Cyclacel Pharmaceuticals Q4 2023 Earnings Call Transcript

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March 19, 2024

There are 7 speakers on the call.

Operator

Good afternoon and welcome to the Cyclacel Pharmaceuticals 4th Quarter and Full Year 2023 Earnings Conference Call and Webcast. At this time, all participants are in a listen only mode. After today's call, members of the financial community will have the opportunity to ask questions. Please note today's call is being recorded. I'd now like to turn the conference call over to the company.

Operator

Please go ahead.

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 Q4 financial year ended December 31, 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 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 10Q and 10 ks. 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 Embadis, President and Chief Executive Officer Paul McSahon, Executive Vice President, Finance and Chief Operating Officer and Doctor.

Speaker 1

Brian Schwartz, Chief Medical Officer. Birrah will begin with an overview of our business strategy and progress. Brian will provide details on Cyclacel's clinical programs, and then Paul will provide financial highlights for the Q4 and full year 2023, which will be followed by a Q and A session. At this time, I'd like to turn the call over to Spiro.

Speaker 2

Thank you, Grace, and thank you, everyone, for joining us today for our Q4 and full year 2023 business update. We are delighted to be joined on today's call by Doctor. Brian Schwartz, who has recently joined Cyclacel as Chief Medical Officer. Many of you may know Brian when he was CMO at ArQule prior to the acquisition by Merck in 2020, at which time he joined our Board of Directors. He has extensive clinical and product development experience, which will be instrumental in guiding our team to deliver key value inflection milestones.

Speaker 2

We are pleased to report on the progress of fadraciclib, our CDK2 and 9 inhibitor or Fadra for short. Having recently discovered a potential precision medicine approach for FADRA, we have determined the recommended Phase 2 dose or RP2D and are ready to start the Phase 2 proof of concept part of our 65-one hundred and one study. Taken together, our clinical and preclinical data suggest the hypothesis that patients with 1 or more chromosomal abnormalities, including CDK N2A, CDK N2B and or MTAP, including deep deletions or loss of function, may be sensitive to FADRA. In this part, we will evaluate patient cohorts selected for their mutation profile and or Phase I activity in various solid tumors and lymphoma. We will initially focus on 2 patient cohorts with CDK N2A and or CDK N2B abnormalities and T cell lymphoma from both of which we saw Phase 1 signals of activity including responses.

Speaker 2

We believe that there is great unmet medical need and industry interest in the cancer patient populations identified by these 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. CDKN2b 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. As mentioned in our press release, we expect 2 key data readouts for FADRA this year. Final data from the dose escalation part of the 65-one hundred and one study at a major medical conference and later on initial clinical activity from the Phase 2 proof of concept part.

Speaker 2

Also at the upcoming AACR 2024 meeting, independent investigators will present the clinical proof of concept data for FADRA in various tumor types. I will now turn the call over to Brian to review our progress in the FADRA and PLOGO studies and discuss some of our clinical results. Brian?

Speaker 3

Thank you, Spiro. We have dosed 47 patients in the dose escalation part of the FADRA 65,101 study, of which 33 are evaluable for efficacy. We have completed dose escalation and based on preclinical and clinical data have determined that dose level 5 or 100 milligrams BID dosed 5 days per week in a 4 week cycle will be our recommended Phase II dose or RP2D. No dose limiting toxicities have been observed at this dose level. We have also observed CDKN2A or B alterations, including loss of function in multiple pretreated Phase I patients with various cancers, including gynecological, hepatobiliary, lung and pancreatic, who has benefited from phagocyclib monotherapy.

Speaker 3

These patient groups are associated with a high unmet medical need and often have poor clinical outcomes. An illustration of this is we were excited to see shrinkage of 22% in the sum of all target lesions of the one cycle of oral fardriciclib in a squamous non small cell lung cancer patient with CDKN2b deletion, refractory to standard of care chemotherapy

Speaker 2

and immunotherapy.

