Q2 2023 Cyclacel Pharmaceuticals Inc Earnings Call

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Good afternoon, and welcome to the fact with sell Pharmaceuticals second quarter 2023 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 the opportunity.

<unk> to ask questions. If you would like to ask a question at that time. Please press star one on your telephone keypad. If at any point. Your question has been answered you may remove yourself from the queue by pressing star to impose on your questions. We ask that you. Please pickup your handset to allow optimal sound quality 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.

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 like with solid financial results and business highlights for the second 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 provision of the private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act.

With 1934 as amended.

I set forth in our press release.

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

Our Form 10-Q and 10-K.

All of our projections and other forward looking statements represent our judgment as of today and so it goes down it does not take any responsibility to update such information.

With us today.

Our spirit Bombardier.

President and Chief Executive Officer.

Paul Mcdonough.

Executive Vice President Finance and Chief operating Officer.

Dr Mark Kirshbaum.

Senior Vice President and Chief Medical Officer.

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

Mark will provide details on Microsoft clinical programs.

And Paul will provide financial highlights for the second quarter of 2020 to be which will be followed by Q&A session. At this time I would like to turn the call over to sphere.

Thank you Grace and thank you everyone for joining us today for our course I lead business update Bo.

Both clinical programs with fraud, recyclable or five drugs and plug on search and our plug though are progressing well.

And we are on track to deliver key data readouts over the coming months.

We expect to report complete dose escalation data with five drive and determination of the recommended phase two dose or our b to D.

And in the plug those study dose escalation data and further elucidation of its novel epigenetic mechanisms.

In the hard drive 065 Dash 101 study in patients with solid tumors and lymphoma. Our immediate task is to determine the recommended phase two dose or a b to D.

And we're very close to achieving this goal.

Pharmacokinetic and Pharmacodynamic data from the initial patients at this dose level suggest that we are achieving level above the predicted target engagement levels on our daily dosing.

In addition to choosing our b to D.

Another parameter that may increase the chance of success in phase two.

The selection of the histology is in which we may expect to see anti cancer activity.

As previously reported we have seen Prs and stable disease in patients with T cell lymphoma.

Women's cancers, including cervical endometrial and ovarian.

And also pancreatic cancer all on father a monotherapy.

Okay.

Our phase two sites have been selected with this in mind and Theyre ready to participate once would declare RP two D and elect to start the phase II proof of concept or POC stage of this study.

Clinical data from this open label P. O C stage will be reported as they become available.

Based on the totality of data collected to date, we believe that five draws CDK to slash nine profile is differentiated from other molecules in its class in terms of safety and anti cancer activity reported thus far.

Of note.

<unk> recently disclosed that after a strategic portfolio prioritization. They have discontinued three clinical trials over there a Z D. Four 573 candidates.

Hazy, the four or 573 is a city canine inhibitor administered intravenously once a week.

We believe that continuous pressure on CDK to and see the canine targets is required to enable apoptosis.

Accordingly far draw is a CDK to nine inhibitor administered by oral tablets on the daily schedule.

Let us now turn to plug though.

We are very excited that bogo could emerge as a P O K one inhibitor with novel epigenetic activity.

And 148 Dash 101 study we are evaluating claw go in escalating doses now at dose level five.

As a treatment for patients with advanced solid tumors and lymphoma.

Plug power has shown early signals of anti cancer activity at low concentrations in patients with adenoid cystic carcinoma.

Biliary tract, non small cell lung and ovarian cancer.

Our preclinical program aiming to elucidate glow goes differentiated biologic our profile has revealed novel epigenetic activity at low concentrations.

If further data corroborate these findings well may enroll in the future one or more patient cohorts selected on the basis of specific biomarkers.

I will now turn the call all votes of Dr. Mark Kirshbaum, our Chief Medical officer to provide details on recent clinical data Mark.

Yeah.

Thank you Spiro, that's you've heard most of the Fargo and Pogo clinical programs, our crewing well alright important stages in their respective studies regarding sabra, we were completing enrollment at dose level six eight and expect to shortly select the RP. Two D of note. We are now dosing of all patients using the oral tablet form of <unk>.

