Q4 2020 Caladrius Biosciences Inc Earnings Call
[music].
Okay.
Welcome to the collateral Biosciences fourth quarter and year end, 'twenty 'twenty financial results and business update conference call.
Currently all participants are in a listen only mode.
Following managements prepared remarks, we will hold a Q&A session to ask a question at that time, Please press star.
Followed by the number one on your Touchtone phone.
If anyone has difficulty hearing the conference call. Please press star zero for operator assistance.
As a reminder, this call is being recorded today Thursday February 25th 2021.
I'll now turn the call over to John men detail, Vice President of Investor Relations and corporate Communications at Collagenase. Please go ahead Sir.
Thank you operator, and good afternoon, everyone welcome to collateral since fourth quarter and year end 2020 conference call to discuss our financial results and provide a business update.
Joining me today is Dr. David Mazzo, the company's President and Chief Executive Officer.
Earlier today, we issued a press release announcing our fourth quarter and year end 2020 financial results, which is available under the investors section of our company website.
You have not received this news release or if you'd like to be added to the company's email distribution list. Please email me at J D do at Yahoo Dot com.
Before we begin I'll remind you that comments made by management. During this conference call will contain forward looking statements that involve risks and uncertainties regarding the operations and future results of collagenase.
I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation. Its forms 10-K, 10-Q, and 8-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements. Furthermore, the content of this conference call contains time sensitive information.
That is accurate only as of the date of the live broadcast Thursday February 25 2021.
I'll address biosciences undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this conference call.
Please keep in mind that the company continues to conduct calls from different locations. During the COVID-19 pandemic. So we appreciate your patience should we have any technical difficulties with that I'll now turn the call over to Dr. Mazzo Dave.
Thank you John and good afternoon, everyone. Thank you for joining us on our call today to discuss our fourth quarter and year end 2020 financial results and recent business highlights.
Before I get into the prepared task. However, I again want to extend the best wishes of the entire collateral on staff to you and yours, hoping that you are well and coping with the challenges that COVID-19 has brought us all in a professional and personal lives now to business.
Despite the continued hurdles of the global pandemic Collagenase closed 2020 with strong momentum across our development programs, which has allowed us to strengthen our financial position, giving us the confidence that means to fund operations for the next several years in the context of our current development plans, while exploring additional pipeline expansion opportunities.
<unk>.
Over the course of 2020, we delivered on a number of strategic priorities in support of our robust autologous CD 34 positive cell technology based clinical programs I will further expand on this in a few minutes. Following my review of <unk> comments on the financial results.
Before that though I will take a moment to acknowledge the hard work focus creativity and perseverance of the entire collagenase staff throughout the pandemic. This because of their dedication individual contributions and team work that we've done so well as a company during 2020.
With that I will now review, our fourth quarter and year end financial results, starting with our operating expenses.
Research and development expenses for the fourth quarter of 2020 with $2 $9 million, a 5% increase compared with $2 $8 million for the fourth quarter of 2019 and $9.3 million for the year ended December 31, 2020 compared to $10.8 million for the year.
Ended December 31, 2019, representing a decrease of approximately 14% on.
R&D expenses in both the current year and prior year periods focused on the advancement of our ischemic repair platform and related to the following expenses.
Associated with C. L. B S 119 <unk>.
<unk> 34 positive cell therapy concept program for repair of COVID-19 induced lung damage targeting patients with severe Sars COVID-19 two infection that required ventilatory support due to respiratory failure.
This program has been indefinitely postponed due to the ever changing characteristics of patients who require chronic therapy post COVID-19 infection as well as our inability to identify investigators enduring institutions with the capacity to take on a clinical study of this type.
Ongoing expenses for her natura in critical limb ischemia in Japan for which we continue to focus spending on patient enrollment and Japanese NDA preparation.
Expenses associated with the proof of concept escape CMT study Christy I'll be a 16 and coronary microvascular dysfunction for which study enrollment was completed in the second quarter of 2019 and full results reported in May 2020, as well as expenses associated with the preparation and initiation of a phase II.
Study for C. L. B S 16, the freedom trial in the second half of 2020, and finally expenses associated with the ongoing dialogue with FDA regarding design and execution of a confirmatory phase III study of all ago there'll be S 14 in Noida.
