Q1 2024 Cyclacel Pharmaceuticals Inc Earnings Call

Operator: Good afternoon, and welcome to the Cyclacel Pharma School's first quarter 2024 results 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 an opportunity to ask questions. If you would like to ask a question at that time, please press star 1 on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing star 2.

Good afternoon, and welcome to the cycle. So pharmaceuticals first quarter 2024 results conference call and webcast. At this time all participants are in a listen only mode.

Speaker Change: After today's call members of the financial community will have an opportunity to ask questions. If you would like to ask a question at that time. Please press star one on your telephone keypad. If at any point. Your question has been answered you may remove yourself from the queue by pressing star two and posing a question. We ask that you. Please pick up your handset to allow optimal sound quality.

Operator: In asking your question, we ask that you please pick up your handset to allow optimal sound quality. Lastly, if at any time during the call you should require operator assistance, please press star 0. Please note today's call is being recorded. I will now turn the conference call over to the company. Please go ahead.

company: Lastly, if at any time during the call you should require operator assistance. Please press Star Zero. Please note today's call is being recorded I would now like to turn the conference call over to the company. Please go ahead.

company: Good afternoon, everyone and thank you for joining today's conference call to discuss <unk> financial results and business highlights.

Operator: Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the first quarter ending March 31st, 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.

company: First quarter ending March 31st 2024.

Management: Before turning the call over to management I would like to remind everyone that during this conference call forward looking statements made by management are intended to fall within the safe Harbor provision of the private Securities Litigation Reform Act of 1995 and section 21 E of the Securities Exchange Act of 1934 as amended.

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.

Management: 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.

Cyclists: All of our projections and other forward looking statements represent our judgment as of today and cyclists that does not take any responsibility to update such information.

Grace Kim: 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 program, and then Paul will provide financial highlights for the first 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.

Speaker Change: With us today are sphere of embodies president and Chief Executive Officer.

Paul McBarron: Paul Mcdonald Executive Vice President Finance, and Chief operating Officer.

Speaker Change: And Dr. Brian Schwartz Chief Medical Officer.

Speaker Change: Spiro will begin with an overview of our business strategy and progress Brian.

Brian Schwartz: Brian will provide details on <unk> clinical program.

Paul McBarron: And then Paul will provide financial highlights for the first quarter of 'twenty, 'twenty, four which will be followed by Q&A session.

Paul McBarron: At this time I would like to turn the call over to Bill.

Paul McBarron: Thank you Grace and thank you everyone for joining us today for our first quarter 2024 business update.

Spiro George Rombotis: Thank you, Grace. And thank you everyone for joining us today for our first quarter 2024 business update. As previously reported, we have closed the financing for $8 million in gross proceeds in a private placement priced at the market per NASDAQ rules.

Paul: As previously reported we have closed the financing for $8 million in gross proceeds and the private placement priced at the market for NASDAQ rules.

Bill: With additional resources in place we have begun dosing patients in the phase two proof of concept part well 065 Dash 101 study evaluating hydro sakes with well Fargo for short in patients with one or more chromosomal abnormalities, including city can too.

Spiro George Rombotis: With additional resources in place, we have begun dosing patients in the Phase 2 Proof of Concept part of our 065-101 study, evaluating Phadra cyclib, or Phadra for short, in patients with one or more chromosomal abnormalities, including CDKN2A and or CDKN2B, deep deletions, or loss of function. You will recall that we are pursuing a potential precision medicine approach for FADRA, an oral silicate 2-9 inhibitor, following findings in our clinical and preclinical data, which suggest the hypothesis that patients with one or more of these chromosomal abnormalities may be sensitive to FADRA.

Ed: Hey, Ed or see began to be deep deletions or loss of function.

Ed: You will recall that we are pursuing a potential a precision medicine approach for fog Gras oral city Q2, nine inhibitor following findings in our clinical and preclinical data would suggest the hypothesis that patients with one or more of these chromosomal abnormalities may be sensitive to foundry.

Spiro George Rombotis: In the phase two part, we are evaluating patients selected for their mutational profile and or phase one activity in various solid tumors and lymphomas. We're initially enrolling two patient cohorts, those with CDKN2A and or CDKN2B abnormalities and also T cell lymphoma, based on observation of anticancer activity, including responses in multiple phase one patients. 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.

Ed: In the phase two part.

Unknown Executive: Evaluating patients selected for the mutational profile and or phase one activity in various solid tumor cell lymphoma.

