Q1 2020 Earnings Call
This time all participants are in listen only mode. After the speakers presentation there'll be a question and answer session to ask a question. During the recession, you will need to press star one on your telephone.
If you acquire any further assistance. Please press star zero I would like to now hand, the conference over to your speakers today carrying that base Chief Financial Officer. Thank you. Please go ahead Sir.
Thank you is one.
Good morning, Ladies and gentlemen, my name is PRB on airport fine be I'm pleased to welcome you to our clinical and operational update and first quarter financial results Conference call.
I'm joined today by bread or aren't CEO by join Chandler I'd be Chief Medical Officer, and also by Marine Stanford RVP are indeed.
Fred will begin with an overview of the company to a personal line lights, then John will provide the clinical update on all ongoing oncology program and she will be followed by Maria will provide an update with respect to the development of orthopedic school that 19 vaccine candidate and finally I will present.
So I like for the quarter.
Before we begin I would like to remind you that except for historical information that's who your presentation contains forward looking statements, which reflects our movies current expectations about future.
These forward looking statements involve known and unknown risks and uncertainties that could cause <unk> actual results to differ materially from those statements.
These risks and uncertainties include look our nothing limits and to our ability to access capital.
[laughter], Poland timely completion of clinical trial, the receivable all regulatory approval and other risks detailed from time to time in our ongoing quarterly filing and our annual information form.
The forward looking statements made on this call are based on several assumptions, which may prove incorrect and they represent views only as of the date of this call and are presented for the purpose of it think potential investors in understanding kind be business and may not be appropriate or are there purposes.
I envy does not undertake to update forward looking statement were written or oral.
He'd be made from time to time by on it yes.
But as required under applicable securities the jurisdiction.
Investors are cautioned not to rely.
On these forward looking statement and are encouraged to read RMB continuous disclosure documents include including in its current annual information form as well as its Oh. This isn't a no consolidated financial statements, which are available on SEDAR and Edgar.
So the the M.D. any in the financial statement are all posted on our website.
You wish to receive a copy of either of these documents. Please do not hesitate to come to.
Finally, please note that we will take questions on the from sell side I know it Oh.
I will now turn the call over to fresh bread.
Thank you PR and good morning, everyone. I Hope you on your loved ones are healthy and safe and I would like to stop we have a few comments about the probably 19 situation on its impact on a work.
In response to the bad image, we had been continuous Lehman monitoring the situation and adapting it would be and that's operations. We've won 29 biology rising the elephant well being of our employees patients clinical investigators and personal and it's in close collaboration with health authorities.
We have successfully transition to a remote walking arrangement to protect our employees and the broader community, while maintaining our business continuing to.
Yeah, so depending mean Cal slowing the pace of clinical development across our industry you to de absolutely.
It's just sorry diversion off Alphacat resources to could be 19, but I am the we remain.
Welcome It didn't ever do I don't want long term goal off of developing your cell therapy, we will focus on patient safety and data integrity. We are proud to continue.
The deleveraging and you've got Softy subtitle D.
We have the potential to offer a bit of value proposition for patients with high unmet medical needs. Our clinical development strategy is centered on the simple goal. How do you is to demonstrate the potential of this T cell therapy to significantly improve the duration of a quality of life.
That is why we are very happy this morning to three ball to see need against that well achieving this goal with patients with richer and refractory diffuse large b cell lymphoma drawn way lot give you some multi do later in the presentation.
As a company wells with Vulcan a to be they're looking at platform with multiple applications in cancer and vaccines against infectious disease, and we feel really privilege and uncle Sam time, we'd be opportunity to contribute technology Baskin Nichols success easy to decide against the Cobiz 19 dynamic we have.
In making great and rapid progress we've ever vaccine candidate for Koby 19, we scale to complete preclinical studies very soon and are getting ready to initiate a phase one clinical study early in the summer.
We also very upbeat about our recently completed financing extending our cash run rate through the end of 2021.
No I don't need great vote of confidence from our existing shareholders. Just that you offer and stay like science, but also an opportunity to bring in new friends supporting our vision and science I'm a strong believer in deal thing that you never have friends. So to me on agenda I won't say welcome and thank you for you'll see bolt.