General and administrative expenses, which focus on general corporate related activities with $2 $5 million per the three months ended December 31, 2020 compared to $2.3 million for the three months ended December 31, 2019, and $9 $9 million.
For the full year ended December 31, 2020, compared to $9 $3 million for the full year ended December 31, 2019, representing an increase of 6%.
Overall net net losses, excluding the benefit from income taxes that is the proceeds from sales of New Jersey, Nols were $19 million and $19 $4 million for the full years ended December 31, 2020, and December 31 2019, respectively.
Turning now to our balance sheet and cash flow.
As of December 31, 2020, glad dress had cash cash equivalents and marketable securities of $34 $6 million, which consisted of the $10.9 million of non dilutive proceeds received from the sale of our qualified New Jersey Nols as well as two registered direct offerings that raised the.
Total of $9.3 million in gross proceeds.
July 2020, we increased our cash position with the closing of a 2 million dollar private placement. It is noteworthy that the two registered direct offerings in the July private placement, where oil price at the Denmark.
During 2020, the company also raised $8 $5 million in gross proceeds through its common stock at the market sales agreement with H C Wainwright and company of which $7 $2 million was raised in July and August of 2020.
Subsequent to the close of the fourth quarter.
We were able to take advantage of investor demand for Collagic shares and successfully completed two strategic capital raises in close proximity.
On January 2021, we announced that we had closed on the $25 million capital raised through the sale of the company's common stock to several institutional and accredited investors and a private placement priced at the market under NASDAQ rules.
Shortly thereafter in February 2021, the company announced that it closed a $65 million capital raised through the sale of its common stock to several institutional and accredited investors and two registered direct offerings priced at the market under NASDAQ rules in total and despite the current economic environment and growing.
Challenges collagenase successfully secured approximately $90 million in new capital year to date in 2021, and approximately $120 million over the last 12 calendar months.
The February 'twenty five 'twenty 'twenty, one we have cash cash equivalents and marketable securities of approximately $116 million and based on existing programs and projections. We remain confident that our current cash balances will provide operations for the next several years, notably through the <unk>.
Completion of the phase two be freedom study of C. L. B F 16 through the registration eligible study completion for her net drip in Japan and through the phase one two proof of concept study for C. L. B S 201, while still providing capital to explore additional pipeline expansion opportunities.
That completes the financial overview and now we'll move on to our exciting clinical development pipeline.
As I've done on previous calls.
I will begin by providing a high level summary of what we are doing a collagenase and why we believe our development programs are an increasingly relevant and attractive investment opportunity.
Collagenase is focused on the development of autologous cellular therapies designed to reverse disease and we have late stage clinical programs underway based on a large database of human clinical data to date, our therapies have shown have shown strong signs of effectiveness and durability with a pristine safety profile. Unlike.
Many allogeneic therapies and present the possibility of substantial pharmacodynamic benefit. Most importantly, we remain focused on the development of personalized curative cell therapy products that will restore human health and improved quality of life with a single administration of the therapy rather than.
One that requires frequent re administration.
Our CD 34 positive cell therapy technology has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia, a condition in which the supply of oxygenated blood to healthy tissue is restricted.
We published preclinical and human clinical studies have demonstrated that the administration of CD 34 positive cells induces angiogenesis of the micro vasculature that is that these cells prompt the development of new blood capillaries, thereby contributing to the prevention of tissue death by facilitating blood flow to the edge.
Area of ischemic insult.
We believe that several chronic conditions caused.
Caused by underlining underlying ischemic injury can be improved through the application of our CD 34 positive cell technology, including but not limited to coronary microvascular dysfunction or C. M. D critical limb ischemia or CLI pre dialysis chronic kidney disease, where CK.
D and no option refractory disabling angina or northern.
I will now speak to the specifics of each of our development programs kicking off with C. L. B S. 16 are promising CD 34 positive cell therapy product candidate for the treatment of coronary microvascular dysfunction.
Like all of our CD 34 cell therapy product candidates <unk> uses a proprietary and patented formulation of CD 34 positive cells, specifically designed for an injection at or near the site of ischemic insult, which in the case of CMT is an infusion into a coronary artery.
