Cyclacel Pharmaceuticals Q2 2024 Earnings Call Transcript

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August 14, 2024

There are 5 speakers on the call.

Operator

Please standby. We're about to begin. Good afternoon, everyone, and thank you for joining today's conference call to Cyclacel's financial results and business highlights for the Q2 ended June 30, 2024. 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 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, our Forms 10 Q and 10 ks.

Operator

All of our projections and other forward looking statements represent our judgment as of today, and Cyclacel does not take any responsibility to update such information. With us today are Spiro Rambadis, President and Chief Executive Officer Paul McBaron, Executive Vice President, Finance and Chief Operating Officer and Doctor. Brian Schwartz, Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Brian will provide details on Cyclacel's clinical programs, and Paul will provide financial highlights for the Q2 2024, which will be followed by a Q and A session.

Operator

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

Speaker 1

Thank you, and thank you, everyone, for joining us today for our Q2 2024 business update. We are pleased to report on our progress with the precision medicine strategy for fadrocycline or Fadra, our oral CDK2nine inhibitor, which was highlighted at the ASCO Annual Meeting in June. Recruitment in the enriched cohort of our AUSIC-four hundred and one Phase 2 proof of concept study is going well. In this cohort, we're evaluating Fadra as monotherapy in patients with CDKN2A and or CDKN2B chromosomal abnormalities, including deep deletions or loss of function. The hypothesis we are testing prospectively builds on preclinical evidence and the Phase I clinical data presented at ASCO, which evaluated PharmBio's monotherapy from an unselected population.

Speaker 1

Clinical benefit was observed in heavily pretreated patients with several tumor types, including endometrial, lung, ovarian, pancreatic cancer and T cell lymphoma. Retrospective analysis suggests that this activity may be associated in part with alterations in certain tumor suppressor genes, specifically CDKN2A and or CDKN2B. We believe that there is great unmet medical need and industry interest in the patient population identified by CDKN2A or B abnormalities, which are closely located on chromosome 9 and are often co deleted. CDKN2A gene deletions occur in several solid tumors, including bladder, breast, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous, melanoma, ovarian, pancreatic and also in certain T cell lymphomas. PDK N2B deletions occur in several solid tumors, including bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous and mesothelioma, melanoma, pancreatic and others.

Speaker 1

Based on currently available data, we believe that Fadra has a strong competitive profile in its therapeutic class. We expect to report on initial clinical activity from the Phase 2 proof of concept part of the study starting in Q4 of this year. I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the FADDL program. Brian?

Speaker 2

Thank you, Spiro. As Spiro mentioned, we are recruiting well in the FODRA PMC study, and I'm very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDKN2AB cohort. Based on the pace of enrollment, we anticipate reporting initial results from around a dozen patients by the end of 2024. We have also opened a second cohort, which is recruiting patients with T cell lymphoma. This was based on Phase 1 signals of activity, including partial responses in 2 out of the 3 patients with T cell lymphoma.

Speaker 2

As we progress with the FASBRA Phase 2 study, let me summarize the data presented at ASCO and the rationale for our clinical strategy. The ASCO data set included 47 patients from the Phase 1 dose escalation part of the CYC065-1 101 study evaluating different FODRID dosing schedules as monotherapy in unselected population. Patients were heavily pretreated, having received a median of 4 prior lines of therapy. Pfizer was generally well tolerated with good compliance between dose level 15. Dose level 5 or 100 milligrams twice daily, 5 days a week, 4 out of 4 weeks was selected for the Phase 2 proof of concept part of the study.

Speaker 2

There were no drug related SAEs at this dose level. The most commonly reported treatment related adverse events were nausea, vomiting, diarrhea, fatigue and hyperglycemia. A total of 25 drug related SAEs were reported in 8 patients. Most common were hyperglycemia in 4 patients, platelet count decrease in 3 and accidental overdose in 3. A total of 34 patients had measurable target lesions at baseline.

Speaker 2

2 partial responses were reported in patients with T cell lymphoma, one of whom had a CDK 2N2A loss. A squamous non small cell lung cancer patient with CDK N2A and CDKN2B loss achieved a 22% reduction in tumor burden at 4 weeks. In addition, clinical benefit was reported in 2 patients with endometrial cancer, 1 each with ovarian and pancreatic cancer. A retrospective analysis of previously treated Phase 1 patients identified an endometrial cancer patient who achieved a complete response over 3 years of treatment in a previous intravenous FODRA monotherapy study and was found to have a CDKN2A, CDKN2B and NTAP loss. Although the Phase 1 hypothesis generating data are limited and cannot be generalized, we believe that the data supports evaluating the 2 patient cohorts with specific cancer types in the Phase II POC part of the study.

Speaker 2

We look forward to reporting initial data in the upcoming months. I will now turn the call over to Paul to review the Q2 results.

