Cyclacel Pharmaceuticals Q1 2023 Earnings Call Transcript

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May 11, 2023

There are 7 speakers on the call.

Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2023 Results Conference Call and Webcast. Please note today's call is being recorded. I would now like to turn the conference call over to the company.

Speaker 1

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the Q1 of 2023. Call. Before turning the call over to management, I'd 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 21E of the Securities Exchange Act of 1934 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 Securities and Exchange Commission, which include, among other things, on Form 10Q and 10 ks. All of our projections and other forward looking statements represent our judgment as of today, President and Chief Executive Officer Paul MacBaren, Executive Vice President, Finance and Chief Operating Officer and Doctor.

Speaker 1

Mark Kirschbaum, and webcast, Senior Vice President and Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Presentation. Mark will provide details on Cyclacel's clinical programs and Paul will provide financial highlights for the Q1 of 2023, Call, which will be followed by a Q and A session. At this time, it's my pleasure to turn the call over to Spiro.

Speaker 2

Thank you, Grace, and thank you, everyone, for joining us today for our quarterly business update. We are on track to deliver key data readouts over the coming months from our 2 clinical programs. In the SANDRA 65-1 hundred and one study in patients with solid tumors and lymphoma, we are enrolling at dose level 6A. Webcast. Pharmacokinetic and pharmacodynamic data from this dose level suggest that we are achieving predicted target engagement levels on continuous dosing at the higher level.

Speaker 2

Choosing the optimal dose schedule is one of many parameters to increase the chance of success in Phase 2. Among others, correlative analysis and translational data can confirm whether the observed drug effects are on mechanism together with learning on how to deal with toxicities webcast observed in early development. At this point in the program, we feel encouraged that our clinical observations support Sadra's presentation. The Phase 2 proof of concept or POC stage will consist of multiple cohorts defined by histology. We expect that cohorts may enroll at different rates.

Speaker 2

For example, it is possible that the fastest ones will be those in which we have already seen anticancer activity during the dose escalation stage. 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 pancreatic cancer, webcast. Clinical data from this open label POC stage will be reported as they become available. Or a strategic exit, preparing the commercial drug product or DP is often kicked down the road to be dealt with by the next owner of the asset. Such an election can have a profoundly negative impact on valuation as the timelines to launch become apparent to the licensee or purchaser.

Speaker 2

Mindful of these matters, The Cyclacel team has been proactively investing in a tablet formulation of HADRA to replace the capsule is currently used in clinical trials. A tablet VP has further advantages to capsules in terms of patient convenience and increased compliance. As a tablet webcast. With that, our VP of Fadra has recently become available, he will treat a few patients with it within the Phase 1 part of our ongoing 65-1 hundred and one study. We will provide further updates on this project as they emerge.

Speaker 2

Let us now turn to PLOGO. In our 140 WES-one hundred and one study, we are evaluating PLOGO in dose escalation stage as a treatment for patients with advanced solid tumors and lymphoma. We are currently dosing patients at dose level 4. Lobo has previously shown early signals of anticancer activity at low dose levels in patients with beta retract, has also demonstrated an epigenetic mechanism of action. This property may lead to a biomarket driven clinical study in the future.

Speaker 2

Over the coming months, we expect key data readouts from the Phase III studies of FADRA and PLOGO. We expect to report complete dose escalation data with FADRA followed by initial data from the FADDL Phase 2 POC stage, which is expected in the second half of twenty twenty three. Dose escalation in the PLOGO study continues and we expect to report initial data in mid to late 2023. We believe that our medicines are differentiated from other molecules in their respective class with properties which may be best in class. Call.

Speaker 2

I will now turn the call over to Doctor. Mark Kirschbaum, our Chief Medical Officer to provide details on recent clinical data. Mark?

Speaker 3

Thank you, Spiro. As you heard, both the fibrocyclib and flogocirid clinical programs are progressing well and are at important stages in their respective studies. Regarding FOGRA, we are currently treating patients at dose level 6A, which is the final dose level as outlined in the 65,101 protocol. In preparation for the upcoming start of Phase 2, we are now introducing a tablet form into this dose level. As we have reported, 2 out of 3 patients with T cell lymphoma achieved PR, including a patient with a very aggressive angioimmunoblastic form of peripheral T cell lymphoma.

Speaker 3

11 of 15 patients with cervical, endometrial, liver and ovarian cancers achieved stable disease with target lesion reductions as their best response. A pancreatic patient maintains stable disease for 5 cycles of treatment. Europe and Asia are now open. Together with our 4 Phase 1 sites, around 10 centers are ready to participate in the proof of concept stage in what will be a global study. The primary objective of the upcoming Phase 2 stage is to assess Fabry's activity and safety in relevant tumor types.

