Q2 2024 Cyclacel Pharmaceuticals Inc Earnings Call

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Speaker Change: number,) From Brickset Swedish Productions, 1011 Orlando, FL 3B10005.

Speaker Change: [inaudible]

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Unknown Executive: Please stand by. We're about to begin.

Operator: Stand by, we're about to begin. Good afternoon, everyone. And thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights, where the second quarter ended June 30th, 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.

Speaker Change: In the next episode, we'll see you in the next episode.

Speaker Change: Please stand by, we're about to begin.

Unknown Executive: Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclist Health financial results and business highlights for the second quarter ended June 30th, 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-K.

Operator: 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-K. All of our projections and other forward-looking statements represent our judgment as of today, and Cyclacel does not assume any responsibility to update such information.

Speaker Change: Good afternoon everyone and thank you for joining today's conference call to discuss Cyclist Health's financial results and business highlights.

Speaker Change: for the second quarter ended June 30, 2024.

Speaker Change: Before turning the call over to management, I would like to remind everyone that during this conference call

Speaker Change: 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.

Speaker Change: 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-K.

Unknown Executive: All of our projections and other forward-looking statements represent our judgment as of today, and Cyclist Cell does not take any responsibility to update such information.

Speaker Change: All of our projections and other forward-looking statements represent our judgment as of today, and Cyclostel does not take any responsibility to update such information.

Unknown Executive: With us today, our Spiral Robotics President and Chief Executive Officer, Paul McBarrant, Executive Vice President, Finance and Chief Operating Officer. and Dr. Brian Schwartz, Chief Medical Officer.

Speaker Change: with us today are Spiro Rombotis, President and Chief Executive Officer, Paul McBarron, Executive Vice President, Finance and Chief Operating Officer, and Dr. Brian Schwartz, Chief Medical Officer.

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

Unknown Executive: Brian will provide details on Cyclacel's clinical programs, and Paul will provide financial highlights for the second quarter of 2024, which will be followed by a Q and A session.

Unidentified: 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 second quarter of 2024, which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.

Spiro Rombotis: At this time, I would like to turn the call over to Spiro. Thank you, and thank you everyone for joining us today for our second quarter, 2022. We are pleased to report on our progress with the Precision Medicine Strategy for Phadra Cyclad or Phadra, our oral CDK29 inhibitor, which was highlighted at the ASCO Annual Meeting in June. Recruitment in the enriched cohort of our O6-5-101 Phase II proof-of-concept study is going well. In this cohort, we are evaluating Phadra as monotherapy in patients with CDK-N2A and/or CDK-N2D 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 Phadra as monotherapy from an unselected population.

Operator: With us today are Spiro Rombotis, President and Chief Executive Officer, Paul McBarron, Executive Vice President, Finance and Chief Operating Officer, and Dr. 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 second quarter of 2024, which will be followed by a Q&A session. At this time, I would like to turn the call over to you.

Spiro Rombotis: Thank you. And thank you everyone for joining us today for our second quarter 2024 business update. We are pleased to report on our progress with the Precision Medicine Strategy for FADRA-Cyclib or FADRA, our oral CDK2-9 inhibitor, which was highlighted at the ASCO annual meeting in June. Furthermore, recruitment in the enriched cohort of our Osig-5-101 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.

Speaker Change: Thank you, and thank you everyone for joining us today for our second quarter, 2024 Business Update.

Speaker Change: We are pleased to report on our progress with the Precision Medicine Strategy for FADRA-Cyclin or FADRA, our oral CDK2-9 inhibitor, which was highlighted at the ASCO Annual Meeting in June.

Speaker Change: Recruitment in the enriched cohort of our Aussie 5-1-1-1 phase 2, truth of concept study is going well.

Speaker Change: In this cohort, we are evaluating Phadra as monotherapy in patients with CDK-N2A and or CDK-N2B chromosomal abnormalities including deep deletions or loss of function.

Spiro Rombotis: The hypothesis we are testing prospectively builds on preclinical evidence and phase one clinical data presented at ASCO, which evaluated phor-based monotherapy in an unselected population. Clinical benefit was observed in heavily pre-treated 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. TdkN2A 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.

Speaker Change: The hypothesis we are testing prospectively builds on preclinical evidence and the Phase I clinical data presented at ASCO, which evaluated FADWAS monotherapy from an unselected population.

