Q1 2020 Earnings Call
Good afternoon, and welcome to the Recycler sell Pharmaceuticals first quarter 2020 results conference call and web cast at this time all participants are no listen only mode. After today's calls members of the financial community will have an opportunity to ask questions if you'd like to ask a question.
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Please note today's call is being recorded Oh now like during the conference over to John Medina Investor Relations for a cyclist sell pharmaceuticals Sir.
Good afternoon, everyone and thank you for joining stays conference call to discuss Cyclacels financial results and business highlights for the first quarter ending March 31st 2020.
Before turning the call ever to management I would like to remind everyone that during this conference call forward looking statements made by management are intended to fall within the Safe Harbor provisions out the private Securities Litigation Reform Act of 1995.
Section once you want to eat at the Securities Exchange Act of 934 as amended.
As set forth in our press release forward looking statements involve risks and uncertainties that may affect the company's business and prospects.
Putting those disgusting our filings what the L.C.C., which include among other things our forms 10, Q. and 10 K. These filings are available from the L.C.C., where our website.
All of our projections and other forward looking statements represent our judgment as of today and cyclists out this not take any responsibility to update such information.
With us today are spear urban Potus, President and Chief Executive Officer.
<unk> Executive Vice President Finance and Chief operating Officer.
Dr. Judy Chow, Vice President of clinical development and regulatory affairs.
Sparrow will begin with an overview of our business strategy and accomplishments on Cyclacels multiple clinical programs and Paul will provide financial highlights were the first quarter of Twentytwenty, which will be followed by A.Q. and a session.
This time I would like to turn the collaborative spirit.
Thank you John and thank you everyone for joining us today for our first quarter 2020 business updates call.
First and foremost we hope that all of you listening to our web cast are safe on well.
The global pandemic caused by corporate 19 disease continues to affect nearly all human activity and creates uncertainty in every business sector.
Events of the last few months I've made it clear, but we need novel Science based solutions to emerge from the crisis.
<unk>, we take our social responsibility very seriously.
Take EULAR protecting their health and safety over our employees the bases reserve and the communities, which we live and work.
As indicated in today's Pressrelease, we have taken relevant protective measures and are following government orders with our employees, mostly working from home.
We're working closely with clinical trial sites to ensure adequacy of clinical supplies and that our trials are following specific F.D.A. guidance during the pandemic.
We have been advised by critical investigators, but they continue to screen and the register patients in our studies and remain on track with enrollments.
At the same time, we cannot assume that circumstances, such as a second surge will not make it more difficult for patients to remain on or join our studies.
Cancer patients faced increased risks in this environment.
Redesign new dosing schedules and subsequent protocols, we are therefore, considering such matters as frequency or visits and translational our research requirements.
Fight. These challenges we are committed to our mission of serving cancer patients and maintaining the integrity of our clinical research.
In fact ourselves business strategy is to build an innovative pipeline addressing the rising problem of cancer resistance.
Well, you're studying the ability of our agents alone and then combinations with other drugs to improve anticancer effectiveness and treatment outcomes.
We are pleased to report continued progress and will briefly described on today's call our plan for advancing our lead drug recycling.
Based on current spending plans, we estimate that are performer cash and equivalents of $27.3 million, including this spring equity raise will provide a cash runway to the end of 2022.
Well first of you'll find recycling, formerly known as C.Y.C.O. six five.
But recycling is a novel CDK inhibitor targeting that C.D.K., two and nine eyes reforms, which act as key components of the 53 pathway.
Activity against Syndicate, two results in reduction of cycling E. and against Cdknine in suppression of M.C.I. one levels.
Secular cell is evaluating fraud recycling as a single agent in patients with solid tumors and in combination with other drugs in patients with came out the logical malignancies.
[noise] over expression of cancer resistance proteins or amplification of ultra proteins, such as M.C.O., one or a second ear, respectively are associated with cancer cell evasion.
M.C.O. one is one of the 10, most frequently overexpressed cancer genes and there's a member of the B.C.O. two protein family, including B.C.O., two B.S.L., one B.C.L. excel and others, which act as pro survival mechanisms for cancer.