I will now I'll turn the conference I went to John will provide a clinical update on our oncology program drawn.
Thank you Fred and welcome to everyone ill first start with a review and update of our phase two spiral study in recurrent refractory diffuse large b cell lymphoma, which as a reminder, isn't investigator initiated study led by Dr. meal bearing.
Hematologist oncologist that'd be Oded cancer Center at Sunnybrook Hillside Center in Toronto.
The clinical trial design provides for an enrollment target the bucket 25, a valuable patients who received more than one prior treatment regimen.
Primary endpoint of the studies to document a minimal objective response rate of 24% to treatment.
Yes, your buyback I need you mentioned logos cyclophosphamide administered with Pembrolizumab in patients with the current survive in expressing PD L B cell.
As it may seven enrollment is ongoing with a total of 20 patients crude at five different clinical sites in Canada.
The next slide provides an update to the poster presented the American Society Hematology annual meeting last December.
Time, we observed to 56% response rate based on five clinical responses in the first nine valuable patients.
Sember, we now have 11 valuable patients into additional reports of clinical response. This is a total of seven clinical responses with an objective response rate of 64%.
We're very happy to report the study has met its primary end point of achieving a minimum of six responses in the plan 25 of valuable patients.
And then Peter previously mentioned, we believe these results continue to provide submission support for accelerating the development of deep yes, you're right you know Bcl two illustrate this point me documented on slide five diffuse the other clinical trials evaluating pembro that Matt has a combination in this population.
You can see on this slide objective response rates in combination with Pembrolizumab had been on around 20, 25%. Although other three an investigational car T therapy in combination with Pembrolizumab shows a similar or our with responses 711 patients.
This being said generally speaking as we've mentioned in the past we consider our approach is not directly comparable to carty given amongst other factors bridging chemotherapy often required before lymphodepletion the series potential adverse reactions to the required hospitalisation higher costs and longer manufacturing time.
Moving onto slide six I'll now provide a quick update on or other ongoing studies in college and starting with the phase to decide study in advanced recurrent ovarian cancer.
Study evaluating safety and effectiveness of de PX or buyback with intermittent dosing for Boston Mike.
In late February I am be provided interim data from this study reported nine disease control duration of response and Tolerability 19, Evaluable patients we reported a 79% disease control rate was 79 patients with 37% achievement clinical benefit with partial response or stable disease blasting wandered inside.
Once the treatment was well tolerated with majority of adverse events being grade one she's injection site reaction.
At the time of the data cut off six or 31% of those patients remained on therapy and five of these patients were still on treatment at greater than six months.
Since then an abstract has been selected for poster presentation at the upcoming ask a conference. The abstract is posted on mine on Wednesday evening on the ask a 20 virtual website. The poster presentation will be made by Dr. Oliver to Rico Associate Professor of obstetrics gynecology oncology at Stanford University Medical Center.
It will provide translational data and an update on clinical responses for those patients that were still on trial in February.
The translational data will include surviving specific T cell analysis in blood in tumors.
This data will be made available with the virtual after meeting taking place May 29, three things first.
Now I'd like to discuss the ongoing phase two basket trial and advanced metastatic solid tumors.
The basket trial. It is an open label Multicenter phase two study evaluating safety and efficacy of DP extra buyback.
Intermittent odors cyclophosphamide in combination with pembrolizumab across five cohorts of patients with bladder liver ovarian and non small cell lung cancer as well as tumor shown to be positive the microsatellite instability high biomarker.
As of May 7th a total of 92 out of the plan 100 need for patients were enrolled across all five indication at 19 clinical sites in Canada and you are.
Unfortunately, due to the cobot 19 pandemic, we've seen an impact on data collection and validation processing.
However, based on our current assessment of the situation. We anticipate recording updated results from this study in second half 2020.
Thank you for your attention I'll now turn the conference over to Marianne Stanford RVP Research and development, who will provide an update with respect to the development of the vaccine candidate against covert 19.
Dan.
Thank you.
Good morning, everyone I'd like to give a brief.