Padre, which may eventually support the commercial launch.

I would like to summarize what we've seen recently in the 065 101 study the patient with heavily pretreated endometrial cancer and dose level six eight is documented tumor shrinkage after one cycle and is ongoing.

We previously reported that two out of three patients with T cell lymphoma achieve P R, including a patient with very aggressive angio immunoblastic form of peripheral T cell lymphoma or <unk>.

13 of 19 patients with cervical endometrial liver and ovarian cancer achieved stable disease with.

Target lesion reductions as their best response.

Pancreatic patient maintained stable disease for five cycles of treatment.

He's a promising responses for this stage of clinical testing and may predict deeper responses in phase two.

The major Texas cities, we have seen thus far continue to be nausea, and hyperglycemia, which were manageable and reversible.

The primary objective of the phase two stage default determination of RPT D is to assess side was activity and safety in relevant tumor types. The.

The design of this registration directed study allows us to recruit different tumor types indiscreet cohorts each running in parallel and independently of each other.

Let's now turn to <unk>, our oral P. L. K one inhibitor in the $1 40, 101 study of <unk> in patients with advanced solid tumors and lymphoma, we have observed intriguing clinical activity at these early low dose concentrations given continuously.

These included stable disease at dose level, one and two patients with non small cell lung cancer for eight cycles in ovarian cancer for five cycles at dose level, two and a patient with biliary tract cancer for three cycles and it does level four in a patient with adenoid cystic carcinoma for three cycles.

We are currently enrolling dose level five no ftes have been reported thus far.

Preclinical data have shown that Pogo hasnt had a genetic mechanism term epigenetics refers to the way self control gene activity without changing DNA sequence the.

Approved drugs with epigenetic mechanisms such as histone Deacetylase inhibitors of HEICO misleading agents typically work at low concentrations.

As opposed to chemotherapy and other traditional forms of cancer therapeutics.

We are actively investigating this potential epigenetic mechanism in the preclinical setting as well as in our clinical correlative studies.

The $1 41, and one study is designed to target several important tumor types, where preclinical models and biology suggest possible single agent activity.

These include colon lung cancer and lymphoma.

The study is designed to efficiently evaluate both dosing schedule to optimize our P. T D for the proof of concept or cohort stage of the study.

We look forward to updating you as we progressed, our evaluation of Sabra and <unk>.

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

Thank you Mark.

As of June <unk>, 2023, cash equivalents totaled $10 $2 million.

Compared to $18 3 million as of December 31st 2022.

Net cash used in operating activities was $8 2 million for the six months ended June 32023, compared to $8 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.

However, the operating plan includes discretionary expenditures.

Which if not incurred could extend our liquidity requirements into the second quarter of 2024.

Research and development or R&D expenses were $4 7 million for the three months ended June 30 of 2023 and.

As compared to $4 2 million for the same period in 2022.

R&D expenses relating to Farnborough with $3 million for the three months ended June 30th two.

2023 as.

As compared to $2 6 million for the same period in 2020 to incur.

Increased non clinical expenditures.

R&D expenses related to Plough go well $1 4 million for the three months ended June 30th 2000 <unk>.

Three as compared to $1 5 million for the same period in 2022 clinics.

Clinical trial cost associated with the progression of the 140 101 study.

General and administrative expenses for the three months ended June 30th 'twenty to 'twenty, three and 2022 remained relatively flat at $1 6 million.

Total other expense net for the three months ended June 30 of 2023 was <unk> 1 million compared to an income of <unk> 2 million for the same period of the previous year.

United Kingdom Research and development tax credits for the three months ended June $32023 6 million compared to $1 million for the same period over the previous year.

Due to a decrease in the tax credit rate that took effect in April of this year.

Research and development tax credits are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended June 32023 was $5 4 million compared to $4 6 million for the same period in 2022.

Operator, we are now ready to take questions.

At this time, if you would like to ask a question. Please press the star and one on your telephone keypad.

You may remove yourself from the queue at any time by pressing star to once again that is star one to ask a question, we will pause for a moment until allow questions to queue.

Our first question comes from AHU Demir Lindenberg.