Cycling E. at protein encoded by these C.C.N.E. Jean is over expressed in several gen ecological cancers, including breast and the matriarch Slash unit Rhine and ovarian.
Addiction to <unk> enables cancer cells to escape death by and to cancer treatments.
Suppressing these proteins forces aberrant cells into apoptosis, Oh programmed cell death.
Cyclacels therapeutic strategy is this oppressed transcription of such proteins and reactivate the apathetic machinery, leading to cancer cell death.
Recent discoveries of the importance of M.C. or one have resulted in a race to bring the market M.C.O. one suppressing medicines.
We believe that find recycling is a leader in this race based on demonstration of durable suppression of the protein in peripheral blood mononuclear cells and aren't that cancer activity as mono therapy in heavily polluted patients with solid tumors.
M.C. one suppression was observed in the majority of patients enrolled at the recommended phase two dos or Arpey two d. in part one of our 065 Dash Oh, one there was this collation study using a sparsely administered schedule.
We enrolled 26 patients who received recycling as a single for our infusion every three weeks.
Nearly all patients were cheap stable disease with Jim or shrinkage.
<unk> relevant to the drugs mechanism, including M.C.O. one.
He and or and make mic amplification.
We have enrolled a further 22 patients in the ongoing part two of this study with the more frequent doses schedule or one hour infusion on days 128, and nine every three weeks.
Escalation in the part two has reached the for those level and additional patients have been enrolled to establish arpey two d.
As previously reported that patient after for those level with heavily been treated M.C.O., one amplified endometrial cancer achieved I do graphically confirm partial response or P.R. after a month and a half on <unk>.
This patient this continuing on study after approximately nine months on the same dos.
After the last Wee staging shrink it you're going to our target tumor lesions has improved to 79 per cent.
Another patient was second e. amplified ovarian cancer achieve stable disease with too much shrinkage of 29% after four months or find recycler therapy.
Based on fact recycling clinical activity.
Durable suppression of M.C.O., one and extensive preclinical in clinical data on over expression of cycling e. and various cancers. We plan to further explore five recycling.
Tissue agnostic precision medicine, driven study evaluating patients with gen ecological cancers.
The concept behind this study broadly follows the precedent setting approval of Pembrolizumab.
Microsatellite instability high or mismatch repair cancers.
Briefly we are planning a phase one slash to open label parallel cohort study design.
The initial sample size is 60 patients with each call hard and rolling 20, abreast endometrial slash <unk> or <unk>, respectively.
Basis will receive Fred recycling mono therapy, and subsequently combination therapy, depending on available options.
Details of the trial will be forthcoming after consultation with experts.
Primary endpoint will be objected response rates or are and duration of response will be an important secondary endpoints.
Successful or our performance will be measured against benchmark response rates.
Once it has started in early 2021, we expect enrollment of this study to take approximately one year notwithstanding pandemic delays.
In addition to intravenous administration, a fad recycling.
We are evaluating an oral capsule formulation.
We have those three patients and reached the second dose level.
Initial pharmacokinetic or B.K. data demonstrated it predictable B.K. profile closely overlapping that over the I.V. administration within encouraging exposure levels.
You know him with a logical Malignances program, we have opened two doses correlation studies.
That's the hypothesis that suppressing M.C.L. one N.B.C.O. two can result in that they cancer activity against relapsed or refractories leukemias.
We are evaluating a fad recycling and whenever plaques combination in patients with their laps refractory A.M.L. or M.D.S. in the O. six five dash or three study and be lobster refractories CLL in O. six five dash or two.
Reflecting the I met need for alternative A.M.L. treatments, we have rapidly enrolled 11 patients in 065 dash or three the primary endpoint or which is the termination of R.P., two d. and safety.
The rationale for R.A.M.L. study is the M.C.O. one plays a dominant role and is supported by for clinical evidence of synergy Oh, five recycling and venetoclax in inducing apoptosis.
This suggests that double hit suppression, maybe more beneficial that's oppressing either protein alone.
Heavily polluted patients received a combination of all venetoclax, an escalating doses of address like live on a four hour infusions schedule. Once every two weeks.
