Q4 2023 Cyclacel Pharmaceuticals Inc Earnings Call
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Okay.
Operator: Good afternoon, and welcome to the Cyclacel Pharmaceuticals fourth quarter and full year 2023 earnings conference call and webcast. At this time, all participants are in a listen only mode.
Good afternoon, and welcome to the cycle sale Pharmaceuticals fourth quarter and full year 2023 earnings conference call and webcast. At this time all participants are in a listen only mode. After todays call members of the financial community will have the opportunity to ask questions. If you would like to ask a question at that time. Please press star one on.
Operator: After today's call, members of the financial community will have the 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.
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 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 Zero. Please note today's call is being recorded I would now like to turn the call.
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 zero. Please note today's call is being recorded. I'd now like to turn the conference call over to the company. Please go ahead.
Call over to the company. Please go ahead.
Operator: Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the fourth quarter and financial year ended December 31st, 2023. Before turning the call over to management, I would like to remind everyone that, during this conference call, forward-looking statements made by management are intended to fall within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and process, 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. With us today are Spiro Rombotis, President and Chief Executive Officer.
Good afternoon, everyone and thank you for joining today's conference call to discuss cyclists Shell's financial results and business highlights for the fourth quarter and financial year ended December 31st 2023.
Before turning the call over to management I would.
Like to remind everyone that during this conference call.
Looking statements made by management are intended to fall within the safe Harbor provision.
Private Securities Litigation Reform Act of 1995, and section 21 E of Securities Exchange Act of 1934 as amended.
I 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.
Microsoft does not take any responsibility to update such information.
With us today are spiro embodies pregnant.
And as Chief Executive Officer.
Paul Mcdonough.
Executive Vice President Finance and Chief operating Officer.
Dr. Brian Schwartz Chief Medical Officer.
Spiro will begin with an overview of our business strategy and progress.
Brian will provide detail I think we've got the clinical programs and then Paul will provide financial highlights for the fourth quarter and full year 2023, which will be followed by Q&A session.
Spiro George Rombotis: 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 then Paul will provide financial highlights for the fourth quarter and full year 2023, which will be followed by a Q&A session. At this time, I'd like to turn the call over to Spiro. Thank you, Grace.
At this time I'd like to turn the call over there.
Thank you Grace and thank you everyone for joining us today for our fourth quarter and full year 2023 business update.
We are delighted to be joined on today's call by Dr. Brian Schwartz, who has recently joined cyclists L S Chief Medical Officer.
Many of you May know, Brian when he was CMO at our Q prior to the acquisition by Merck in 2020 at which time he joined our board of directors.
He has extensive clinical and product development experience.
Spiro George Rombotis: And thank you, everyone, for joining us today for our fourth quarter and full year 2023 business update. We are delighted to be joined on today's call by Dr. Brian Schwartz, who has recently joined Cyclacel as Chief Medical Officer. Many of you may know Brian when he was CMO at RQ prior to the acquisition by Merck in 2020, at which time he joined our board of directors.
Which will be instrumental in guiding our team to deliver key value inflection milestones.
We are pleased to report on the progress of fibrosis at our CDK to an nine inhibitor or <unk> for short.
Having recently discovered a potential precision medicine approach for cadre, we have determined the recommended phase two dose or our b to D.
And are ready to start the phase two proof of concept parts of 065 Dash 101 study.
Taken together, our clinical and preclinical data suggest the hypothesis that patients with one or more chromosomal abnormalities, including CDK into a C D K and to be and or N type <unk>.
Spiro George Rombotis: He has extensive clinical and product development experience, which will be instrumental in guiding our team to deliver key value inflection milestones. We are pleased to report on the progress of FADRA-Cyclib, our CDK2N9 inhibitor. Having recently discovered a potential precision medicine approach for FADRA, we have determined the recommended phase 2 dose, or RP2D, and are ready to start the phase two proof of concept part of our 065-101 study. Taken together, our clinical and preclinical data suggest the hypothesis that patients with one or more chromosomal abnormalities, including CDKN2A, CDKN2B, and or MTAP, including deep deletion In this part, we will evaluate patient cohorts selected for their mutation or profile and or phase one activity in various solid tumors and lymphomas.