Speaker Change: We're initially enrolling two patient cohorts those with CDK into a <unk> or CDK into be abnormalities and also T cell lymphoma based on observation of anti cancer activity, including responses in multiple phase one patients.

We: 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 nine and I often call deleted.

Spiro George Rombotis: CKN2A 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. CDK and 2B lesions 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. There are no approved drugs to treat patients with CDKN2A or B abnormalities. We expect two key data readouts for PHADRA this year.

Gilles: Okay, and two a gene deletions well car in several solid tumors, including bladder breast endometrial and so far Gilles <unk> head and neck, hepatobiliary lung, including squamous melanoma ovarian pancreatic and also insert in T cell lymphoma.

Gilles: All of Us see.

CDK: CDK and too many lesions occur in several solid tumors, including bladder breast Cholangiocarcinoma endometrial esophageal believed all my head there, Nick Hepatobiliary lung, including the squamous and mesothelioma melanoma pancreatic and others.

Speaker Change: There are no approved drugs to treat patients with CDK and two a or b abnormalities.

Foundry: We expect to key data Readouts for foundry this year.

Spiro George Rombotis: Final data for the dose escalation part of the 065-101 study, to be presented at the ASCO 2024 annual meeting in a few weeks, and a report on initial clinical activity from the phase two proof of concept part of the study in the second half 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 FADRO study.

Foundry: Final beta.

Foundry: The dose escalation part of the 065 Dash 101 study.

Nick Hepatobiliary: To be presented at the ask what 2024 annual meeting in a few weeks.

Nick Hepatobiliary: And.

Speaker Change: Report on initial clinical activity from the phase two proof of concept part of this study in the second half of this year.

Speaker Change: I will now turn the call over to Brian to review, our progress and discuss some of our clinical results in the fibro study Bryan.

Brian Schwartz: Thank you Spiro.

Brian Schwartz: Thank you, Spiro. In our recently completed O65-101 study, we determined the recommended phase 2 dose for FODRA. As a reminder, this is 100mg BRD administered orally, 5 days per week, on a 4 week cycle. No dose-limiting toxicities were observed on this schedule.

Brian Schwartz: Our recently completed.

Bryan: It was 65101 study we determined the recommended phase two dose how far drop.

Brian Schwartz: As a reminder, this is 100 milligrams b I D dosed orally five days a week in a four week cycle.

Bryan: No dose limiting toxicities were observed on the schedule.

Spiro: We have now dosed the first patient in the phase II proof of concept cost of this study.

Brian Schwartz: We have now dosed the first patient in the Phase 2 proof of concept part of the study, with the initial focus of the cohort being patients with CDK2NA or B alterations. In order to speed up enrollment, we have opened additional slides, with up to seven participating in phase 2. We expect to deliver initial results by the second half of 2024.

Speaker Change: With the initial focus of the cohort in patients with CDK to an a or b alterations.

Speaker Change: In order to speed up enrollment, we have opened additional sites with up to seven participating in the phase two.

Speaker Change: We expect to deliver initial results by the second half of 'twenty 'twenty four.

Brian Schwartz: As we progress through the Phase 2 study, let me summarize the rationale for our clinical strategy. We have observed CDK, N, 2A, or B alterations, including loss of function, in multiple pre-treated phase I patients with various cancers. These included gynecological, hepatobiliary, lung, pancreatic, and recently testicular, who benefited from far-recycled monotherapy. These patient groups are associated with a high unmet need and often have poor clinical outcomes.

Unknown Executive: As we progressed through the phase II study, let me summarize the rationale for a clinical strategy.

Speaker Change: We have observed P. D K N two eight or be alterations, including loss of function in multiple pre treated phase one patients with various cancers. These included gynecological he patted billary lung pancreatic.

Speaker Change: And recently, there's particular, who benefited from farthest cyclic mono therapy.

Speaker Change: These patient groups are associated with a high unmet need and often have poor clinical outcomes.

Brian Schwartz: As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions after one cycle of oral FODRA monotherapy in a squamous non-small cell lung cancer patient with CDKN2B deletions refractory to standard of care chemo and immunotherapy. A recently enrolled patient with advanced testicular cancer patient post-surgery achieved a 12% reduction in the sum of all target lesions in the first cycle and continues on therapy now at cycle 3.

Speaker Change: As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions after one cycle of auto.

Speaker Change: Further a bolus therapy.