We have reached those level five with two patients on 200 milligrams per meter squared or approximately 302 400 milligrams total those well find recycling and Vanessa flux in combination.
Truman licensed syndrome, or T.L.S. was reported in both patients consistent with anti leukemia activity related to the drugs mechanism.
This follows previously reported reductions of leukemic blasts in the peripheral blood of patients treated the lower doses with a combination.
Based on these findings were planned to evaluate this are no more frequent dosing schedules.
In C.L.D.C.O. two overexpression is the main feature and M.C., one isn't escape mechanism.
Leukemia cells, especially in that lymph nodes may stop responding to whenever clocks, followed by a relapse often associated with M.C.R. one over expression.
Eradicating C.L.L. in the lift nodes and achieving minimal residual disease or M.R.D. negativity isn't important treatment objective.
In the O. six five dash or two and <unk> has been slow reflecting the long relapse free survival after frontline see it I'll therapies.
Given that eventually a large number of phases, we'll relapse.
That's the Gators have advised cyclists l. to persist isn't a unmet medical need is emerging.
In order to increase enrollment we have implemented certain protocol amendments and open to new sites. In addition to M.D. Anderson.
Five patients have been treated so far after dose level, four or 150 milligrams per meter squared.
The first two patients failed at Britain, it therapy and one of the two also failed car tea.
There were those once every two weeks at 64 milligrams per meter square or find recycling and whenever clocks as per label post ramp for five and six cycled, respectively, which was well tolerated.
Both patients had continuing shrinkage of their lymph nodes and one was M.I.D. negative after five cycles on the combination.
Both of these studies are part of our risk sharing alliance with the University of Texas, M.D. Anderson Cancer Center.
Whereby MD Anderson assumes patient costs for all studies.
And we provide investigation on drugs and other limited support.
The M.D. Anderson Alliance also includes clinical trials with our other programs Sapacitabine and C.Y.C. 140.
You know D.N.A. damage response program, we enrolling patients with relapsed or refractory A.M.L. or M.D.S. in part to over six city to Dash 11 study, what's up instead of being or Nicholas side analog.
This those Escalations study has enrolled 12 patients and his evaluating safety and effectiveness over and all combination of <unk> with another clocks.
In addition, and investigator sponsor trial or I.S.T. is enrolling at but they're not far breast cancer Institute evaluating a combination of <unk> with all opera.
<unk> in patients with a broken mutants breast cancer.
You know anti mitotic program, we're evaluating see what c. 148 ball or like kind a.'s or be okay, one inhibitor, which like Federer psych lid was discovered in house.
Five patients with advanced leukemias have been recruited to 140 dash or one or first in the human single agent doses Collation study.
No dose limiting toxicities have been observed thus far.
See what C. 140 is a small molecule selective P.L.K. one inhibitor there has demonstrated potent and selective target inhibition and high activity intergraph models of human cancers.
Like many peer to buy a from accompanies we have responded to societies coal by volunteering or medicines for testing and indications where there may be helpful to patients affected by the coroner virus.
To this and we have recently announced a collaboration with the University of Edinburgh to evaluate the potential over R.C.D.K. inhibitors, Fad recycling and Sally Psych lab for reducing runaway inflammation in acute lung injury in patients with covered 19 disease.
In addition to I.S.D.'s at Cedar Sinai Medical Center, and the University of Newcastle are evaluating cell is like live our first generation C.D.K. inhibitor in patients with Cushings disease, and the rheumatoid arthritis, respectively.
During the quarter, we laid the foundations for multiple data outcomes over the next two years.
As we continue executing our strategy and advancing or clinical development programs are upcoming key milestones includes.
Report updated fat recycling phase, one safety and efficacy data with frequent Ivy dosing schedule in patients with advance solid cancers.
Report initial safety and B.K. data from phase, one study or find recycling or formulation.
Treats first patient in French recyclable phase one two precision medicine driven study.
Report initial data from five recycling, but epic locks phase one study in relapse refractory M.L.R.M.D.S.N.C.L.L.