Spiro Rombotis: Clinical benefit was observed in heavily portrayed patients with several tumor types, including endometrial, lung, ovarian, pancreatic cancer, and anticell lymphoma. Reprospective analysis suggests that this activity may be associated in parts with alterations in certain tumor suppressor genes, specifically CDK-N2A and/or CDK-N2B. We believe that there is great unmet medical need and industry interest in the patient population identified by CDK-N2A or B abnormalities, which are closely located on chromosome 9 and are often co-deleted. CDK-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 Change: Clinical benefit was observed in heavily pre-treated patients with several tumor types including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma.

Speaker Change: Reprospective analysis suggests that this activity may be associated in parts with alterations in certain tumor suppressor genes, specifically CdKN2A and OR, CdKN2B.

Speaker Change: 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.

Speaker Change: TdkN2A gene deletions occur in several solid tumors, including bladder, breast, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous.

Speaker Change: Melanoma, Ovarian, Pancreatic, and also in certain T-cell lymphomas.

Spiro Rombotis: PDKN2B 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. Based on currently available data, we believe that FA We expect to report on initial clinical activity from the Phase 2 proof-of-concept parts of the study starting in the fourth quarter 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 FADRA program. Brian?

Speaker Change: CDKN2B deletions occur in several solid tumors.

Speaker Change: including bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous and mesothelioma, melanoma, pancreatic, and others.

Spiro Rombotis: Based on CARM-y available data, we believe that FADRA has a strong competitive profile in its therapeutic class.

Speaker Change: Based on currently available data, we believe that FADRA has a strong competitive profile in its therapeutic class.

Spiro Rombotis: We expect to report on initial clinical activity from the Phase 2 pool of concept parts of the study, starting in the fourth quarter of this year.

Speaker Change: We expect to report on initial clinical activity from the Phase II proof-of-concept parts of the study starting in the fourth quarter of this year.

Brian Schwartz: I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the FADRA program. Brian? Thank you, Spiro. As Spiro mentioned, we are recruiting well in the Farak-Fodra PLC study and are very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDK into a B cohort. Based on the pace of enrollment, we anticipate reporting initial results from around a dozen patients by the end of 2024.

Speaker Change: I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the further progress. Brian ?

Brian Schwartz: Thank you, Spiro. As Spiro mentioned, we are recruiting well in the FROG-FODRA PLC study. And I'm very encouraged by the enthusiasm of our clinical investigators about enrolling patients in the 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 I signals of activity, including partial responses in two out of three patients with T-cell lymphoma.

Brian: Thank you, Spiro. As Spiro mentioned, we are recruiting well in the Farokh Fadra PLC study, and I'm very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDKN2AB cohort.

Speaker Change: Based on the pace of enrollment, we anticipate reporting initial results from around a dozen patients by the end of 2024.

Brian Schwartz: We have also opened the second cohort, which is recruiting patients with T cell lymphoma. This was based on phase one signals of activity, including parcel responses in two out of the three patients with T cell lymphoma.

Speaker Change: We have also opened a second cohort which is recruiting patients with T-cell lymphoma. This was based on phase one signals of activity including partial responses in two out of the three patients with T-cell lymphoma.

Brian Schwartz: As we progress with the father phase two study, let me summarize the data presented at ASCO and the rationale for our clinical strategy. The Ascho data sets included 47 patients from the phase one dose escalation part of the CYC065-101 study evaluating different father dosing schedules as monotherapy in unselected population. Patients were heavily pre-treated, having received the median of four prior lines of therapy. The father was generally well-tolerated with good compliance between dose level one and five. dose level five, or 100 milligrams twice daily, five days a week, four out of four weeks, was selected for the phase two proof of concept part of the study.

Brian Schwartz: As we progress with the PHADRA Phase II 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 CYC 065-101 study, evaluating different FODRA dosing schedules as monotherapy in unselected populations. Patients were heavily pretreated, having received a median of four prior lines of therapy. Traca was generally well-tolerated with good compliance between dose levels 1 and 5. Dose level 5 or 100 milligrams twice daily, five days a week, four out of four weeks, was selected for the Phase II Proof of Concept part of the study.

Brian Schwartz: There were no drug-related FAEs 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; the most common were hyperglycemia in four patients, platelet count decrease in three, and accidental overdose in three.

Speaker Change: As we progress with the FODMAP Phase 2 study, let me summarize the data presented at ESCO and the rationale for our clinical strategy.

