Q3 2023 Cyclacel Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to this like the cell Pharmaceuticals third quarter 2023 results conference.

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I would now like to turn the conference call over to the company. Please go ahead.

Good afternoon, everyone and thank you for joining today's conference call to discuss its like yourselves financial result, and business highlights for the third quarter of 2023.

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.

Private Securities Litigation Reform Act of 1995 and section 20 money.

Curious exchange of 1934.

Yeah.

As set forth in our press release.

Forward looking statements involve risks and uncertainties that may affect the company's specific prospects, including those discussed in our filings with the Securities Exchange Commission, which include among other things our forms 10-Q and 10-K.

All of our projections and other forward looking statements represent our judgment as of today.

Microsoft does not take any responsibility to update such information.

With us today are spiro.

President and Chief Executive Officer.

Paul Mcdonald Executive Vice President.

And Chief operating officer.

And Dr Mark Kirschbaum.

Senior Vice President and Chief Medical Officer.

Spiro will begin with an overview of our business strategy and progress.

Mark will provide details on insecticides clinical programs.

And then Paul will provide financial highlights for the third quarter of 2023, which will be followed by a Q&A session.

At this time I would like to turn the call over to Spiro.

Thank you Grace and thank you everyone for joining us today for our quarterly business update.

Both of our clinical stage cell cycle programs with hard recycle LIBOR far draw.

And plug all started our program are.

We are progressing well.

We expect to shortly reports complete dose escalation data we saw a drop in.

And the determination of the recommended phase two dose or RP two D to be used in subsequent studies.

We also expect to report interim dose escalation data from the Pogo study and disclose preclinical data supporting its novel epigenetic mechanisms.

Bose So far drive logo have demonstrated single agent anti cancer activity.

With all of our drugs, we have observed complete response partial response and stable disease in patients across a number of solid tumors and lymphoma with good tolerability.

Okay.

With all of the Pogo, we have seen stable disease in several patients with various solid tumors at low dosing levels.

Which is normal for this class of medicines.

We believe that based on the innovative properties and demonstrated clinical activity both for dry and Togo has the potential to be best in class in their respective classes.

Based on encouraging results in the Fabry program, we have implemented a capsule to tablet switch with patients now receiving the more convenient tablet form of the drug.

We expect that the tablet is more convenient for patients and reduces the burden of taking many capsules by a mouse.

As the tablets would ultimately be used in a commercial put up with sabra if it reaches the market. The switch also represents strategic value to an acquirer or a licensee.

At the present time small cap biotech companies are not in favor by the investment community.

However, the cyclists L team how's it been hard at work building pharmaceutical value for the long term.

This is a tested by the enthusiasm demonstrated by our clinical investigators across the globe.

And their interest in doing preclinical work.

And offering our medicines as clinical trial options to patients in their care.

By developing two innovative high value medicines, both of which were discovered by think Lasalle, we hope to offer our stockholders the opportunity to realize strategic value.

I will now turn the call over to Marc to review, our progress and the father Brown logo studies and discuss some of the clinical results.

Mark.

Thank you Spiro.

And the 065 101 phase one two study with <unk>, we have enrolled 26 patients so far.

<unk> has been well tolerated and anti cancer activity has been observed including P. R and two out of three T cell lymphoma patients treated and stable disease in 15 solid tumor patients.

Of these 15 patients four out of forehead, gynecological cancers, including endometrial ovarian cervical two out of two cholangiocarcinoma biliary tract cancers, two out of two hepatic cellular two out of two cross state one out of two head and neck.

One out of one pancreatic and one out of one colorectal cancer.

<unk> has a unique activity profile inhibiting both CDK to empty the canine, which together complement one another leading to enhanced anti tumor activity compared to your the CDK to already see the canine alone.

We have been able to maintain continuous inhibitory pressure on the tumor cells with twice daily dosing five days a week without hematologic toxicity at the current dose level.

We have one patient away from completing the dose escalation segment of the study and expect to declare the RP two D. Shortly.

We are also studying the PK and PD results and have identified mutational in molecular patterns on Ngls and RNA seek that may be predictive of clinical activity.

This exciting data May guide patient selection for the phase two segments of the study.

The mutational profile, we had identified as frequently observed in many large tumor populations.