Report initial state of from C.Y.C. 140 Phase one first any human study in a lobster factory leukemias.
Report the initial data from <unk> whenever clocks phase one study.
Lobster factory M.L. or M.D.S.
And report data from Phase one B. slash two separate said it'd be an elaborate I.S.T. in bruck on mutant metastatic breast cancer when reported by the investigators.
With capital on hand estimated the end of 2022, we have the resources to deliver a key milestones you know clinical studies.
Oh, well not like the turn of the call over to Paul to review, our first quarter 2020 financials full.
Thank you sparrow.
I find in today's press release for the quarter ended March 31st Twentytwenty cash and cash equivalents totals $8.9 million compared to 11.9 million as of December 31st 2019.
Decrease of 3 million was primarily due to net cash use the operating activities of 2.8 million and put 1 million of net cash you used in financing activities.
The company raise net proceeds of approximately 18.4 million from an equity financing an April 2020.
Again for the same period in 2019.
Expenses relating to our transcription regulation program increased by approximately point 3 million for the three months ended March 31st 2020, as we continue to progress the clinical development of fat recyclable.
General and administrative expenses for the three months ended March 31st Twentytwenty, well 1.3 million compared to 1.2 million for the same period of the previous yeah.
Total other income net for the three months ended March 31st Twentytwenty was point $9 million.
Compared to point 1 million for the same period of the previous year.
The increase of point 8 million for the three months ended March 31st 20 is primarily related to income received under an acid purchase agreement with their remote Fisher scientific.
United Kingdom Research and development tax credits, we're point 3 million for each of the three months ended March 31st 2020 and 2019.
And our net loss for three months set in March 31st Twentytwenty was 1.2 million compared to 1.8 million for the same period in 2019.
Funding May April equity financing are common stock outstanding is 4.9 million shares.
Operator, we're now ready to take questions.
Ladies and gentlemen, as a reminder, please press start the number one on your telephone keypad in order to ask a question once again when posing your question. We ask that you. Please pick up your handset to allow optimal sound quality. Our first question. It's a line of Jonathan Ash off with Ross capital partners.
Jonathan.
I think.
Okay. I was wondering given the increase effort five or six solid tumors could you describe to sell it to my landscape potentially address for by the drugs such as breast cancer. You know after let's say C.D.K. four six inhibitor failure.
Or something like well, they're getting cancer after platinum selling your or park inhibitor.
Yeah.
And then after that what you consider you combine actress equipped with.
<unk> over expressing solid tumors, yes monotherapies.
[noise] Jonathan Thank you very much for your question.
Landscape for John ecological cancers is evolving but the important clinical data has been reported in recent months for example, with regard to the first part of your question in breast cancer. This is of course from one of our receptor positive breast cancer, which is nearly three quarters of the entire breast cancer population the standard of care.
Siddiqa for six inhibitor together with hormonal therapy drugs like <unk>.
When the city, Okay for six inhibitors fail the primary correlate for resistance to.
This activity of this type of class of drugs is overexpression or amplification of cycle. Any this was showing and pfizer's below my three study with <unk> two hours ago.
So we know that the vast majority of patients will receive standard of care. This is the combination of hormonal therapy and sitting here for six will eventually fail. This therapy combination and it will overexpress like the knee. So this is clearly a very important subset we estimate from literature sized citations.
Approximately a third of this formula receptor positive population were present with second the amplification. It may take a few years I remember the publicized was launched in the U.S. and 2015 before we see that but we're now starting to see it.
Resistance to sit there for six plus hormone therapy inhibition is a very important marketplace.
And there are literally more than 50000 patients available based on our modeling to address with affecting the amplification redux, reducing therapy like for recycling.
Now in terms of combinations I will last Judy to comment on this population before I go on to discuss ovarian cancer jury.
Okay. So I think I'd strategy is really.
Try to combine it with.
One of the whole more family that commonly used in the population interface into a failure. Your plans line you know that that we basically have three.
Hi, I'm wonder if they leave the oldest one of Hamas and then we have several minutes inhibitor.
So the estrogen receptor degrading.
Think about I'll play is the combined with one of those in patients with failed. The four six inhibitor went flying.