Speaker Change: The ASCO dataset included 47 patients from the Phase 1 dose escalation part of the CYC 065-101 study.

Speaker Change: Evaluating different FODRA dosing schedules as monotherapy in unselected population.

Speaker Change: Patients were heavily pretreated having received a median of four prior lines of therapy.

Speaker Change: Tracker was generally well-tolerated with good compliance between dose level 1 and 5.

Speaker Change: Those Civil Five, or 100 Money Grams, Dwight Staley, five days a week, four out of four weeks, was selected for the face soup and for the concept part of the study. They were no drug related if they use at this dose level.

Brian Schwartz: There were no drug-related SAE at this dose level. The most commonly reported treatment-related adverse events were nausea, vomiting, diarrhea, fatigue, and hypoglycemia. A total of 25 drug-related SAEs were reported in eight patients. Most common were hypoglycemia in four patients, platelet count decreasing three, and accidental overdose in three. A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with P-cell lymphoma, one of whom had a CDK to end to a loss. A squamous non-small cell lung cancer patient with CDK end to A and CDK end to B loss achieved a 22% reduction in tumor burden at four weeks.

Speaker Change: The most commonly reported treatment-related adverse events were nausea, vomiting, diarrhea, fatigue and hyperglycemia.

Speaker Change: 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.

Paul McBarron: A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with T-cell lymphoma, one of whom had a CDK to end with a loss. A squamous non-small cell lung cancer patient with CDKN2A and CDKN2B loss achieved a 22% reduction in tumor burden at four weeks. In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer. A retrospective analysis of previously treated Phase I patients identified an endometrial cancer patient who achieved a complete response over three years of treatment in a previous intravenous FADRA monotherapy study and was found to have a CDKN2A, CDKN2B, and NTAP loss.

Speaker Change: A total of 34 patients had measurable target lesions at baseline.

Speaker Change: Two partial responses were reported in patients with T-cell lymphoma, one of whom had a CDK2N2A loss. Thank you for your time.

Speaker Change: Asquamous non-small cell lung cancer patient

Speaker Change: with CDK N2A and CDK N2B loss achieved a 22% reduction in tumor burden at four weeks.

Brian Schwartz: In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer. A retrospective analysis of previously treated phase one patients identified an endometrial cancer patient who achieved a complete response over three years of treatment in a previous intravenous phardromonotherapy study and was found to have a CDK end to a CDK end to b and end-tap loss. Although the Phase 1 hypothesis-generating data are limited and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific answer types in the Phase 2 POC part of the study.

Speaker Change: In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer.

Speaker Change: A retrospective analysis of previously treated Phase I patients.

Speaker Change: identified an endometrial cancer patient.

Speaker Change: who achieved a complete response over three years of treatment in a previous intravenous FADRA monotherapy study and was found to have a CDKN2A, CDKN2B, and NTAP loss.

Paul McBarron: Although the Phase I hypothesis-generating data are limited and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific cancer types in the Phase II POC part of the study. We look forward to reporting initial data in the coming months. I will now turn the call over to Paul to review the second quarter results. Thank you, Brian. As of June 30, 2024, cash equivalents total $6 million, compared to $3.4 million as of December 31, 2023.

Speaker Change: Although the Phase I hypothesis-generating data are limited.

Speaker Change: and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific cancer types in the Phase II POC part of the study.

Brian Schwartz: We look forward to reporting initial data in the upcoming month.

Speaker Change: We look forward to reporting initial data in the upcoming months.

Paul McBarron: I will now turn the call over to Paul to review the second quarter results. Thank you, Brian. As of June 30, 2024, cash equivalent total 6 million compared to 3.4 million as of December 31, 2023. Net cash years and operating activities were 3.6 million for the 6 months ended June 30, 2024, compared to 8.2 million for the same period of 2023. Net cash provided by financing activities was 6.3 million for the 6 months ended June 30, 2024, as a result of receiving approximately 6.3 million net of expenses from the issue of common stock and warrants under a security's purchase agreement.

Paul McBarron: Net cash use and operating activities was $3.6 million for the six months ended June 30, 2024, compared to $8.2 million for the same period of 2023. Net cash provided by financing activities was $6.3 million for the six months ended June 30, 2024, as a result of receiving approximately $6.3 million net of expenses from the issuance of common stock and warrants under a securities purchase agreement. The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024. Research and Development, or R&D expenses, were $2 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023.