They'll be F. 16 is the subject of the completed escape CMT trial, a 20 patient proof of concept clinical trial evaluating <unk> as a treatment for coronary microvascular dysfunction, a disease involving damage to the tiny arterial blood vessels, the micro circulation in the heart with no.
Accompanying discernible large vessel blockages.
Despite the absence of large vessel disease CMT patients have an equally poor prognosis related to major adverse cardiac events and death as to patients who have identifiable large vessel blockages.
Notably <unk>.
People living with CMT are often underdiagnosed misdiagnosed and are untreated because there are no large artery blockages to visualize it is especially important to recognize that C. M. D is more prevalent in females than males, making this an important emerging women's health care issue.
<unk> 16 is designed to address and reverse the underlying pathology of C. M. D by a clause by employing the CD 34 positive cells innate ability to increase micro circulation and thereby hopefully improve the long term outcomes and quality of life of those living with C. M D.
In May of 2020, the company announced the full data results from the escape CMT trial at the society for cardiovascular angiography and interventions or Skye 2020, scientific Session's virtual conference as predicted by preliminary results announced at the American Heart Association scientific.
Sessions in November 2019 day.
Data showed highly statistically significant improvement in coronary flow reserve relating.
Excuse me correlating with symptom relief for patients with CMT after.
After a single intra coronary injection of C. L. B S 16.
We remain committed to raising awareness of women's heart health issues in general and in particular C. N D and C. M. D is increasingly cited as a growing womens health crisis, and we are working diligently to find an effective treatment for consequently, the company recently initiated a rigorous phase two b clinical trial no.
And that's the freedom trial, which is currently recruiting and treating patients and is targeted to complete enrollment by the end of 2021 with top line data anticipated for the third quarter 2022.
There seems to be some confusion around the size and scope of the freedom trial based on a recent analyst report so to be clear.
The freedom trial is a 105 patient double blind randomized placebo controlled phase two b trial, which will evaluate the efficacy and safety of delivering autologous CD 34 positive cells in subjects with C M D and without obstructive coronary artery disease.
Knowledge freedom is the first controlled regenerative therapy study in CMT and in support of the Freedom trial. The company is engaging with the American Heart Association for a variety of initiatives designed to raise awareness of this debilitating condition.
Turning now to a merger or C. L. B S 12, our product candidate for the treatment of critical limb ischemia in Japan.
As I have described previously.
Lbs excuse me CLI is characterized by severe obstruction of the arteries that significantly reduces blood flow to the lower extremities, principally the feet and legs and represents the end stage of peripheral arterial disease C.
CLI patients often experience severe rest pain limited mobility, non healing skin ulcers, and if not successfully treated eventual amputation.
On <unk> was awarded a soccer hockey designation from the Japanese regulatory authorities for the treatment of CLI.
Sakigake designation is akin to our Mac designation in the United States and affords the recipient prioritized regulatory consultation a dedicated review system to support the development and review process, including the option of a rolling registration submission as well as reduced review time of six.
Months for the C. L. P. S 12 registration application once filed.
<unk> is also eligible for early conditional approval and possibly full approval in Japan based on the compelling nature of the complete data set from our ongoing prospective randomized controlled open label Multicenter study in CLI patients, which was designed in direct collaboration with the Japanese.
DMA.
Note that conditional approval of a soccer gawky product only requires demonstration of a trend toward therapeutic effect along with acceptable safety requirements that are current study should be able to meet.
The ongoing study in Japan comprises subjects divided into two cohorts totaling 37 patients a number agreed to with the Japanese regulatory authorities before mentioned inaccurate Research report states that there are only a handful of patients in this study.
Specifically there is a 30 subject group with traditional arterial sclerotic no option CLI and the seven subject group with burgers disease, a subcategory of CLI that has orphan in size and it's often associated with heavy smoking.
Those subjects, who are allocated to treatment are dosed with our CD 34 positive cell therapy in a single treatment through a series of intramuscular injections. In addition to receiving standard of care pharmacotherapy.
Subjects randomized to the control arm only receive standard of care with drugs approved in Japan, including anti platelet agents anticoagulants and days of Dilator is the choice of which is made by the investigators according to the protocol.