<unk>.
Thank you Judy so the second part of your question was about ovarian cancer and what the combined with that landscape isn't even more flux. We just saw literally a couple of days ago and you approval for purple inhibitors. This is addressing patients not only who are potentially braca mutant.
After testing, possibly have H.I.D. homologous your combination deficient disease.
There's not been proven that in the sub group of patients who we are H.I.D. positive and possibly also broke a positive that apartment inhibitors other alone or in some suitable combination of high levels of activity yet there tends to not have extremely long durability. Most patients tend to progress after about a year.
In the sub group of patients were H.R.D. negative new standard of care appears to be emerging which is that about Boston or bevacizumab based on recent data and it's going to entirely clear whether frontline ovarian cancer maintain those with <unk> in H.I.D. negative patients have the same benefit for patients as.
In based therapy may and of course, one could combine apartment inhibitors and they have us isn't above asked him to achieve some disease control. However, ovarian experts are telling us the the vast majority of patients who are never offered perp inhibitor therapy possible because they have insensitivity to platinum typically have sex in the amplification.
Oh.
Estimated addressing population about 27000 patients.
With the Highgrade serious ovarian type or they're in cancer, which is the lion's share of this disease, who would present with.
Not being suitable or not being candidates fry the plot to them and or prop inhibitor therapy.
A third of that as I mentioned, approximately 27000 pace and total are addressable market by a drug that can regulate the second the amplification.
Judy could you answer a what might be possible components in the ovarian cancer setting, particularly for patients were not suitable for apartment hypnotherapy.
Oh I think.
The question that certainly.
We have very good discussion.
Oh, that's good enough.
You know that traditionally we consider.
We treat patients.
With <unk> Yeah. Initially they were planning sensitive. So you know I think there should we be combining and looking at the <unk>. We read the apartment and then we treat them and with a combination.
Funny that with one example, or some other agent that commonly used in the basement factory setting.
Okay. Thank you.
Questions just wondering what.
<unk>.
Program.
<unk>.
Thank you Jonathan weekend set and then give to you and our audience an update on that collaboration as you all know from the press release.
Some days ago, the University of Edinburgh published research starting in 2006 and with subsequent papers I in 2012 and 2014.
<unk> that in three different animal models of lung injury, ranging from my cute lung injury to <unk>.
There appears to be anti inflammatory activity or <unk> first generation C.D.K. inhibitor.
Further localize this anti inflammatory activity on the effects on activated neutrophils you truffles are of course any important part of the immune system, but after inflammatory injury such as the one caused by this blio mice and and do this models of lung damage can produce overactive neutral feels the need to be.
The directed to up up doses or they're going to cause massive inflammatory cascade problems oftentimes called set of kind storm.
In addition group from Dana Farber Cancer Institute in Boston, and published data about that same time, many years ago, showing that silly cycling is also active and slowing down the rate of occasion of my alarm ourselves.
When attaching to bone marrow stromile, so again, another inflammatory cascade hallmark in the context of my Loma, which is of course, a cancer of the blood.
They have also demonstrate in that set of experiments sends intergraph models that <unk> also regulates the transcription I mean, they're looking six it to look in six is found in a post mortem studies have covered 19 patients to have been a major prognostic factor in the rapid decline.
So for this reason are they going against the vet embrace keen to first of all demonstrate whether the same observations apply it to fight recycling our newest it. They can have better there has not been tested so far in models of information if they see a systemic affect then perhaps this is a class property and that would certainly encourage them.
That they are confident that what we have is or producible that would like to go onto a exploratory medicine study.
<unk>.
Universal very abrupt, possibly other center, so collaborate with them under the auspices of a U.K. white effort to stop covered a program called stop covet, which is funded by both charitable and government sources.
Although we're not an inflammation company, where and we'll we'll say an ontology company. This is our area of expertise were very keen to help <unk>. The extent of it can also in addition to helping patients potentially learn more about our drug this is for us when when effort.
Thank you very much good.
Thank you Jonathan.
And the next we have a question from one of <unk> with the Ladenberg.
Airline is open.