Hello, and thank you very much for taking my question, Steve on our site first one would be given the recent developments in knees in the <unk> field. This weeks could you elaborate more on the differential profile of Pogo compared to other PD. One inhibitors I know mechanical question will be disclosed later in time, but just curious.

However, much you can disclose.

<unk> mentioned some details to us.

Thank you for your question Oh, that's an excellent question. There are two clinical stage P. L. T. One inhibitors as you mentioned the difference between placebo and the other candidates is that that we have in it the genetic mechanism as evidenced by cross reactivity with B I D for <unk>.

Alidade epigenetic target was that a molecule does not.

Very importantly, our molecule has resumed single agent activity would you have seen in several patients at.

At the same time, we believe that the molecule has never been tested in a single agent protocol. It's always been tested in combinations lost to the developments of this week relates to a change in clinical trial plans without the molecule and frontline though.

Colorectal cancer is it certainly got cancer of interest to us as as they put down sorry kiosk mutation, but that is only a part of the story that will emerge when we disclose the full details of logos epigenetic mechanisms.

The last point that perhaps answer to consider here is that both of these drugs are given oddly we have a potential best in class horsefly around 11 hours versus about 24 without the molecule. We believe both molecules have a chance to make it to market.

I'll leave on different indications based on the very different biological functions.

Thank you Spiro and then follow up question would be what are there any indications that you see a greater efficacy all plug all they will go then you try in the clinical trial.

While it's still early days as I think Mark reported we have seen activity in four different tumor types and about that doesn't arcella patients. So far are these adenoid cystic carcinoma, obviously non small cell lung cancer, which is very exciting given the importance of this market of any oncology new drugs and also.

In ovarian and biliary tract cancers, so women's cancers remain of great interest to us for the reasons that we have seen before in this class as is the potential for activity in lung you have not had any colorectal patients that are also far that may change and that of course will change. Our picture. We believe also bladder cancer is sensitive to PLT wanted.

In addition, and possibly a triple negative breast. So it remains as it started to unfold but of course, what main matter here is that if the epigenetic mechanisms Fargo is fully corroborated when could be able to enrol mutations they selected patients in other words choose patients based on the mutation, but he is driving the tumor.

And then all of a specific cohort with this type of patient profile that can sometimes be tumor agnostic, regardless of the tumor tissue in which the tumor originated when I put that all patients only because that the mutation more of that in the next quarters as the story as far as that unfolds.

Makes sense and my last question will be when should we expect any efficacy data from any of the programs. Todd dollar plug already then what is the timeline look like.

Well the first report, but we.

Mention would be the full phase one resolves for far draw in the <unk> five Dash 101 study of this should come by the end of this year, possibly a bit sooner.

You should be aware that the extensive preclinical data are being worked on by collaborators a cycle of selling the company itself that will complete the story of Hydra as it unfolds in the clinic prior to US beginning phase two which we're ready to go at this moment as soon as the last patients complete follow up and thinking yourself logo, we will disclose the mechanism.

At the end of this year, we expect data.

The summer but of course, we need to have additional confirmation bias Atlas a sponsored studies, which are in progress and expect to have the first clinical results from Florida. Early next year conservatively, assuming will take us at least two or three more cohorts because other companies dose escalation. So both of these products will have a beta slow over the next two to four.

Four quarters.

Sounds good. Thank you very much for answering my questions.

Thank you all.

Our next question comes from Jeff Jones Oppenheimer.

Good afternoon, guys and thanks for taking the questions.

Just a couple of follow ups to.

On a spot draw.

I just wanted to confirm.

For that dose level six eight that you need to call your RP T D.

Do you have.

Six patients enrolled at this point and how long.

Does it take from enrollment to be able to call RP Tuesday, and then from there.

What is the timing look like to start the phase two POC study.

Thank you for your question Geoff So let me ask Dr correspond to answer the first part of the question Mark and then I'll come back and talk about since to what my completes his response to your questions.

Sure.

We have the last few patients are consented and.

I expect it to start.

Any day now.

Yes.

So at that time.

<unk> achieved a pizza Denmark.

Well the last time I'll follow up a protocol that's F S. So technically.

The the.

The DLP periods is one cycle so.

If they get through one month.

