NASDAQ:CYCC Cyclacel Pharmaceuticals Q1 2024 Earnings Report $0.26 +0.03 (+14.41%) As of 10:39 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Cyclacel Pharmaceuticals EPS ResultsActual EPS-$2.27Consensus EPS -$4.93Beat/MissBeat by +$2.66One Year Ago EPS-$7.05Cyclacel Pharmaceuticals Revenue ResultsActual Revenue$0.03 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ACyclacel Pharmaceuticals Announcement DetailsQuarterQ1 2024Date5/14/2024TimeAfter Market ClosesConference Call DateTuesday, May 14, 2024Conference Call Time4:30PM ETUpcoming EarningsCyclacel Pharmaceuticals' Q1 2025 earnings is scheduled for Wednesday, May 7, 2025, with a conference call scheduled on Tuesday, May 13, 2025 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Cyclacel Pharmaceuticals Q1 2024 Earnings Call TranscriptProvided by QuartrMay 14, 2024 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Cyclacel Pharmaceuticals 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. Please note, today's call is being recorded. I would now like to turn the call over to the company. Operator00:00:42Please go ahead. Speaker 100:00:45Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the Q1 ending March 31, 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 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 Rumbadis, President and Chief Executive Officer Paul MacBaron, Executive Vice President, Finance and Chief Operating Officer and Doctor. Speaker 100:01:56Brian Schwartz, Chief Medical Officer. Vera 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 Q1 of 2024, which will be followed by a Q and A session. At this time, I would like to turn the call over to Spiro. Speaker 200:02:20Thank you, Grace, and thank you, everyone, for joining us today for our Q1 2024 business update. As previously reported, we have closed the financing for $8,000,000 in gross proceeds in a private placement priced at the market per NASDAQ rules. With additional resources in place, we have begun dosing patients in the Phase 2 proof of concept part of our 65-one hundred and one study evaluating fadraciclib or Fadra for short in patients with 1 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, oral CDK2nine inhibitor following findings in our clinical and preclinical data, which suggest the hypothesis that patients with 1 or more of these chromosomal abnormalities may be sensitive to FADRA. In the Phase 2 part, we are evaluating patients selected for their mutational profile and or Phase 1 activity in various solid tumors and lymphoma. Speaker 200:03:43We're initially enrolling 2 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 I 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. 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 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. Speaker 200:05:07We expect 2 key data readouts for FADRA this year. Final data for the dose escalation part of the 65-1 hundred and one study to be presented at the ASCO 2024 Annual Meeting in a few weeks and report on initial clinical activity from the Phase 2 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. Brian? Speaker 300:05:45Thank you, Spiro. In our recently completed 65,101 study, we determined the recommended Phase 2 dose for FODRA. As a reminder, this is 100 milligrams BID dosed orally 5 days per week in a 4 week cycle. No dose limiting toxicities were observed on the schedule. We have now dosed the 1st patient in the Phase 2 proof of concept part of the study with the initial focus of the cohort in patients with CDK2NA or B alterations. Speaker 300:06:27In order to speed up enrollment, we have opened additional sites with up to 7 participating in the Phase 2. We expect to deliver initial results by the second half of twenty twenty four. As we progress through the Phase 2 study, let me summarize the rationale for our clinical strategy. We have observed CDK N2A or B alterations including loss of function in multiple pre treated Phase 1 patients with various cancers. These included gynecological, hepatobiliary, lung, pancreatic and recently testicular who benefited from Fardrocyclib monotherapy. Speaker 300:07:17These patient groups are associated with a high unmet need and often have poor clinical outcomes. As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions after one cycle of oral FODMAP monotherapy in a squamous non small cell lung cancer patients 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. After retrospectively analyzing a subset of previously treated Phase 1 patients, we found a total of 8 patients with CDKN2A or 2B alterations, all of whom experienced clinical benefit of the FODRA monotherapy. These included an endometrial cancer patient who achieved a CR and over 3 years of