Including deep deletions or loss of function may be sensitive to QUADRA.
In this box, we will evaluate patient cohorts selected for their mutational profile and or phase one activity in various solid tumors and lymphoma.
We will initially focus on two patient cohorts with CDK, and two eh and or CDK into be abnormalities and T cell lymphoma.
Both of which we saw phase one signals of activity, including responses.
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 co delete it.
CDK into a gene deletions occur in several solid tumors, including bladder breast endometrial and so for G. L Gliomas head and neck, hepatobiliary lung, including screen was melanoma ovarian.
<unk> and also in certain T cell lymphomas.
C D can to BD lesions occur in several solid tumors, including bladder <unk>.
Spiro George Rombotis: We will initially focus on two patient cohorts with CDKN2A and or CDKN2B abnormalities and T-cell lymphoma, for both of which we saw phase one signals of activity, including responses. We believe that there is great 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. TDK N2A 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.
Rest cholangiocarcinoma endometrial esophageal glioma Hasnt next havent thought there'd be theory long, including squamous in mesothelioma melanoma pancreatic and others.
As mentioned in our press release, we expect two key data Readouts for <unk> this year.
Final data from the dose escalation part of the O six Psi of Dash 101 study at a major medical conference in.
And later on initial clinical activity from the phase two proof of concept part.
Also at the upcoming ACR 2024 meeting independent investigators will present preclinical proof of concept data for far draw in various tumor types.
I will now turn the call over to Brian to review our progress in the father and plug those studies and discuss some of our clinical results Brian.
Thank you Spiro, we have dosed 47 patients in the dose escalation part of the far dry eye was 65101 study.
Spiro George Rombotis: TDK and 2B deletions occur in several solid tumors, including bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous and mesothelioma, melanoma, pancreatic, and others. As mentioned in our press release, we expect two Final data from the dose escalation part of the 065-101 study at a major medical conference and later on initial clinical activity from the phase two proof of concept part. Also, at the upcoming AACR 2024 meeting, independent investigators will present preclinical proof-of-concept data for FADRA in various tumor types. I will now turn the call over to Brian to review our progress in the FADRA and PLOGO studies and discuss some of our clinical results.
Of which 33 are evaluable for efficacy.
We have completed dose escalation and based on preclinical and clinical data.
Chairman that does stable five or 100 milligrams B I D. Dosed five days per week in a four week cycle will be a recommended phase II dose or P. D. R. <unk> two dee.
No dose limiting toxicities have been observed at this dose level.
We have also observed CDK into a or b alterations, including loss of function in multiple pre treated phase one patients with various cancers, including gynecological he patch of Billary lung and pancreatic who has been.
That's it for the farthest cyclic monotherapy.
These patient groups are associated with a high unmet medical need and also often have poor clinical outcomes.
An illustration of this is we were excited to see shrinkage of 22% in the sum of all target lesions. After one cycle of our own farthest cycling in of squamous non small cell lung cancer patient with CDK in T B deletion.
Brian Schwartz: Thank you, Spiro. We have dosed 47 patients in the dose escalation part of the FODRA 065101 study, of which 33 are revaluable for Africa. We have completed dose escalation, and based on preclinical and clinical data, have determined that dose level 5, or 100 milligrams BID administered five days per week in a four-week cycle, will be our recommended phase 2 dose, or RP2D. No dose-limiting toxicities have been observed at this dose level.
Refractory to standard of care chemotherapy and immunotherapy.
Oscar retrospectively analyzing subset of previously treated phase one patients we experienced clinical benefit with QUADRA. We found an additional five patients with CDK into eight with CDK into be alterations.
These included in endometrial cancer patients, who achieved a CR and over three years on treatment in a previous study with IV fall drive monotherapy and was found to have CDK into a CDK into b and in cap loss.
Brian Schwartz: We have also observed CDKN2A or B alterations, including loss of function, in multiple pre-treated phase 1 patients with various cancers, including gynecological, hepatobiliary, lung, and pancreatic, who have benefited from fodder-cyclab monotherapy. These patient groups are associated with high unmet medical needs and often have poor clinical outcomes. An illustration of this is we were excited to see shrinkage of 22% in the sum of all target lesions of one cycle of oral FOD recycLAB in a squamous non-small cell lung cancer patient with CDKN2B deletion, refractory to standard of care chemotherapy and immunotherapy. After retrospectively analyzing a subset of previously treated phase 1 patients who experienced clinical benefit with FODRA, we found an additional five patients with CDKN2A or CDKN2B alterations.