Speaker Change: I will now turn the call over to Paul to review the second quarter results.

Speaker Change: [inaudible]

Paul: Thank you, Brian .

Paul: As of June 30, 2024, cash equivalents total $6 million compared to $3.4 million as of December 31, 2023.

Paul: Net cash use and operating activities was 3.6 million for the six months ended June 30 of 2024, compared to 8.2 million for the same period of 2023.

Paul: Net cash provided by financing activities was 6.3 million for the six months ended June 30th 2024 as a result of receiving approximately 6.3 million net of expenses from the issue of common stock and warrants under a securities purchase agreement.

Paul McBarron: The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024. Research and development or R&D expenses were 2 million for the 3 months ended June 30, 2024, as compared to 4.7 million for the same period in 2023. R&D expenses relating to Fadra were 1.5 million for the 3 months ended June 30, 2024, as compared to 3 million for the same period in 2023, due to the decrease in clinical trial and other non-clinical expenditures. R&D expenses raised your pro-cosocative RPLK1 inhibitor were 0.5 million for the 3 months ended June 30, 2024, as compared to 1.4 million for the same period in 2023, due to a decrease in manufacturing costs and other non-clinical expenditures.

Paul: The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Paul: Research and Development, or R&D expenses, were $2 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023.

Paul McBarron: R&D expenses relating to FADRA were $1.5 million for the three months ended June 30, 2024, as compared to $3 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses relative to progazolotib, our PLK1 inhibitor, were $0.5 million for the three months ended June 30, 2024, as compared to $1.4 million for the same period in 2023, due to a decrease in manufacturing costs and other non-clinical expenditures. General and administrative expenses will remain flat at approximately $1.6 million for each of the three months ended June 30, 2024, and 2023.

Paul: R&D expenses relating to FADRA were $1.5 million for the three months ended June 30, 2024 as compared to $3 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures.

Speaker Change: R&D expenses raise you positive RPLK-1 inhibitor, will point 5 million for the 3 months and the June 30th, 2024.

Speaker Change: has compared to 1.4 million with the same period in 2023 due to a decrease in manufacturing costs and other non-clinical expenditures.

Paul McBarron: General and administrative expenses remained flat at approximately 1.6 million for each of the 3 months ended June 30, 2024, and 2023. Total other expenses net were 0.1 million for each of the 3 months ended June 30, 2024, and 2023. United Kingdom research and development tax credits for 3 months ended June 30, 2024, were 0.4 million, compared to 6 million for the same period in the previous year, and are directly correlated to qualifying R&D expenditure.

Speaker Change: General and administrative expenses remain flat at approximately 1.6 million for each of the three months and the June 3rd with 2024 and 2023.

Paul McBarron: Total other expenses net will be 0.1 million for each of the three months ended June 30, 2024 and 2023. United Kingdom Research and Development Tax Credits for the three months ended June 30th 2024 or 0.4 million compared to 6 million for the same period of the previous year and are directly correlated to qualifying R&D expenditure. The net loss for the three months ending June 30, 2024 was $3.3 million, including stock-based compensation expense of $0.2 million, compared to $5.5 million, including stock-based compensation expense of $0.4 million, for the same period in 2023.

Speaker Change: Total other expenses net will be 0.1 million for each of the three months ended June 30th, 2024 and 2023.

Speaker Change: United Kingdom Research and Development Tax Credits for 3 months ended June 30, 2024, were $0.4 million, compared to $6 million for the same period of the previous year, and are directly correlated to qualifying R&D expenditure.

Paul McBarron: Net loss for the 3 months, June 30, 2024, was 3.3 million, including stock-based compensation expense of 0.2 million, compared to 5.5 million, including stock-based compensation expense of 0.4 million for the same period in 2023.

Speaker Change: Net loss for the three months of June 30, 2024 was $3.3 million, including stock-based compensation expense of $0.2 million, compared to $5.5 million, including stock-based compensation expense of $0.4 million for the same period in 2023.

Unknown Executive: Operator, we are now ready to take questions. Thank you, Mr. Barron. Ladies and gentlemen, at this time, if you would like to ask a question, please press... of Star One on your telephone keypad, and you may remove yourself from the queue at any time by pressing Star Two. Once again, that's Star One for questions today.

