaceutical products to the hospitals, often with current portfolio of marketed products.
Speaker 4: These companies are leaders in selling pharmaceutical products to the hospitals, often with current portfolio of marketed products, have stronger established commercial infrastructures, exhibit a deep understanding of clinical and pharmacoeconomic benefits in the hospital channels, and maintain strong relationship with the hospital medical and administrative.
Strong established commercial infrastructure.
It is a deep understanding of clinical and pharma clinical genomics, Tennessee.
With those channels and maintain strong relationships with the hospital medical and administrative staff.
Speaker 4: importantly, there continues to be high level of interest in Deepx 100 from these potential positives. While there is currently no formal timeline related to the exact executing any potential positives in the US or other regions.
Importantly, there continues to be high level of interest in duplex 100 of these potential partners.
There is currently no formal timeline related to executing any potential partnership for the U S or other region.
Speaker 4: Our most critical objective is to maximize the value of the plate 100 in any potential.
Most critical objective is to maximize the value of <unk> 100 in any potential transaction.
Speaker 4: So if at when we do finalize partnership agreement, this will be the determining fact.
<unk> said when we do finalize partnership agreement this will be the determining factor.
Speaker 4: As we continue to advance the Plex 100 in the clinic, execute on our commercial prep plan and conduct partnering discussion, we also remain focused on building the significant body of evidence in support of the safety and efficacy of this promising product.
As we continue to advance it takes 100 in the clinic execute on our commercial trucking and Quebec partnering discussion. We also remain focused on building a significant body of evidence.
Support of the safety and efficacy of this promising product candidates.
Speaker 4: as such, we plan to have a number of peer-reviewed publications and data presentation at important medical meetings throughout 2012.
As such we plan to have a number of peer reviewed publications and data presentations at important medical meetings throughout 2022.
Speaker 4: This is obviously an important strategy for all of our key audience. Physician, payers and potential.
This is obviously an important strategy for all of our key audio physician payer and <unk>.
Potential partners.
Speaker 4: Now I'd like to further elaborate on the status of Ong.
Now I'd like to further elaborate on the status of all.
Speaker 4: our interest in the chemical therapy products. Initially targeting solid brain tumors, including those that are chemotherapy.
Intra tumoral chemotherapy product candidate initially targeting solid tumors, including those with chemotherapy or anti crazy.
Speaker 4: As a reminder, ON COPLACS provide local prolong and control exposure to DOSA-TEXL in the intraoperative tumor resection.
As a reminder, on complex provide local prolong can control exposure to dust have excelled in the intraoperative tumor resection.
As you know Jeff with Excel is one of the most widely used chemotherapy agents worldwide.
Speaker 4: As you know, Dothatexcel is one of the most widely used chemotherapy agents worldwide. Following a recent train investigation on your drug meeting, late last year, the FDA indicated that on-complex will be considered.
Following a recent trade investigation.
Meeting late last year, the FDA indicated that on complex will be considered as part of a potential first line combination therapy.
Speaker 4: part of the potential first-line combination therapy of patient newly diagnosed with GBM. This is very encouraging.
Patients newly diagnosed with GBM.
This is very encouraging news for arc <unk>.
Speaker 4: We believe this is indicative of its significant potential to treat brain tumors and could have substantial commercial damage. If shown to be safe and effective in clinical trials and subsequent.
We believe this is indicative market significant potential to treat brain tumors and could have substantial commercial benefits.
If shown to be safe and effective in clinical trials.
And subsequently.
We are now focused on working on the design of our planned phase one two trial of <unk> complex with our World Class Technology Advisory Board for <unk>.
Speaker 4: We are now focused on working on the design of our Plan Phase 1 Tutorial of Uncomplex with our World Class Ecology Advisory Board, for which we are thrilled to add two distinguished members to this group over the past few months.
We are thrilled to add two distinguished members.
This group over the past few months.
Speaker 4: Dr. Federiclán is the chairman of neurosurgery at the University of Texas and the Anderson Cancer Center and is co-leading and the Anderson Glaoblastoma's Munschrute Initiative.
February .
He is the chairman of neurosurgery at the University of Texas, MD Anderson Cancer Center and is call, leading and beyond just on Glioblastoma launch which initiative.
Speaker 4: This initiative is dedicated to saving the lives of patients throughout the development of new therapies and better treatment approach.
Initiate team is dedicated to saving the lives of patients throughout the development of new therapies and better treatment approach.
Speaker 4: Dr. Lain is considered as one of the world's far most experts in the treatment of brakes.
Dr. <unk> is considered as one of the world's plasma.
Expert in the treatment of pain.
Speaker 4: Dr. Mitchell Bergho is the Guggenheim Professor of the Department of Neurological Stairdury at the University of California.
Dr. Mitchell, Doug is the Guggenheim Professor of the department of neurological surgery at the University of California, San Francisco.
Speaker 4: The Services Director of the UCS-CLAF Brain Tumor Research Cancer, a leader in translational research and is a principal investigator of its specialized program of research excellence in neuro-oncology funded by the National Research Cancer Institute.
This is a director of the Ucs pit brain tumor research cancer, a leader in translational research and the principal investigators.
It's specialized program research excellence in neuro oncology funded by the National.
Yes.
Speaker 4: We are working enthusiastically with this world-renowned position and are excited to have the opportunity to leverage the rest experience and commitment to innovation in dreams.
We are working on Tuesday, ethically with DS World renowned physician and are excited to have the opportunity to leverage their vast experience and commitment to innovation in grain.
Speaker 4: With that, I will now review of 4 quarters financial rewards. Let's begin with polypide balance sheeting for more.
We did I will now review our fourth quarter financial results, let's begin with policy the balance sheet information as of December 31, 2021, the company had cash cash equivalents and short term deposit.
Speaker 4: As of December 31, 2021, the company had cash, cash equivalent and short-term deposits of $32.2 million, as compared to $66.6 million, as of December 31, 2021.
$2 2 million, that's compared to $66 6 million as of December 31, 2020.
Speaker 4: Cash use in operations for the 12 months ended with September 31, 2021, total $32.4 million.
Cash used in operations for the 12 months ended December 31st 2021.
Total $22 4 billion.
All right.
Now, let's turn to our income statement.
Research and development expenses for the three months ended December 31 2021.
Speaker 4: Research and development expenses for the three months ended December 31, 2021 were $9.5 million compared to $5 million in the same three months period of 2020. The increase in research and development expenses resulted from the increased cost and activity related to the ongoing shield one and shield two, phase three clinical trials in abdominal surgery.
$9 5 million compared to $5 million in the same three months period of 2000.
The increase in research and development expenses resulted from the increased costs and activities related to the ongoing shield, one and shield two phase III clinical trials in abdominal surgery.
Speaker 4: For the full year ended December 31, 2021 and 2020, R&D expenses were $30.4 million and $17 million.
For the full year ended December 31st 2021, and 2020 R&D expenses with <unk>.
$34 million.
$17 million respectively.
Speaker 4: Marketing and business development expenses for the fourth quarter of 2021 were 1.1 million compared to $710,000 for the same period of 2020. The increasing marketing and business development expenses are due to initiating the pre-launch activity .
Getting that business development expenses for the fourth quarter of 2021 were $1 1 million compared to $710000 for the same period of 2020, the increase in marketing and business development expenses.
Two initiation in the prelaunch activities.
Speaker 4: General and administrative expenses for the fourth quarter of 2021 were $2.8 million, slightly higher than the $2.2 million recorded in the fire.
General and administrative expense for the fourth quarter of 2021 were $2 $8 million slightly higher than the $2 2 million.
Recorded in the prior period.
For the fourth quarter of 2021, the company had a loss attributable to ordinary shares of $13 2 million as compared to seven 5 million.
Speaker 4: For the fourth quarter of 2021, the company had a lost tributable to ordinary share of $13.2 million as compared to $7.5 million in the prior year.
Higher yields.
This was primarily driven by a solid rate of patient recruitment in the shield, one and shield II phase III clinical trials and the associated costs.
Speaker 4: This was primarily driven by a solid rate of patient recruitment in the shield 1 and shield 2, 3 clinical trials and be associated.
Speaker 4: For the year end of December 31st, 2021, the company had a loss that's revutable to ordinary shares of $42.00, compared to a loss of $39 million in the full year, 2021. We will now open the call to your question. Operator.
