Q2 2021 Cyclacel Pharmaceuticals Inc Earnings Call
Ill say its on hold we do appreciate your patience of asks could you. Please continue to stand by your program will begin shortly.
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Good afternoon, and welcome to the cycle of sell Pharmaceuticals second quarter 2021 results conference call and webcast. At this time all participants are in a listen only mode. After todays call members of the financial community will have an opportunity to ask questions. If you would like to ask a <unk>.
Western at that time, please press the star and one on your Touchtone phone if at any point of your question has been answered you may remove yourself from the queue by pressing the pound key in posing your question. We ask that you. Please pickup your handset to allow optimal sound quality.
The company will also be accepting a limited number of questions submitted via email to the address I are at cyclists L. Dotcom.
Lastly, if at any time during the call you should require operator assistance. Please press star zero.
Please note today's call is being recorded I would now like to turn the conference over to the company.
Good afternoon, everyone and thank you for joining today's conference call to discuss <unk> financial results and business highlights for the second quarter ending June 30th 2021 before turning the call over 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 provision of the private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act of 19.
<unk> 30 for 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, including those discussed in our filings with the SEC, which include among other things our forms 10-Q and 10-K. These filings are available from the S. E C.
Or our website all of our projections and other forward looking statements represent our judgment as of today and Cyclostyle does not take any responsibility to update such information with US today are spear of robotics, President and Chief Executive Officer.
Paul make Barron Executive Vice President Finance, and Chief operating Officer, and Doctor, Marc Kirshbaum, Senior Vice President and Chief Medical Officer, Spiro will begin with an overview of our business strategy and progress on cyclists, all clinical programs and Paul will provide finance.
Highlights for the second quarter of 'twenty, 'twenty, one, which will be followed by a Q&A session. At this time I would like to turn the call over to Spiro.
Thank you Irina and thank you everyone for joining us today for our second quarter and business update call.
On our last call in May we reported on F. D a clearance or I N D for of recyclable or farther out for short.
On a streamlined phase one slash two clinical study designated zero of six five dash one on one in patients with advanced solid tumors.
We are pleased to report that in July we dosed our first three patients in this trial, which is led by prominent oncology thought leaders.
We are excited to have the study up and running and believe that fall draw has the potential either as the single agent or in combinations to become an important new therapy for the treatment of advanced solid tumors.
Has been described in detail the framework for our clinical trial designs for both for recycling and see what's the 140 on our prior of quarterly call, but would like to discuss today, our overall strategic direction in developing innovative oncology medicines that focus on sales cycle then.
Sure.
But we'll also address why we believe investors should be interested in following our progress over the next several months.
There is the large universe of development stage oncology focused companies all working diligently to provide cancer patients with safe and effective alternatives.
It may therefore be useful to explain how the unique biological and mechanistic properties all of our two leading drug candidates differentiator of pipeline is a unique pure play in cell cycle inhibition for the treatment of cancer.
Our mission is to.
Net relentlessly pursue setup to the innovations, which can serve unmet patient needs.
We do so by converting insights into the biology of cell cycle control into novel oncology medicines.
The development of far draw is a Prime example of this approach.
Yeah.
<unk> is a highly selective second generation inhibitor of cyclin dependent kinase or CDK and is differentiated by its ability to inhibit both city canine and CDK too.
Yeah.
Well city canine plays a central role in regulating gene transcription within normal cells.
It is up regulated in many cancer cells, including biliary tract colorectal liver women's cancers, and also on leukemias and lymphomas.
It leads to overexpression of select proteins, such as Mcl, one of the mic, which block apoptosis or program suicide of cancer cells and in turn helps propagate their survival and growth.
Inhibiting CDK nine on blocks the bodies antiapoptotic machinery, how long of the immune system to dispose of cancer cells.
The recent advancements in our understanding of the biology of CDK to fight. The second target have led to increased recognition of its role in cell cycle control and its impact on resistance pathways.
Inhibiting CDK to kind of the comm resistance of cancer cells to treatment, which arises when such cells become addicted to cyclin E. The partner of protein of CDK too.