Program.
[laughter].
[laughter].
In March we announced our intention to do not become a 19 vaccine leveraging our previous work.
Exactly.
And the time since then our research team has identified and tested our selected peptide epocal candidates and we are currently on track to complete these studies.
We have had preliminary discussions on our plans with health, Canada and based on their feedback we are finalizing the phase one studies.
We have also submitted grant to all relevant authorities to assist in the funding of this program.
The next slide on slide eight we overview our approach we are using b cell peptide epitopes targeting the spike protein.
Just a sars koby to Cronto by refuses to enter sell Spike has two main functional area known it S. One too.
Yes, one portion came to answer receptor binding domain and his involvement attached to the wholesale while two primarily me media fusion and entry into itself.
Epitopes have been designed to target several of these key areas and a non overlapping fashion.
Antibodies to these target should efficiently inhibit virus entry into cells and by targeting several area that one.
Lessen the potential for immune escape.
Even in the case about mutation.
On the next slide on slide nine we illustrate our progress to date.
Have completed our preliminary selection of epitopes and the animal studies that facilitate a prioritization of peptide is ongoing.
The final targets will be selected based on both their ability to generate strong immune responses as well as neutralize the virus from formulated and bps.
This candidate will then be formulated at a GMP quality for entry into a phase one clinical study this summer.
This concludes my presentation and I will now turn the conference over to Peter Levy.
So as I envy to discuss the quarter's financial highlights.
But your Marie.
I will start by reminding you that all the numbers, though will be discussing yarn spinning in dollars.
On May seven we completed the non brokered private placement of 25.1 million. So if we added to our cash balance of 7.4 at the end of the first quarter on a pro forma basis. Its represented 32.5 million dollar cash and we also have access to 2.5 million dollar of receivables.
Coming from investment tax credit and trade receivable for a total of approximately three to 5 million of existing and potential sources of cash on a pro forma basis that March through differs 2000 into it.
And this amount does not include the one points with 1.8 million coming from the use of the ATM since April 1st 2000 and Quinn.
The ATM or add the market's off like most put in place during the first quarter 2000, and twin we decided to implement that because meetme program creates Berger optionality and satisfying capital raising goals, we can decide to use it or at or convenience and it give us more flexibility.
And the money is always a race at marketplace. He ends up becoming increasingly popular beat killing the capital markets in recent here and in 2019, only 185 care Haiti ends at work.
So with the completion of work 25.1 million private placement.
Last week, we extended our cash runway well into 2021 and are well Tom did with many milestones and what their books.
For the first quarter 2020, we incurred a net and comprehensive loss of 9.7 million or 19.
Centsper share for the quarter. It was 3.7 million higher than the net loss of the comparative period than 2019. This is mainly explained by the R&D expenses increased 2.8 million for the quarter compared to 2019. These increases are mainly due to a spike in enrollment.
Prior to the onset of endemic related to the ongoing basket trial and also the opening of new side and nonrecurring purchases of 1.3 million of GMP grade raw materials and contract manufacturing or do you get for buyback.
With this purchase Onvias GNP green materials cover all the needs of the corporation for ongoing BPX <unk> trial until mid 2021.
The increase in R&D expenses is also relate the related to a lesser extend to preclinical development of depicts our means for bladder cancer and personal cost due to an increase in income in 2019.
Gene expenses increased by 1.1 million for the quarter Anderson, increasing is mainly due to non cash fee of two compensation cost by share price fluctuation frying exchange loss and investor relation activities, including travel costs into your prior to this car of the Cohen.
In February.
For the quarter, our cash burn rate.
Thats, we define the net loss for the period that just the full cooperation not going well all being cash was 8.6 million, we expect that the cash burn poured the remaining of 2022 returned to a between five to 6 million per quarter due to the nonrecurring expenditure incur in Q.
Q1, and also or because of the impact of code in 19.
Finally as of May 14, 2020, the number of issued and outstanding common shares was 60.4 million and a total of 5.1 million stock option, the best use and warrants were outstanding.
Please note that our Oh now that the interim consolidated financial statements for the three months ended March stay there for 2020.