The study allows for the rescue of subjects in the control arm by indicating the crossover to treatment if their CLI is deemed to be progressing.
The primary objective of this study is to show that <unk> can prevent the serious consequences of CLI by reverting the patients to a CLI free condition through improved blood flow in the affected limb.
C. L. I free status is defined as two consecutive monthly visits in which rest pain is absent and previous non healing skin ulcers are completely healed as determined by an independent adjudication Committee.
As previously reported net and as you can review in our corporate presentation on our company website. The burgers disease cohort is completely enrolled and the results from that group are very positive and consistent with the beneficial therapeutic effect and safety profile as reported by previously published clinical trials.
In Japan, and the United States.
For patients with burgers disease, amputation, and even death are likely outcomes and no available pharmacotherapy prevent amputation. However subjects in the burgers disease cohort in our study have achieved a remission rate of approximately 60%, meaning net four out of seven subjects had.
Met the primary endpoint and our CLI III.
This is an outstandingly positive result for these patients who normally see continued progression leading to amputation we.
We are very encouraged by the study results to date and believe that they suggest a positive outcome for the overall trial, recognizing however that the final conclusions of the trial will be dependent on the full data set from all subjects.
Of all of our clinical programs. The <unk> study has been the most impacted by the COVID-19 pandemic in Japan as a result of the pandemic state of emergency was in effect for most of 'twenty, 'twenty, which effectively prevented patient recruitment into clinical studies like ours.
Since the onset of the new year and despite a new state of emergency in Japan being implemented from January 7th to March seven we are encouraged by the patient Prescreening Prescreening pipeline that has been identified we have only a small number of patients remaining to be enrolled and expect to conclude the trial enroll.
During the second quarter of 2021, leading to top line data for the full study in the second quarter of 2020 to.
Regarding commercialization our strategy remains to license or partner <unk> in Japan and to that end our conversations continue with prospective partners and we continue to seek to consummate a deal in concert with the completion of the study if not before.
Moving on to see L. B S 201 for the treatment of pre dialysis chronic kidney disease or CK D.
Our most recently proposed development program C. L. B S. 201 is designed to assess the safety and efficacy of CD 34 positive cell therapy as a treatment for pre dialysis CK D base.
Based on a wealth of published preclinical and early clinical data. It appears that the inevitability of the CD 34 positive cells to promote the growth of new micro vasculature could be a means to attenuate the progression of the disease or even reverse the course of CK D. The.
The company plans to file an IND for this program in the second quarter of 2021 and to initiate a proof of concept study of <unk> 201, and a moderate to severe pre dialysis Hague CK D population shortly thereafter.
Chronic kidney disease remains a largely underserved medical need, especially as the general population ages and the incidence of diabetes and hypertension increases.
And lastly, all ago or <unk> 14 for the treatment of no option disabling angina.
As communicated on previous quarterly calls Collagic acquired the rights to data and regulatory filings for CD 34 positive cell therapy program for Noida that had been advance to phase III by a previous sponsor.
Based on the clinical evidence from the completed studies that a single administration of all ago reduces mortality improves angina and increases exercise capacity in patients with otherwise untreatable angina. This product received regenerative medicine advanced therapy or our Mac designation.
<unk> from the FDA.
We remain in discussion with the FDA regarding the size and scope of the phase III trial, which in combination with previously filed phase one two and phase III data would be considered for the registration of all ago.
Notably the arm that designation affords the product a six month review time for a biologics license application or BLA once submitted.
So in closing we are very pleased with the corporate and development achievements made throughout 2020, which attests to our ability to successfully navigate the current global economic landscape with agility and to deliver on key strategic initiatives, we expect to build on this momentum as we further advance and <unk>.
Spanned our clinical development pipeline, while working to achieve a number of important upcoming development milestones and with that overview operator, we're now ready to take questions.
As a reminder to ask a question. Please press the star key followed by one on your Touchtone phone.
Please offer only one question apparently center at a time and then be prepared to return to the queue for additional questions.
Your first question is from the line of Manuela branch Eddie.
Good afternoon, guys on thank you for taking my questions and congratulations on all the progress.