Speaker Change: In the squamous non small cell lung cancer patients with CDK into be deletions refractory to standard of care chemo and Immunotherapies.

Speaker Change: Ah recently enrolled patients with advanced is particular cancer patient post surgery achieved a 12% reduction in the sum of all target lesions in the first cycle and continues on therapy now let's cycle three.

Brian Schwartz: After retrospectively analyzing a subset of previously treated Phase I patients, we found a total of eight patients with CDKN2A or 2B alteration, all of whom experienced clinical benefit of FADRA monotherapy. These included an endometrial cancer patient who achieved a CR after over three years of treatment in the previous IV FADRA monotherapy study and was found to have CDKN2A and CDKN2B loss. We are also encouraged by the Phase 1 anti-cancer activity observed in T-cell lymphoma patients, including PRs in two out of three patients treated.

Ah: After retrospectively analyzing a subset of previously treated phase one patients. We found a total of eight patients with CDK into eight or to be alterations.

QUADRA monotherapy: All of whom experienced clinical benefit of the QUADRA monotherapy.

Unknown Executive: These included in endometrial cancer patients, who achieved a CR in over three years of treatment.

Previous speaker: Oh, the previous IV QUADRA monotherapy study.

Speaker Change: And was found to have CDK into a M CDK into be loss.

Speaker Change: We all same courage by phase one anticancer activity.

Speaker Change: In T cell lymphoma patients.

Speaker Change: <unk> PR in two out of three patients treated.

Brian Schwartz: One of you who had loss of CDKN2A. Literature suggests that a large percentage of T cell lymphoma patients have loss of CDKN2A. Although the Phase I hypothesis-generating data are limited and cannot be generalized, we believe that the data supports evaluating patients with these cancer types in the Phase II proof-of-concept part of the study. I will now turn the call over to Paul to review our first quarter results.

Asia: Why don't we had lost the CDK into Asia.

Literature: Literature suggests that a large percentage of T cell lymphoma patients have loss of CDK into eight.

Speaker Change: Although the phase one hypothesis generating data are limited and cannot be generalized we believe that the data supports evaluating patients with these cancer types in phase two proof of concept part of the study.

Paul McBarron: As of March 31st, 2024, pro forma cash and cash equivalents totaled $9.9 million, which includes proceeds from this month's private placement and $0.8 million cash received for the second and final part of the United Kingdom Research and Development Tax Credit Claim for 2023. Cash and cash equivalents as of March 31st, 2024 total $2.8 million, compared to $3.4 million as of December 31st, 2023. Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in respect of the first part of the 2023 R&D tax credit claim, compared to $6.3 million for the same period in 2023.

Paul: I will now turn the call over to Paul to review, our first quarter results.

Paul: Thank you Brian.

Paul: As of March 31, 2020, full pro forma cash and cash equivalents totaled $9 $9 million.

Paul: Which includes proceeds from this private placement.

Paul: And zero point $8 million cash received for the second and final part.

Paul: The United Kingdom Research and development tax credit claim for 'twenty to 'twenty three.

Speaker Change: Cash and cash equivalents as of March 31, 2020 full totaled $2 8 million.

Speaker Change: Compared to $3 4 million as of December 31st 2023.

Speaker Change: Net cash used in operating activities was <unk> 5 million for the three months ended March 31st 2024.

Speaker Change: Which includes $2 9 million received in March in respect to the first part of the 2023 R&D tax credit claims.

Speaker Change: Compared to $6 9 million for the same period of 2023.

Speaker Change: Research and development or R&D expenses were $2 8 million for the three months ended March 31, 2024, as compared to $5 7 million for the same period in 2023.

Paul McBarron: Research and Development or R&D expenses were $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same period in 2023. R&D expenses relating to FADRA were $1.8 million for the three months ended March 31, 2024, as compared to $4.1 million for the same period in 2023, due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to PLOGO were $1 million for the three months ended March 31, 2024, as compared to $1.4 million for the same period in 2023, due to a decrease in manufacturing and other non-clinical expenditures.

Speaker Change: R&D expenses relating to Fabra, while $1 8 million for the three months ended March 31st 2024, as compared to $4 1 million for the same period in 2023.

Speaker Change: Due to a decrease in clinical trial and other non clinical expenditures.

Fabra: R&D expenses relates to <unk> 1 million for the three months ended March 31, 2024, as compared to $1 4 million for the same period in 2023 due to a decrease in manufacturing and other non clinical expenditures.