Speaker 3

Webcast. The design of this registration directed study allows us to recruit different tumor types in discrete cohorts, each running in parallel and independent of each other. Let's now turn to our second program with filgocertib, our oral PLK1 inhibitor, currently in 140,101, a Phase III study in patients with advanced solid tumors and lymphoma. Published for clinical evidence suggests that low dose continuous administration may be an effective strategy for PLK1 inhibitors as well as Standard High Dose Pulse Type Strategy. In 140,101, we have observed intriguing clinical activity at the lowest doses of total given continuously.

Speaker 3

Call. These included stable disease at dose level 1 in 2 patients, one with non small cell lung cancer for 8 cycles and one with ovarian cancer for 5 cycles respectively and at dose level 2 in the patient with biliary tract cancer for 3 cycles. We are currently enrolling at dose level 4 and have seen no SAEs thus far. We are conducting a comprehensive preclinical program to elucidate this novel mechanism of action of Plogo and expect to report additional preclinical data later this year. Webcast.

Speaker 3

What we can say at this point is that Plovo is an active BRZ4 inhibitor and there appears to be a broader epigenetic story. 14101 is designed to target several important tumor types where preclinical models and biology suggest single agent activity, call, including colon cancer, lymphoma and small cell lung cancer among others. Our study is designed to efficiently evaluate both dose and schedule with the FDA to optimize RP2D for the proof of concept or cohort stage of the study. We look forward to updating you as we progress our evaluation of SVODREN implogo. I will now turn the call over to Paul to review our Q1 and financial results.

Speaker 4

Thank you, Mark. Last week, we announced receipt of £3,900,000 or $4,700,000 as a research and development or R and D tax credit from HMRC, the tax agency of the United Kingdom. The tax credit is for R and D costs incurred during the year ended December 31, 2022, and is the amount disclosed on the income tax benefit line of the statement of operations. This R and D tax credit is an important source of non dilutive capital and we anticipate receiving the 2023 tax credit in early 2024. Pro form a cash and cash equivalents totaled $16,100,000 presentation comprised of the R and D tax credit of $4,700,000 and cash and cash equivalents as of March 31, 2023 call of $11,400,000 Cash and cash equivalents as of December 31, 2022 was 18,300,000 webcast.

Speaker 4

Net cash used in operating activities was $6,900,000 for the 3 months ended March 31, 2023, compared to $6,800,000 for the same period of 2022. The company estimates that its available cash will fund currently planned programs into the Q1 of 2024. R and D expenses were $5,700,000 for the 3 months ended March 31, 2023, as compared to $5,000,000 for the same period in 2022. R and D expenses relating to fibrocyclib were $4,100,000 for the 3 months ended March 31, 2020 3 as compared to $3,600,000 for the same period in 2022 due to increased non clinical expenditures. R and D expenses related to Plogo were $1,400,000 for the 3 months ended March 31, 2023, as compared to $1,100,000 for the same period in 2022 due to clinical trial costs associated with progression of the Phase III study.

Speaker 4

Webcast. General and administrative expenses for the 3 months ended March 31, 2023, 2022 remained relatively flat at $1,600,000 Total other income net for the 3 months ended March 31, 2023 was 0 point $1,000,000 compared to an income of $1,300,000 for the same period of the previous year. The decrease of $1,100,000 for the 3 months ended March 31, 2023, is primarily related to royalty income received in the prior year. Net loss for the 3 months ended March 31, 2023 was $5,800,000 compared to $4,100,000 for the same period in 2022.

Operator

Our first question comes from Ahu Damir with Ladenburg Thalmann.

Speaker 5

Good afternoon. Thank you for taking my question and congrats on the Development. I just have two questions. First one is on the eficasitron. What are we expecting to see in terms of data from both ADRA and PLK1 programs.

Speaker 5

In terms of number of patients, what can you tell us in terms of expectations what we are expecting to see.

Speaker 2

Hello, Rahul. Thank you for your question. I think we should, Consistent as we have been saying for some time now, report data from the Phase 1 study of FADRA, the And the sample size would be around 25 patients, assuming that enrollment continues as we have seen up to now. We should be reporting both our recommended Phase 2 dose decision as well as PK and TD analysis, in particular on the relevant protein targets from webcast, as well as some translational data that has been generated by both the company and collaborators. For Plogo, we think the initial data set will appear towards the Q4 of this year, perhaps a little bit earlier, but that depends on enrollment.

Speaker 2

We're still on dose level 4, so a bit over halfway in the protocol and enrollment remains robust. So it could surprise to the upside, but we think conservatively 4th quarter. Finally, we expect to report initial data from the Phase II cohorts of FADRA or 65,101, probably towards the end of the year. That, of course, depends on which cohorts are rolled first. Webcast.