The design of the 065 101 study provides for a rapid transition to phase two and the opportunity for multiple catalyst through 'twenty 'twenty four leading to registration pathways. As a reminder, the protocol provides for seven independent cohorts by tumor type and in a basket cohort defined by relevant biomarkers.

We've added major clinical sites in the U S and one more overseas to our current phase one sites in order to rapidly achieve our enrollment objectives.

Let us now turn to L. P. L. K one inhibitor program. We are very excited that <unk> has emerged as a new oral P. L. K, one inhibitor with novel epigenetic activity when given continuously at low doses.

And now at 140 101 study, we are evaluating logo and escalating doses as a treatment for patients with advanced solid tumors and lymphomas.

We have enrolled 14 patients so far currently enrolling dose level five.

Dose levels, one through five plug those administered once daily by mouth for five consecutive days either for two weeks out of three or three weeks out of three.

With this novel dosing approach leaves observed anti cancer activity in patients with biliary tract non small cell lung ovarian and other tumor types with no drug related SAE is thus far.

And have a preclinical program we have identified that logo acts through a novel epigenetic mechanism. This epigenetic activity. They are a crucial role in the presence of certain common tumor mutations patients carrying these mutations are frequent in several large tumor populations.

Following these findings we have entered into scientific collaborations with major global research centers to help further characterize this novel activity of logo and define the tumor subsets that will benefit the most from this approach.

As additional data corroborate. These findings we may enroll in the future, possibly as an expansion of our current phase one two study one or more patient cohorts, specifically selected on the basis of such Biomarkers.

I will now turn the call over to Paul to review, our second quarter and financial results.

Thank you Mark.

As of September 30 is 2023 cash equivalents totaled $5 9 million compared to $18 3 million as of December 31st 2022.

Net cash used in operating activities was $12 2 million for the nine months ended September 32023, compared to $15 7 million for the same period of 2022.

The company estimates that its available cash will fund currently planned programs through the end of 2023.

The operating plan includes discretionary expenditures, which if nothing could and taken together with the anticipated receipt of research and development tax credits of approximately $3 $1 million in the first quarter of 2020 full could expand available cash into the second quarter.

Research and development or R&D expenses were $5 2 million for the three months ended September 32023, as compared to $4 4 million for the same period in 2022.

R&D expenses relating to Farnborough with $3 6 million for the three months ended September 30th 2023, as compared to $2 5 million for the same period in 2022 due to increased costs associated with manufacturing scale up and introduction of the tablet form.

R&D expenses reacts to plough go well $1 5 million for the three months ended September 30th 2023, as compared to $1 7 million for the same period in 2022.

General and administrative expenses for the three months ended September 32020 316 million.

As compared to $2 1 million for the same period in 2022 due to a nonrecurring professional fees a point 4 million last year.

Total other income net for the three months ended September 32023 was <unk> 1 million.

Third to an income of <unk> 4 million for the same period of the previous year.

United Kingdom Research and development tax credits for the three months ended September 32023.

6 million compared to 1 million for the same period of the previous year.

The decrease is due to legislative changes that took effect in April 2023, which reduces the amount of tax credit which could be claimed.

The R&D tax credits are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended September 32023, with $6 1 million.

Compared to $5 1 million for the same period in 2022.

Operator, we're now ready to take questions.

Thank you at this time, if you would like to ask a question. Please press the star key followed by the Whangee on your telephone you.

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

Once again that is star one to ask a question.

We will pause for a moment to allow questions to queue.

Again that is star one.

Our first question comes from AHU Demir.

Ladenburg Thalmann.

Good evening. Thank you so much for taking my questions I have three questions first one is regarding the biomarker studies.

What type of Biomarkers like the novel targets or are they known Biomarkers that we have seen before and then do you plan to disclose and report on the biomarker study.

Thank you for your question well these are known Biomarkers in terms of a theater and saw.

Nextgen sequencing scams and past reports and so forth. However, there are novel for the CDK class. We believe we have made a discovery that has not been reported previously for this class and we think that there is a sufficient.

Sufficient clinical support for this hypothesis to be pursued further in the clinic.

