Q2 2022 Cyclacel Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to the cycles sell Pharmaceuticals second quarter 2022 results conference call and webcast.

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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 the strike with all financial results and business highlights for the second quarter of 2022.

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 provisions of the private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act of nine.

734 as amended.

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 Form 10-Q filing.

Filing is available from the FCC or our website.

All of our projections and other forward looking statements represent our judgment as of today and Psych Lasalle does not take any responsibility to update such information.

Today, Our Bureau, robotic President and Chief Executive Officer, Al Mcferran, Executive Vice President Finance, and Chief operating Officer, and Dr. Mark Kirshbaum, Senior Vice President and Chief Medical Officer.

Arrow will begin with an overview of our business strategy and progress Mark will review cycle cells clinical programs and Paul will provide financial highlights for the second quarter of 2022, which will be followed by 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 quarterly business update.

The major highlight of the second quarter was a midyear update on June 30th.

We reported initial clinical results with all federal cyclic or <unk> for short.

Our lead product candidate <unk> is an orally available CDK to and CDK <unk> inhibitor enrolling patients in a phase one slash two study for the treatment of solid tumors and lymphomas designated 065 Dash 101.

Thus far we have enrolled 17 patients in the dose escalation part of the study reaching dose level five without dose limiting toxicity.

Based upon preliminary results in the first five dose levels with far draw. Those daily we are highly encouraged with evolving safety and anti cancer activity profile of all of <unk> monotherapy.

Importantly, this anti cancer activity has been observed during the phase one dose escalation stage, which typically pet treats all comer sicker patients will have received multiple prior therapies.

Ordinarily, we don't expect to see much or any significant evidence of clinical benefit in such very heavily pretreated phase one population.

Initial observations of all fiber activity as a single agent dose daily build on those in a prior clinical study, which those far drug intravenously, albeit with a suboptimal dosing schedule.

These included patients with heavily pretreated mcl, one amplified endometrial cancer, who achieved a confirmed complete response.

This should be achieving partial response.

This patient remains on study after more than two and a half years of treatment.

<unk> 5101 study of oral Fabra continues to enroll very well at four U S South Korean and Spanish sites and is on track to establish recommended phase two dose or our b to D within 2022.

We anticipate starting the phase two stage of the study shortly after our B to D.

So tomorrow Kirshbaum, our Chief Medical Officer will provide further details on this study and our other programs.

As clinical data with all five drugs in all six five dash one O. One are starting to emerge. We're also encouraged by far address competitive attributes, particularly as we survey the next generation CDK inhibitor landscape.

Relative to other development stage CDK inhibitors, we believe that all of them far draw has the potential for best in class. Thus far based on dual targeting of Cdk's two N city canine very good tolerability at higher dose levels, a daily dosing schedule and.

Preliminary anti cancer activity in patients with lymphomas, endometrial and pancreatic cancers.

We note that targeting CDK to appears to be gaining more visibility as an important target for the biopharma industry.

For example, Pfizer recently disclosed plans to advance its syndicate two inhibitor into a substantial phase two study for the treatment of breast cancer, which clearly represents a sizable investment and a vote of confidence in the class.

Notably these Pfizer molecule does not inhibit CDK nine.

Data from cycling cells clinical studies show that patients with Gynaecological cancers, often over express multiple proteins that can be suppressed by targeting both see the Q2 and CDK nine.

Hence a dual inhibitor may have advantages over inhibitors that target a single enzyme.

Our second clinical protocol designated all six five dash one O two is evaluating or foundry leukemias or myelodysplastic syndromes, and there's no dosing patients at dose level four.

Or six five dash, one or two may provide further opportunity to differentiate the father or from other CDK inhibitors. If it is effective in both solid tumors and blood cancers.

Let me also briefly mention our third protocol 140 Dash, one O one which is actively enrolling patients with solid tumors and lymphomas in a streamlined phase one slash two trial of our oral B O K, one inhibitor C Y C 140.

We believe that preclinical and early clinical data generated thus far support that put them. So let's see what see 140 single agent activity.

Importantly, this molecule is differentiated from the only other P. L. K one inhibitor in clinical development on several attributes.