Operator: Operator, we are now ready to take questions. Thank you, Mr. McBarron. Ladies and gentlemen, at this time, if you would like to ask a question, please press... Pet, and you may remove yourself from the list. Again, that's star number one for questions today, first to Ahu Demir at LADNR. Good afternoon. Thank you very much for taking my questions. We have a couple.

Speaker Change: Operator, we are now ready to take questions.

Speaker Change: Thanks for watching, and don't forget to like, share, and subscribe to our channel.

Speaker Change: Thank you, Mr. McBarron, ladies and gentlemen, at this time, if you would like to ask a question, please press star 1 on your telephone keypad and you may remove yourself from the queue at any time by pressing it star 2. Once again, that's star 1 for questions today. We'll go first to Ahu Damir at Laddenburg home.

Ahu Demir: We'll go first to Ahu Demir at Laddenburg, Holman. Good afternoon. Thank you very much for taking my questions. We have a couple.

unknown: The first question is, what is the enrollment target for the CDKN2A and 2B programs? And the other part of the question is, what would be 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? Well, thank you for your question. I think this is for Brian. Brian, it's over to you.

Ahu Demir: First question is, what is the enrollment target for the CDK and to A and to B program? And other part of the question is, 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?

Ahu Damir: Good afternoon. Thank you very much for taking my questions. We have couple first question is what is the enrollment target for the CDKN2AN2B program and other part of the question is

Ahu Damir: 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?

Brian Schwartz: Ahu Demir, thank you for your question. I think this is from Brian.

Brian Schwartz: Brian, what are you? Hi, Ahu. The first question is, it's sort of a two-stage process. The stage one is to look at approximately 12 to 14 patients where you need to see more than two responses. And then you would move on to the next phase of the study. So success for the first part would be at least two recess responses in the first 12 to 14 patients. I hope that that terrifies in the next phase will be just be to confirm that those responses just confirm in a bigger cohort.

Brian Schwartz: Finally, so the first question is it's sort of a two-stage process. Stage one is to look at approximately 12 to 14 patients where you need to see more than two responses, and then you would move on to the next phase of the study. So success for the first part would be at least two recessed responses in the first 12 to 14 patients. I hope that Terrified in the next phase will just be to confirm that those responses just confirm in a bigger call.

Speaker Change: I would thank you for your question. I think this is for Brian. Go on over here.

Brian: Finals, I'll say the first question is it's a sort of a two stage process, a stage one, it's to look at approximately 12 to 14 patients.

Speaker Change: where you need to see more than two responses and then you would move on to the next phase of the study. So, success for the first part would be at least two racist responses in the first

Speaker Change: 12 to 14 patients.

Speaker Change: I hope that Terrified in the next phase will just be to confirm that those responses just confirm in a bigger cohort.

Unknown Executive: Yes, that's hard for Brian.

Brian Schwartz: 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?

Brian Schwartz: And from how many patients are planning to show data in the second half of this year? And what is the target enrollment for this program? A crew has been good, and the patients required have, you know, that we need have been screened. So we anticipate that's why we reasonably confident we'll be able to, you know, present at least just around a dozen patients' worth of response data by the end of the year. Just to remind everyone, we scan, yeah, every two months. So, you know, we already in August; it would be sort of two months for the first scan and two months for the second scan to get the efficacy data on that group.

Speaker Change: Yes, that's that's how we'll run and how many patients are planning to show data in the second half of this year and what is the target enrollment?

Brian Schwartz: for this program. The crew has been good, and the patients required have, you know, 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, yeah, every two months. So, you know, we're already in August; it would be sort of two months for the first scan, two months for the second scan to get the efficacy data on that.

Speaker Change: for this program.

Speaker Change: A Krill has been good

Speaker Change: and the patience.

Speaker Change: required, you know, that we need have been screened.

Speaker Change: 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 two months.

Speaker Change: So, you know, we already in August, it would be sort of two months for the first scan and two months for the second scan to get the efficacy data on that group.

Brian Schwartz: If I could ask one more question, Brian, I think that would, I would refer that question to you as well. In terms of the alterations. Is there any reason to think the local TDK and to and B to A and to B would be more potent form instead of the mutations and other and other alterations or it could be any of these and. And with the data disclosure in the second half, would we be able to see what is the status of these different alterations? You bring up a really interesting point in terms of, you know, the different either deletions or different different mutations that are present.