For the year ended December 31, 2021, the company had a loss attributable to ordinary shares of <unk>.
$42 3 million compared to a loss of $39 million in the full year 2000.
We will now open the call for your questions operator.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the <unk>.
Speaker 1: Thank you. As a reminder to ask a question, you will need to press star one on your telephone to restore your question, press the pound hash key. Once again, to ask a question, please press star one on your telephone keypad. Your
Pound Husky once again to ask a question. Please press star one on your telephone keypad.
Your first question today comes from the line of.
Speaker 1: Gary Nachman from BMO Capital Markets, please go ahead your line is open.
Gary Nachman from BMO capital markets. Please go ahead your line is open.
Speaker 5: Hi, good morning. This is Ed and the Hualp, a villain in for a game happen. Well, first of all, I can grasp on the updates and the CEO transition to both Vicklo and Ameri. So first, for the plan in term now, it's for SHI of one, would you be able to share some more detail on what specific now to should be conducting to determine the efficacy or fertility? And how about the different from the recently completed, funded sample size reassessment? That was completed.
Hi, Good morning, this is <unk> filling in for Gary Nachman.
First of all congrats on the updates and the CEO transition to both pick one up here.
So first for the planned interim analysis for ship, one would you be able to share some more detail on what specific analysis will be conducted to determine the efficacy or futility and how would that be different from the recently completed blinded sample size reassessment that was completed.
Thank you and thank you for Woodward.
Speaker 4: Thank you and thank you for your warm words. It's very different. The 500 was unblinded. We are talking here about the full untrim blinded, we are talking here about an unblinded in-trim analysis, full in-trim analysis, where the DMC will be reviewing the effect and actually calculating the effect rate.
It's very different the 500 was unblinded.
We are talking here about full interim I'm.
I'm glad we're starting to 500 was blinded we are talking here about an unblinded interim analysis for the interim analysis, where the DMC will be reviewing the.
Effect and actually calculating the.
The effect right.
And we have the opportunity here because it's unblinded to have an early stop which we didn't have.
And that's that's the main.
Speaker 4: aspects of it is de-risking the program and allowing us to have an earlier, if you say, peak or inflection point in terms of the interim and real insight into the effect.
Aspects of it is de risking the program and allowing us to have an earlier.
You could say peak or inflection point in terms of the interim and we are.
Insight into the effect right.
Speaker 4: And would you have to take a statistical hit to unblind that data to provide that? So we have a small statistical penalty, a few dozens of patients. Again, this goes to the specific guidelines that the FDA issued regarding COVID. So it's a small statistical penalty, yes.
Got it and would you have to take a statistical hit blend that data. So we haven't we have a small a statistical penalty.
Dozens of patient again this goes to the specific guidelines that the FDA issued regarding coffee. So it's a small statistical penalty yet.
A patient.
Great and one more follow up.
Speaker 5: And one more follow up for for uncle flex. Would you be able to share some color on the study design for phase one, two trial in GBM in terms of size or dose strength or any other parts of the product?
For Aimco perplexed.
Would you be able to share some color on the study design for the phase one two trial.
GBM in terms of size or strength.
Strange or any other parts of the protocol.
Speaker 4: So as we said today, we met the FDA late last year for pre-I and emitting.
As we said today, we met the FDA late last year for the <unk> meeting and got a general agreement around the preclinical and clinical.
Speaker 4: and got a general agreement around the pre-cleaner, color and cleaning, color program. We are now working on the design of the, of the phase one, two together also with our care.
Program, we are now working on the design of the trial of the phase one two.
Together also with our Kols. So once we get a better clarity internally of the design and then I'm sure we will be able to share, but we are still at the pace of designing the trials based on the comments that we got.
Speaker 4: So once we get the better clarity internally of the design, then I'm sure we will be able to share. But we are still at the pace of designing the trial based on the comments that we got.
Got it thank you.
Speaker 1: Thank you. Thank you. Your next question comes from the line of Elliot Wilber from Raymond James. Please go ahead. Your line is open.
Thank you.
Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James. Please go ahead. Your line is open.
Hello, J class panel.
Speaker 6: Hello, I'm Declas. This is Hannah Smith on behalf of Elliott. I'm assuming 750 patients in term breed out delivers positive results on shield one. Will you continue to recruit and enroll the full 900 patients to support generation of various secondary and marketing endpoints that you've previously planned on doing? So...
Smith on behalf of Elliot.
750 patient interim read out until the first positive results in shield. One will you continue to recruit and enroll the full 900 patients to support generation of various secondary and marketing endpoint.
You had previously planned on doing.
So the.
Speaker 4: The reality, first of all, we will be very happy with such overwhelming results. The reality of the pace of recruitment that we are in.
First of all we will be very happy with such overwhelming result.
The other appeal if the pace of equipment that we our aim is that probably by the time that we get the input from the D. S. M. B a commit to the D. M D. S M a.
Speaker 4: is that probably by the time that we get the input from the DSMB committee, the DSM...
Speaker 4: Seek of needy, we will be at 900 patients. So practically, this will come at the same point. As we said, if you remember, we said that we expect to recruit the last patient during the second quarter, so with the approximately 900 patients. So timeline here are our lines.
He called me a T.
We will be at 900 patient. So practically this will come at the same point as we said if you remember we said that we expect to recruit the last patient doing.
In the quarter, so with the approximately 900 patients so timeline here are aligned.
Speaker 4: I see. Um, also do you, what is your timeline for uncleplex, the phase one study in 2022? Can you elaborate a little bit more about that? I think so. So first, I want to remind everyone that this is an early stage program. We're still at the pre-cleaning club stage. We expect to be ready.
Okay.
Also can you what is your timeline for uncle plaques. The phase one study in 2022 can you elaborate a little bit more about that.
But first I want to remind everyone that this is an early stage program. We are still at the preclinical stage, we expect to be ready for phase one two by the end of year and we are working diligently on that this.
Speaker 4: for phase one, two by the end of this year. And we are working diligently on that. This will be including submitting towards the end of the year and I&D application, producing the product with the...
This will be including submitting towards the end of the year in India application could you see the product with the GMP.
Speaker 4: condition and a lot of other parameters that are required to go into phase one two in GBM. So it's early to say what will be the actual timeline for the phase one two. Once we have the design and we can share details on the design, we can also be in a position to give more clarity on the time.
I should add a lot of other kind of metrics that are required to go into.
I just want to in GBM.
So it's early to say what will be the actual timeline for the phase one two and once we have that design and we can share details on the design and we can also be in a position to to give more clarity on the timeline for this trial.
Okay, great. Thank you so much day clock and congratulations thank you.
Speaker 6: Okay, great. Thank you so much, DuCla, and congratulations. Thank you.
Speaker 1: Thank you. Your next question comes from the line of Brandon Falks from Cantor. Please go ahead, your line is open.
Thank you your next.
Question comes from the line of Brandon Folkes from Cantor. Please go ahead. Your line is open.
Speaker 7: Hi, I think things like questions and congratulations on the progress. I mean, I would be congratulations on their retirement and particularly from the point of view. What was it? Thank you.
Hi, Thanks for taking my question and congratulations on the progress.
Obviously, congratulations on the retirement and.
Congrats on the appointment what was it.
Thank you.
Maybe just following on from the similar line of questioning.
Speaker 7: Maybe just following on from the similar line of questioning, and you talk about, you know, by the time you've come up with the committee's completed the interim look, you're gonna have that data or be close to having the data on the 900 patients. So there's the agreement with the FDA to potentially submit
You talked about.
By the time you booked.
The committees.
<unk>. The interim look you are going to have that data.
Close to having the data on the 900 patients is the agreement with the FDA to potentially submit.
Speaker 7: I'm the 750, or would you be submitting both efficacy and safety on potentially close to 900? And then similarly, does the agreement still include shield to safety data time and submission? Thank you.
On the 750.
Would you be submitting both efficacy and safety on potentially close to 900.
Similarly.
Agreement still include Shield two safety data Commerce Commission. Thank you.
Speaker 4: So thank you, Brodans. We will be submitting based on the 900 patient that will be recruited at the time.
So thank you both.