We will have more to report on this compound including details of its mechanism of action at our upcoming R&D day.

I'd like to now turn the call over to Mark who will provide additional details on the further clinical development program and the rest of our pipeline Mark.

Thank you Spiro I would first like to review preliminary results of the phase one dose and schedule finding part of 0651 O. One given the promising safety and early efficacy results we're seeing.

We have a new rule 70 patients thus far with no severe drug related adverse events reported.

Oral viagra has been well tolerated at all dose levels at this point.

With regard to responses, although we are still in the dose finding portion of the trial with a higher dose level still study we have already seen one patient with cutaneous T cell lymphoma or <unk> achieved.

We achieved a partial response or PR as measured by the most widely used method to monitor C. T cell known as the modified Swat or modified severity weighted assessment tool.

At the current systems level, which is 100 milligrams twice a day for five days every week.

Over a four week cycle to further patients are showing signs of clinical activity.

A patient with a very aggressive form of T cell lymphoma achieved 38% reduction in target lesions my pet scan during the first treatment cycle.

A third patient with advanced endometrial cancer achieved stable disease, along with a 15% reduction of target lesions within the first treatment cycle.

It is also noteworthy that a pancreatic cancer patient on dose level four achieved stable disease by confirmatory scan following five treatment cycles or approximately five months. This.

A remarkable result in pancreatic cancer, which is notoriously difficult to treat.

Given the activity and safety of Fabra, we plan to optimize dosing by evaluating up to two more dose levels to ensure that we do not miss any activity.

This is supported by our preclinical models, which we intend to present at our upcoming R&D day.

As you are not seeing toxicity.

All clinical investigators in the study have agreed that it would make medical and scientific sense to continue dose escalation with the current four week schedule.

The two additional dose levels will follow the usual three plus three design to determine the recommended phase two dose or <unk> before we enter phase two where patients with defined tumor types, who will be treated with the primary objective of response to treatment.

Based on the streamlined design of the trial once the dose and schedule are established we went directly into the phase two stage, which is designed with the appropriate bio statistics to a lot of discussion with regulatory authorities in the event of continued activity in certain tumor types.

The tumor types to focus upon and phase two will reflect phase one experience.

As well as extensive preclinical work by the company and by several of our investigators and we'll also consider indications of unmet medical need that may lead to an accelerated approval strategy.

We are also testing oral viagra for the treatment of leukemia, and Myelodysplastic syndrome and studied 065 when they were too.

This study continues to enroll patients at city of hope and MD Anderson Cancer Center.

Based on good Tolerability and dosing side, one O. One we recently introduced the protocol amendment in Zurich, So I wanted to.

That allows us to admit those levels two and three.

We are now enrolling at those levels for which we believe should shorten the timeline for reaching our P. T D.

Similar to the solid tumor study once RPT D has determined the study will enter into proof of concept cohort stage, where <unk> will be administered both as a single agent and in combinations.

Patients at up to seven cohorts relevant to the drug's mechanism of action.

I'm informed by the clinical activity of <unk> in previous studies.

Oh agent cohorts will include patients with acute myeloid leukemia or myelodysplastic syndromes.

Who have an inadequate response or progressed on venetic likes combinations with hypo misleading agent or low dose Ara C.

We will also enroll a cohort with relapsed refractory AML or Mds patients.

With three kids learn map kinase pathways, including N K, Ras BRAF, PTP and 11 and F. One.

The trial will also include patients with Cielo, who have progressed after at least two lines of therapy, including a PTK inhibitor and identical X.

In April we were pleased to announce the publication in the journal leukemia, the confirmed <unk> ability to suppress mcl, one and synergize with vanilla clocks in CLO.

Results from the preclinical study confirmed that Farquhar inhibitors CDK nine mediated transcription.

Reduced levels of the short lived anti an antiapoptotic protein mcl, one and induced apoptosis in primary CLO itself.

To repeat an earlier theme.

These data highlight the importance of continued treatment to prevent recovery of mcl one protein levels.

Importantly, it's allowed to combine two distinctly with the Bcl two antagonist vanilla clocks.

Demonstrated even greater synergy when targeted against 17 P deleted CLO cells, which were not sensitive to either agent alone.