And the related Mindy and be any are available on SEDAR and on Edgar.
Thank you for your attention and now we'll now turn the call back over to Fred for his closing comments before they join this session Fred.
[noise] thanks, Yeah.
In India challenging times, we are looking at two to remind you of 2020 with optimism.
Upcoming optical mutual scientific program, which will be how do you kind of might we expect to read both abated clinical response data from the decided one trial at the big somebody that can advance on recurrent ovarian cancer patients. Additionally, we look for a while to reporting topline phase two results from digital Vivek basket trial.
On spiral study in relapsed refractory LTL before the end of the year.
We believe our excellent results in relapsed refractory DLT Michelle taken together, we if imaging providing data from I decided one study in ovarian cancer to both our plan to accelerate development in this indication.
Also beyond our lead program, we are preparing to advance clinical candidate will probably 19 as quickly as possible and continue to leverage.
Multiple opportunities of our platform again sort of target so insurance.
We thrive continuing making progress unlocking the value of that platform for patients afflicted with cancer and order status is including coping 19 on after grateful for it continues to both of our partners shareholders and employees continue as a team to de lever on I'm just great opportunities. Thank you.
For your attention operator, we're now ready to take questions.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound or hashi. Please standby, we compile the Q and a roster.
Your first question comes in line of Tom Shrader from BTG. Your line is now open.
Hi, good morning.
Regulations on the progress.
So I guess the first question I have is since the last data. The stock has struggled really because of the cyclophosphamide confusion really the goal of that drug and I understand youre arguments I'm. Just wondering if you've had discussions with regulators isn't an issue for them or or is it or your arguments.
Widely accepted or have you not had discussions you got any update would be great.
Hi, Tom Thanks, Thanks for the question.
No honestly, it's never been an issue for US it's never came as other discussion point there is no.
Strong clinical evidence off the activity of CECO fulfill my does the way while using it in either deal Bcl ovarian cancer. So for the regulators you know what there is not you know its trends.
You know base all foundation to the question you know the the development. Dave did you know the last time, we had meeting we did you did they didn't have ask you know how to too.
Two to two to prove anything related to see to fulfill might so so it's I think it's more of a market perception, but nonetheless. This is something you know when were thinking you know very seriously and that you know we want to a two you know to address and in that vein, we are planning to.
You know provide some updates when we released the updated clinical data to decide trial at school.
Great. Thank you and then so to switch to the cobot vaccine approach you have this elegant approach with specific peptides.
Partially driven by the idea of avoiding this antibody enhanced disease.
When do you know with in fact, that's a problem with the covert vaccines and whether you get around that is no until sort of deep phase three or do you get earlier signs.
Well, if I if I make correct one thing Dom about you know the at the targeted approach that we are pursuing it you know it's very much you know a line and we wish you know the idea that well developing in oncology off your it really targeting.
De immune response.
On on a multi clearly defined earlier that we believe it is important for the disease. So weve you know in for example in cancer with you know we [laughter], we had been Adam and you know about the importance of so vying for cancer, it's not just a flag on cancer cell, but it's something that tencent needs through.
So by that's what the Coke surviving and it's really the same concept 12, playing to probably 19, we like 2 million was explaining you know we have targeting what we believe out the most important functional you need south of the spike protein and get more than one you know doubts the yes, that's going to the receptor, but you Hot you also have.
Fusion and entry.
Without treaty offense that Keith that seem to make any of them of action for infection and we believe that you know the opportunity that we have without platform I now would technology to target the immune response on those weak spot for the virus has the potential.
First I would say between trees efficacy. So I know a driver for what we do which is we want to make debate specs and possible for coffee 19, focusing on on white matters on the virus the potential benefit of that to answer. Your question. He is also because we are Uh huh.
Get do you know when when we discussed Weve dealt regulatory authorities about you know the issue of it for example up none neutralizing antibodies you know if we saw the eliminated from from the vaccine design from the get called because everything we do with based on full characterization.
Ill.
In adults that the vaccine is targeting and and we really remove you know the.