We will be submitting based on the 900 patient it will be recruited at the time it can vary and it could be a little bit smaller than that but more or less at that range and we do plan on submitting also the safety data from shield two that now includes <unk>.
Speaker 4: very, and it will be a little bit smaller than that, but more or less at that range. And we do plan on submitting also the safety data from SHIL2 that now includes over 200 patients. Probably by the time we will have slightly larger number of patients in this trial.
Over 200 patient probably by the time, we will have some upside.
Have slightly larger.
Larger number of patients in this trial.
Great. Thank you very much.
Thank you.
Speaker 1: Thank you. Your next question comes from line of, will you be canon from JMP the security's? Please go ahead, your line is open.
Thank you. Your next question comes from the line of <unk> <unk> from JMP Securities. Please go ahead. Your line is open.
Hi, great. Thanks for taking the questions.
Speaker 8: I think we're taking the questions. I guess kind of in the same vein as the prior questions, it sounds like not really seeing any impact from Omicron or anything else on enrollment, it's going quickly, sounds like this interim could occur. I mean, that's only 70 patients from 680 to 750. So it sounds like it could occur very early in the second quarter. I guess the question is, was there anything in the blinded interim, the 500 patient interim that informed the addition of the 750 patients?
Hey, I guess kind of in the same vein as the prior questions it sounds like.
Not really seeing any impact from omicron or anything else on enrollment it's growing quickly it sounds like this interim could occur.
I mean, that's only 70 patient from six eight to 750, so it sounds like it could occur very early in the second quarter.
I guess the question is was there anything on the blinded interim the 500 patient interim that inform the addition of the 750 patient.
Speaker 8: And then where you guys at with manufacturing?
Interim and then where are you guys out with manufacturing thanks.
Speaker 4: So, first of all, thank you for your question. And I'll go one by one.
So first of all thank you for your question and I'll go one by one.
Speaker 4: The interim by the time that we asked, we submitted to the FDA the request for the interim. This was before we had the
750, the interim but at the time that we ask we submitted to the FDA to request for the entry and this was before we had the.
The blinded.
Speaker 4: blinded assessments of the 500, so there was no influence on dead. The way we look at the in-tream is an earlier ability for the risking of the program, earlier peak to result as well as having the ability to adjust if needed. And I think you had one question that I missed, but with regards to manufacturing,
And it's up to 500, so there was no influence on that the way we look at the the entry is and then earlier ability for de risking of the program earlier peak to result, as well as having the ability to adjust if needed.
And I think you had a one question that I missed but with regards to manufacturing.
Speaker 4: We are very pleased with the progress. If you remember last year, we've done care-lap processes, and now we are in the process of getting the manufacturing.
We're very pleased with the progress if you remember last year.
Done Carol up processes and now we are in the process of getting the manufacturing facility back into capacity as well as the validation needed for that and things are progressing in parallel to our phase III. So by the time.
Speaker 4: facility, back into capacity, as well as the validation needed for this, and things are progressing in parallel to our phase three. So by the time that we
We finalize the phase III and submit the data for an NDA, we should be ready for FDA inspection and all the review that comes with that.
Speaker 4: finalize the space we submit the data for an NDA. We should be ready for FDA inspection and all the review that comes with that. And so you add another question.
Sorry, you had another question.
I think you've covered it but actually that.
Speaker 8: I think he covered it, but actually the interim, I guess how much time do you think it'll take you to clean up the data following the 30 days?
Actually the interim I guess, how much time do you think it'll take you to get.
Clean clean up the data following the 30 days. Thanks. He said so as you rightly mentioned, we are now even with less than 70 patient from from last patient to the 750 <unk> required for the interim.
Speaker 4: Thank you. So as you rightly mentioned
Speaker 4: We are now even with less than 70 patients from last patient to the 750 required for the interim. It's a process. It's a process we need to wait for the 30 days follow up. There is a cleanup and there is a time that the DMC requires to evaluate and unblind the day time, get? We give guidelines that we are very comfortable with.
Process is the process, we need to wait till the 30 day follow up there is a clean up at the time.
The DMC required to evaluate and unblinded data and get we gave guidance that we are very comfortable with.
Speaker 4: having the inter-induing the second quarter.
Having the interim during the second quarter.
Speaker 4: And as we progress and we could do 750 if we can.
And as we progress and recruit the 750.
If we can even be more specific we will but we're very comfortable with the.
Speaker 4: even the most specific we will, but we're very comfortable with the
Speaker 4: relatively few months from now to second courses to have the interim data. The unblinded
Relatively few months thrown out to the second quarter to have the interim data.
<unk>.
Speaker 8: Great. And then I guess on an uncleplex, you kind of answered it probably. It's still, you're still designing the phase one, two. But I'm just curious how you're thinking about the combinations, you know, investigators' choice or you're going to allow additional chemotherapy on top of the uncleplex.
Okay, Great and then.
I guess on the uncle place you've kind of answered it probably it's still you're still designing the phase one two but I'm just curious how youre thinking about.
The combinations you know investigator's choice or are you going to allow additional chemotherapy on top of the uncle Plex. Thanks.
Speaker 4: So first I think that important that investor will recognize that the feedback from the FDA was very positive. I think the ability to be first-line treatment, first-line combination treatment for not newly diagnosed. This is really from our perspective a great achievement. It opens.
So first I think that.
It's important that investors will recognize that the feedback from the FDA was very positive I think the ability.
To be first line treatment first line combination treatment for newly diagnosed.
It's really a from our perspective, a great achievement it opens.
Speaker 4: large sets of patients that could be enrolled to the stride as well as the ability to.
Large sets of patient that could be enroll to this trial.
Well as the ability to.
Speaker 4: So this is from a lot of perspective. This is...
Treat newly diagnosed so this is from our perspective this is.
Speaker 4: Everything that we wanted from the 3-IND meeting, we do expect it to be part of other combination therapy. I must say that
Everything that we wanted from from the pre IMD meeting, we do expect it to be part of other combination therapy I must say that.
Speaker 4: Unfortunately for the patient, there is no real efficacious chemotherapy for GBM. There are some that are passing the BBB, but they are not viewed as various efficacious. And also another thing to remember, the systemic chemotherapy is usually given a few weeks after surgery. So there is some...
Unfortunately for the patient there is no real efficacious chemotherapy for GBM.
There are some that are passing the pvp, but they're not viewed as very efficacious, so and and also another thing to remember.
Systemic chemotherapy is usually given a few weeks after surgery. So there is some.
Tie.
Time between the surgery to the time the patient actually get this line of treatment they own complex.
Speaker 4: time between the surgery to the time the patient actually gets this line of treatment. The onker flex is part of the surgery and the treatment starts immediately. The patient gets it as part of the surgery. The exposure to the chemotherapy is immediate.
Part of the surgery and the treatment starts immediately patients get it as part of the surgeries the exposure to the chemotherapy is immediate.
Speaker 4: And this is very important to the ability to potentially delay or even eliminate reoccurrence of the tumor.
And this is very important to the ability to potentially delay or even 11 eliminate reoccurrence of the tumor.
Yeah.
Okay. Thank you.
Speaker 1: Thank you. We will now take our last question from the line of Cindy Lee from Bargley's. Please go ahead your line is open.
Thank you we will now take our last question from the line of Cindy Lee from Barclays. Please go ahead. Your line is open.
Speaker 6: Hi, good morning. This is Cindy on for a bloggy. Just a quick one from us. Could you share your thoughts on the Shield II study, especially as it relates to current cash levels and capital requirements? Thank you.
Hi, Good morning. This is Cindy on fertilizer you just a quick one from US could you share your thoughts on the shield two study, especially as it relates to current cash levels and capital requirement.
So thank you, yes, so as we said in the last two calls.
Speaker 4: Thank you. Yes. So as we said in the last two calls, we are focusing on shield one, both in terms of our resources as well as timelines. From the time that we heard from the FDA last year, under the breakthrough therapy designation that they will request only one phase three, we decided to prioritize shield one in terms of resources, timelines, and everything that is associated with that.
We are focusing on shield one Boe.
In terms of our resources as well as time lag from the time that we heard from the FDA last year under the breakthrough therapy designation that they will request only one phase III, we decided to prioritize shields one in terms of resources timeline and everything that these associates.
We did and.