Speaker 3

Thank you, Brian. As of during 30 20 24, cash equivalents totaled $6,000,000 compared to $3,400,000 as of December 31, 2023. Net cash used in operating activities was $3,600,000 for the 6 months ended June 30, 2024, compared to $8,200,000 for the same period of 2023. Net cash provided by financing activities was $6,300,000 for the 6 months ended June 30, 2024, as a result of receiving approximately CHF 6,300,000 net of expenses from the issue of common stock and warrants under a securities purchase agreement. The company estimates that its current cash resources will fund planned programs into the Q4 of 2024.

Speaker 3

Research and development or R and D expenses were $2,000,000 for the 3 months ended June 30, 2024, as compared to $4,700,000 for the same period in 2023. R and D expenses relating to Fadra were $1,500,000 for the 3 months ended June 30, 2024, as compared to $3,000,000 for the same period in 2023, due to a decrease in clinical trial and other non clinical expenditures. R and D expenses were atypelogitab, our PLK1 inhibitor, were $500,000 for the 3 months ended June 30, 2024, as compared to 1,400,000 for the same period in 2023, due to a decrease in manufacturing costs and other non clinical expenditures. General and administrative expenses remained flat at approximately $1,600,000 for each of the 3 months ended June 30, 2024, and 2023. Total other expenses and net were $100,000 for each of the 3 months ended June 30, 2024 2023.

Speaker 3

The United Kingdom research and development tax credits for the 3 months ended June 30, 2024, were $400,000 compared to $6,000,000 for the same period in the previous year and are directly correlated to qualifying R and D expenditure. Net loss for the 3 months June 30, 2024 was $3,300,000 including stock based compensation expense of $200,000 compared to $5,500,000 including stock based compensation expense of $400,000 for the same period in 2023. Operator, we are now ready to take questions.

Operator

Thank you, Mr. We'll go first to Ahu Demir at Ladenburg,

Speaker 4

Holman. We have a couple. First question is, what is the enrollment target for the CDKN2A and 2B program? And other part of the question is, what would be the what are the scenarios for this program and what would be the benchmark and success that you would consider based on the data that you plan to disclose in the second half of this year?

Speaker 1

I will thank you for your question. I think this is for Brian. Brian, over to you.

Speaker 2

So the first question is it's a sort of a 2 stage process. So stage 1 is to look at approximately 12 to 14 patients where you need to see more than 2 responses and then you would move on to the next phase of the study. So success for the first part would be at least 2 RECIST responses in the first 12 to 14 patients. I hope that terrifies in the next phase will be just to confirm that those responses just confirm in a bigger cohort.

Speaker 4

Yes. That's helpful, Brian. And how many from how many patients are you planning to show data in the second half of this year? And what is the target enrollment for this program?

Speaker 2

Accrual has been good. And the patients required have that we need have been screened. So we anticipate that's why we're reasonably confident we'll be able to present at least just around a dozen patients' worth of response data by the end of the year. Just to remind everyone, we scan here every 2 months. So we're already in August, would be sort of 2 months for the 1st scan, 2 months for the 2nd scan to get the efficacy data on that group.

Speaker 4

If I could ask one more question, Brian, I think I would refer that question to you as well. In terms of the alterations, is there any reason to think the loss of CDKN2 and B2A and 2B would be more potent form instead of the mutations and other alterations Or it could be any of these and with the data disclosure in the second half, would we be able to see what is the status of these different alterations?

Speaker 2

You bring up a really interesting point in terms of the different either deletions or different mutations that are present. I think from what we've seen so far is we'll be able to get at least a feel from our old treated patients plus the knee set, which should be way over 20, 25 patients to see is there a specific alteration that's more sensitive to the drug. So we'll get an idea. There are numerous different ones. And then hopefully from that from that analysis, we'll be able to hold it down even a little bit more.

Speaker 4

Great. Thank you so much for answering my questions.

Operator

Thank you. And gentlemen, it appears we have no further questions this afternoon. Mr. Rambadis, I'll turn things back to you, sir, for any closing

Speaker 1

comments. Thank you, both. And our thanks to all of you for joining Sacros Health's Q2 2024 Earnings Call. We have achieved key milestones for PHADRA with multiple patients dosed in the Phase 2 proof of concept stage and look forward to important catalysts in 2024. These include reporting interim data from initial cohorts in the Phase 2 open label of concept stage of the 65-eleven study with oral FADRA in patients with advanced solid tumors and lymphoma.

Speaker 1

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.

Operator

Thank you, Mr. Rambadis. Again, ladies and gentlemen, that will conclude Cyclacel's financial results conference call. Again, thanks so much for joining us, everyone, and we wish you all a great remainder of your day. Goodbye.

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Earnings Conference Call
Cyclacel Pharmaceuticals Q2 2024
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