The idea known by doing that because when you use the full virus I'll use the full spiked protein you know you have a hundreds of off anybody's you know generated some saddam neutralizing somehow not neutralizing. We just don't have that you know with vaccines. So it it makes an easier discussion with the regulatory authority.
Ladies.
You mean, and then you know there's so many a non about it I don't know Marianne if you want to talk about it but we feel Lisa.
So many things are unknown at this stage a that's difficult to to figure out you know I would use will unfold you know we study transaction technology I know man, if you want to get about your perspective on it.
Yeah, I think that it's really very much in evolving field and and not only is the science evolving the models in which we can you.
And then the clinical studies to assess Susser holdings, I think I think will learn a lot.
About the potential for the from the animal models that they have Paul and I don't think we'll have to wait.
Okay.
Alright, great. Thank you for detailed answers.
Thanks, Tom.
Your next question comes in line of Joe Pin pad Guinness from H.C. Wainwright. Your like your line is now open.
Hey, everyone. Good morning, Thanks for taking the question and I'm glad you're all well congratulations on the spiral data I wanted to start with that when if you don't mind a couple of questions.
So with the state in mind, and this being an iced tea and I know my question might be going into the competitive arena here, but I was just curious if you could take some broad strokes as to the potential path forward for I M. B as you talk about a potential accelerated path forward.
John you want to.
At least once that gets one.
Sure. Yes, we are very excited about this data we thought it was tracking this way and so now we really.
Wed be able to report that we have seen that [laughter] patient and actually a 711 a valuable. So we do believe this is very promising we are now moving along or discussions about what that next step will be in terms of the sponsor initiated trial. So we are.
During the process of doing that we do understand you know there is the pandemic and so were trying to.
Manage that to make sure. We can move this quickly forward, but exact timing will depend upon how all of this cleaned out in the next several months.
I understand thank you and then with regard to the basket study.
Obviously, you know due to the pandemic move some data timing to the second half so I'm just curious.
You do have a lot of patients enrolled in this study already so is it more of a function of ensuring that you have a I guess a.
Certain amount of patients enrolled in each tumor type to be able to disclose a full fuller dataset.
Yes, yes, yes, I'm sorry, you're trying to go ahead.
No.
Thanks, Fred Thanks, a question, yes that is true we had no before the pandemic, we basically had a bolus of patients come in and they have been followed and we're still accruing additional patients, but it was also a matter of bringing in the data set and make.
Sure we had enough of the data to be able to report on you know a significant number at this patients so they're worried though those pieces that needed to come together and so where we're still doing that it just takes a little bit of time working through all of this remote monitoring and things like that to come together to make sure that we.
Had the appropriate dataset in you know with the appropriate number of patients as well.
Got it. Thank you and my last question I guess I'm you know thank you for the additional detail for the Cobot 19 vaccine approach and.
We have the timing for the started the clinical study. It was just curious around your communication strategy around the preclinical data that you might generate.
Well, we'd like to so we we believed that the well we're well doing is is unique and.
Global scientific if folks to to develop a vaccine because again going back to my.
Answer earlier, you know we are really developing a targeted approach that's focused on neutralizing antibodies on basically.
[noise] mapping, yeah, which you know where the best interesting.
Weakness is even nautical weaknesses of the virus.
And so so you know we we'd like to be able to all too you know to publish that we believe that will be a you know that's great information for us to setting the vaccine for sure but that's also great information to the scientific community. So we'd like to to look at the passivity off off doing it publication on these you know obviously, we don't try to make it you know.
A quick but but you know like a million said you know we don't will have completed you know.
Important piece off off the preclinical studies before the end of May on schedule, and then we'll be able to moving into clinical.
Study and you know in between that you know will should be able to to put out the publication on on the debt resume.
Great. Thanks, everyone stay well.
Thank you.
Your next question comes from line of 10, CAD 10 times from Piper Shanler. Your line is now open.
Great. Thank you remember in America.
I will update you know it's harder to me that's like a password, but it's a question considering.
Oh it she is what's the parties as well so or get the push back I think that's a clear signal for sports.
For additional updates on that.
With respect to the baskets Carol.
I understand sort of how you would see either.
From though.