treatment on for the previous IV FODR monotherapy study and was found to have CDKN2A and CDKN2B loss. Speaker 300:08:46We are also encouraged by Phase 1 anticancer activity observed in T cell lymphoma patients, including PRs in 2 out of 3 patients treated, one of whom who had loss of CDKN2A. Literature suggests that a large percentage of T cell lymphoma patients have loss of CDKN2A. Although the Phase 1 hypothesis generating data are limited and cannot be generalized. We believe that the data supports evaluating patients with these cancer types in Phase 2 proof of concept part of the study. I will now turn the call over to Paul to review our Q1 results. Speaker 400:09:35Thank you, Brian. As of March 31, 2024, pro form a cash and cash equivalents totaled $9,900,000 which includes proceeds from this month's private placement and $800,000 cash received for the 2nd and final part of the United Kingdom Research and Development Tax Credit claim for 2023. Cash and cash equivalents as of March 31, 2024, totaled $2,800,000 dollars compared to $3,400,000 as of December 31, 2023. Net cash used in operating activities was $500,000 for the 3 months ended March 31, 2024, which includes $2,900,000 received in March in respect to the 1st part of the 2023 R and D tax credit claim compared to $6,900,000 for the same period of 2023. Research and development or R and D expenses were $2,800,000 for the 3 months ended March 31, 2024, as compared to $5,700,000 for the same period in 2023. Speaker 400:10:49R and D expenses relating to FALDRA were $1,800,000 for the 3 months ended March 31, 2024, as compared to $4,100,000 for the same period in 2023 due to a decrease in clinical trial and other nonclinical expenditures. R and D expenses related to Plogo were $1,000,000 for the 3 months ended March 31, 2024, as compared to $1,400,000 for the same period in 2023 due to a decrease in manufacturing and other nonclinical expenditures. Expenses related to PLOGO will be greatly reduced in 2024 as we have paused the 140-one hundred and one study while a new salt formulation becomes available. General and administrative expenses remain relatively flat at approximately $1,600,000 for each of the 3 months ended March 31, 2024, 2023. Total other expenses net for the 3 months ended March 31, 2024, were $100,000 compared to $200,000 for the same period of the previous year. Speaker 400:12:04United Kingdom research and development tax credits for the 3 months ended March 31, 2024, were $1,400,000 which includes $800,000 related to the 2023 claim, which as I mentioned previously, we have now received payment compared to $1,300,000 for the same period of the previous year and are directly correlated to qualifying research and development expenditure. Net loss for the 3 months ended March 31, 2024, were $2,900,000 which includes stock based compensation expense of $200,000 compared to $5,800,000 including stock based compensation expense of $400,000 for the same period in 2023. As we concentrate our resources on recruiting patients in the specific cohorts in the FIDRIA Phase II 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 Q4 of 2024. Operator, we are now ready to take questions. Operator00:13:40Our first question comes from Ahu Kamir with Ladenburg Thalmann. Speaker 500:13:46Thank you very much for taking my questions. 2 from us. First one is, what are we expecting to see at ASCO from the padrecyclib101 study? Speaker 200:13:56Could you Speaker 500:13:57provide more color? How many patients are we going to see? Subset analysis and any additional information would be very helpful. Speaker 200:14:07Thank you for your question, Ahu. I will turn over to Brian to answer the question on the ASCO content. Speaker 300:14:12Yes. Ahu, we're basically planning to present almost the totality of the dose escalation portion of the study. The data cut was a couple of weeks ago, but we should have full data set around the Phase 1 dose escalation portion, including both the safety and efficacy seen so far. There will also be PK and PD included. Speaker 500:14:43Thank you, Brian. And nice to chat with you again. Another question I have is on the proof of concept Phase 2 portion of the same study. We are expecting to see data later this year. Curious what is the timeline? Speaker 500:14:57What are you going to present? And currently, how many sites are open? And what are your thoughts on the enrollment? How fast that might move forward? Brian? Speaker 300:15:10We've just opened the T cell lymphoma site. They're starting to open slightly different from the Phase 1 solid tumor sites. The solid tumor sites, we had already 4 sites enrolling. So it's just opening an additional 3. In terms of timing, these known mutations are sometimes