We are also encouraged by phase one anticancer activity.
<unk> in our T cell lymphoma patients, including P ores in two out of three patients.
A cohort in the part two of the six five why no one will evaluate patients with T cell lymphoma.
Although the phase one hypothesis generating data.
Limited and cannot be generalized we believe patients with these cancer types should be evaluated in the phase two proof of concept thought of the study.
Initially we expect to enroll 10 to 12 patients each of the two cohorts with CDK in to a or b alterations in T cell lymphoma.
We estimate that approximately eight sites will take part in the phase two and have completed civil site initiation visits. So we can quickly start enrollment and deliver results by the second half of 'twenty 'twenty four.
Let me now make a few remarks on our second program.
Brian Schwartz: These included an endometrial cancer patient who achieved a CR and over 3 years on treatment in a previous study with IV FADRA monotherapy and was found to have CDKN2A, CDKN2B, and NTAP loss. We are also encouraged by phase 1 anti-cancer activity observed in our T cell lymphoma patients, including PRs in two out of three patients. A cohort in Part 2 of the 065-101 will evaluate patients with T-cell lymphoma.
Hello go searching.
Go.
In the 140 101 dose escalation study of <unk>, we have enrolled 15 patients with good tolerability so far.
Although we observed early evidence of anticancer activity in multiple patients.
Preclinical and clinical data suggest that the optimum dosing may be achieved with an alternative salt formulation of <unk>.
Which has been under development.
Additionally, independent groups have shown that certain I read one day or smock CAE mutated cancers may benefit from treatment with <unk>.
Alright, and other mutations are found in several cancers, including bladder endometrial esophageal hepatic delivery and colorectal.
Brian Schwartz: Although the Phase I hypothesis-generating data are limited and cannot be generalized, we believe patients with these cancer types should be evaluated in the Phase II proof-of-concept part of the study. Initially, we expect to enroll 10 to 12 patients in each of the two cohorts with CDKN, 2A or B alterations, and T-cell lymphoma. We estimate that approximately eight sites will take part in Phase 2 and have completed several site initiation visits so we can quickly start enrollment and deliver results by the second half of 2024. Let me now make a few remarks on our second program. PLOGO Certain or PLOGO?
For these reasons, we have chosen to pause.
140 101 study.
With the current formulation and resumed dose escalation once the new formulation becomes available.
Following assessment of bioavailability and patients we will now be taking into account potential selection biomarkers for patients enrolling in 140 101 study.
I will now turn the call over to Paul to review, the fourth quarter and full year results.
Thank you Brian.
As of December 31st 2023, pro forma cash and cash equivalents totaled $6 $3 million, including $2 9 million of United Kingdom Research and development tax credits received after the end of the.
Cash and cash equivalents as of December 31st 2023 totaled $3 4 million compared to $18 4 million as of December 31st 2022.
Brian Schwartz: In the 140-101 dose escalation study of PLOGO, we have enrolled 15 patients with good tolerability so far. Although we observed early evidence of anti-cancer activity in multiple patients, preclinical and clinical data suggest that the optimum dose may be achieved with an alternative salt formulation of PLOGO, which is under development. Additionally, independent groups have shown that certain ARID1A or SMARCCA mutated cancers may benefit from treatment with PLOGA. ARID and other mutations are found in several cancers, including bladder, endometrial, esophageal, hepatobiliary, and colorectal.
Net cash used in operating activities was 16 1 million for the 12 months ended December 31st 2023, compared to $20 8 million for the same period of 2022.
The company estimates that its available cash, including the United Kingdom Research and development tax credit received a $2 9 million will fund currently planned programs into the second quarter of 2024.
Research and development or R&D expenses were $3 5 million and $19 2 million for the three months and year ended December 31st 2023.
As compared to $6 7 million and $20 3 million for the same period in 2022.
R&D expenses relating to fog draw with $2 7 million and $13 4 million.
Three months and year ended December 31st 2023 <unk>.