Brian Schwartz: If I could ask one more question, Brian, I think that would be, I would refer that question to you as well. In terms of the alterations, is there any reason to think the local TDK and to and be to A and to be would be a more potent form instead of the mutations and other and other alterations, or it could be any of these, and with the data disclosure in the second and as, would we be able to see what the status of these different alterations are?

Speaker Change: If I could ask one more question, Brian, I think that would be for that question to you as well.

Brian: In turn, both the alterations.

Brian: Is there any reason to think the lawful PDK and 2NB to A and 2B would be more potent?

Speaker Change: 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?

Brian Schwartz: You bring up a really interesting point in terms of, you know, the different deletions or different mutations that are present. I think from what we've seen so far, we'll be able to get at least a feel for the old treated patients plus the new set. Which would be way over 20, 25 patients to see if there is a specific alteration that's more sensitive to the drug? So we'll get an idea. There are numerous different ones, and hopefully, from that, from that analysis, we'll be able to hone them down even a little bit more.

Speaker Change: You bring up a raving to student point in terms of...

Speaker Change: You know, the difference in the deletions or different limitations that are present. I think from what we see so far is we'll be able to get.

Brian Schwartz: I think from what we've seen so far is we'll be able to get at least a feel from, you know, our old treated patients custom new set, which would be way over 20, 25 patients to see, is there specific alteration that's more sensitive to the drug. So we will get an idea; there are numerous different ones, and hopefully from that, from that analysis, we'll be able to hold it down even a little bit more.

Speaker Change: At least a

Speaker Change: Field from...

Speaker Change: You know, our old treated patients trust the new step.

Speaker Change: which would be way over 2020 for our patients to see is there a specific alteration that's more sensitive to the drug.

Speaker Change: So, we'll get an idea. There are numerous different ones, and hopefully from that analysis, we'll be able to hone it down even a little bit more.

Ahu Demir: Great. Thank you so much for answering my questions.

unknown: Great, thank you so much for answering my question. Thank you. And just a quick reminder, ladies and gentlemen, of Star Wars. Thank you for your questions today. Ladies and gentlemen, it appears we have no further questions this afternoon, Mr. Rombotis. Thank you both and thanks to all of you for joining Cyclacel's second quarter 2024 earnings call. We have achieved key milestones for FADRA with multiple patients dosed in the phase two 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 level of concept stage of the OSIX-5-11 study with oral FADRA in patients with advanced solid tumors and lymphoma.

Speaker Change: Grace, thank you so much for answering my questions.

Unknown Executive: Thank you. And just a quick reminder, ladies and gentlemen, Star One, please, for any further questions today.

Speaker Change: Thank you, and just a quick reminder, ladies and gentlemen, star one, please for any further questions today.

Speaker Change: [inaudible]

Speaker Change: Hello, I'm Brian Schwartz, and I'm

Unknown Executive: And gentlemen, it appears we have no further questions this afternoon.

Speaker Change: i

Spiro Rombotis: Mr. Rombotis, I'll turn things back to you, sir, for any closing comments. Thank you both. And thanks to all of you for joining Cyclacel's second quarter 2024 Herding School. We have achieved key milestones for FADRA with multiple patients, dozed in the phase two, proof of conscious stage, and look forward to important catalysts in 2024. These include reporting interim data from initial cohorts in the phase two, proof of concepts stage of the 065-11 study with oral FADRA 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 Change: And gentlemen, it appears we have no further questions this afternoon. Mr. Rombotis, I'll turn things back to you, sir, for any closing comments.

Spiro Rombotis: Will you look forward to providing you with further updates? I hope to meet some of you. I hope to meet some of you. Operator, at this time, you take the call. Thank you, Mr. Rombotis. 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. Dr. Paul McBarron, Dr. Paul McBarron, Dr. Paul McBarron, In the next episode, we'll see you in the next episode.

Rombotis: Thank you both, and thanks to all of you for joining SACWIS Health's second quarter 2024 earnings call.

Speaker Change: We have achieved key milestones for FADRA with multiple patients dosed in the phase 2 proof of concept stage and look forward to important catalysts in 2024.

Speaker Change: This includes reporting interim data from initial cohorts in the Phase 2 of the Global Proof Concepts stage of the OSX5-11 study with oral fibroindications with advanced solid tumors and lymphoma.

Speaker Change: will look forward to providing you with further updates and hope to meet some of you at upcoming conferences.