difficult to determine the frequency, but we're quite encouraged at the moment of patients being identified. Speaker 300:15:47We anticipate most probably by the end of the year, we've enrolled both cohorts. Speaker 400:15:54Okay. Thank you. Speaker 200:15:55Let me 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 the to treat these patients once they identify with Evomelody. Speaker 500:16:21Very helpful. Thank you, Sapiro. Thanks, Brian. Speaker 200:16:26Thank you, Ajo. Operator00:16:30We 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. Speaker 200:16:40Thank you, operator. And thanks to all of you for joining Cyclacel's Q1 2024 earnings call. Fibrocyclib has achieved a key milestone with the first patients dosed in the Phase 2 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 report data from the dose escalation stage of the 65-one hundred and one study of oral FODRA in patients with advanced solid tumors and lymphoma at the ASCO 2024 Annual Meeting. Report interim data from initial cohorts in Phase 2 open label proof of concept part of OX55-1 hundred and one study with oral fundercyclib in patients with advanced solid tumors and lymphoma. Speaker 200:17:40We 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. Operator00:17:50Thank you, sir. This does conclude today's program. Thank you for your participation. You may disconnect at any time.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallCyclacel Pharmaceuticals Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Cyclacel Pharmaceuticals Earnings HeadlinesStockNews.com Initiates Coverage on Cyclacel Pharmaceuticals (NASDAQ:CYCC)April 18, 2025 | americanbankingnews.comCyclacel Pharmaceuticals Reports Fourth Quarter Financial Results and Provides Business UpdateApril 2, 2025 | globenewswire.comTrump to unlock 15-figure fortune for America (May 3rd) ?We were shown this map by former Presidential Advisor, Jim Rickards, one of the most politically connected men in America. Rickards has spent his fifty-year career in the innermost circles of the U.S. government and banking. And he believes Trump could soon release this frozen asset to the public. April 25, 2025 | Paradigm Press (Ad)Cyclacel Pharmaceuticals Announces $1 Million Private Placement Offering of Convertible Preferred StockMarch 24, 2025 | globenewswire.comCyclacel Pharmaceuticals Announces Closing of a Change of Control Transaction and Appointment of New Executive LeadershipFebruary 27, 2025 | globenewswire.comCyclacel Pharmaceuticals adjusts shareholder rights, amends stockFebruary 12, 2025 | msn.comSee More Cyclacel Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Cyclacel Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Cyclacel Pharmaceuticals and other key companies, straight to your email. Email Address About Cyclacel PharmaceuticalsCyclacel Pharmaceuticals (NASDAQ:CYCC), a clinical-stage biopharmaceutical company, develops medicines for the treatment of cancer and other proliferative diseases in the United States, the United Kingdom, and internationally. The company's lead product includes fadraciclib, a cyclin dependent kinase Inhibitors (CDK) that is in Phase 1/2 clinical trial for the treatment of solid tumors and hematological malignancies, as well as in combination with venetoclax to treat relapsed or refractory chronic lymphocytic leukemia; and Plogosertib, a polo-like kinase inhibitor program, which is in Phase 1/2 clinical trial for the treatment of advanced solid tumors and hematological malignancies. It has a clinical collaboration agreement with the University of Texas MD Anderson Cancer Center to clinically evaluate the safety and efficacy of three cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias, acute myeloid leukemias, myelodysplastic syndromes, and other advanced leukemias. The company was founded in 1996 and is headquartered in Berkeley Heights, New Jersey.View Cyclacel Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Tesla Earnings Miss, But Musk Refocuses and Bulls ReactQualcomm’s Range Narrows Ahead of Earnings as Bulls Step In Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Booking (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 6 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Cyclacel Pharmaceuticals 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. Please note, today's call is being recorded. I would now like to turn the call over to the company. Operator00:00:42Please go ahead. Speaker 100:00:45Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the Q1 ending March 31, 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 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 Rumbadis, President and Chief Executive Officer Paul MacBaron, Executive Vice President, Finance