On just a couple of questions for me so a footnote about I'm not sure how much you can disclose obviously, but can you give us a sense on what Keith on your wish list for that day discussion would be asked.
And I guess like what what would be an acceptable patient population in your opinion on it.
It comes from decides that he has been the fact that you have accumulated at the outset that accumulated a large amount on our clinical data.
Yeah.
Well, thanks, and now new Ella for your nice words and also for your question and I appreciate your your interest.
I'll I'll I'll be very careful with my words, because we are in an ongoing discussion with FDA and that discussion is constantly evolving but our position has been from the beginning that this arm at designated <unk>.
Program should be considered perhaps eligible for conditional approval based upon the completed datasets already available and that if that is not the case certainly a phase III confirmatory sized trial should be of such size and scope that it shouldn't take.
39 months and more than $70 million to complete registration requirements. Those latter numbers 39 months and $70 million our estimates of the.
Protocol cost and duration.
For the trial that FDA has to date asked us to complete so our wishlist is to reduce that size and scope and to be in a position to do a trial that is affordable and short enough and timeline that it makes sense competitively to to execute.
Sure Andy.
Thank you for that and if I remember correctly that was designed to include a 400 patient total more than from the patients right.
That's correct.
Okay got it thank you and.
So for C&I.
You can go on.
Can you help us it like you mentioned in your prepared remarks that flow condition on up to about it it would be sufficient to school are positive trends.
In the patient population, but like can you give us more color on that and maybe help us in setting our expectation also based on the positive data we obtain we eat in that bucket.
And right what would make you happy as an outcome and.
What would you say is the bottom work on.
And on approval.
Again, thank you I appreciate the opportunity to clarify that.
A number of people continue to.
Either believe in even a communicate to others that the that it would be necessary for us to demonstrate a positive P value that is a P value of less than zero point, there are five to achieve.
Approval for this product in Japan, and then they go on to indicate that a trial of this size that we're conducting is not going to be large enough to never achieved such a P value and I want to be very very clear that the ability to achieve conditional approval for Osaka got from designated product and <unk>.
Japan in no way depends on the calculation of a P value. In fact, there are no P value requirements for this particular study and it's important to note that I've stated multiple times today and in the past that the study size was determined in direct collaboration with the Japanese <unk>.
<unk> authorities. So they have determined what is sufficient in terms of the number of patients to demonstrate a trend and really what we need to do is to show that there is the possibility, let's say of a therapeutic effect.
Without the ability to do any harm and the product would be eligible for conditional approval and depending upon the compelling nature of that trend. The authorities have it at their discretion to actually grant a full approval. So there've been a number of products that with sakigake designation that have actually.
Achieved approval over the last several years in a variety of indications and I would suggest that you go back and look at some of them and you will recognize that that many of them were not.
Necessarily providing P values and that really the safety issue was primarily the reason why they were approved that has the ability to be safe with the promise of a future therapeutic effect and those that received full approval already demonstrated some leather.
All of therapeutic effect.
During the the smaller trials, so I hope that clarifies the situation.
Sure It does.
But he has pool and lastly for me on.
And you mentioned.
Congratulations on the CMV at trough cash there and I know you mentioned topline data are expected in the third quarter.
In 2022, and but are you planning to present at some off day data, let's say from from some of the patients who why accumulating damage what he's done.
Tamminga confidence.
Yeah.
E Comm sales yet at this time the trial does not have a prescribed.
The interim analysis.
And so it is a placebo controlled randomized double blinded trial. So we will not be breaking the blind until the end of the trial unless at some point, we're motivated to amend the protocol to include an interim analysis, but.
Unfortunately.
You know in blinded trials, we all are on the same position we wait until the end of the trial before we can divulge any of the results.
Got it thank you very much.
Okay. Thanks Emmanuel.
Yeah.
Your next question is from the line of Pete <unk>.
Enderlin.
Thank you.
Are you.
Well first question how much did you spend on 119 last year. You mentioned there is your first item of R&D expenses.
We spent a little under $2 million last year on on 119.
Okay.
So we're looking back at that.
There was a commentary going alone.
Could be thousands of patients and then.
Problem was really with that specific.
On the hospital side, not so much with the overall potential so what have you learned about the decision making process.