Unknown Executive: Operator, at this time, you may end the call. Thank you, Mr. Rombotis. Again, ladies and gentlemen, that will conclude Cyclacel's financial results conference call.

Speaker Change: Operator, at this time you may end the call.

Speaker Change: Thank you Mr. Rombotis, again ladies and gentlemen that will conclude Cyclicel'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.

Unknown Executive: Again, thanks so much for joining us, everyone, and we wish you all a great remainder of your day. Goodbye.

Spiro Rombotis: and Dr. 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 second quarter of 2024, which will be followed by a Q and a session.

Spiro Rombotis: At this time, I would like to turn the call over to Spiro. Thank you and thank you everyone for joining us today for our second quarter, 2022. We are pleased to report on our progress with the Precision Medicine Strategy for Phadra Cyclad or Phadra, our oral CDK29 inhibitor, which was highlighted at the ASCO Annual Meeting in June. Recruitment in the enriched cohort of our O6-5-101 Phase II proof of concept study is going well.

Spiro Rombotis: In this cohort, we are evaluating Phadra as monotherapy in patients with CDK-N2A and or CDK-N2D 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 Phadra as monotherapy from an unselected population. Clinical benefit was observed in heavily portrayed patients with several tumor types, including endometriol, lung, ovarian, pancreatic cancer, anticell lymphoma. Reprospective analysis suggests that this activity may be associated in parts with alterations in certain tumor suppressor genes, specifically CDK-N2A and or CDK-N2B.

Spiro Rombotis: We believe that there is great unmet medical need and industry interest in the patient population identified by CDK-N2A or B abnormalities, which are closely located on chromosome 9 and are often co-deleted. CDK-N2B deletions occur in several solid tumors, including bladder, breast, colangio carcinoma, endometriol, esophageal, glioma, head and neck, hepatobiliary, lung, including scramus and mesotholeoma, melanoma, pancreatic and others. Based on CARM-y 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 pool of concept parts of the study, starting in the fourth quarter of this year.

Brian Schwartz: I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the FADRA program. Brian? Thank you, Spiro. As Spiro mentioned, we are recruiting well in the Farak-Fodra PLC study and are very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDK into a B cohort. Based on the pace of enrollment, we anticipate reporting initial results from around a dozen patients by the end of 2024.

Brian Schwartz: We have also opened the second cohort which is recruiting patients with T cell lymphoma. This was based on phase one signals of activity, including parcel responses in two out of the three patients with T cell lymphoma.

Brian Schwartz: As we progress with the father phase two study, let me summarize the data presented at Ascho and the rationale for our clinical strategy. The Ascho data sets included 47 patients from the phase one dose escalation part of the CYC065-101 study evaluating different father dosing schedules as monotherapy in unselected population. Patients were heavily pre-treated having received the median of four prior lines of therapy. The father was generally well-tolerated with good compliance between dose level one and five, dose level five, or 100 milligrams twice daily, five days a week, four out of four weeks, was selected for the phase two proof of concept part of the study.

Brian Schwartz: There were no drug-related SAE at this dose level. The most commonly reported treatment-related adverse events were nausea, vomiting, diarrhea, fatigue, and hypoglycemia. A total of 25 drug-related SAEs were reported in eight patients. Most common were hypoglycemia in four patients, platelet count decreasing three, and accidental overdose in three. A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with P-cell lymphoma, one of whom had a CDK to end to a loss.

Brian Schwartz: A squamous non-small cell lung cancer patient with CDK end to a and CDK end to b loss achieved a 22% reduction in tumor burden at four weeks. In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer. A retrospective analysis of previously treated phase one patients identified an endometrial cancer patient who achieved a complete response over three years of treatment in a previous intravenous phardromonotherapy study and was found to have a CDK end to a CDK end to b and end-tap loss. Although the Phase 1 hypothesis generating data are limited and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific answer types in the Phase 2 POC part of the study.

Brian Schwartz: We look forward to reporting initial data in the upcoming month.

Paul McBarron: I will now turn the call over to Paul to review the second quarter results. Thank you, Brian. As of June 30, 2024, Cash equivalent total 6 million compared to 3.4 million as of December 31, 2023. Net cash years and operating activities were 3.6 million for the 6 months ended June 30, 2024, compared to 8.2 million for the same period of 2023. Net cash provided by financing activities was 6.3 million for the 6 months ended June 30, 2024, as a result of receiving approximately 6.3 million net of expenses from the issue of common stock and warrants under a security's purchase agreement.