During the second quarter. We also made important progress advancing our novel P. L. K one inhibitor.

See what I see 140 into a phase one two study for the treatment of solid tumors and lymphomas.

Similar to the two five year protocols 141 and one.

Is it a registration directed study now enrolling patients in phase one dose escalation.

Vote, and MD Anderson cancer Center with two further overseas centers ready to enroll patients.

We are encouraged with the drug's performance in the clinic, thus far having observed no dose limiting toxicities.

With respect to early signs of activity one ovarian cancer patients with metastases have achieved stable disease with tumor shrinkage. After the first treatment cycle and it's continuing on treatment after three cycles.

As previously mentioned.

We plan to hold an R&D day in the fall at which we intend to provide a comprehensive update on both the oral thorough and oral <unk> hundred 40 clinical programs in patients who have received multiple treatment cycles and higher doses.

As well as the preclinical work that has been done by cycle, so and our collaborators.

Given the importance of demonstrating on target activity, we've made it a high priority it's cyclical to develop collaborations with the outside research groups to further inform us on the molecular pharmacokinetic and biological properties of Sabra and see what I see 140.

This should be an exciting event as it will highlight the unique competitive attributes of Fargo and see what I see $1 40 in their respective classes.

I will now turn the call over to Paul.

Thank you Mark.

As of June 30 of 2022 cash and cash equivalents totaled $29 1 million compared to $36 6 million as of December 31, 2021.

The company estimates that available cash resources will fund currently planned programs into the second half of 2023.

Research and development or R&D expenses were $4 2 million for the three months ended June 30.

2022, as compared to $4 1 million for the same period in 2021.

R&D expenses relating to Farnborough with $2 6 million for the three months ended June 32022, as compared to $2 8 million for the same period in 2021.

Due to the increased clinical call cost of <unk> 5 million.

Sure. It is the clinical trials evaluating cadre in phase one two studies offset by a reduction of <unk> 7 million in non clinical expenditures.

Additionally, R&D expenses related to C Y C $141 5 million for the three months ended June 32022, as compared to $1 1 million for the same period in 2021 due to clinical trial costs associated with the start of the <unk> hundred 40 phase one two study.

Yeah.

General and administrative expenses for the three months ended June 32020 to $1 6 million.

Compared to $2 million for the same period last year due to a decrease in facilities professional and recruitment costs.

United Kingdom Research and development tax credits were $1 million each of the three months ended June 32022 at June 30 was 2021 and that related to qualifying R&D expenditure.

Net loss for the three months ended June 32022 was $4 6 million compared to $5 1 million for the same period in 2021.

Operator, we're now ready to take questions.

Yeah.

At this time, if you would like to ask a question. Please press the star and <unk> on your Touchtone phone.

You may remove yourself from the queue at any time by pressing star Q.

Once again that is star one to ask a question.

And our first question will come from Arthur <unk> with Ladenburg Thalmann.

Good afternoon. Thank you very much for taking my question. My first question will be about the R&D day.

I have to disclose that R&D day, do we expect to see any data from the Apache program and they do have a follow up question after that.

Hello. Thank you for your question, Yes of course, so it will shut down.

Kannan data, including any maturity we have some patients are all subsequently until the midyear announcements during the R&D day event, which should be in the middle of the Q3 period.

That's helpful. Another question I have Spiro I E. Do you see any can you just stick toxicities inhibiting T D K T.

CDK nine are there anything.

And that causes a synergistic toxicity there.

There was a question for Mark.

Hi, we haven't really seen toxicity at all in the study so far.

So.

Hopefully it will stay that way.

That sounds great and my last question is on the P. O. K program, you are assessing public tumors as well as the heme malignancies, and we have seen some data from other P. I K program P. L. K one program.

I'm curious if there's a particular indication you think there is a higher chance for $1 40 to be successful or youre more excited about I would love to know about that as well.

Well, that's a great question and I would like to know more answers as we go further in the clinic, we're still in dose escalation much earlier than the federal program, but we have disclosed our target indications for phase two which are based on a variety of factors, including preclinical results and so the ability of the target and as you can see these are.

Bladder cancer lung cancer as well as a hematological tumors old mentioned earlier, putting something from us.