You know the fact that you jumped in quickly and then jumped out quickly, but there is still a large potential.
Well you know.
Myself, specifically in many of the people who work at Collagic have.
A foundation.
From Big Pharma, and most successful big pharma and even small pharma companies.
Spouse, a philosophy that that basically says rapid fail or rapid decision you don't want to continue to spend money on things that aren't going to go anywhere just simply because you think it's a good idea. So we think that the decision making process was actually quite good we had a strong scientific rationale.
And our strong engagement from a very reputable investigator and research institution right here on our backyard in New York that that indicated to us at the time that they had more than 400 patients available that would qualify for this study.
Now as we went through the process of filing the I N D getting the emergency use authorization preparing manufacturing getting things approved through their site IRB et cetera.
They're contracting offices, probably because.
Like so many institutions in New York at the time, they were feeling the effects of many people being out six and also the inefficiencies of having to work remotely.
They werent able to turnover the contracts quickly and so by the time, we got.
Everything approved so that we could actually enroll patients at their institution. It was late summer and at that point in time. The 400 patients that they had originally defined evaporated and they couldnt find any more patients with the profile that they had originally.
Described.
Part of that was simply because of the timing of the situation and the pandemic at that point was we're seeing a.
And adding in New York, but mostly it was because.
As the disease became apparent during the course of the early spring and then into the summer the treatments that were used for patients with the disease, especially those who had the serious cases of disease, we're evolving extremely rapidly and so what was in the early stages of the disease.
Standard protocol serious patients got put on ventilators Les.
Later became something that was actually contraindicated you put patients on ventilators as a last resort because it was determined that you were actually making patients worse in that case.
That coupled with antibiotic.
And monoclonal cocktails and all sorts of other things changed the profile of the patient.
And the chronic patient profile.
While that chronic patients still exists the profile is extremely heterogeneous because all of those patients have received different types of treatments.
Used upon at what point since last February they received the disease and in fact, the type of treatment and the treatment paradigms continue to evolve so until we can actually define.
Our profile for a chronic patient that is constant.
Trying to hit a moving target and for us it didn't make any sense to keep chasing that moving target.
Because it is spending a lot of money and basically what we're doing is getting nowhere. So we decided to take a pause and now we sit back and wait and see if at some point that patient population become stabilized and in fact.
Has characteristics that we believe we can treat with our technology then we'll revisit the rationale for doing that at that time.
Thanks for clarifying that and I'm not going to get back to them.
CLI 12.
And that is the burgers component of that which I think it's been stated is basically four out of seven achieved successful results since maybe almost a year ago. So what happens with the other three people I know one didn't make it but.
I mean, there's just no further progress no treatment.
Or change in the other two people or what's happening with them no. The other three people did not achieve a positive.
Okay positive NOI.
During the 12 months of the study.
So that's on that and that's the data that we report.
Fair enough and then on us.
201.
Is there some simple way to say how sick the people have to be because you know chronic kidney disease has a lot of effort.
So these would be right.
They'll they'll they're going to be what we call moderate to severe teekay D. So most people would characterize them as stage three b or for patients. So these are patients.
Our egfr rate reading for that level.
There are but I'm not going to quote that just yet because we're still.
We're still working on that now well actually give me give me a moment here I will give you some information in that regard that.
That will help you identify that just bear with me one second I want to be sure I quote the right numbers. So.
For patients who are in stage three D.
Ah.
C. K D. There G. F ours are generally considered in the area of 44 to 30 and for those in stage four G. F. Ours are in the area of 15 to 29, so we're going to pick a group of patients who have gfr's that span sort of 15 to the low.
Low forty's the exact range is going to be.
Defined in the protocol, which will be obviously available on clinical trials dot Gov. Once it's once it's finalized so it will be those patients. They also will have to be patients who are demonstrating rapid progression. So these are sick patients who are quickly getting sicker those are the ones on century.
How many people in.
And the overall target population could be available as patients.
Sure.
Yes, there the current let's see let's see in the census from 2015 and 2000 2016, it was reported that.
15% of all U S. Adults had evidence of CK D stages.
Stages, one through four so 15 per cent of the entire U S population that reduces to about 15 to 18 million people with stage three or four CK day. So it's a huge population.