Speaker 3

After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with FODRA, we found an additional 5 patients with CDKN2A or CDKN2B alterations. These included an endometrial cancer patient who achieved a CR and over 3 years on treatment in a previous study with IVFODRA monotherapy and was found to have CDKN2A, CDKN2B and NTAP loss. We are also encouraged by Phase 1 anticancer activity observed in our T cell lymphoma patients, including PRs in 2 out of 3 patients. A cohort in the Part 2 of the 65,101 will evaluate patients with T cell lymphoma. Although the Phase 1 hypothesis generating data are limited and cannot be generalized, we believe patients with these cancer types should be evaluated in the Phase 2 proof of concept part of the study.

Speaker 3

Initially, we expect to enroll 10 to 12 patients in each of the 2 cohorts with CDKN2A or B alterations in T cell lymphoma. We estimate that approximately 8 sites will take part in the Phase 2 and have completed several site initiation visits, so we can quickly start enrollment and deliver results by the second half of twenty twenty four. Let me now make a few remarks on our second program, Plogosertib or PLOGO. In the 140, 101 dose escalation study of PLOGO, we have enrolled 15 patients with good tolerability so far. Although we observed early evidence of anticancer activity in multiple patients, preclinical and clinical data suggest that the optimum dosing may be achieved with an alternative salt formulation of Glovo, which has been under development.

Speaker 3

Additionally, independent groups have shown that certain ARID1a or SMARCB mutated cancers may benefit from treatment of CLOGO. ARID and other mutations are found in several cancers including bladder, endometrial, esophageal, hepatobiliary and colorectal. For these reasons, we have chosen to pause 140,101 study with a current formulation and resume dose escalation once a new formulation becomes available. Following assessment of bioavailability in patients, we will now be taking into account potential selection biomarkers for patients enrolling in 140,101 study. I will now turn the call over to Paul to review the Q4 and full year results.

Operator

Thank you, Brian.

Speaker 4

As of December 31, 2023, pro form a cash and cash equivalents totaled $6,300,000 including $2,900,000 of United Kingdom Research and Development Tax credits received after the end of the year. Cash and cash equivalents as of December 31, 2023, totaled $3,400,000 compared to $18,400,000 as of December 31, 2022. Net cash used in operating activities was $16,100,000 for the 12 months ended December 31, 2023 compared to $20,800,000 for the same period of 2022. The company estimates that its available cash, including the United Kingdom research and development tax credit received of $2,900,000 will fund the currently planned programs into the Q2 of 2024. Research and development or R and D expenses were $3,500,000 19,200,000 dollars for the 3 months year ended December 31, 2023, as compared to $6,700,000 $20,300,000 for the same period in 20 22.

Speaker 4

R and D expenses relating to FADRA were $2,700,000 13,400,000 for the 3 months and year ended December 31, 2023, as compared to $5,300,000 $14,000,000 for the same period in 2022, due to a decrease in clinical trial costs, offset by an increase in manufacturing and other non clinical expenditures. R and D expenses related to Clogo were $700,000 $5,000,000 for the 3 months and year ended December 31, 2023, as compared to $1,300,000 $5,500,000 for the same period in 2022 due to decrease in manufacturing and other non clinical expenditures. General and administrative expenses for the 3 months and year ended December 31, 2023 were $1,900,000 $6,700,000 compared to $2,100,000 $7,400,000 for the same period of the previous year due to a decrease in professional fees. Total other income net for the 3 months year ended December 31, 2023, were an expense of $300,000 and an expense of $100,000 compared to an expense of $200,000 and income of $1,700,000 for the same period in the previous year. The decrease of $1,800,000 for the year ended December 31, 2023 is primarily related to royalty income received in the previous year.

Speaker 4

United Kingdom research and development tax credits for the 3 months year ended December 31, 2023, were $400,000 $3,000,000 compared to $1,600,000 $4,700,000 for the same period of the previous year and are directly correlated to qualifying research and development expenditure. Net loss for the 3 months and year ended December 31, 2023 was $5,300,000 $22,600,000 including stock based compensation expense of $300,000 $1,500,000 respectively, compared to $7,400,000 21,200,000 including again stock based compensation expense of $300,000 $1,500,000 respectively for the same period in 2022. Operator, we are now ready to take questions.