Different cohorts from there's different read out so you, though if you have activity or two or three what are the Cleveland.
That's true and how quickly that occur. Thank so much card so keep up the great work.
Thanks, Ted Yeah to your comment on C. feel fulfillment I would just had that India copti context, it's you that very high dose much higher those on whats, while using and it's also use all the time you complete in combination we fludarabine, Saudi none Anita.
Using a couple of somebody idled or using for that reason, which is also a very active drug.
It's also for but thanks for really a reinforce huh.
Thank you Frank said that we have.
And you know we are definitely know convened Sunday investigators you know walking on distraught. They can keep convinced that you know we we are showing a very strong signs of activity.
On on the basket fly all you know, we I think it was that.
I don't remember sorry, but we published a pass through on the design of the bucket basket trial, where we described the design of the trial and this fall through you fine.
You know information on this twist to stage design that that you know, we American and Ivy developed together to make decision on on on you know with where are the best opportunity for for the combination out of those five indication and it's really based on.
You know.
Simon two stage design, where are you defined.
You know.
Minimal response rate and you want to eliminate you know that the I put this that George country, it's going to be below that I need to alter that Dan.
Have you aren't youre, you'll decision point to a moving to stage two and eventually you know moving to a bigger fish to even potentially registrational trial. So that's where you always the basket trolleys is is designed.
Great. Thanks, guys keep a good work.
That said.
Your next question comes on line of David Novak from Raymond James Your line is now open.
Good morning, and thanks for taking my questions and so starting off the spiral study here at the deal Bcl results continue to look quite good and I. Just wanted to first confirmed that the two additional clinical responses being recorded here are indeed responses per modified shazam criteria.
Yes, they are there either.
Excellent great and I also just wanted to clarify if the trial is still aiming to hit target enrollment of 25 patients and if so can you talk a little bit about enrollment rate looks like about one patient every two months a is that what we should be expecting here or is enrollment being closed or.
Lee based on the results that you've generated to date.
Well, it's it's a difficult question to answer a full through reason first of all its an investigator sponsored trials. So it's not you know they aren't out some limitation in terms of often on both sides on on that you know.
You know I spent the better control of Ivy.
I'm just thinking you know element, it's called the 19, you know it's well we all hope obviously that the situation is going to improve over time, we see confinement happening, but you know we've we've learned you're going to last few months that you know, it's very difficult fought for for US on I guess for any biotech company to provide guidance on.
You know what might be happening.
Deals beetles and on you know, we just suppliers that are involved in collecting the data on all of that so we just wanted to be careful in you know, creating expectation where are we we had very limited to really be visibility and what you know what could be the situation in three months from now.
How are you going to give you more but that's really.
A challenging time for for making prediction for sure.
Fair enough, but it doesn't sound like the.
The assumption right now is to continue to enroll at all yet regardless of yeah. Okay. That's great and then finally, just lastly on the decide trial and so in the ASCO abstract you know we're still looking at no argue about 15.8% now obviously that as of February so things can change however, assuming.
Monotherapy anti tumor activity does indeed shake out around that sub 20% level is the company adamant that driving toward here as a monotherapy, maybe looking to tackle a survival endpoint rather than a response based endpoint going forward or is the company currently evaluating gulfport combination opportunities.
Well I think you know, we we want to really.
Good deal opportunity to look at the final results you know why not the Omakase immunotherapy is due to loan is the long tail off off you know benefits on responses and you know since we started the development of CPFL buybacks. You know do something you know we have been seeing across.
Whole our.
Indication so far.
I I you know this is part of the challenge of immuno therapy as well as you know the checkpoint inhibitors. You know there I'm not you know successful because of high response rate. So six successful because off off a really a long durations of off of benefits. So so you know we want to get the opportunity to.
You get to the final results and on you know really be able to assets you know.
What out to the benefits of these drugs and now with these trucks did seem to current you know standard of care for ovarian cancer and think about you know where our what is the most you know.
You know interesting you know path to market for fall just struck ovarian cancer, we should we should reach that point before the end of the year on really be able to to provide you know I'm more information on on the way, we're going to be choosing to to move ahead.