Speaker 2

It's consistently expected that those that have seen previous activity, which are the lymphoma cohorts in women's cancers, will enroll first. So these are the likely data sets will report this year.

Speaker 5

Thank you. Very helpful. My second question is on the Could you maybe comment on the safety profile of the patients you have been treating? Is there anything that's taxes. How does it look in terms of the safety front?

Speaker 2

There is a question for Mark. Mark, would you like to take this?

Speaker 3

Yes, sure. So we've previously disclosed the we had incidents of hyperglycemia in patients who had underlying issues with Sugar Control in the past. Those have been well treated with insulin and other such treatments. That may be an on target effect of the same way that it's active in the women's tumors and other such things. And we have we had a bit of an issue with nausea, which we believe the introduction of the tablet may abrogate.

Speaker 3

In other words, the dose that we the safety of this drug was even more than we anticipated and we got the higher doses than we initially has conceived, so we were giving a lot of capital. So now with the introduction of proper tablets, we think that will be resolved. But other than that, we have on FODRA, we have no other consistent SAEs of of high grade or even low grade frankly. And with the PLK1 that the doses that we are at now, we have not seen any SAEs at all. So both drugs are doing very nice on the safety front.

Speaker 5

Thank you, Mike. Thank you, Shapiro.

Operator

Our next question comes from Shubhindhu with Synroy with Brookline Capital Markets.

Speaker 6

Hi, I'm Shubhindhu for Kempe. Regarding the 140 program, I was wondering if you could elaborate on the dosing schedule. Currently, you are in dose level 4. How are you planning to escalate? Thank you.

Speaker 2

Thank you for your question, Shubhrantu. This is another one for Mark.

Speaker 3

So overall, without getting deep into the biology and what's going on now. We have we're actually studying 2 dosing schedules at each dose at the same time, which are testing more or less of a pulse type schedule, which was the classic way of doing these drugs, but the new science seems to suggest that low dose continuous treatment may be even more efficacious as we've mentioned. So, this science is being confirmed in a lot of ways. And we believe that this may provide a more a good way of treating multiple tumor types in a safe way. So these are the we'd escalate both of these in an alternate fashion as we go into higher doses of webcast.

Speaker 6

Okay. Thank you. And with 140, what are your thoughts about maybe possible combinations with target therapies like BRAZSTRAB inhibition or maybe even immunotherapies.

Speaker 2

Again, there's a question for Mark, please.

Speaker 3

Yes. I believe that's an excellent question. It's a little early to disclose all that. I can tell you that we're Aggressively pursuing all of these fronts in our preclinical work. So we have a very deep profile of preclinical work with major investigators looking at many of these possibilities.

Speaker 3

I'll say is that what we're able to do with this low dose continuous dosing is really sensitize a lot of types of therapy without incurring

Speaker 2

Thank you, Mark. Perhaps I could add some further color to Mark's commentary. In one of the cases webcast. I mean, combinatorial strategies with plobasertib, the drugs that we're combining with are in an approved class, that gives us a lot of degrees of freedom to combine with possibly even address some of the toxicities of the approved drug by titrating. So we are optimistic at this stage, but of course, we need to, 1st of all, prosecute our strategy, which is to find whether onforty, progosertib has single agent activity.

Speaker 2

As you may recall, Shubhendu, this could lead us potentially to registration strategy rather efficiently. If not, then combinations will become the order of development. But these things need to happen in that order, not simultaneously.

Speaker 4

Very useful. Thank you so much.

Speaker 2

Thank you, Fernando.

Operator

Thank you. At this time, there are no further questions in queue. I'll turn the call back over to Mr. Ram Bothas for any additional or closing remarks.

Speaker 2

Thank you very much, operator, and thanks to all of you for joining Cyclacel's Q1 earnings call. Both our programs are approaching important catalysts with a strong competitive profile in their respective classes. As a reminder, Our upcoming key milestones for 2023 are: report final data from dose escalation stage presentation RP2D determination from the 65-one hundred and one study of oral FADRA in patients with advanced solid tumors and lymphoma. 1st patient dosed with oral FODRA in Phase II proof of concept stage of O65-one hundred and one study in patients with advanced proof of concept stage of OZYNSKI-one hundred and one study of oral FODRA in patients with advanced solid tumors and lymphoma. We look forward to providing you with further updates and hope to meet some of you at upcoming conferences.

Speaker 2

Operator, at this time, you may end the call.

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Earnings Conference Call
Cyclacel Pharmaceuticals Q1 2023
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