Speaker 4: manage CO2 on a slower pace. And this is what we are. The slower price still added 200 patients. We look at it as an expansion of the indication. CO2 would be submitted post approval.
And it shows two at a slower pace and this is what we ought to be slower pace still added.
Added 200 patient we look at it as an expansion of the indications feel to it to be submitted post approval.
Speaker 4: And probably determining what will be the result and the data from shield one will also do a judgment in terms of the size of the trial. We will not need it to be a phase three in terms of the size and the...
And probably determining what will be the result of the data from shield. What we'll also do a judgment in terms of the size of the trial, we will not need it to be.
This fee in terms of the size and the design.
Got it thank you.
Thank you.
Speaker 1: Thank you, I will now hand the call back for any closing remarks.
Thank you I will now hand, the call back for any closing remarks.
Speaker 3: Thank you for joining us. We have fought quarter and full year 2021 and looks good.
Thank you for joining <unk> fourth quarter and full review of 2021 earnings Conference call.
Speaker 3: I would like to say again how excited we are about the progress we have achieved today. Specifically regarding our Difflex 100 Clinical Programme, as well as the opportunities that lay around.
I would like to say again, how excited we are about the progress we have achieved to date, specifically regarding <unk> clinical program as well as the opportunities that lay ahead.
Uh huh.
We remain grateful to our team members and all our external counsel.
Speaker 3: We remind us for our team members and all our external partners for their commitment to our mission and their support in continuing to advance toward achieving our goals of bringing, bringing complex one and all complex to health care providers and patients as quickly as possible. I look forward to speaking with you on our next quarterly call.
Their commitment to our mission and their support in continuing to advance towards achieving bringing duplex one out of it.
Providers.
And patients as quickly as possible I look forward to speaking with you on the list.
During the quarter.
Okay.
Thank you that does conclude our conference for today. Thank you for participating you may now disconnect.
Speaker 1: Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.
Thanks.
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Speaker 2: Thank you all for participating in PolyPid's fourth quarter and full year 2021 conference call. Joining me on the call today will be a mere Royceburg Chief Executive Officer and and Declay Choskas-Oxel-Brown Executive Vice President and Chief Financial Officer.
Thank you all for participating in poly peds.
Fourth quarter and full year 2021 conference call.
Joining me on the call today will be a mere weisberg, chief Executive Officer, and <unk> <unk> Oxo Braun Executive Vice President and Chief Financial Officer.
Earlier today, the company released financial results for the three months and 12 months end December 31 2021 a.
Speaker 2: Rollerlier today, the company released financial results for the three months and 12 months in December 31st, 2021. A copy of the press release is available in the best reception of the company's website, www.polypid.com.
A copy of the press release is available in the investors section of the company's website www dot piloted dot com.
Speaker 2: I'd like to remind you that on this call, management will make sword-looking statements than the meeting of the Federal Security's laws. For example, management is making forward-looking statements when it discusses the expected recruitment for trials, the interim analysis.
I'd like to remind you that on this call management will make forward looking statements within the meaning of federal Securities Laws. For example management is making forward looking statements. When he discusses the expected of recruitment for trials the interim analysis.
Speaker 2: timing and potential implications, timing of trials and release of the results hereof.
Timing and its potential implications timing of trials and released the results thereof.
Capacity of the company's manufacturing facility, the company's pipeline the potential benefits that duplex 100, and a couple blocks the.
Speaker 2: capacity of the company's manufacturing facility, the company's pipeline, the potential benefits of D plus 100 and aqua plot.
Speaker 2: companies' potential partners and the sufficiency of the company's cash to fund future operations.
The company's potential partners and the sufficiency of the company's cash to fund future operations.
Speaker 2: For the constable, they're subject to numerous risks and uncertainties, many wish are beyond our control, including the risks and uncertainties described from time to time in RSEC filings. Our results may differ materially.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.
Our results may differ materially from those projections.
Speaker 2: these statements about material risks and uncertainties that could cause actual results or events to materialy different.
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.
Speaker 2: Accordingly you should not place a new reliance on these states.
Speaker 2: I encourage you to review the company's filings with the SEC, including without limitation the company's form 20F, which identify specific factors, which may cause actual results or events, give from materially, from those described and the four looking statements.
I encourage you to review the company's filings with the SEC, including without limitation. The Companys form 20-F, which identify specific factors that may cause actual results or events differ materially from those described in the forward looking statements.
Speaker 2: Polypid displays any intentional replication.
<unk> disclaims any intention or obligation, except as required by law to update or revise financial projections or forward looking statements, whether because of new information future events or otherwise the conference call contains time sensitive information and speaks only as of the <unk>.
Speaker 2: is required by law to state or revise financial projections or for the statements, whether because of new information, future events or otherwise. The conference call contains time-sensitive
Speaker 2: speaks only as of the live broadcast today, February 9, 2022.
Cap today February nine 2022.
Speaker 2: completion of those prepared remarks. It's my pleasure to turn the call over to Mayor Weisberg, CEO , I'm here. Mayor.
Please turn to host prepared remarks.
My pleasure to turn the call over to EMEA Weisberg CEO Amir.
Thank you Bob.
On behalf of our team at <unk> I would like to welcome everyone to our fourth quarter and full year 2021 earnings call.
Speaker 3: I would like to welcome everyone to our fourth quarter in full year 2021.
I will begin today with some brief comments on the planned transition in our senior leadership team.
Speaker 3: I will begin today with some brief comments on plant transition in our senior leaders.
Speaker 3: The cloud will provide a detailed business update and then she will review our financial results after which we will open the call for you.
<unk> will provide the detailed business update and then she will review our financial results after which we will open the call for your questions.
As you know, we recently announced a plan to CEO transition. This year I will be reaching the formal entitlement H, which typical for a company executive in Israel.
Speaker 3: As you know, we recently announced a plan to see your turn.
Speaker 3: this year I will be reaching the formal retirement age, which typical for a company.
Speaker 3: So effective on July 1st 2020.
Effective on July one 2022, I will retire as CEO at all in which I have fulfilled for over 11 years. It has been an honor to serve as the CEO of fully paid throughout the development phase of our company.
Speaker 3: I will retire as a CEO , a role in which I have fulfilled for over eleven...
Speaker 3: It's been an honour to ever serve as a CEO of Polypide throughout the development phase of our
Our board of directors has appointed <unk> as Poly Pizza, Chief Executive Officer effective July <unk> 2022.
Speaker 3: Our Board of Directors has appointed the client as PolyPiz Chief Executive Officer Effective July 1st, 2020.
Speaker 3: As we prepare for our next phase of growth, the client is the ideal future leader of the company.
As we prepare for our next phase of growth decline.
Future leader of the company.
Speaker 3: She brings clear focus on operations and proven track record on driving, growth and
She bring clear focus on operations and proven track record on driving growth and innovation.
Speaker 3: She has also led our strategic and financial planning and capital raising efforts, including our IPO.
She has also led our strategic and financial planning and capital raising efforts, including our IPO in 2020.
I look forward to continuing to work closely with decline in order to ensure a smooth transition.
Speaker 3: I look forward to continuing to work closely with the KLA in order to ensure a smooth transition.
Speaker 3: I would also like to take a moment to acknowledge the plan in retirement of Dr. Schaulmuchter, Chief Operating Officer, who will be retiring from...
I'd also like to take a moment to acknowledge the plane that retirement of ductile shoulder more style chief operating officer will be retiring from the company next month, we would like to thank shareholders for successful leading the scale up of the manufacturing capabilities.
Speaker 3: We would like to thank Shao for successful leading the scale up of the manufacturing capabilities, which is now complete and advancing our clinical development.
<unk> is now complete and advancing our clinical development programs.
Speaker 3: We believe that polypide is in the strongness operational position in each history and we are well positioned for long term.
We believe that policy the easing the strong net operation level.
Position in its history, and we are well positioned for long term success.
We continue to strongly believe that our equivalent balance sheet will be sufficient to complete the shield one study and prepare for the submission of an NDA to the FDA as well as further advanced our own complex development platform.
Speaker 3: continue to strongly believe that our current balance sheet will be sufficient to complete the shield one study and prepare for the submission of NMDA to the FDA as well as further advance our own complex development.
With that.
Speaker 3: With that, I will now turn the call over to the class to provide some further updates on our build.
I will now turn the call over to the cloud to provide some further updates on our business.