Paul McBarron: Expenses related to PLOGO will be greatly reduced in 2024 as we have paused the 140-101 study while a new SALT formulation becomes available. General and Administrative expenses remain relatively flat at approximately $1.6 million for each of the three months ended March 31st, 2024, and 2023. Total other expenses net for the three months ended March 31st, 2024 were 0.1 million compared to 0.2 million for the same period of the previous year. United Kingdom research and development tax credits for the three months ended March 31st 2024 were 1.4 million, which includes 0.8 million related to the 2023 claim which, as I mentioned previously, we have now received payments for, compared to 1.3 million for the same period of the previous year, and are directly correlated to qualifying research and development expenditure.

Speaker Change: Expenses related to <unk> will be greatly reduced in 'twenty 'twenty four as we have paused the $1 40 cash 101 study, while the new salt formulation becomes available.

Speaker Change: General and administrative expenses remained relatively flat at approximately $1 6 million for each of the three months ended March 31, 2024 and 2023.

Speaker Change: Total other expenses net for the three months ended March 31, $2024 1 million compared to <unk> 2 million for the same period of the previous year.

United Kingdom: United Kingdom Research and development tax credits for the three months ended March 31, 2024, or one 4 million.

Speaker Change: Which includes <unk> 8 million related to the 'twenty to 'twenty three claim which as I mentioned previously we have now received payment.

Speaker Change: Compared to $1 3 million for the same period of the previous year.

Speaker Change: Directly correlated to qualifying research and development expenditure.

Speaker Change: Net loss for the three months ended March 31, 2024, with $2 9 million, which includes stock based compensation expense of <unk> 2 million compared to $5 8 million.

Paul McBarron: Net loss for the three months ended March 31st, 2024 was $2.9 million, which included stock-based compensation expense of $0.2 million, compared to $5.8 million, including stock-based compensation expense of $0.4 million, for the same period in 2023. As we concentrate our resources on recruiting patients in the specific cohorts in the Pfizer Phase 2 study, we anticipate that our expenditures in 2024 will continue to decrease. The company estimates that its current cash resources will fund currently planned programs into the fourth quarter of 2024. Operator, we are now ready to take questions. Yes, sir. At this time, if you...

Speaker Change: Stock based compensation expense of <unk> 4 million for the same period in 2023.

Speaker Change: As we concentrate our resources on recruiting patients into specific cohorts in the fall of the phase two study, we anticipate that our expenditures in 'twenty 'twenty four will continue to decrease.

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

Speaker Change: Operator, we're now ready to take your questions.

Speaker Change: Yes, Sir at this time, if you'd like to ask a question. Please press the star and one on your telephone keypad you may remove yourself in the queue at any time by pressing star to once again that is star one to ask a question, we'll pause for a moment to allow questions to queue.

Operator: Yes, sir. At this time, if you would like to ask a question, please press the star and 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. We will pause for a moment to allow questions to queue. Our first question comes from Ahu Demir from Leyden, Virginia.

Speaker Change: Our first question comes from AHU Demir.

Ahu Demir: With Ladenburg Thalmann.

Ahu Demir: Thank you very much for taking my questions. Two from us. The first one is, what are we expecting to see at ASCO from the FUD RecycLAB 101 study? Could you provide more color? How many patients are we going to see? Subset analysis and any additional information would be very helpful.

Ahu Demir: Thank you very much for taking my questions two from US first money what are we expecting to see at ash coal from the Padras Pikelet 101 study could you provide more color. How many patients are we going to see subset analysis and any additional information would be very helpful.

Ahu Demir: Thank you for your question I'll, who I will turn it over to Brian to answer the question on the ask or content.

Spiro George Rombotis: Thank you for your question, Ahu. I will turn it over to Brian to answer the question on the ASCO content.

Brian Schwartz: Ahu, we're basically planning to present almost the totality of the dose escalation portion of the study. You know, the data cut was a couple of weeks ago, but we should have a full data set around the phase one dose escalation portion, including both the safety and efficacy seen so far. There'll also be PK and PD included.

Ahu Demir: Yes.

Brian Schwartz: We basically planning to present them almost the totality of the dose escalation portion of the study.

Brian Schwartz: You know the data Tech was a couple of weeks ago, but.

Brian Schwartz: But we should have full data set.

Brian Schwartz: Around the phase one dose escalation portion, including both the safety and efficacy and so far I'm jealous of the PK and PD included.

Brian Schwartz: Okay.