Excellent. Thanks, very much tried and I'll hop back into queue.
Thanks, David.
Your next question comes from the line of Andre Leno from National Bank. Your line is now open.
Hi, Good morning, guys. Thanks for taking my questions just a couple up or we are really you're saying, it's all your clinical trials.
Based on the on the basket trials, there still open I recouping any patients.
Still it's my first questions on how do you see or if you have any comment on patient recruitment.
For the year.
Sure. John can you can you give more information on on hours, it's walking and what's the station.
Yeah, and so we're monitoring that on a regular basis, we are still having patients recruited they're being screened and enrolled on exerted by site, but it is definitely still occurring and we expect that to sort of change over time, depending upon where.
Pandemic may be worse at times and getting better so as things begin to open but it's also expect things to pick up at different centers at different times <unk>.
<unk> approval is ongoing.
Okay, great. Thank you have you seen any patient drops so.
To date.
Because of the pandemic that it.
In terms of numbers, so yeah, yeah, yeah, no real numbers.
I would say that there has been a little bit of slowing at particular centers.
Overall.
The there's a little bit of the slow, but it's not like it's come to a trickle or anything like that we're still seeing activity and many other centers.
That has not changed.
Okay, great. Thank you and I still on the patient side, but on Oh, no. We could have been but looking at more on the call. The trial I mean, given that there is they did have a rush with different companies developing treatments and vaccines like how do you see.
I do you see a recruitment therefore for subjects.
Come Palmer.
Sure.
HM.
Question in regards to the covert 19 program itself.
Yes, the they probably yeah backed into to develop.
So in healthy volunteers, that's where we will be going has as other companies have gone.
We anticipate that accrual will go quite smoothly.
And then three if you could you could do get some recent examples of off a phase one studies, where are you know oh, there's a lot of volunteers are coming either coming either at the site. So you know a lot of people are interesting and being that any difficulty 19. So we don't them to space, there's going to be a challenge you know, what's gonna get shot and fall.
You know every election play years into all these really you know the small the if you could see no phase three development that hopefully it will will happen quickly after fees went to about.
They are doing some.
Collaborations are hopefully you know happening we the WD true on some other players to provide a a framework in an environment, where I would do phase three trial would be able to to run you know.
Not necessarily either into country, where the vaccine is being developed but anywhere in the world.
Okay, great. Thank you.
Again, if you would like to ask a question. Please press star one on your telephone. Your next question comes from line of Jan Bertsch in cash from Wells Fargo. Your line is now open.
Hi, Good morning, it's Nick home to 10 this morning.
Just going back to a very intensive spread.
I thought at the beginning of the you'd already decided to you would approach 50 a.
For Lincoln into Phase two meeting to discuss potential single arm studies to be registration trial is do I understand now that you've decided to wait for the data to mature.
Until you decide whether or not to go.
And meet with the FDA.
Yeah in any case you know we you noted the pattern of responses that we are seeing you know those those are I'm very long duration as these that we wish we highlighted in February.
You know, it's something that we have to consider in when we go back to you.
And plus you know there could be 19 situation also influencing you know the speed at which we can we can move machine tool to get or.
We believe it's a it's a better strategy to two you know I get was saying to really get full understanding of the final resolution and and figure out you know what's the best buy full lot for for the development you know in cancer before before we go in front of easy.
Yeah that makes sense you you can send that some of these patients that are potentially benefiting from the vaccine, but then moving onto other therapies sort of.
Ladies your ability to.
Associate what the impact to the vaccine is versus you know a subsequent therapy.
Well, it's small the fact that you know you know like we said you know we.
We have a long tail off off off you know clinical benefits that you know maybe they will translate into a that definition of off response rate, that's 50% and way too. It's it's a absolutely.
Required oh, okay any color you 11.
Well have to be discussed, but but you know you've seen that you're seeing the pattern of responses. We are seeing a number of patients that are stable over I've seen if you can period of time and and you know its those you know discussion weve investigators people, you where I'd be.
Okay, well meeting you know the feedback were getting is that due to his passion those patients ice dancing.
Clear clinical benefit.