Thank you Amit and thank you all for joining us on the call on behalf of the management team, we would like to thank him for his leadership qualities for over a decade.
Speaker 4: Thank you, Amir, and thank you all for joining us on the call. First, on behalf of the management team, we would like to thank Amir for his leadership of polypide for over a decade.
Speaker 4: strong belief in our plexed technology and its potential benefit for patient has been a driving force at our
Strong belief in our flex technology and its potential benefit for patients has been a driving force.
Speaker 4: He has recruited and built a strong management team established on manufacturing base that lets us control this critical aspect of our business and establish our operation team in Israel and the US. It has been my privilege to work with Amir and we look forward to his continued leadership and active involvement for the next several months.
Yes.
Recruited and built a strong management team.
Thanks to our manufacturing base.
Control of the critical aspects of our business and established our operation team in Israel and thank you.
It has been my privilege to work with them all and we look forward to his continued leadership and active involvement for the next several months.
Next I would like to express how grateful and proud I am to have the opportunity to lead quality.
Speaker 4: Next, I would like to express how grateful and proud I am to have the opportunity to lead polypids at this exciting time in our corporate evolution. You won't find many Israel's
This exciting time in our call.
Great.
You won't find many Israeli biopharma companies.
Speaker 4: that have reached our current stage. Where we are well on our way to complete a phase three pivotal trauma with several hundred of patients. And this is a milestone that we are approaching at a steady pace.
<unk> reached our could change.
Well on our way to complete a phase III pivotal trials with several hundreds of patients and this is a model of selling.
Approaching at a steady pace.
Speaker 4: I'm excited to continue working with our talented and passionate team to achieve further clinical and operational success.
I'm excited to continue working with our talented and passionate team to achieve better clinical and operational success.
Speaker 4: execute on the many opportunities that lie ahead of for us.
And execute on the many opportunities that lie.
Hello Hello.
Speaker 1: with that, I will now provide a brief update on the status of a
With that I will now provide a brief update on the pipeline.
Pipeline.
Speaker 10: Most importantly, a few days ago the FDA agreed
Most importantly, a few days ago, the FDA agreed.
So please please request.
Speaker 10: Let me request for the addition of an unblinded interim analysis in shield one. Our base three study evaluating D-plates 100 for the prevention of abdominal soft tissue surgical site insects.
In addition, often on blinded interim analysis and shared one.
As III study evaluating <unk> 100 for the prevention of Donovan for soft tissue surgical site infection.
Speaker 10: A request was based on the FDA recently established guidance for pharmaceutical companies to address the impact of COVID-19 on meeting, involvement, and study of...
Ill request was based on the FDA.
Since we established guidance.
Pharmaceutical companies to address the impact of COVID-19 on meeting enrollment in study objective.
Speaker 10: for clinical trials conducted during the ongoing pandemic.
Clinical trial conducted during the ongoing pandemic.
Okay.
The interim analysis is expected during the second quarter of 2021 750 patients completed the 30 day follow up and will allow for early trials choppy due to efficacy.
Speaker 10: The entry analysis is expected during the second quarter of 2020 to 1,750 patients complete their 30-day follow-up and will allow for early trial stopping due to a sick-sleeve, fertility, or for sample size wear-
<unk> all four sample size reassessment.
Speaker 10: and early stop to the trial will occur if there's sicker serious on the SSI rate is better than
An early start to the trial will occur.
We could see results on the Ssi rate is better than this.
Speaker 10: This entry analysis is an exceptional opportunity for polypies to more precisely define the targeted patient enrollment range for the Shield 1 study. Also, as planned, a recent blinded sample size reassessment was conducted following the completion of the 30-day follow-up period for the 500 patient enrolls. And it supports the continuation of Shield 1.
This interim analysis is an exceptional opportunity for quality.
More precisely define the targeted patient enrollment range of a shield one.
Also as plan a recent blinded sample size reassessment.
<unk> following the completion of the 30 day follow up period for the fifth Congress patient enrolled and it supports the continuation of shield one trial.
Speaker 10: Looking forward, the pace of enrollment in the SHELD-1 trial continues to be robust. And we expect this trend to continue in 2022, targeting 200 to 250 enrolled patients per
Looking forward the pace of enrollment in the shield one trial continues to be robust.
And we expect this.
Trend to continue in 2022 targeting 200 to 250 enrolled patients.
Speaker 10: We now have approximately 680 patients involved into the study across approximately 60 centers in the United States, Europe and Israel. As such, we expect to reach the 750-n-volt patient for the entry analysis by the end of the first course.
We now have approximately 680 patients.
The study.
Approximately 60 centers.
I would say Europe and Israel.
We expect to reach the 750 enrolled patients for the <unk>.
<unk> analysis by the end of the first quarter, we are very pleased with the rate of goodwill.
Speaker 10: We are very pleased with the rate of involvement, especially considering the holiday season and the disruption to hospitals caused by the surge of COVID-19 infection, driven by the Omricondale.
Especially considering the holiday season.
Destruction to hospitals caused by the surge of COVID-19 infection, driven by the on recon volumes.
So both financial standpoint as discussed.
Speaker 10: for the financial standpoint as discussed on our last call, because we only need to conduct shield one to potentially receive FDA approval and do not need to run some involvement in shield two. We continue to expect that our cash runways will be extended to the end of the-
Because we only need to conduct share one to potentially receive FDA approval.
To wrap up enrollment.
Two we continue to expect with our cash runway will be extended to the end of this year.
Speaker 10: Shield 2 has currently over 200 patients involved, and as a reminder, it includes broader eligibility criteria including minimally invasive procedure. Now let's switch gear to this.
<unk> is currently over 200 patients enrolled and as a reminder, it includes <unk>.
Legibility criteria, including minimally invasive procedure.
Now, let's switch gears to discuss commercialization.
Speaker 10: In terms of potential collaboration for the future commercialization of SIPLEC100 in the US, Europe and Asia, we remain in dialogue with several large and mid-sized pharmaceutical companies.
In terms of potential collaborations for the future commercialization of <unk> 100 in the U S Europe and Asia, we remain in dialogue with several large and midsize pharmaceutical companies that we believe would be ideal commercial partner with Eplex 100.
Speaker 10: that we believe would be ideal commercial partners for the Plex 100.
As we have said previously.
Speaker 10: These companies are leaders in selling pharmaceutical products to the hospitals, often with current portfolio of marketed products, have stronger established commercial infrastructures, exceeded a deep understanding of clinical and pharmacoeconomic benefits in the hospital channels, and maintain strong relationships with the hospital medical and administrative.
These companies are leaders in selling pharmaceutical products to the hospitals, often with current portfolio of marketed products.
Strong established commercial infrastructure.
It is a deep understanding of clinical and pharma clinical genomic benefit.
With those channels and maintain strong relationships with the hospital medical and administrative staff.
Speaker 10: importantly, there continues to be high level of interest in DPSX100 from these potential partners. While there is currently no formal timeline related to executing any potential partnership in the US or other region.
Importantly, there continues to be high level of interest in duplex 100 of these potential partners.
There is currently no formal timeline related to executing any potential partnership for the U S or other regions.
Speaker 10: Our most critical objective is to maximize the value of the Blit 400 in any potential trends.
Most critical objective is to maximize the value of <unk> 100 in any potential transaction.
Speaker 10: So if at when we do finalize partnership agreement, this will be the determining fact.
<unk> said when we do finalize partnership agreement this will be the determining factor.
Speaker 10: As we continue to advance the Plan X100 in the clinic, execute on our commercial trap plan and conduct partnering discussion, we also remain focused on building the significant body of evidence in support of the safety and efficacy of this promising product.
As we continue to advance it takes 100 in the clinic execute on our commercial trucking and Quebec partnering discussion. We also remain focused on building a significant body of evidence.
The support of the safety and efficacy of this promising product candidates.
Speaker 10: As such, we plan to have a number of peer-reviewed publications and data presentation at important medical meetings throughout 2012.
As such we plan to open a number of peer reviewed publications and data presentations at important medical meetings throughout 2022.
Speaker 10: This is obviously an important strategy for all of our key audience. Physician, payers and potential.
This is obviously an important strategy for all of our key audience.
<unk> <unk> and <unk>.
Potential partners.