Disclosure should occur as we said when we gave the full phase one update we're obviously, hoping to present this data at upcoming medical meetings and that would be important as far as deadlines that concern as to when we'll make the announcement, but I would expect probably around the end of the year already next year.

Thank you Spiro.

My second question is on the Pogo program.

<unk> aspect is very unique and unlike any other P&L kidney be curious I am curious given that you already dosed 12 patients.

What type of activity do you observe is there anything that is so unique that you see activity in certain indications given the P. Genetics agent targeting so just curious on the clinical activity.

Yes, I think it's a question for Mark who is also an expert in epigenetics Mark.

Well some of it is still a.

A little early to disclose but you know we have been seeing at these low dose levels very prolonged stable disease in a number of very bad tumors.

So you know that lead the search for the mechanism of why this would be happening at these low doses.

And it turns out to be a really interesting story I think there'll be some abstracts and things some things in the near future.

As I said at the disclosure.

<unk> little reveals that.

Sounds good thanks, Mark and my last question is on the slide nine shows Paul It looks like there is an increase as you pointed out on the given the manufacturing and the clinical activity. So curious how much increase are we expecting in the next quarters is the manufacturing going to continue to increase.

Hum how should we model for cats.

No exactly who thanks for the question. So the manufacturing costs was at Spero mentioned as we move from a capsule form to.

To the tablet form so that was the active ingredient manufacturing, which happened in Q3, so that should decline in Q4.

Okay. Thank you so much thanks for taking my questions.

Okay. Thank you.

Okay.

Just a reminder to ask a question. Please press star and one on your telephone keypad.

Our next question comes from Jonathan Aschoff Ross at <unk>.

Thank you hi.

Hi, guys I was wondering if you could say anything about the Sadrists nicolette strategic options that you're looking at can you give us any clarity there has to the level of interest or you know.

What's the real gating factor to moving out a conversation how it works and where it is now.

Thank you Jonathan this is a topic we have discussed before this calls there is strategic interest in Nextgen cdk's and side dress cyclic in particular.

This interest comes from multiple parties at different points in time will have a different hurdle rates.

I think the disclosure in the very near future of the Biomarkers as I mentioned to the previous questioner is an important catalyst that would bring home our muscles and crespo is preliminary.

But now actually we have not only evidence of single agent activity, including CRP or a stable disease, but we also know now, possibly which patient population to target future trials. So I would expect that this will catalyze further strategic interest and we look forward to continue those discussions with relevant parties.

Also lastly, you I don't want to tell us if you're you know.

Finishing off the phase <unk> dose five or six a REIT that's that's it.

Okay.

Well I think it's a question for Mark and then I can come back and give you a bit more color, but mark why don't you take that.

What's your guess about beauty.

Well you know, we're one patient away from finishing six eight so.

I'm, hoping that that will be that will be it we have the data looks very good we have shown it.

You know it seems to be doing what we want those dose level. So I'm, hoping that this last this will conclude and we will be able to formally announce but until then we don't know.

Okay, Hey, Mark there's nothing telling you that you need to get any sort of a slightly different dosing schedule correct no.

Okay.

We're very happy as it stands right now.

We can't say anything until it is complete.

Alright, Thank you very much.

Thank you gentlemen.

Yeah.

Again, if you would like to ask a question. Please press star one now.

We have no further questions in the queue at this time I would now like to turn the call back over to the company for closing remarks.

Thank you operator, and thanks to all of you for joining cyclists house third quarter earnings call.

Both of our programs are approaching important catalysts, such as starting phase II proof of concept stage with a strong competitive profile in the therapeutic classes.

As a reminder, our upcoming key milestones are.

Report final data from dose escalation stage and RP to determination.

From the 065 Dash 101 study.

Water fall drop in patients with advanced solid tumors and lymphoma.

Yes.

First patient dosed with oral <unk> in phase two stage of OS X five Dash 101 study in patients with advanced solid tumors and lymphoma.

Report phase one data from 140 Dash 101 study.

Our optimal got started in patients with advanced solid tumors and lymphoma and elaborate the novel mechanism of action of logo.

We look forward to providing you with further updates and hope to meet some of you at upcoming conferences.

Operator at this time you may end the call.

This does conclude today's program. Thank you for your participation you may disconnect at anytime.

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