and Chief Operating Officer and Doctor. Speaker 100:01:56Brian Schwartz, Chief Medical Officer. Vera 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 Q1 of 2024, which will be followed by a Q and A session. At this time, I would like to turn the call over to Spiro. Speaker 200:02:20Thank you, Grace, and thank you, everyone, for joining us today for our Q1 2024 business update. As previously reported, we have closed the financing for $8,000,000 in gross proceeds in a private placement priced at the market per NASDAQ rules. With additional resources in place, we have begun dosing patients in the Phase 2 proof of concept part of our 65-one hundred and one study evaluating fadraciclib or Fadra for short in patients with 1 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, oral CDK2nine inhibitor following findings in our clinical and preclinical data, which suggest the hypothesis that patients with 1 or more of these chromosomal abnormalities may be sensitive to FADRA. In the Phase 2 part, we are evaluating patients selected for their mutational profile and or Phase 1 activity in various solid tumors and lymphoma. Speaker 200:03:43We're initially enrolling 2 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 I 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. 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 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. Speaker 200:05:07We expect 2 key data readouts for FADRA this year. Final data for the dose escalation part of the 65-1 hundred and one study to be presented at the ASCO 2024 Annual Meeting in a few weeks and report on initial clinical activity from the Phase 2 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. Brian? Speaker 300:05:45Thank you, Spiro. In our recently completed 65,101 study, we determined the recommended Phase 2 dose for FODRA. As a reminder, this is 100 milligrams BID dosed orally 5 days per week in a 4 week cycle. No dose limiting toxicities were observed on the schedule. We have now dosed the 1st patient in the Phase 2 proof of concept part of the study with the initial focus of the cohort in patients with CDK2NA or B alterations. Speaker 300:06:27In order to speed up enrollment, we have opened additional sites with up to 7 participating in the Phase 2. We expect to deliver initial results by the second half of twenty twenty four. As we progress through the Phase 2 study, let me summarize the rationale for our clinical strategy. We have observed CDK N2A or B alterations including loss of function in multiple pre treated Phase 1 patients with various cancers. These included gynecological, hepatobiliary, lung, pancreatic and recently testicular who benefited from Fardrocyclib monotherapy. Speaker 300:07:17These patient groups are associated with a high unmet need and often have poor clinical outcomes. As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions after one cycle of oral FODMAP monotherapy in a squamous non small cell lung cancer patients 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. After retrospectively analyzing a subset of previously treated Phase 1 patients, we found a total of 8 patients with CDKN2A or 2B alterations, all of whom experienced clinical benefit of the FODRA monotherapy. These included an endometrial cancer patient who achieved a CR and over 3 years of treatment on for the previous IV FODR monotherapy study and was found to have CDKN2A and CDKN2B loss. Speaker 300:08:46We are also encouraged by Phase 1 anticancer activity observed in T cell lymphoma patients, including PRs in 2 out of 3 patients treated, one of whom who had loss of CDKN2A. Literature suggests that a large percentage of T cell lymphoma patients have loss of CDKN2A. Although the Phase 1 hypothesis generating data are limited and cannot be generalized. We believe that the data supports evaluating patients with these cancer types in Phase 2 proof of concept part of the study. I will now turn the call over to Paul to review our Q1 results. Speaker 400:09:35Thank you, Brian. As of March 31, 2024, pro form a cash and cash equivalents totaled $9,900,000 which includes proceeds from this month's private placement and $800,000 cash received for the 2nd and final part of the United Kingdom Research and Development Tax Credit claim for 2023. Cash and cash equivalents as of March 31, 2024, totaled $2,800,000 dollars compared to $3,400,000 as of December 31, 2023. Net cash used in operating activities was $500,000 for the 3 months ended March 31, 2024, which includes $2,900,000 received in March in respect to the 1st part of the 2023 R and D tax credit claim compared to $6,900,000 for the same period of 2023. Research and development or R and D expenses were $2,800,000 for the 3 