Hey, Thanks for taking my question can you hear me.
But can hear your Wednesday Hello.
Okay. Good so.
The the <unk>, we got in the 30, secondly single eight and I read those escalation.
Maybe I Miss it but I wonder what level you are now it's still good to one's really I now.
So you're talking about the fed recycling phase one studying solid tumors is that correct.
Correct.
Okay. So this is the o. six several one part to study we're testing a frequent dosing schedule and all that Judy to maybe describe what we see a 213 and what happens next over to your Judy.
Yeah.
30 milligrams level.
We're not going about it.
Okay, so and what what would be that those level for the preseason to murder trial.
It would be precision family trials.
<unk>.
It will be the to suit in Munich windows or it'd be for news.
Well I think it back to one <unk>.
Hmm.
It's going to be.
Recommended.
It would be either 200 <unk>.
Or eight windows.
If we.
When we expenditures.
Not horrible, but so far that is tolerable, we don't have access to those remedy toxicity. We have some things are quite those actions.
No no.
Oh, we don't have access.
<unk>.
Okay.
<unk>.
I mean.
Or should we.
You know needed to India or.
<unk>.
Both both the principal investigators in identify rubber accounts France's your program with home, we've been doing or phase one studies both for the I.V. in the World I came to publish the results. We have had those discussions with them. There are two conferences to the end of this year major on college in meetings with her life, there will be held physically or virtually.
But somehow they will be held as we have seen with A.S.A.C.R. and soon with ASKO. So we expect by 20 end of 2021 Z., we'll have the data available in a peer review setting.
<unk>.
And then keep excuse to the oral firmly in you have three patients so far looks P.D. <unk> and not just wondering how many do <unk> Asian Unity D.C. do you really see or.
<unk> and you know replaced the I we <unk>.
Okay. So first of all we have indeed as you said three patients one at 75 milligrams flat those and two at 150. So we are still a little bit below where we expect to be with the formulation given that we're using exactly the same schedule, but this time with an all capsule days 128 and nine.
Let me ask Judy about her expectations with a caveat, but it's still early in the all development.
Oh well.
A big <unk>.
Between the two from your life and I think the Grand uses that the P.R. outlook.
And I think that we are close.
We may be able to go up my windows level, but I don't think.
A lot.
The because they they buy available.
<unk>.
Okay got it.
<unk> Oh, you you so to M.R.D. neck negative response now just wondering what do you think it.
<unk> or or or do you are.
Yeah, he's sending to give you a competence to advance he's <unk> in this thing.
This is great question, but I think we are still in a dose escalation study, which was the first we ever did with this combination the primary endpoint for this study is recommended phase two those in safety.
So I don't think that this study was designed being that most patients forget the drug that's a lower doses to determine advocacy, we're still learning as to what the properties of the combination are but as I think we mentioned in this yeah they'll setting in our press release and previous communications patients do very well on frontline ready.
<unk>.
Are they are BDK inhibitor based chemo immunotherapy based or even combinations of unethical acts with anti cdtwenty. They tend to last for at least two or three years before relapse.
More than 85% of patients would relapse because most of them will survive that initial period. So there was a a large repository overlap spacious to treat wants to fail frontline therapy. Once we wait for the patients to fail all available therapies and come to a phase. One study things are sometimes very hard says really hard to benchmark.
Disappointed wang's the what the right level of response as well as duration or response would be we are encouraged by the M.I.D. negativity observed certainly concomitantly with introduction and lymph node size, which appears to be sustained on the combination even if the patients were sensitive to the metroplex alone they clearly not achieve.
And where do you negativity on so long before the patient was persuaded to stay on treatment, but I would call. Those exploratory findings I don't think where yet at that level. They can give the drug consistently they start to make projections or what would be a suitable level of activity, let alone duration and therefore design I suppose ultimately randomized study and see a low.
First thing is to define our p. two d. and we think we are close we're now at 150 millimeters square, which is of course much more than one giving in solid tumors, but consistent where we have in the M.L.. So as an A.M.L., where topping around 200 million for me to square, we're not too far so we should be able.