Speaker 10: Now I'd like to further elaborate on the status of Ohm.
Now I'd like to further elaborate on the status of all.
Speaker 10: are interest-tumoral chemotherapy products, candidates, initially targeting solid brain tumors, including those that are chemotherapy.
Intra tumoral chemotherapy product candidate initially targeting solid tumors, including those with chemotherapy or anti crazy.
Speaker 10: As a reminder, ON COPLACS provide local prolong and control exposure to DOSA-TEXEL in the intraoperative tumor resection.
As a reminder, on complex provide local prolong can control exposure kudos opex scale and the intraoperative tumor resection.
As you know does have excelled as one of the most widely used chemotherapy agents worldwide.
Speaker 10: As you know, Dothatexcel is one of the most widely used chemotherapy agents worldwide. Following a recent train investigation on your drug meeting, late last year, the FDA indicated that on-complex will be considered...
Following a recent trade investigational new drug meeting late last year. The FDA indicated that on complex will be considered as part of a potential first line combination therapy.
Speaker 10: part of the potential first line combination therapy of patient newly diagnosed with GBM. This is very encouraging.
Patients newly diagnosed with GBM.
This is very encouraging news for our company. We believe this is indicative market significant potential to treat brain tumors.
Speaker 10: We believe this is indicative of its significant potential to treat brain tumors and could have substantial commercial benefits. If shown to be safe and effective in clinical trials and subsequent.
Could have substantial commercial debt.
Shown to be safe and effective in clinical trials.
And subsequently.
We are now focused on working on the design of our planned phase one two trial of all complex with a world class Oncology Advisory Board for which we are thrilled to add two distinguished members.
Speaker 10: We are now focused on working on the design of our Plan Phase 1 2 trial of Oncoplex with our World Class Ecology Advisory Board, for which we are thrilled to add two distinguished members to this group over the past few.
Group over the past few months.
Speaker 10: of Frederick Lann is the chairman of neurosurgery at the University of Texas and the Understown Cancer Center and is co-leading and the Understown Glaodlastoma's Munschroot Initiative.
Until February .
He is the chairman of neurosurgery at the University of Texas, MD Anderson Cancer Center and is call, leading and beyond just on Glioblastoma launch week initiative.
Speaker 10: This initiative is dedicated to saving the lives of patients throughout the development of new therapies and better treatment approach.
This initiative is dedicated to saving the lives of patients throughout the development of new therapies and better treatment approaches Dr.
Speaker 10: Dr. Lange is considered as one of the world's far most experts in the treatment of break.
<unk> is considered as one of the worlds most.
<unk> in the treatment of breakthrough Dr.
Speaker 10: Dr. Mitchell Bergho is the Guggenheim professor of the Department of Neurological Stairdury at the University of California.
Dr. Mitchell, Doug is the Guggenheim Professor of the department of neurological surgery at the University of California, San Francisco.
Speaker 10: He services the director of the UCS-CF Brain Tumor Research Cancer, a leader in translational research and is a principal investigator of its specialized program of research excellence in narrow oncology funded by the National Research Cancer Institute.
These services the director of the UCSF brain tumor research cancer, a leader in translational research and is the principal investigator.
It's specialized program research excellence in neuro oncology funded by the National Cancer Institute.
Speaker 10: We are working enthusiastically with this world-renowned position and are excited to have the opportunity to leverage the rest experience and commitment to innovation and dreams.
Our working on Tuesday, ethically with DS World renowned physicians and are excited to have the opportunity to leverage the vast experience and commitment to innovation and growth.
Speaker 10: With that, I will now review of fourth quarter financial report. Let's begin with polypide balance sheeting from...
We did I will now review, our fourth quarter financial results.
Begin with policy the balance sheet information.
Speaker 10: As of December 31, 2021, the company had cash, cash equivalent and short-term deposits of $32.2 million. As compared to $66.6 million, as of December 31, 2021.
As of December 31, 2021, the company had cash cash equivalents and short term deposits of $22 2 million as compared.
Compared to $66 6 million as of December 31, 2020.
Speaker 10: Cash use in operation for the 12 months ended the September 31, 2021, total $32.4 million.
Cash used in operations for the 12 months ended December 31st 2020.
Total $22 $4 million.
Let's turn to our income statement.
Speaker 10: Research and development expenses for the three months ended the December 31, 2021 were $9.5 million compared to $5 million in the same three months period of 2020. The increase in research and development expenses resulted from the increased cost and activity related to the ongoing shield one and shield two, phase three clinical trials in abdominal surgery.
Research and development expenses for the three months ended December 31st 2021 40.
$9 $5 million compared to $5 million in the same three months period.
The increase in research and development expenses resulted from the increased cost and activity related to the ongoing shield, one and shield two phase III clinical trials in abdominal surgery.
Speaker 10: For the full year ended December 31st, 2021 and 2020, R&D expenses were $30.4 million and $17 million.
For the full year ended December 31st 2021, and 2020, R&D expenses were $30 4 million.
And $17 million respectively.
Speaker 10: Marketing and business development expenses for the fourth quarter of 2021 were 1.1 million compared to $710,000 for the same period of 2020. The increasing marketing and business development expenses are due to initiating the pre-launch activities.
Marketing and business development expenses for the fourth quarter of 2021 were $1 1 million compared to $710000 for the same period of 2020, the increase in marketing and business development expenses argued to initiation in the prelaunch activities.
Speaker 10: General and administrative expenses for the fourth quarter of 2021 were $2.8 million, slightly higher than the $2.2 million recorded in the fires.
General and administrative expenses for the fourth quarter of 2021 were $2 8 million slightly higher than the $2 2 million.
Recorded in the prior year period.
For the fourth quarter of 2021, the company had a loss attributable to ordinary shares of <unk>.
Speaker 10: For the fourth quarter of 2021, the company had a lost tributable to ordinary share of $13.2 million at compared to $7.5 million in the prior use.
$13 2 million as compared to seven 5 million.
Prior year period.
Speaker 10: This was primarily driven by a solid rate of patient recruitment in the shield 1 and shield 2, 3 clinical trials and the associated...
This was primarily driven by a solid rate of patient recruitment in that showed one in shield II phase III clinical trials and the associated costs.
Speaker 10: For the year end of December 31st, 2021, the company had a lot of three-bitable, two-ordinary shares of $42.3 million compared to a loss of $39 million in the full year, 2021. We will now open the call to your question. Operator.
For the year ended December 31, 2021, the company had a loss attributable to ordinary shares of $42 $3 million.
<unk> to a loss of $39 million in the full year 2016.
We will now open the call for your questions operator.
Yes.
Speaker 1: Thank you. As a reminder to ask a question, you will need to press star one on your telephone to restore your question, press the pound hash key. Once again, to ask a question, please press star one on your telephone keypad. Your.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound Husky once again to ask a question. Please press star one on your telephone keypad.
Your first question today comes from the line of <unk>.
Speaker 1: Gary Nachman from BMO Capital Markets, please go ahead your line is open.
Gary Nachman from BMO capital markets. Please go ahead your line is open.
Speaker 5: Hi, good morning. This is Ed and Flaw, a villain in for a gay napkin. Well, first of all, I can dress on the updates and the CEO transitioned to both Vicklo and Amer. So first, for the plan in term now, it's for SHI of one, would you be able to share some more detail on what specific now to should be conducting to determine the efficacy or fertility? And how about the difference from the recently completed, funded sample size reassessment? That was completed.
Hi, Good morning, this is <unk> filling in for Gary Nachman.
Well first of all congrats on the updates and the CEO transition to both pick one up here.
So first for the planned interim analysis for ship, one would you be able to share some more detail on what specific analysis will be conducted to determine the efficacy or futility and how about being different from the recently completed blinded sample size reassessment that was completed.
Thank you and then Q4 would.
Speaker 4: Thank you and thank you for your warm words. It's very different. The 500 was unblinded. We are talking here about the full intrim blinded. Sorry, the 500 was blinded. We are talking here about an unblinded intrim analysis, full intrim analysis, where the DMC will be reviewing the effect and actually calculating the effect rate.
It's very different the 500 was unblinded.
We are talking here about full interim I'm.
I'm glad we're starting to 500 was blinded we are talking here about an unblinded interim analysis for the interim analysis, where the DMC will be reviewing the.