Second he plays a key role in the evolution of resistance in the many malignancies and in particular of women's cancers, including breast cervical endometrial slash uterine and ovarian.
In addition, CDK to contribute to faster recovery of Mcl, one of the protein levels and complementary fashion to CDK <unk> effects on the Mcl one for.
The other justifying our choice of address target profile to inhibit both the CDK to earn nine.
In the prior clinical testing of <unk> as a single agent targeting of CDK to earn nine has resulted in durable suppression of mcl, one and anti cancer activity, including durable PR with 100% shrinkage of target lesions in Mcl, one amplified endometrial.
Cancer.
Our second drug candidate see what's the 141.44 short also disrupts the progression of the cancer cell cycle.
By inhibiting polo like kinase, one or P. L. K, one at low none of them all of our potency.
Interfering with multiple stages of cell division or mitosis.
The Okay. One plays a central role in the mitosis and is an important on regulator of the late cell cycle checkpoint in normal cells.
Went over expressed however, the okay, one becomes oncogenic, causing cellular transformation and other writing the cell cycle checkpoint.
Unlike normal cells cancer cells cannot tolerate loss of P. O K, one and then they go off of doses.
P O K one inhibition helps restore checkpoint control and is there for are considered a promising therapeutic strategy.
Yeah.
We believe that what 40 is differentiated from previous and current the okay. One inhibitors among others by its P O K family selectivity.
Intravenous and oral administration and best in class short half life.
It shows selective target inhibition.
Impressive preclinical efficacy on cures and the human solid tumor and leukemia xenograft, respectively at non toxic doses.
And also of both oral and intravenous forms were found to be highly potent in xenograft animal models.
We have treated seven leukemia patients with escalating doses of intravenous route of 40 and have observed anti leukemic activity at the center of dose level.
Yeah.
Optimal biological dosing of the P. O K one inhibitor is likely by the daily oral administration.
Protecting cancer patients from exposure to viral infection, if they receive intravenous therapy at an infusion center also supports using oral one of 40, which they can receive at home.
Similar to our strategy of developing an oral formulation of <unk>. We believe that oral administration of 140 will lead to more of a consistent pressure against the sends the miotic target of P. L. P of one versus the IV formulation of 140.
We are currently completing toxicology studies of oral one of 40 and are planning to open two phase one two studies in both solid tumors and leukemias.
To summarize we're very excited about the potential of our pipeline.
We believe both for draw and the 140 holds the potential to position the size of ourselves the leader in developing next generation anti cancer therapies that originate from cell cycle biology.
Yeah.
Let us now turn to what investors can expect in terms of clinical study initiations and possible data readouts over the next six to 12 months.
We expect the dose our first patient with all the far draw in the phase one slash two of leukemia study designated 065 of Dash, one or two in the second half of 2020 one.
This study at the same trial design and the solid tumor or six five dash one on one study that just launched.
The the kidney of protocol provides for a three plus three dose escalation to determine the recommended phase two dose and we'll move immediately to the phase II part across multiple cohorts, both as a single agent and in combinations.
We recently received FDA clearance to proceed with the father of leukemia study.
Towards the end of 'twenty to 'twenty. One we also plan to dose the first patient with all of 140 in the phase one slashed true advanced solid tumor study designated 140 Dash one on one.
Following a similar trial design as the father of program.
In the first half of 'twenty 'twenty, two we plan to dose the first patient with aura of 140 in the phase one slash two leukemia study designated 140 Dash, one or two and also hope the report initial data from the Farnborough or six five dash one on one and that's one of two studies.
With the capital on hand estimated to last through early 2023, we have the resources to deliver key milestones in our clinical studies.
I will now turn on the call over to Paul to review, our second quarter financials Paul.
Okay.
Thank you Spiro.
As of June 2021, cash and cash equivalents totaled $43.6 million.
Compared to $47.8 million as of March 31, 2021.
The decrease of $4.2 million was primarily due to net cash used on.
Operating activities.