The end of this year to get to the primary and point of this study and then start defining next steps.
Got it next identifies my crashes.
<unk>.
[noise] and our next question into one of <unk> with Brooklyn, Okay, I'm, sorry, Brookline capital markets to Mark.
I. Thank you <unk>, so with regard to that.
<unk>.
What would be distracted game.
<unk>.
My name diagnosing that.
So why did that vacationing.
You are.
Alright, obviously bit down to get it back there are no good public and what about your expectation in <unk> <unk>, there would be like <unk>.
Based on the identity background.
Go ahead and.
Get down a little based on that.
Yeah, but you know going forward and back.
<unk>. Thank you for your multiple questions and of course that addressing a lot of important issues, which we are not yet ready to address because we don't have enough data.
Pick on the first few and then Judy we'll discuss regulatory strategy and other options.
I think we are very seriously and diligently thinking of a companion diagnostic strategy.
There are however, some important differences in solid tumors at least in the large U.S. tertiary referral centres most patients get screened via N.G.S. next generation sequencing.
It's possible to determine the status of sex in the end or M.C.L., one by doing N.G.S. profiling of these patients.
And therefore, we don't need the classic <unk> for example, Braca I say to determine the patients suitable for <unk>, some three or four years ago. So that's an important distinction as the state of technological evolution.
Determine genomics data base and advanced by leaps and bounds in a short time.
We know that there are some needs to have standardized centralized testing and would like to explore the further with potential investigators and that will determine how we'll move forward I would feel comfortable at least we can determine the status of amplification of a protein a baseline <unk> N.G.S. data.
Ultimately in solid tumors with want to have follow on assessment of genomic status, but this would be quite challenging, particularly in the ear of coffee 19.
On easily ask a relatively young patient with genetic a logical answer to come in and give more bar specimens to determine that that will have to determine along the way, but certainly to determine patients a baseline seems to be feasible. As this is done routinely.
In terms of over a response rate and duration of response benchmark of course, this would be different by cohort.
We have some pretty good ideas of what those are in breast cancer and ovarian cancer based on the sub groups with discussed before but as you dimensions isn't it it'd be validated by K.L.L. dialogue, which is on going.
And we have to learn a little bit more about the rapidly evolving landscape and and Dimitrios last uterine cancer, which has a lot of new options, but none that appears to be compelling as both its incidents and poor survival come thing that to be feature of this disease, it's probably the only women's cancers that has increasing mortality.
Over the last half a decade or so so it remains a very big on that medical need. So these are important questions will be better place to answer them. Once were more precise are defined eligibility criteria for our precision medicine, driven study that will happen in the second half of this year, then we'll be able to give more color.
Let me ask you to comment on your other question about regulatory strategy.
Oh, thank you.
I think the recipe.
I I considered that's pretty straightforward.
And.
By which I imagine that.
Yeah.
Aging activity.
In that we see population that could be.
Bye.
Haitian.
<unk>.
Hmm.
The phones.
Define.
<unk>.
The magnitude of response rate will suffice and I think you've probably already see the precedent in other F.D. approval, we're talking about something.
Around 15% that range and a higher than that.
Good.
And we need your abilities well, that's just what the crap.
I think for.
Well <unk> make your approval after salary that's cool, though it's probably the.
Study.
This is where the questions Oh combination chemotherapy.
And they had two ways to think about combination fancy.
One or two drugs.
That actually both.
Together, but they don't have overlapping toxicity, one single eight in the long.
For example, yeah why the I'm just using example, very.
She is to combine went platinum.
Cobble platinum and you know that predominant toxicity of flattening yours.
Planning and and and and the Myelosuppression, especially if I was that opinion, yet Oh then.
Six five certainly we have not yet see any euro toxicity.
Yeah, you a little hypothesis will be both you and your benchmark again.
Impatient, who had the chance to respond disappoint me because they previously.
Let me.
So I and and and of course, the second hypothesis.
Based on mechanism of action, whether we do you think and feel when we're actually chemo sensitizer the cells to sit and chemotherapy.
That I think is something that we you know we don't have any.