Effect and actually calculating the.
The effect right.
Speaker 4: And we have the opportunity here because it's unblinded to have an early stop, which we didn't have. And that's the main thing.
And we have the opportunity here because it's unblinded to have an early stop which we didn't have.
And that's that's the main.
Speaker 4: aspects of it is de-risking the program and allowing us to have an earlier you could say peak or inflection point in terms of the interim and real insight into the effect.
Aspects of it is de risking the program and allowing us to have an earlier.
You could say peak or inflection point in terms of the interim and we are.
Insight into the effect right.
Speaker 4: And would you have to take a statistical hit to unblind that data to provide? So we have a small statistical penalty, a few dozens of patients. Again, this goes to the specific guidelines that the FDA issued regarding COVID. So it's a small statistical penalty, yes.
Got it and would you have to take a statistical hit blend that data. So we haven't we have a small a statistical penalty.
Dozens of patient again this goes to the specific guidelines that the FDA issued regarding coffee. So it's a small statistical penalty yet.
Thousands of patients.
Great.
Speaker 5: Great. And one more follow-up. For OncoPlex, would you be able to share some color on the study design for the Phase 1-2 trial in GBM in terms of size or strength or any other parts of the protocol?
And one more follow up.
For Encore flex.
Would you be able to share some color on the study design for the phase one two trial.
GBM in terms of size or strength or any other parts of the protocol.
Speaker 4: So as we said today, we met the FDA late last year for pre-I and emitting.
So as we said today, we must be FDA late last year for the <unk> meeting.
Speaker 4: and got a general agreement around the preclinical and clinical program. We are now working on the design of the phase 1-2 together also with our care...
<unk> got a general agreement around the preclinical and clinical programs.
Program, we are now working on the design of the trial of the phase one two.
Together also with our Kols. So once we get better clarity internally of the design and then I'm sure we will be able to share, but we are still at the pace of designing the trials based on the comments that we got.
Speaker 4: So once we get the better clarity internally of the design, then I'm sure we will be able to share, but we are still at the pace of designing the trial based on the comments that we got.
Got it thank you.
Speaker 1: Thank you. Thank you. Your next question comes from the line of Elliot Wilber from Raymond James. Please go ahead. Your line is open.
Thank you.
Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James. Please go ahead. Your line is open.
How about I'll take clients TANF Smith on behalf of Elliot.
Speaker 6: Hello, I'm Declan. This is Hannah Smith on behalf of Elliott. I'm seeing 750 patients in term breed out delivers positive results on shield one. Will you continue to recruit and enroll the full 900 patients to support generation of various secondary and marketing endpoints that you've previously planned on doing? So...
750 patient interim read out until the first positive results. Michelle one will you continue to recruit and enroll the full 900 patients to support generation of various secondary and marketing endpoint that you had previously planned on doing.
So.
Speaker 4: The reality, first of all, we will be very happy with such overwhelming results. The reality of the pace of recruitment that we are in.
First of all we will be very happy with such overwhelming result, the reality of the pace of recruitment that we our aim is that probably by the time that we get the input from.
Speaker 4: is that probably by the time that we get the input from the DSMB committee, the DSMB
The D S M B a committed in D. S M a C.
Speaker 4: So, we will be at 900 patients. So, practically, this will come at the same point. As we said, if you remember, we said that we expect to recruit the last patient during the second quarter. So, with the approximately 900 patients. So, timeline here are our lines.
With me today.
We will be at 900 patient. So practically this will come at the same point as we said if you remember we said that we expect to recruit the last patient during the second quarter. So with the approximately 900 patients. So timeline here I would have liked.
Speaker 10: I see. Also, do you, what is your timeline for Onkaplex, the Phase I study in 2022? Can you elaborate a little bit more about that? I can. So first, I want to remind everyone that this is an early stage program. We are still at the pre-cleaning phase. We expect to be ready.
Okay.
Also can you what is your timeline for uncle Plex. The phase one study in 2022 can you elaborate a little bit more about that.
Okay.
I want to remind everyone that this is an early stage program. We are still at the preclinical stage, we expect to be ready for phase one two by the end of this year and we are working diligently on that this.
Speaker 4: for phase one, two by the end of this year, and we are working diligently on that. This will be including submitting towards the end of the year an IND application, producing the product with the...
This will be including submitting towards the end of the ear and Iot applications could you see the product with the GMP.
Speaker 4: condition and a lot of other parameters that are required to go into phase one, two in GBM. So it's early to say what will be the actual timeline for the phase one, two. Once we have the design and we can share details on the design, we can also be in a position to give more clarity on the time.
This should add a lot of other parameters that are required to go into.
Phase one two in GBM.
So it's early to say what will be the actual timeline for the phase one two and once we have the design and we can share details on the design. We can also be in a position to to give more clarity on the timeline for this trial.
Speaker 6: Okay, great. Thank you so much, Declah, and congratulations. Thank you.
Okay, great. Thank you so much day clock and congratulations thank you.
Speaker 1: Thank you. Your next question comes from the line of Brandon Fox from Canto. Please go ahead, your line is open.
Thank you. Your next question comes from the line of Brandon Folkes from Cantor. Please go ahead. Your line is open.
Speaker 7: Hi, I think things like questions and congratulations on the progress. I mean, I would be congratulations on the retirement and particularly from the appointment. What was it? Thank you. Thank you.
Hi, Thanks for taking my question and congratulation on the progress.
EMEA, obviously, congratulations on the retirement in particular.
On the appointment what was it.
Yes.
So maybe just following on from the similar line of questioning in particular you talked about.
Speaker 7: Maybe just following on from the similar line of questioning, and Diggler, you talked about, you know, by the time you've come, well, the committee's completed the interim look, you're gonna have that data, or be close to having the data on the 900 patients. There's the agreement with the FDA to potentially submit
Tom.
The committees.
The interim look you're going to have that data could be close to having the data on the 900 patients does the agreement with the FDA to potentially submit.
Speaker 7: on the 750 or would you be submitting both efficacy and safety on potentially close to 900? And then similarly, does the agreement still include shield 2 safety data time and condition? Thank you.
On the 750.
Would you be submitting both efficacy and safety on potentially close to 900.
Similarly does in agreements still include shield two safety data Commerce Commission. Thank you.
Speaker 4: So thank you, Brodans. We will be submitting based on the 900 patient that will be recruited at the time.
So thank you both.
And we will be submitting based on the 900 patients will be recruited at the time it can vary and it could be a little bit smaller than that but more or less at that.
Speaker 4: very and to be a little bit smaller than that, but more or less at that range. And we do plan on submitting also the safety data from SHILD 2 that now includes over 200 patients. Probably by the time we will have some will have slightly larger number of patients in this trial.
Change and we do plan on submitting also the safety data from shield two that now includes over 200 patient probably by the time, we will have some will have slightly larger.
Larger number of patients in the.
To that.
Great. Thank you very much.
Thank you.
Yes.
Yes.
Speaker 1: Thank you. Your next question comes from line of, will you be canon from JMP Securities? Please go ahead, your line is open.
Thank you. Your next question comes from the line of <unk> <unk> from JMP Securities. Please go ahead. Your line is open.
Hi, great. Thanks for taking the questions.
Speaker 8: I think we're taking the questions. I guess kind of in the same vein as the prior question, it sounds like not really seeing any impact from Omicron or anything else on enrollment, it's going quickly, it sounds like this interim could occur. I mean, that's only 70 patients from 680 to 750. So it sounds like it could occur very early in the second quarter. I guess the question is, was there anything in the blinded interim, the 500 patient interim that informed the addition of the 750 patients?
Hey, I guess kind of in the same vein.
Prior questions it sounds like not.
We're not really seeing any impact from <unk> or anything else on enrollment it's growing quickly it sounds like this interim could occur.
I mean, that's only 70 patient from $6 80 to 750, so it sounds like it could occur very early in the second quarter.
I guess the question is was there anything on the blinded interim the 500 patient interim that inform the addition of the 750 patient.
Speaker 8: interim and then where you guys are with with manufacturing
Interim and then where are you guys out with manufacturing thanks.
Speaker 4: So first of all, thank you for your question. And I'll go one by one. The...
So.
First of all thank you for your question and I'll go one by one.