Research and development the expenses were $4.1 million for the three months ended June 30 of 2021 as compared to $1.2 million for the same period in 2020.
Research and development expenses relating to <unk> increased by approximately $1.9 million for three months ended June 32021, with the start of the solid tumor and the permit study of six by one of the one and preparations for the opening of enrollment of the of six by one of two study of <unk>.
The cyclic in leukemias.
Additionally, R&D expenses relate to $1.40 increased $1 million for the quarter as IMD directed activities are completing and clinical trial supplies of being manufactured.
General and administrative expenses for the three months ended June.
The 21 with 2 million compared to $1.3 million for the same period of the previous year due to the costs of approximately <unk> 4 million related to the exit from the long term facility lease increasingly.
The increase in legal and professional expenses.
And recruiting costs related to expansion of the clinical team.
The United Kingdom Research and development tax credits, where the 1 million for the three months ended June 30th.
2021, as compared to four 3 million for the same period in 2020 due to the increase in R&D expenditure eligible for the R&D tax credits.
Net loss for the three months ended June 32021 was $5.2 million, Okay. The $2.2 million for the same period in 2020.
The company estimates the cash resources will fund currently planned programs through.
The early 2023.
Operator, we are now ready to take questions.
At this time, if you would like to ask a question. Please press the star and the one on your Touchtone telephone you may remove yourself from the queue at any time by pressing the pound key.
Once again, if you would like to ask a question today, Please press star and one.
And we will take our first question today from Jonathan a shop with Roth Capital. Your line is open.
Thank you very much steer on regarding the sites for the phase one day, two solid tumor saturate trial, how do you see enrollment unfolding in the phase one day portion.
Okay.
Yeah.
Okay.
Hello Spiro.
Yeah, Hi, Jonathan Hello, Jonathan I'm joined here momentarily the that disconnect tissue.
I think this is the question for Mark Crisp on Mark would you like to take this question.
The.
Really happy to take this question so that's the way.
The exciting time for us and it's a very exciting time for the trial.
That's just the answer your question by saying that.
And to the oven for enrollment on the study has been on.
The extraordinary we.
We enrolled our first cohort within.
The first week of opening it and we already have a waiting list for the.
The second.
The second cohort that will be opening shortly.
Yes.
It looks good.
Right.
The good news can be part of it can be done.
For all of Us.
Perhaps Jonathan I cannot deliver the more color.
As Mark explained the the initial two sides of MD Anderson in the city of Hope of you also have the lymphoma groups within the two hospitals, which are distinct from the phase one units. We're also interested in recruiting patients for the study and we also of preparing to open two more sites that are outside of the United States is of course required regular.
Troy of process to be put in place of that will take a bit longer in the second half of 'twenty 'twenty. One. So we may have actually six groups for the time. The study concludes contributing patients. All of this gives you some sense of confidence of enrollment.
Definitely second question of has one of the range of possible outcomes from the phase two part of the sides of it solid tumor trial that could lead to regulatory discussions.
Thank you Jonathan I think we have.
Reported on seven cohorts with specific histology is ranging from women's cancer, two bile duct cancer of lymphoma is on the colon cancer as well as an eighth cohort for us as a basket study where patients can enroll the goddess of the tissue of origin histological background of the cancer provide.
They have one back in the corner, let's debate of the drug's mechanism such as amplification of the Mcl one second on the MC.
This means that we have eight shots on goal in the solid tumor study, which when we add the leukemia program total about 14 chances to get its regulatory discussions with the.
The end of phase II data, which typically would be of consultation with the FDA as to whether they will support the.
Potential use of the accelerated approval pathway. So very excited about this design as it will give us with the very efficient use of capital multiple shots on goal and produce a range of outcomes for investors.
Thank you spear of can you be also a little more granular in the indications that youll target in the upcoming phase one to a $1.40 trial.
Sure. This trial hasn't started yet and we have not disclosed all of the target indications.
Believe we have disclosed the colorectal cancer, where activity with this class of drugs has been seen in chaos mutant disease, which is a very exciting development. Because this is an area of huge unmet medical need and also of breast cancer, which is known to be susceptible to this type of the O K one inhibition mechanism we expect on.