Okay. Thank you and.
I just had one kind of outside the box off the wall question.
Sure. Okay. That's because this question before given.
Efficacy of CD 34 positive cells for regenerating vasculature is there any potential not necessarily for you guys, because you're moving a whole lot more stuff to work on but as it.
As a.
Potentially with a partner, perhaps or something to apply that technology to serve on vasculature.
There are.
Some some considerations in fact, we had explored at one point a number of years ago, the application of our trial in stroke.
But you know the that there are several problems that come with with this one that you have to ensure that the that the cells can cross the blood brain barrier and can end up being becoming integrated into the brain in order to.
To grow the microvascular true there and that you can do it in the right places.
And that takes a bunch more preclinical work that we haven't done so I think you know.
CNS applications of the technology are on the list of hypothetical possibilities, but as you said, we've got enough on our plate right now and I think just to be candid until we demonstrate some more positive data from from some of these cardiovascular indications I think it would be unlikely.
<unk> that a CNS company would try to take this up on their own.
Okay. Thanks, I'll get back in line. Thank you alright. Thank you. Thanks Pete.
Okay.
Your next question is from the line of Hindus generally.
Mhm.
Hi, I'm sure Ben Lu from Brooklyn on it.
On behalf of Kumar from our factory Purdue. Thank you hi, Thank you for the presentation and discussing the brokers with US I have a question with regards to the <unk> 16, sorry.
So I was wondering what kind of background medication.
This concludes patients beyond I mean like would they be on an ace inhibitor or high intensity statins.
Or something like that.
They'll they'll likely be on stat in the full range.
Of.
Ah.
Products that they're on or actually I'm, not going to try to quote them by memory, but the protocol is posted on clinical trials Dot Gov.
So you can look it up there and it will give you the exact background medications that are allowed.
Got it okay. Thank you.
Another quick question. So what is the expectation with respect to frequency for the study I know youre going from Missouri.
I'm just wondering what what's the what else would be net.
Well I mean, we're we're we're looking at something that would be a clinically meaningful reduction now remember the purpose of this phase II study is not to generate P values toward a registration.
With the FDA. The purpose of this trial is in fact to give us a good definition of effect sizes. So that we can appropriately size a phase III trial for registration using endpoints that the regulatory authorities traditionally require and angina frequency is among them, but so is.
<unk> tolerance and a few others I think if you look at the data that was presented in the escape C. M. D trial from you know.
From angina frequency, we were able to reduce.
Daily angina frequency from four point to excuse me 4.42 episodes a day per patient.
A round two episodes a day per patient. So that's you know that's more than a 50% reduction in engine of frequency now I don't know that we'll be able to.
Replicate that magnitude of reduction in this larger trial, but whatever that magnitude is it'll give us a sense of how many patients will be necessary. If we choose to use that as the primary endpoint in phase III.
Right. Thank you another follow up question. So so you have the data in by the end of clinically taboo. So what do you think would be the pox two potential growth.
Well I mean right now our thought process is.
Probably obvious to most people we expect to have data in the third quarter of 2022 from this phase II study, which will give us the opportunity to do two things in parallel.
One with the control data from this trial, we can file an application for an arm that designation for <unk> 16, which would then afford us a certain number of regulatory benefits, which should accelerate the potential approval of the product and in parallel. We'll then go to FDA with our proposed protocol.
Using <unk>.
Traditional traditionally accepted endpoints for angina trials.
And get their agreements added into phase two meeting on the path to registration hopefully with an arm that designation and compelling results coming out of phase two b will be able to convince the agency that two large phase III trials will not be necessary and one trial.
<unk> can be agreed to as being sufficient but all this remains to be discussed, but that's the regulatory strategic thinking at the moment.
Thank you so much snow deal okay.
Okay. Thank you.
This concludes the question and answer portion of the presentation and now I will turn the call back to Dr. Matt <unk> for closing remarks.
Thanks, operator, and again, thank you all for participating on today's call and we look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress and we remain grateful for your continued interest in and support of collateral Biosciences stay well and have a great evening.
This concludes the fourth quarter and year end 2020 financial results and business update conference call. Thank you for participating you may now disconnect.
Yeah.
Yes.
Okay.