Improve in the in the Clinton it until we get a randomized study so I hope this answers your question.
Yes, it does and maybe one more.
And all the main thing that.
There you know in 19 clean and the investigation.
So what I'm, what I'm lying on like.
The thing.
And why.
Right.
Some state opening up.
No.
The global so what kind of.
The site.
<unk>.
Yeah.
You know what kind of thing that started leaving monitoring the patient what altogether crime.
Thank you Kumar I'll take the first part of your question and Julia would handle the F.D.A. guidance that recently came out due to cope with 19.
So in terms of regional enrollment our primary locus of enrollment is Boston within a fiber is of course in Houston, where M.D. Anderson is we have not seen dramatic a decline we know that Boston isn't it the center of the pandemic.
And yet that appears to be some downward slope in the curve based on the port at new infections.
It appears that Dana Farber as one of the many hospitals in the harbor medical complex is somewhat less affected.
That mass general is the primary a referral center for covered 910 patients.
It was recently an article in the press about reduction in chemotherapy Sedena Farber. It was in the L.A. times and integrity at 15%. Obviously are drug is not chemotherapy. So you're not at this point encountering issues, but it's hard to say how things will go if there was a second surge late in the year for example that is a risk factor.
Houston has been relatively spared in relative terms compared to our New York, New Jersey area of Boston than Seattle, but it remains of course of concern M.D. Anderson has imposed restrictions on access they have control entry few entrances them before and complete prohibition of unnecessarily visits and no family and.
So on but so far we have been able to continue to enrolled patients are being screened and enter into our studies because their face very poor prognosis.
Anybody on this call is unaware of the very short survival that A.M.L. patients can expect so that becomes a very serious problem for these patients. If they are not receiving treatment or being consider for potential investigation on trials.
In our CLL study as we mentioned we have to news sites. Both of those are the main Atlantic region, they're not in a major metro area like Washington, D.C. or Philly. So they are so far not <unk> exposed to risks from the virus as as of this moment, we don't know how this will move forward, but so far they have been able to.
Roll their respective patients for this study continues so in relative to ask have been spared this hard to predict how the future. We'll go but for instance, we have stopped pursuing a dialogue with European investigators Europe is in the midst of the pandemic they are.
Can I have to first of all demonstrate that they can safely handle go back to work over the months to come before we can consider opening studies there and we have also slow down the possibility of adding new sites in the U.S. until we further understand the trajectory of the pandemic pretty much on the lines of what you described.
So well that let me turn to Judy to address the regulatory question.
Well I think that'd be a guidance.
Maybe I'm trying to provide some frame work how to do the clinical study into right.
And challenging pandemic.
So I think the first of all is that.
That is somebody who doesn't need to be in the hospital then they don't need to be in a hospital well it means that criteria.
It's not terribly relevant to the population patients that we tried to to tie that you know that when you're failed the multiple lines.
You have reflected disease and the two mixed growing I mean that.
<unk> issue, but nothing can you pass it on in a way to four months until I'm kidding.
<unk>, yeah, well, we have seen is that.
That could be sites are getting better because we work with major side.
Q prescreen that patients.
Trying to to.
Specific in the making sure if they do come in they eligible.
Yeah, I'm, taking a lot of patients screen them and then three of them says you know what has something else is they they doing a much can't just I think that's good news.
The second in terms of how we monitor we work with the sides closely and we we what we have been anyway.
Phone calls and and and so that to US is it remains the same.
So traditional monitoring.
Is that we we see most of the site we work with a a line as to access the medical <unk>.
And damaged so that is helpful to us directly get to this was you making sure that they had a cat.
Here.
And at this time I'm sure we have no other questions on the phone lines I'd like to turn it back over to spirit Ramada's for any closing remarks.
Thank you operator, and think all of you for participating in Cyclacels first quarter 2020 earnings call.
And your ongoing support of our efforts to deliver on our strategy to realize talk hold a value by demonstrating safety advocacy and cost effectiveness of our pipeline assets. We'll look forward to updating you on our progress and meeting although virtually some of you at upcoming conferences or the annual meeting.
Stay safe.
Operator at this time you may end the call.
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