As compared to $5, three and $14 million.
Brian Schwartz: For these reasons, we have chosen to pause 140-101 Study with a current formulation and resume dose escalation once the new formulation becomes available, following assessment of bioavailability in patients.
Same period in 2022.
Due to a decrease in clinical trial costs.
Offset by an increase in manufacturing and other non clinical expenditures.
R&D expenses related to <unk> <unk>.
7 million and 5 million for the three months and year ended December 31st 2023.
Paul McBarron: We will now be taking into account potential selection biomarkers for patients enrolling in the 140-101 study. I will now turn the call over to Paul to review the fourth quarter and full year results. Thank you, Brian.
As compared to $1 3 million and $5 5 million for the same period in 2022 due to a decrease in manufacturing and other non clinical expenditures.
General and administrative expenses for the three months and year ended December 31st 2023 were $1 9 million and $6 7 million compared to 2.1 and $7 4 million for the same period of the previous year due to a decrease in professional fees.
Paul McBarron: As of December 31, 2023, pro forma cash and cash equivalents, total $6.3 million, including 2.9 million of United Kingdom Research and Development Tax Credits received after the end of the year. Cash and cash equivalents as of December 31st, 2023 total 3.4 million compared to 18.4 million as of December 31st, 2022. Net cash used in operating activities was $16.1 million for the 12 months ended December 31, 2023, compared to $20.8 million for the same period in 2022.
Total other income net for the three months and year ended December 31st 2023, or an expense of <unk> 3 million and they can expense of <unk> 1 million compared to an expense of <unk> 2 million and income of $1 7 million for the same period in the previous year.
A decrease of $1 8 million for the year ended December 31st 2023 is primarily related to royalty income we've seen in the previous year.
United Kingdom Research and development tax credits for the three months and year ended December 31st $2023 four.
$4 million and 3 million.
Compared to $1 6 million and $4 7 million with the same pay to the previous year.
And are directly correlated to qualifying research and development expenditure.
Net loss for the three months and year ended December 31, 2023 was $5 3 million and $22 6 million.
Including stock based compensation expense of <unk>, three and $1 5 million respectively.
Paul McBarron: The company estimates that its available cash, including the United Kingdom Research and Development Tax Credit received of $2.9 million, will fund currently planned programs into the second quarter of 2024. Research and Development or R&D expenses were $3.5 million and $19.2 million for the three months and year ended December 31, 2023, as compared to 6.7 million and 20.3 million for the same period in 2022. R&D expenses relating to FADRA were $2.7 million and $13.4 million for the three-month year ended December 31, 2023, as compared to $5.3 and $14 million for the same period in 2022.
That's a $7 4 million and $21 2 million, including against stock based compensation expense of <unk> 3 million and more qualified one respectively for the same period in 2022.
Operator, we're now ready to take questions.
Yeah.
Thank you 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 from the queue at any time by pressing star to once again that is star one to ask a question, we will pause for a moment to allow questions to queue.
My first question comes from AHU Demir with Ladenburg Thalmann.
Good afternoon, Thanks for taking my questions and Brian will come back great to see you back on the operational feat I have two questions first one is there an on the fly drive program.
You have two major data Readouts you mentioned for the phase one portion of the data Readouts are you going to disclose any of the PD biomarker data, including C D K and to a and b or others. That's my first question.
Okay. Thank you very much for your question Oh, Yes, there's yes, we intend to close.
You need data.
Yes.
Paul McBarron: Due to a decrease in clinical trial costs, offset by an increase in manufacturing and other non-clinical expenditures. R&D expenses related to PLOGO were $0.7 million and $5 million for the three months and year ended December 31, 2023, as compared to $1.3 million and $5.5 million for the same period in 2022, due to a decrease in manufacturing and other non-clinical expenditures. General and administrative expenses for the three months and year ended December 31, 2023 were $1.9 million and $6.7 million compared to $2.1 and $7.4 million for the same periods of the previous year due to a decrease in professional fees.
Remarks press release, we have six patients.
Specific genotype.
Correct.
Patients, whose phosphorus pumps, so that's clearly the generating des.
To share more with our investors.
Scott.