Speaker 4: The interim by the time that we asked, we submitted to the FDA the request for the interim. This was before we had a
750, the interim by the time that we ask we submitted to the FDA to request for the entry and this was before we had the.
The blinded.
Speaker 4: assessments of the 500, so there was no influence on that. The way we look at the interim is an earlier ability for the risking of the program, earlier peak to result as well as having the ability to adjust if needed. And I think you had one question that I missed, but with regards to manufacturing,
That's up to 500, so there was no influence on that the way we look at the the entry is and then earlier ability for de risking of the program earlier peak to result, as well as having the ability to adjust if needed.
And I think you had a one question that I missed but with regards to manufacturing them.
Speaker 4: We are very pleased with the progress. If you remember last year, we've done care-lap processes, and now we are in the process of getting the manufacturing facility back into capacity as well as the validation needed for this and things are progressing in parallel to our phase three. So by the time that we...
We're very pleased with the progress if you remember last here.
Done.
<unk> processes and now we are in the process of getting the manufacturing facility back into capacity as well as the validation needed for that and things are progressing in parallel to our phase III. So by the time that we find.
Speaker 4: finalize the space, we submit the data for an NDA. We should be ready for FDA inspection and all the reviewers come with that. And so you had another question.
Liza phase III asset if it makes the data for an NDA, we should be ready for FDA inspection and all the review that comes with that so you you had another question.
I think you've covered it but actually that.
Speaker 8: I think you covered it, but actually the interim, I guess how much time do you think it'll take you to clean up the data following the 30 days?
Actually the interim I guess, how much time do you think it'll take you to clean.
Clean clean up the data following the 30 days. Thank you. So as you rightly mentioned, we are now even with less than 70 patient from from last patient to the 750 <unk> required for the interim.
Speaker 4: Thank you. So as you rightly mentioned,
Speaker 4: We are now even with less than 70
Speaker 4: patient from from last patient to the 750 required for the interim. It's a process. It's a process we need to wait for the 30 days follow up. There is a cleanup and there is the time that the EMC requires to evaluate and unblind the day time. Get we gave guidelines that we are very comfortable with.
This is the process, we need to wait till the 30 day follow up there is a clean up in the time that the DMC requires to evaluate and unblinded data and guests. We gave guidance that we are very comfortable with having.
Speaker 4: having the inter-induing the second quarter.
Having the interim during the second quarter.
Speaker 4: as we progress and we could do 750 if we can.
And as we progress and recruit those 750.
If we can even be more specific we will but we're very comfortable with the.
Speaker 4: even the most specific we will, but we're very comfortable with the
Speaker 4: relatively few months from now to second quarters to have the interim data. The unblinded.
Relatively few months going out to the second quarter to have the interim data.
This.
Speaker 8: Great. And then I guess on an uncle plug, you kind of answered it probably. It's still, you're still designing the phase one, two. But I'm just curious how you're thinking about the combinations, you know, investigators' choice, or you're going to allow additional chemotherapy on top of the uncle plug.
Okay, Great and then.
I guess on Alco place, you've kind of answered it probably it's still you are still designing the phase one two but I'm just curious how youre thinking about.
The combinations.
Investigator's choice or are you going to allow additional chemotherapy on top of the uncle Plex. Thanks.
Speaker 4: So first I think that important that investor will recognize that the feedback from the FDA was very positive. I think the ability to be first-line treatment, first-line combination treatment for not newly diagnosed. This is really from our perspective a great achievement. It opens.
So first I think that.
The investor will recognize that the feedback from the FDA was very positive I think the ability to.
To be first line treatment first line combination treatment for not newly diagnosed.
It's really a from our perspective, a great achievement it opens.
Speaker 4: Large sets of patients that could be enrolled to the stride as well as the ability to.
Large sets of patient that could be enrolled this trial as well as the ability to.
Speaker 4: Street newly diagnosed so this is from full-up perspective. This is
Treat newly diagnosed so this is for perspective this is.
Speaker 4: Everything that we wanted from the 3-IND meeting, we do expect it to be part of other combination therapy. I must say that
Everything that we wanted from from the three I N D meeting, we do expect it to be part of other combination therapy I must say that.
Speaker 4: Unfortunately for the patient, there is no real efficacious chemotherapy for GBM. There are some that are passing the BBB, but they are not viewed as very efficacious. And also another thing to remember, the systemic chemotherapy is usually given a few weeks after surgery.
Unfortunately for the patient there is no real efficacious Cumulus tariff fees would you be in them. There are some that are passing the pvp, but they are not viewed as very efficacious, so and and also another thing to remember.
Systemic chemotherapy is usually given a few weeks after surgery. So there is some.
Time between the surgery to the time the patient to actually get this line of treatment. They own complex is part of the surgery and the treatment starts immediately patients get it as part of the surgery the exposure to the chemotherapy is immediate.
Speaker 4: time between the surgery to the time the patient actually gets this line of treatment. The oncoplex is part of the surgery and the treatment starts immediately. The patient gets it as part of the surgery. The exposure to the chemotherapy is immediate.
Speaker 4: And this is very important to the ability to potentially delay or even elaminate reaclevels of the tumor.
It is very important to the ability to potentially delay or even eliminate reoccurrence of the two of them.
Okay. Thank you.
Speaker 1: Thank you. We will now take our last question from the line of Cindy Lee from Barclays. Please go ahead your line is open.
Thank you we will now take our last question from the line of Cindy Lee from Barclays. Please go ahead. Your line is open.
Speaker 6: Hi, good morning. This is Cindy on for a bloggy. Just a quick one from us. Could you share your thoughts on the Shield II study, especially as it relates to current cash levels and capital requirements? Thank you.
Hi, Good morning. This is Cindy on fertilizer E. Just a quick one from US could you share your thoughts on the shield two study, especially as it relates to current cash levels and capital requirement.
Yeah.
Speaker 4: So thank you. Yes, so as we said in the last two calls, we are focusing on shield one, both in terms of our resources, as well as timelines, from the time that we heard from the FDA last year, under the breakthrough therapy designation, that they will request only one phase three. We decided to prioritize shield one in terms of resources, timeline, and everything that is associated with it. And so we decided to prioritize shield one in terms of resources, timeline, and everything that is associated with it.
So thank you, yes, so as we said in the last two calls we.
We are focusing on shield one both in terms of our resources as well as time lag from the time that we heard from the FDA last year under the breakthrough therapy designation that they will request only one phase III, we decided to prioritize shield one in terms of resources.
Timeline and everything that is associated with that.
Matt It shows two at a slower pace and this is what we are at a slower pace still added 200 patient we look at it as an expansion of the indications feel to it to be submitted post approval.
Speaker 4: manage CO2 on a slower pace. And this is what we are. The slower price still added 200 patients. We look at it as an expansion of the indication. CO2 would be submitted post approval.
Speaker 4: And probably determining what will be the result and the data from shield one will also do a jasmine in terms of the size of the trial. We will not need it to be a phase three in terms of the size and the design.
And probably determining what will be the result of the data from shared what we'll also do a judgment in terms of the size of the trial, we will not need it to be.
Three in terms of the size and the design.
Got it thank you.
Thank you.
Speaker 1: Thank you, I will now hand the call back for any closing remarks.
Thank you I will now hand, the call back for any closing remarks.
Speaker 3: Thank you for joining us. We have four quarters in full here in 2021 and we'll call...
Thank you for joining <unk> fourth quarter and full year 2021 earnings conference call.
Speaker 3: I would like to say again how excited we are about the progress we have achieved today, specifically regarding our DIPLEX 100 clinical program, as well as the opportunities that lay out the... and also the significance of healthy health for the most part.
I would like to say again, how excited we are about the progress we have achieved to date, specifically regarding <unk> 100 clinical program as well as the opportunities.
We remain grateful to our team members and all our external partners.
Speaker 3: We remind our team members and all our external partners for their commitment to our mission and their support in continuing to expand through the achieving our goal of bringing deep-lex 100 and on-complex to healthcare providers and patients as quickly as possible. I look forward to speaking with you on our next quarter-league call.
Their commitment to our mission and their support and continue.
Continuing to advance toward achieving our goal.
Glenn Greene.
Bringing duplex 100 uncompleted.
Provider.
And patients as quickly as possible I look forward to speaking with you on our list.
Quarterly core.