On some more of the histology is later on in the year. However, there are a number of sites will have already received drug and are doing preclinical studies in preparation to joining the program. Once the study opens at that time I expect we will can give a lot more color on the additional indications that will be probably as many of seven that's one of the baskets similar to the father of Dizzy.
But not the same indications of of course.
Okay. Thank you very much of it.
Thank you gentlemen.
And we will take our next question today from Kumar of Roger with Brookline capital markets. Your.
Your line is open.
Hi, Thanks for taking my questions the.
The only for the solid tumors.
When will you start screening patients for the proof of concept and will you be enrolling patients in all the cohorts badly.
Yeah.
Thank you very much.
For the question Kumar of I think again, Mark should answer that question. Please.
Kelly are you asking about for the partner channel.
A further one on one yet.
So.
As I mentioned, we've already completed one cohort.
The thing that were about the size the <unk>.
Dosing of.
Cohort so.
Moving along we were already.
Screening patients in the we have quite a waiting list.
Already so.
I hope that answers your question once we achieve of course, we need to.
We need to have the.
The phase two dose in hand, and the dosing schedule. So when we once we complete the phase one part of the study.
We will automatically into the eight on them that were described you earlier because.
There's no great there's no new protocols that needs to be written on it all goes part of medically within within the same study.
Okay. Okay. Thank you.
Sorry for the fact that all of the leukemia study.
In terms of the cohorts, where do you what are the radial how combinations. How are you thinking about those combinations in terms of safety.
Thank you Mark.
Yeah.
So it's gonna be similar idea the.
Once again, we we need to really establish the the.
The best and most of the most effective phase two dose and schedule for two of the leukemias. So we will be going through that period of the study.
That should be opening fairly shortly.
And.
Once that is established.
There will be some single agent arm as well.
On the standard combination of them that had been described and that the.
It will be part of the thing.
The phase two part of the study is that again the.
Automatically once the phase two doses of reach in the study it's all part of one being studied.
Okay, so kind of little bit more color to Mark's answer of leave have several choices for combinations, but the most the appropriate and conservative strategy is to use the current standards of care and acute on chronic leukemia.
Sure either of another class or HMA drugs, including either side of the dean or decitabine, and that's precisely what we're doing in the middle cohorts in the course ex five dash one of two leukemia protocol.
And again from a safety point of view, we have some experience with giving the fraud drop with the net took lex with all of that then a dozen patients or so with AML and the half of dozen patients with the CLO that was well tolerated and are moving.
You have seen until leukemic activity in both AML and CLO. So we have some confidence given the high or above in the ability of the oral version of the THAAD rather similar results can be obtained and the combination of program. We have not had clinical experience with that sort of been decided in combinations of these drugs tend to be out of.
Little bit less.
Toxic than the other classes as single agents. So we feel that these are quite reasonable to propose from the safety standpoint than ever done in the so did the FDA thing Kevin per dose study to proceed I hope. This gives you some more color.
Yeah, that's very helpful.
And in terms of the factor of intravenous dosing of what's happening in that front.
Well. This study is the of enrolling but we expect that patients will have a choice between all of my V will vote with their feet to take gave me the.
Now as it was the oil but this will change once of the oral study opens I think most people with the at this time of the pandemic prefer to have the oral drug. So we'll make the decision of the next few months of that study opens.
Okay. So they will be able to you know once you have the optimal at all the state would be able to shift to the what are the dosing.
Well they put the liquids shift the only if they have not been treated before we cannot pick of patient has been treated who of the protocol to switch within the study that there's probably not the normal procedure, but my guess is that the if we look at the patient choices on both protocols are open most patients would vote for the oral.
Okay, but of course, what is being on the entirety of Montana.
19 of the follow them.
Well at this point, yes, yes.
Okay, great. Thank you so much.
Thank you.
We will take our next question from Kevin to cater with Oppenheimer. Your line is open.
Hi, This is Susan on for Kevin.