Of course to many investors following the P. Okay. One space is chaos in a rectal cancer and we are excited to see that perhaps in the early stages of our phase one program might see colorectal patients based on their sites will have to close in our trial. So it's still very much work in progress, but there are several indications not pollute.

And the other companies program that we intend to pursue as part of our phase two protocol.

Well, thank you very much for taking my call.

Thank you I hope.

Thank you. Our next question comes from Tomorrow, Russia with Brookline capital.

Hi, and tremendous handler for Kumar.

So with regards to the CIC One party dosing you had mentioned earlier about the initiative.

In the single digit milligram range.

Uh huh.

Kind of those levels have you been able to test how does it look so far.

Okay.

This is the question about 140 right.

Yes, yes.

Okay. Thank you I'll ask Mark to answer the question about the starting dose level and the way, we expect that to top out.

Yeah, Hi.

No. We're still early in that trial. So we're still in the AR and the low dose ranges.

Were following it with pks and we will.

As we move forward, but even at the low dose level.

We're starting to see some activity of course, we have there's published preclinical data that suggests that low dose continuous dosing with this drug may also have.

Another form of clinical activity and we're sort of seeing that now so.

That's kind of where we are.

Right now in the trial, it's still early.

We'll be continuing to dose upward.

I hope that answers your question.

Yeah, Yeah. It does.

And my follow up question would be so could you talk a little bit about the enrollment in the one point your trial.

And our boot boot solid and liquid cancers enrolling at the same rate.

I think that earlier.

Talking about issues with enrollment in liquid cancers, so any color on that would be useful.

And are you planning to activate any additional sites other than the MD Anderson single hook. Thank you.

Australia, so you're asking about.

100 <unk>.

Bindra from Madras about one four can stomach similar then the future plans for him.

And 140.

Yeah I think.

Again, 140th very early so it's important for us first too.

Figure out the dose and schedule.

And when we learn as we get close to that I think then we will activate the leukemia part of the study for now the focus is on.

On solid tumors, and lymphomas, which we successfully grouped together in.

In the <unk> trial as well it turned out to be a good idea and we're doing it in the $1 40 program as well.

Yeah.

Okay. Thank you so much I'll get back in line.

Thank you. Thank you.

Once again that is star one to ask a question.

Our next question will come from Jonathan Aschoff with Roth Capital Partners.

Thank you guys I was wondering if you could help us understand what conferences, we might be seeing some data at things, where you put a placeholder abstract or something that makes you reasonably sure we'll have stuff that where those conferences.

Hello, Jonathan I think you were asking a question about whether we have plans to present data at upcoming conferences is that correct yes.

Which ones in particular, and if you've submitted any place holding abstracts or had any other reasonable surety that we will see data at that or those conferences.

Right, we have submitted an abstract at an upcoming medical conference and oncology. This is later in the year.

We do not know yet if our abstract was accepted.

As you may be aware there are various conferences that have different rules about updating placeholders.

Placeholders anymore. Some due at this point do we expect to provide updated data sometime in the middle of the second half.

Probably after R&D day as to when the abstract was accepted and that will fall off a horse sense. When it's when it's available to fall on some vessels, but they will be at least one presentation. If accepted this year.

Okay at least one thank you very much.

Thank you.

Yeah.

Once again that is star one to ask a question.

Alright, we have no further questions at this time I would like to turn the call back over to Mr. <unk> for any additional or closing remarks.

Thank you operator, and thank you everyone for joining cycle ourselves second quarter earnings call.

We're excited by far the safety Tolerability and observations of anti cancer activity in the ongoing solid tumor study and the momentum of enrollment.

We anticipate building even more momentum as the father of solid tumor trial advances along with the other two clinical stage programs.

They they would have generated thus far would not have been possible without the support of our dedicated physician collaborators and their teams and above all the patients and their families.

Our mission that cyclists Atlas to develop innovative therapies that address some of the most difficult to treat cancers.

We look forward to providing further updates on our progress in the second half of the year.

Operator at this time you may end the call.

Ladies and gentlemen, this does conclude today's teleconference and webcast. We appreciate your participation and you may disconnect at any time.

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