months ended March 31, 2024, as compared to $5,700,000 for the same period in 2023. Speaker 400:10:49R and D expenses relating to FALDRA were $1,800,000 for the 3 months ended March 31, 2024, as compared to $4,100,000 for the same period in 2023 due to a decrease in clinical trial and other nonclinical expenditures. R and D expenses related to Plogo were $1,000,000 for the 3 months ended March 31, 2024, as compared to $1,400,000 for the same period in 2023 due to a decrease in manufacturing and other nonclinical expenditures. Expenses related to PLOGO will be greatly reduced in 2024 as we have paused the 140-one hundred and one study while a new salt formulation becomes available. General and administrative expenses remain relatively flat at approximately $1,600,000 for each of the 3 months ended March 31, 2024, 2023. Total other expenses net for the 3 months ended March 31, 2024, were $100,000 compared to $200,000 for the same period of the previous year. Speaker 400:12:04United Kingdom research and development tax credits for the 3 months ended March 31, 2024, were $1,400,000 which includes $800,000 related to the 2023 claim, which as I mentioned previously, we have now received payment compared to $1,300,000 for the same period of the previous year and are directly correlated to qualifying research and development expenditure. Net loss for the 3 months ended March 31, 2024, were $2,900,000 which includes stock based compensation expense of $200,000 compared to $5,800,000 including stock based compensation expense of $400,000 for the same period in 2023. As we concentrate our resources on recruiting patients in the specific cohorts in the FIDRIA Phase II 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 Q4 of 2024. Operator, we are now ready to take questions. Operator00:13:40Our first question comes from Ahu Kamir with Ladenburg Thalmann. Speaker 500:13:46Thank you very much for taking my questions. 2 from us. First one is, what are we expecting to see at ASCO from the padrecyclib101 study? Speaker 200:13:56Could you Speaker 500:13:57provide more color? How many patients are we going to see? Subset analysis and any additional information would be very helpful. Speaker 200:14:07Thank you for your question, Ahu. I will turn over to Brian to answer the question on the ASCO content. Speaker 300:14:12Yes. Ahu, we're basically planning to present almost the totality of the dose escalation portion of the study. The data cut was a couple of weeks ago, but we should have full data set around the Phase 1 dose escalation portion, including both the safety and efficacy seen so far. There will also be PK and PD included. Speaker 500:14:43Thank you, Brian. And nice to chat with you again. Another question I have is on the proof of concept Phase 2 portion of the same study. We are expecting to see data later this year. Curious what is the timeline? Speaker 500:14:57What are you going to present? And currently, how many sites are open? And what are your thoughts on the enrollment? How fast that might move forward? Brian? Speaker 300:15:10We've just opened the T cell lymphoma site. They're starting to open slightly different from the Phase 1 solid tumor sites. The solid tumor sites, we had already 4 sites enrolling. So it's just opening an additional 3. In terms of timing, these known mutations are sometimes difficult to determine the frequency, but we're quite encouraged at the moment of patients being identified. Speaker 300:15:47We anticipate most probably by the end of the year, we've enrolled both cohorts. Speaker 400:15:54Okay. Thank you. Speaker 200:15:55Let me 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 the to treat these patients once they identify with Evomelody. Speaker 500:16:21Very helpful. Thank you, Sapiro. Thanks, Brian. Speaker 200:16:26Thank you, Ajo. Operator00:16:30We 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. Speaker 200:16:40Thank you, operator. And thanks to all of you for joining Cyclacel's Q1 2024 earnings call. Fibrocyclib has achieved a key milestone with the first patients dosed in the Phase 2 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 report data from the dose escalation stage of the 65-one hundred and one study of oral FODRA in patients with advanced solid tumors and lymphoma at the ASCO 2024 Annual Meeting. Report interim data from initial cohorts in Phase 2 open label proof of concept part of OX55-1 hundred and one study with oral fundercyclib in patients with advanced solid tumors and lymphoma. Speaker 200:17:40We 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. Operator00:17:50Thank you, sir. This does conclude today's program. Thank you for your participation. You may disconnect at any time.Read morePowered by