And then my second question is on the Pogo formulation and the clinical studies are currently not ongoing bank do you thing the formulation efforts will be completed and when do you think you were raised in the clinical efforts and also then are we going to see the data.
Clinical data from the program.
Well, Paul Who's in charge of our manufacturing for them to comment on the first question and I will discuss the second one.
To you.
Yeah, we and then the formulation the old new oral formulation of plug all Ctrip is ongoing we've been doing it for.
In short, while so we would anticipate about six months to complete.
That process.
As far as that goes.
Yeah that was the second part of your question was around 15 patients.
That's interesting.
Putting in tumor shrinkage and prolonged stable disease in five of those patients.
To be sure we can get the targeting he's been involved because we have that.
Paul McBarron: Total other income net for the three months and year-end of December 31st, 2023 was an expense of 0.3 million and an income of 0.1 million compared to an expense of 0.2 million and an income of 1.7 million for the same period of the previous year. The decrease of $1.8 million for the year ending 7-31-2023 is primarily related to royalty income received in the previous year. United Kingdom Research and Development Tax Credits for the three months and year ended December 31st, 2023 were $0.4 million and $3 million, compared to $1.6 million and $4.7 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure. Net loss for the three months and year ended December 31st, 2023 was 5.3 million and 22.6 million, including stock-based compensation expense of 0.3 and 1.5 million, respectively, compared to $7.4 million and $21.2 million, including, again, stock-based compensation expense of $0.3 million and $1.5 million, respectively, for the same period in 2022.
On the alternative salt, which gave us much higher than what was yours, we obviously need to go with that so that's the reason to pause the program and if any of them.
Improving kinetics.
Thank you.
Yeah.
Our next question comes from Kemp Delaware.
With Brookline capital markets.
Alright, thank you.
So.
The press release and in your transcript.
Refers to the cash runway.
Going into second quarter, which as you know, it's a short period of time away. So two questions related to that I mean, how far into the second quarter can you continue operating and then which.
Milestones.
Can you achieve.
Between now and then.
Yeah.
We can go after April of 2024.
One agenda that this processes.
Hey.
Oh, raising additional funds as well as considering other options for all of the strategic.
But as far as most of them got close that we expect to begin.
Phase two program.
Thanks, Brian.
On phase one.
The phase two is that recently, our pizza D, but can be onboarding phase two.
Question on when we see the abstracts from major medical meeting.
Year, which historically come out before we start to see those.
Okay.
[laughter] contain the phase one data for phase one data.
Some handle on the Pharmacodynamic profiles of patients not all of them because the cutoff was in winter, we expect to have someone in the public domain within this timeframe.
Great. Thank you.
Thank you Sam.
We have no further questions at this time I would now like to turn the call back over to the company for any additional or.
Operator: Operator, we're now ready to take questions. Thank you, sir. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two.
For closing remarks.
Thanks, operator, and thanks to all of you.
Joining zac.
Sure.
2023 earnings call.
Recycling has achieved a key milestone.
To start phase two.
Operator: Once again, that is star number one to ask a question. We will pause for a moment to allow questions to queue. Our first question comes from Ahu Demir with Leidenberg Thalmann.
Stage, one important catalysts anticipated didn't following 24 and a strong competitive profile.
Therapeutic class.
As a reminder, our key milestones are.
Patients dosed with oilfield recycling.
Ahu Demir: Good afternoon. Thanks for taking my questions. And Brian, welcome back.
Thanks Sue.
<unk> parts.
101 study in patients with advanced Thomas Kim lymphoma.
Ahu Demir: Great to see you back, back on the operational seat. I have two questions. First one is whether they are on the FADRA program.
Report final data.
Those escalation stage from I'll say, that's one of them.
Thanks, Ed.
Sure.
Ahu Demir: You have two major data readouts you mentioned for the phase one portion of the data readout. Are you going to disclose any of the PD biomarker data, including CDKN2A and B or others? That's my first question.
Sorry.
Hello.
Report interim data from initial call.
It's two open label.
Concept part.
Ashwin the one study with <unk>.
In fact, we're cycling in patients with advanced.
Lymphoma.