Ahu Demir: Thank you, Brian, and nice to chat with you again. Another question I have is about the proof of concept, phase two portion of the same study. We are expecting to see data later this year. Curious, what is the timeline? What are you going to present? And currently, how many sites are open, and what are your thoughts on enrollment, how fast that might move forward?

Brian Schwartz: Thank you, Brian and nice nice to chat with you again. Another question I have is on the proof of concept phase two portion of the same study we are expecting to see data later this year curious what is the timeline what are you going to present it.

Brian Schwartz: During the how many sites are open and where where are your talks on the enrollment how fast that might that might move forward.

Brian Schwartz: Hi, Brian.

Brian Schwartz: The, we've just opened the T cell lymphoma site. They are starting to open slightly differently from the phase one solid tumor sites. The solid tumor sites, we had already four sites enrolling, so it's just opening an additional three.

Brian Schwartz: So the we've just opened the T cell lymphoma side. They are starting to open slightly different from the phase one solid tumor sites the solid tumor sites.

Brian Schwartz: We had already four sites enrolling them. So it's just outgrew an additional three.

Brian Schwartz: In terms of timing, you know, these known mutations are sometimes difficult to determine the frequency of, but we are quite encouraged at the moment of patients being identified. We anticipate, most probably by the end of the year, we'll have enrolled both.

Brian Schwartz: In terms of timing.

Brian Schwartz: You know these these new studies known mutations or.

Speaker Change: Sometimes it's difficult to determine.

Speaker Change: The the frequency, but we're quite encouraged at the moment of patients being identified we anticipate that's probably by the end of the we've enrolled both cohorts.

Spiro George Rombotis: And we also add to Brian's color, Ahu, that these mutations are readily available as part of standard panels. We do not need a companion diagnostic to identify the patients, although the company is collecting data for future regulatory discussions. But the important point is that they are readily available, and there is no approved drug to treat these patients once they are identified with abnormalities.

Speaker Change: Okay.

Bryan: To Bryan's color Oh is that are these mutations are readily available as part of standard panels with did not need a companion diagnostic to identify the patients over a company is collecting data plus future regulatory discussions, but the important points up there are amply available and there is no approved.

Spiro George Rombotis: Drug too.

Bryan Smith: Treat these patients once they're identified would ever melody.

Ahu Demir: Very helpful. Thank you, Spiro. Thanks, Brian.

Speaker Change: Very helpful. Thank you spirit Thanks, Brian.

Speaker Change: Okay.

Paul McBarron: Thank you.

today's speakers: We have no further questions in the queue at this time I'd now like to turn the call back over to today's speakers for any additional or closing remarks.

Operator: We have no further questions in the queue at this time. I'd now like to turn the call back over to today's speakers for any additional or closing remarks.

Spiro George Rombotis: Thank you, operator. And thanks to all of you for joining Cyclacel's first quarter 2024 earnings call. Thaddeus Zickleb has achieved a key milestone with the first patients dosed in the phase two proof of concept stage, with important catalysts anticipated in 2024 and a strong competitive profile in its therapeutic class. As a reminder, our upcoming key milestones are, to report data from the dose escalation stage of the 065-101 study of oral FADRA in patients with advanced solid tumors and lymphoma at the ASCO 20

Operator: Thank you operator, and thanks to all of you for joining cycle ourselves first quarter 'twenty 'twenty four earnings call.

Clip: Clip has achieved a key milestone with the first patients dosed in the phase II proof of concept stage.

Spiro George Rombotis: With important catalysts anticipated in 2024.

Spiro George Rombotis: And the strong competitive profile and its therapeutic class.

Spiro George Rombotis: As a reminder, our upcoming key milestones are report data from the dose escalation stage of the 065 Dash 101 study of oral <unk> in patients with advanced solid tumors and lymphoma at the <unk> 2024 annual meeting.

Spiro George Rombotis: Report interim data from initial cohorts in the Phase 2, Open Label, Proof of Concept part of the 065-101 study with oral phagocyclib 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. Operator, at this time, you may end the call.

Spiro George Rombotis: Report interim data from initial cohorts in our phase two open label proof of concept part of our six five dash 101 study or for recycling in patients with advanced solid tumors and lymphoma.

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

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

Operator: 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.

Operator: Okay.

Operator: Hum.

Operator: [music].

Operator: Yeah.

Operator: Yeah.

Operator: Yeah.

Operator: Yeah.

Operator: Okay.

Operator: Yeah.