Just a couple of questions on well.
Hydro can.
Can you comment on the profile of the first three portion of tariffs.
Gross.
And does the company anticipate presenting at Ash.
What are some of the other logical venue.
Well like we.
We have not we have not disclosed the profile of the first three patients Susan.
You'd mentioned that in the context of the study. This is not the study designated for efficacy at the.
The primary objective of the endpoint that we're seeking is as Marc explained recommended phase two dose. So the choice of the patients in the history is not the specified by the protocol and therefore, the physician has come off of the political to any of the patients that they feel may benefit. So at this point I don't think we can make any predictions about the scientific conference.
Says well what might present data. This is something that we will do in due course, but more of like they would think early next year what might have some results kind of be worthwhile following up in terms of mature patient follow up.
Okay that makes sense.
Yeah. The second question on just what are the logical venues.
The data either sell it tomorrow or the metallurgy.
The call.
And I think for solid tumors, we have a lot of our venues I would think a CR and ask all of the principal ones with historical reported data and they seem to I think in terms of cadence of our clinical enrollment likely to happen early 'twenty to 'twenty two.
Ash of course, and other smaller hematology meetings happened at the end of the year. So that's a possibility and we have also as well as the triple meeting in the second half of 'twenty 'twenty, two so that probably for a five venues they'll get the logical for presenting data next year.
Okay that makes sense and then just one question on the BLK one inhibitor.
Can you provide some color on the remaining I M D activities and what the expected timeline for completion of the turbine.
Well, that's going to the question for you on perhaps ball kind of help out with the timing for the first park.
Yeah.
Well you know, we're creating a new family of new formulations. So I think for a little bit of time, but we are.
We are close to being done with the toxicology studies that were required for the FDA filing.
And we will hopefully.
Could we be moving quickly.
From there I mean, we ended the.
The state, having the clinical design and all of that and rapid time.
So and this is Paul so on tens of of hoping to open the study with projecting towards the end of this year.
Yeah.
And that's the cleaning opinion of what Mark has said in terms of toxicology studies being completed.
Okay.
And if I kind of just one last question I got no question.
That's the.
The company.
I expect COVID-19 infection rates to impact on that and the <unk>.
Second half of 'twenty one.
Yeah, that's a huge issue for our industry is in all of that many companies have faced headwinds we did not experience that in the past year and large means because these are of course terminal patients facing dietary choices, including hospice care versus enrolling in the investigational trials. So so far that hasn't been an issue of Mark of course.
As a historically practicing physician on that but he has a different perspective for a lot of things might look like next year.
Well you know again.
Accruing very rapidly right now at the moment.
So yeah, we're aware of Waitlisted for enrollment on the site.
So I don't see the things are going to the worse in that regard.
I think.
You know, particularly given COVID-19.
They don't require lengthy hospital stays and one of them.
Most of the scary outpatient.
They they just show up the the.
Have you seen the pills and do it in the blood or the need of this is the really like.
Like a perfect solution for for most of these.
For these patients.
It's it's far superior to having to come into the hospital and extend the time.
In the in the treatment group.
All of what we are getting very strong enthusiasm from the investigators.
From the patient.
This time.
Great. Thank you so much for answering the question.
Thank you Susan.
And as a reminder, if he would like to ask a question. Please press star and the one and we'll pause for a moment.
Yeah.
And I'm showing that we have no further questions. At this time I will turn the call back to Spiro for any closing or additional remarks.
Thank you and thank you all for participating in cycle of ourselves second quarter 2021 call.
Secondarily, the entering an exciting period in its history in the months of had investors can expect continued expansion of our clinical programs for both foundry and a lot of 40, we believe that these trials will generate encouraging data readouts throughout 2022 and early 'twenty two 'twenty three.
As always we appreciate your support as we continue our efforts to deliver on our strategy and realize talk all the value. We look forward to updating you on our progress and meeting some of you at upcoming conferences or the virtually all hopefully in person.
Operator at this time you may end the call.
This does conclude today's program. Thank you for your participation and you may disconnect at any time.
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