Safety, we can you could declare it.

We will still be following them for activity, obviously, one month would be early for that.

But the safety part of it is 20 days.

Okay. Great. Thanks, Thank you Mark Jeff to your second question with whenever were ready to start phase II. Obviously, one prerequisite is exploration of RP two D. As Mark explained the other one is corporate initiatives underway to pursue both our balance sheet and strategic options available to the company right.

Now, we obviously face a challenging capital markets environment, but there's a lot of them in.

In both of our drug with the companies.

Thoughts on just that whole car arbuckle create stockholder value. So all of these parameters play into the decision to stop the phase two and that's explained in his section of the prepared remarks.

Something that our board will make the world's best Q3.

Okay great.

Just one follow up you mentioned presenting the data on the dose escalation and Thomas solid tumor patients.

So the totality of the phase one data towards here and are you thinking about that at a conference or a company sponsored event to walk through all of that data how are you thinking about that.

Okay.

Wed like to do.

[noise] above obviously friends deadlines.

Past us for some of our friends at year end like on Telemundo.

While I have you.

Therefore, we will have to cause company announcements sourced.

Submissions were already planned for.

Great. Thank you very much guys and congrats on the quarter.

Thank you.

Our next question comes from Kemp, Oliver Brookline capital markets.

Great.

So with regard to discretionary spending given where you are with the likely timing of data and your resources and what's the dollar amount of discretionary spending you're talking you're thinking about when you talk about extending the runway into second quarter.

I think this one is for Paul Thank you Ken.

Thank you Ken Thanks.

I think that the what we would look at clearly.

Is uncommitted expenditure at the moment.

And that's what we referred by discretionary I think the important fact is that by limiting some of that uncommitted spend it allows us to bring in in the early part of 2024.

About three and a half million dollars all of the U K R&D tax credit.

That's a significant cash flow into the company, which allows us to then.

Extend into that Q2 2020 full number that I mentioned in our prepared remarks.

Got it.

And.

Not yet.

Focus too much on this but.

<unk> still looks like the more interesting program over <unk>. If you had to make a choice is that fair.

And that is a fair question almost as far as asking of patents, which of the two children. They lack the most it's definitely the most advanced and has the most clinical data and its an active compound with an excellent safety record as well.

In my prepared remarks, we had actually two competitors, who seem to have lost momentum if not terminating programs and the next generation of CDK seal and are hoping and increase hydro scarcity value.

So exit value for stockholders.

As I mentioned of your question, Kevin that we should bring it to the attention of investors that there is a lot of interest in these compounds from strategics.

And that interest can manifest itself in various corporate developments as well as alignment obviously, we need to explore those in due course in parallel to other initiatives and that will dictate which molecule could come forward. The fastest example, visa work just theoretically out license five dravo could develop logo.

Non dilutive funding coming from Fargo, while the opposite.

Barclays. The Cam as excited as we are about the mechanism of action of plug or the inverse would happen and therefore non dilutive capital from cargo transactions could support Fabra. So we are committed to taking both drugs forward at this time given that the spend is relatively modest to get to the end of phase one for gogo and to get cadre phase II ready. So I hope you understand.

The company is exploring all available avenues to maximize stockholder value in this difficult time in the capital markets.

Yes, that's clear thank you.

Thank you for your questions Ken.

We have no further questions in the queue at this time I would now like to turn the call back over to today's speakers.

Thank you very much operator, and thank you everybody for joining us today.

Courtney.

Earnings call.

Both of our programs are approaching important catalysts with a strong competitive profile in the therapeutic classes.

As a reminder, our upcoming key milestones for 2023 or <unk>.

Report final data from dose escalation stage and RP to determination from the 065 Dash 101 study of oral <unk> in patients with advanced solid tumor cell lymphoma.

First patient dosed with all cadre in phase two proof of concept study of.

065, that's 101 in patients with advanced solid tumors and lymphoma.

Report phase one data from 140, 101 study or a placebo in patients with advanced solid tumors and lymphoma.

And elaborate novel mechanism of action of club.

We look forward to providing you with further out.

I hope to meet some of you at upcoming conferences.

At this time you may end up.

Yes.

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

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