Operator

Thank you, sir. First question comes from Ahu Demir with Ladenburg Thalmann.

Speaker 5

Good afternoon. Thanks for taking my questions. And Brian, welcome back. Great to see you back on the operational seat. I have two questions.

Speaker 5

First one is on the FADRA program. You have 2 major data readouts you mentioned. For the Phase I portion of the data readout, are you going to disclose any of the PD biomarker data, including CDKN2A and B or others? That's my first question.

Speaker 2

Okay. Thank you very much for your question. I will answer the yes. We intend to disclose from our PD data in the mid May committee. As we have heard in the remarks and the press release, we have 6 patients that have the specific genotype.

Speaker 2

We're very encouraged for the best patients as far as response. So that's clearly hypothesis generating data set and we'll look to share more with our investors when the conference comes.

Speaker 5

Understood. My second question is on the Plogo formulation. As the clinical studies are currently not ongoing, when do you think the formulation efforts will be completed? And when do you think you will resume the clinical efforts? And also when are we going to see the data clinical data from this program?

Speaker 2

I will ask Paul, who is in charge of our manufacturing, for to comment on the first question. I will discuss the second one over to you.

Speaker 4

Yes. The formulation, the new oil formulation of plovosertib is ongoing. We've been doing it for a short while. So we'd anticipate about 6 months to complete that process, Aju.

Speaker 2

As far as the clinical data, with the second part of your question, if you enroll 15 patients seeing clinical benefit in treating tumor shrinkage and prolonged stable disease in fibroblast patients. But we need to be sure we can get to targeting even levels. As we have the backup formulation or the alternative salt which gave us much higher exposures, we obviously need to go with that. That's the reason we decided to pause the program in favor of improving our kinetics.

Speaker 5

Thank you.

Operator

Our next question comes from kimpe Dolliver with Brookline Capital Markets.

Speaker 6

Great. Thank you. So the press release and your transcript refers to the cash runway going into Q2, which as you know is a short period of time away. So two questions related to that. I mean, how far into the second quarter can you continue operating?

Speaker 6

And then which milestones can you achieve between now and then?

Speaker 2

Thank you, Kim. We can go into April of 2024, as we said. One can imagine that this process is going to be underway as far as raising additional funds as well as considering other options for the strategic fund. As far as milestones are concerned, we expect to begin our work on our Phase 2 program. The patients are being lined up who could go either into the current Phase 1 or go on to Phase 2.

Speaker 2

As we have recently declared RP2D, which can be enrolling Phase 2. And then the question, when we see the abstracts from major medical need in the middle of the year, which historically come out the month before. So we expect to see those around the same timeframe. This will contain the Phase I data, the full Phase I data, including some detail on pharmacodynamic profiles of patients, but not all of them because the cutoff was in winter. We expect to have some volatility in the public domain within this time frame.

Speaker 6

Great. Thank you.

Speaker 2

Thank you, Tim.

Operator

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

Speaker 2

Thanks, operator. And thanks to all of you for joining Cyclac Health's Q4 and full year 2023 earnings call. Fabraciclib has achieved a key milestone in ready to start Phase 2 stage with important catalysts anticipated in 2024 and a strong competitive profile in its therapeutic class. As a reminder, our upcoming key milestones are: 1st patient dosed with oral fadriciclib in Phase II for the onset part of 65-one hundred and one study in the patients with long term tumor lymphoma. For final data from dose escalation stage, PROMOCIC-five thousand one hundred and one, and the evore of fibrostixib in patients with a lab from December 7.

Speaker 2

Report interim data from initial cohorts in Phase II open label proof of concept part of 65-1 hundred and one study with oral fibrocycline in patients with advanced solid tumors and lymphoma. And independent investigators to report preclinical proof of concept data for flabricitab at the American Association's Cancer Research, or AACR, Annual Meeting by 2024. We look forward to providing you with further updates and also meet some of you at conference conferences. Operator, at this time, you may end the call.

Operator

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

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Earnings Conference Call
Cyclacel Pharmaceuticals Q4 2023
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