We have meaningful quality of life.
And that we should consider that you know Atlanta, So that's why we want to do.
And then just moving onto diffuse large b cell lymphoma, so 20 patients have been enrolled.
You know at this stage nine nine or ineligible for analysis per the investigator I know we've discussed about this before that.
After Bernstein sort of.
Find his own Craig set of criteria for that so oh, if some of these patients being recently enrolled such that you know that tend not eligible because they've not reach that particular time point pool or is this it now we have 11 patients now what we're looking at is sort of again the journey.
The two of those responses.
[noise], John I, I think we add new patients coming in and that that correct I'd been evaluable and 'em we.
I think we said we yeah, we had 20 so.
And again, you know just to repeat what was discussed you know when we did you update in December a bridging chemotherapy is not a lot in this trial. So you know that poses a challenge for.
For the treatment a into you know at the time between their annual and the time. They can stop the trial and you know it's dose that that's you know long enough to for some of those patients to be in a in a very.
Dramatic you know operation on the very done it in a very dramatic green and permission path that you know make them you know coming to trial and go out immediately.
This is something you know we will be you know looking at you know into next trial, we're going to doing deals we showed for sure.
And that was my follow up question that Fred inside.
Well.
Again, you've talked about <unk>.
He said the next trial trying to avoid these cost progress that patients.
What are your latest thoughts in terms of water next trial would look like in when could that start.
I'll, let you answer.
So that that is exactly what we're looking out to consider this we think that this is a population of patients where we do see activity.
I think we would be and this same place. We also believe those even with the newest therapies that may be coming in we're always going to have teaching to me that so we'll be looking at that population patients and I'm looking at the design with Baird Cana wells.
To take that next step.
And is that something that can happen Miss this year or do you think that'll be into 21.
I think we will do our best to move it has rapidly forward as we can in environmental.
Okay.
Yes, and then really hard right now king team.
No I understand how quickly things, maybe able to move right now.
Thank you and then just moving to the vaccine Fred in in terms of obviously vaccine supply Youve commented in the past no. It you'll vaccines and amenable to rapid scale up but just in terms of.
Current manufacturing plans and what you can support.
We'd current cash and then you know if he can expand on your comments on the grounds applications and you know how far you can go without getting some of those grants applications granted and just for the level of confidence on the way.
What the outcome of those applications will be.
It's a tough strengths make no well I were plan is is is we don't we don't you know plateau foresee to two developed you know a vaccine for coffee 19 in the absence of off you know granted grants is one thing give you the money.
To do it but I think to me what's more important is is the collaboration with the government because at the end of the day, they're going to be the decision makers, they're going to be to buyers and I believe that didn't doesn't make sense for a company to.
Being involved in in this dynamic you know Weve out you know walking in close collaboration we took them and so so in a sense you know we won't you know proceed to develop a vaccine.
In the absence off of those those are grandson on the collaboration we took about a month, we feel very confident that you know we're gonna we're going to be able to to get those grants for it can nicole.
Development of the product.
And and governments, obviously, the Canadian government is your number one priority, but are you looking at getting support from other governments as well.
Yeah. We we are focusing you know the early phase one on scale up manufacturing a in Canada, but but you know.
One of the big advantage out that technology that we had is that a you know the manufacturing process is actually fully scented taken and pretty simple.
Meaning that it's multiple anyplace into world, we've kept at Stifel, Lyophilized vaccine and as many of them across the world.
We'd be a.
Potentially become a manufacturer.
Pretty short period of time.
Thoughts or you know, we're focusing in Canada. We have already you know factors into us in terms of manufacturing that you know couldn't be mobilized for a far U.S. you know.
Expansion out of Canada.
You know after the fees one off before the phase one and we'll see and then beyond that we had had some preliminary discussions weve ordered potential manufacturers that could expand into a a mobile they fall that you know w. issue and organization like safety for example on trying to a two hour today.
Yup.
Right.
So ill jump back in the Q.
Thanks, Nick.
There are no further questions at this time I will turn the call back over to the presenters.
Well I have nothing to had just want to thank you hold for your time. This morning really appreciate it appreciate it.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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