Paul McBarron: The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024. Research and development or R&D expenses were 2 million for the 3 months ended June 30, 2024, as compared to 4.7 million for the same period in 2023. R&D expenses relating to Fadra were 1.5 million for the 3 months ended June 30, 2024, as compared to 3 million for the same period in 2023, due to the decrease in clinical trial and other non-clinical expenditures.

Paul McBarron: R&D expenses raised your pro-cosocative RPLK1 inhibitor were 0.5 million for the 3 months ended June 30, 2024, as compared to 1.4 million 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 1.6 million for each of the 3 months ended June 30, 2024, and 2023. Total other expenses net were 0.1 million for each of the 3 months ended June 30, 2024, and 2023. United Kingdom Research and Development Tax Credits for 3 months ended June 30, 2024, were 0.4 million, compared to 6 million for the same period in the previous year, and are directly correlated to qualifying R&D expenditure.

Paul McBarron: Net loss for the 3 months, June 30, 2024, was 3.3 million, including stock-based compensation expense of 0.2 million, compared to 5.5 million, including stock-based compensation expense of 0.4 million for the same period in 2023.

Unknown Executive: Operator, we are now ready to take questions. Thank you, Mr. Barron. Ladies and gentlemen, at this time, if you would like to ask a question, please press.., of Star One on your telephone keypad, and you may remove yourself from the queue at any time by pressing Star Two. Once again, that's Star One for questions today.

Ahu Demir: We'll go first to Ahu Demir at Laddenburg, Holman. Good afternoon. Thank you very much for taking my questions. We have a couple. First question is, what is the enrollment target for the CDK and to A and to B program? And other part of the question is, 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? Ahu Demir, thank you for your question. I think this is from Brian.

Brian Schwartz: Brian, what are you? Hi, Ahu. The first question is, it's sort of a two stage process. The stage one is to look at approximately 12 to 14 patients where you need to see more than two responses. And then you would move on to the next phase of the study. So success for the first part would be at least two recess responses in the first 12 to 14 patients. I hope that that terrifies in the next phase will be just be to confirm that those responses just confirm in a bigger cohort.

Brian Schwartz: Yes, that's hard for Brian. And from how many patients are planning to show data in the second half of this year? And what is the target enrollment for this program? A crew has been good and the patients required have, you know, that we need have been screened. So we anticipate that's why we reasonably confident we'll be able to, you know, present at least just around a dozen patients worth of response data by the end of the year.

Brian Schwartz: Just to remind everyone we scan, yeah, every two months. So, you know, we already in August, it would be sort of two months for the first scan and two months for the second scan to get the efficacy data on that group.

Brian Schwartz: If I could ask one more question, Brian, I think that would, I would refer that question to you as well. In terms of the alterations. Is there any reason to think the local TDK and to and B to A and to B would be more potent form instead of the mutations and other and other alterations or it could be any of these and. And with the data disclosure in the second half, would we be able to see what is the status of these different alterations?

Brian Schwartz: You bring up a really interesting point in terms of, you know, the different either deletions or different 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, you know, our old treated patients custom new set, which would be way over 20, 25 patients to see, is there specific alteration that's more sensitive to the drug. So we will get an idea there are numerous different ones and hopefully from that, from that analysis, we'll be able to hold it down even a little bit more.

Ahu Demir: Great. Thank you so much for answering my questions. Thank you.

Unknown Executive: And just a quick reminder, ladies and gentlemen, Star One, please, for any further questions today.

Unknown Executive: And gentlemen, it appears we have no further questions this afternoon.

Spiro Rombotis: Mr. Rombotis, I'll turn things back to you, sir, for any closing comments. Thank you both.

Spiro Rombotis: And thanks to all of you for joining Cyclacel's second quarter, 2024, Herding School. We have achieved key milestones for FADRA with multiple patients, dozed in the phase two, proof of conscious stage, and look forward to important catalysts in 2024. These include reporting interim data from initial cohorts in the phase two, proof of concepts stage of the 065-11 study with oral FADRA in patients with advanced solid tumors and lymphoma.

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

Unknown Executive: Operator at this time, you may end the call. Thank you, Mr. Rombotis. 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.

Unknown Executive: Goodbye.