Spiro George Rombotis: Okay, thank you very much for your question, Ahu. The answer is yes. We intend to disclose some of the NAPID data at a mid-medical meeting. As we have heard in the remarks in the press release, we have six patients that have the specific genotype. We're very encouraged that these are the best patients as far as response goes, so there's clearly a hypothesis-generating data set, and we'll look to share more with our investors when the conference comes. Okay. My second question is about the PLOGO formulation.
An independent investigators to report clinical proof of concept data.
At the American Association for cancer research or ACR meeting by 'twenty four.
We look forward, providing you with further updates.
Some of you.
Frances.
At this time.
Thank you Sir this does conclude today's program. Thank you for your participation you may disconnect at anytime.
Okay.
Uh huh.
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Paul McBarron: As the clinical studies are currently not ongoing, when do you think the formulation efforts will be completed? And when do you think you will resume the clinical efforts? And also, when are we going to see the data, clinical data, from this program? I will ask Paul, who is in charge of our manufacturing effort, to comment on the first question. I will discuss the second one. Yeah, we in the formulation department, the new oral formulation of pluripositive is ongoing. We've been doing it for a short while.
Okay.
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Paul McBarron: So we'd anticipate about six months to complete that process. As far as the clinical data, on the second part of your question, we've enrolled 15 patients in the same clinical method, including tumor shrinkage and prolonged stable disease in five of those patients. But we need to be sure we can get to targeting different levels. As we have the backup formulation of the alternative salt, which gave us much higher exposures, we obviously need to go with that.
Hum.
Okay.
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Hum.
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Paul McBarron: And that's the reason we decided to pause the program in favor of improving our pharmacokinetics. Thank you. Our next question comes from Kemp Dolliver, with Brookline Capital Market. Great. Thank you. The press release and your transcript refer to the cash runway going into the second quarter, which, as you know, is a short period of time away. So two questions related to that.
Yeah.
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Yeah.
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Yeah.
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Unknown Caller: I mean, how far into the second quarter can you continue operating? And then what is the Milestone? Can you achieve it between now and...
Spiro George Rombotis: Thank you, Kim. We can go into April 2024, as we said. One can imagine that this process is going to go away as far as raising additional funds as well as considering other options for the strategic plan. As far as most of us are concerned, we expect to begin our work on our Phase 2 program. There are patients who are being lined up who could go either into the current Phase 1 or go into Phase 2. As I recently declared RP2D, we can begin enrolling in Phase 2. The question of when we see abstracts for major medical needs in the middle of the year historically comes out the month before. So we expect to see those around the same time frame. This will contain the Phase 1 data, the full Phase 1 data, including some detail on the pharmacodynamic profiles of patients, but not all of them, because the cutoff was in winter. We expect to have some of that data in the public domain within this time frame.
Uh-huh.
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Hum.
Hum.
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Okay.
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Spiro George Rombotis: Great, thank you. Thank you. We have no further questions at this time. I would now like to turn the call back over to the company for any additional closing remarks. Thanks to all of you for joining Cyclacel's first quarter and full year 2023 earnings call. Phytocycline has achieved a key milestone in the ready-to-start phase 2 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 the first patient dosed with oral phagocycline in Phase 2, the most important part of the O6-5-101 study, and the patient with advanced polychemical lymphoma. Report final data from the dose escalation stage from O6F-101, target oral fibrocyclic inpatients would advance to some December 7th of March. Report interim data from the initial cohort in the Phase 2 Open Label Proof-of-Concept part of 65-101 study with oral fibrocytin in patients with advanced cytotumors and lymphoma, and independent investigators to report the clinical proof-of-concept data for Thundercyclib at the American Association of Cancer Researchers, or AACR, annual meeting in 2024.
Okay.
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Hum.
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Hum.
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Hum.
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Operator: We look forward to providing you with further updates and hope to meet some of you at our conferences. Operator, at this time, you may end the call. Thank you, sir. This does conclude today's program. Thank you for your participation. You may disconnect at any time.
Operator: [inaudible] Ahu Demir, Mark Kirschbaum, Ahu Demir, Ahu Demir, Ahu Demir, Ahu Demir, Ahu Demir, Ahu [inaudible] Unknown Executive, Paul McBarron, Ahu Demir, Cyclacel Pharms, Unknown Executive, Paul McBarron, Ahu Demir, Cyclacel Pharms, [inaudible]