Q3 2022 Cyclacel Pharmaceuticals Inc Earnings Call
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Please standby your program is about to begin.
Good afternoon, and welcome to the <unk>.
Mike Lasalle Pharmaceuticals third quarter 2022 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'd 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 your question, we ask that you. Please pickup your handset to allow optimal sound quality. The company will also be accepting eliminate a number of questions submitted via email to <unk>.
The address IR at <unk> Dot Com 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.
Good afternoon, everyone and thank you for joining today's conference call to discuss <unk> financial results and business highlights for the third quarter of 2022 before turning call over to management I would like to remind everyone.
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 21 E of.
The Securities Exchange Act of $19 34 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 SEC, which include among other things our Form 10-Q. This filing is available from the SEC or.
Our web site.
All of our projections and other forward looking statements represent our judgment as of today and Frank Lasalle does not take any responsibility to update such information.
With us today are Spiro <unk>, President and Chief Executive Officer, Palmer, Barron Executive Vice President Finance, and Chief operating Officer, and Dr. Mark Kirshbaum, Senior Vice President and Chief Medical Officer.
I will begin with an overview of our business strategy and progress on <unk> clinical programs and Paul will provide financial highlights for the third quarter of 2022, which will be followed by Q&A session.
At this time I would like to turn the call over to Spiro.
Thank you Eric and thank you everyone for joining us today for our quarterly business update.
We have made excellent progress in our ongoing phase one plus two clinical programs.
But the likelihood of Agra and see what <unk> <unk> or <unk> in patients with solid tumors and lymphoma.
But we're excited to provide new data with oral <unk>.
Maam, DNA 2022, or triple meeting with exceeded our expectations for the phase one study primarily designed to study safety and optimal dosing.
Last week, we also reviewed farquhar and one for the clinical and preclinical data at our R&D day.
In addition to the clinical data, which will be reviewed later on by Mark Kirshbaum two of our principal investigators summarized the treatment landscape for T cell lymphoma, and Hepatobiliary cancers.
Each of these challenging indications has its own dedicated cohort phase II study.
Cancers of interest profile growth for several reasons.
One of these reasons what presented by the investigator firm So National University Hospital.
Sure preclinical data from hemlo.
Showing sensitivity to Barbara in biliary tract cancer cells.
So Jeff important potential for our drug in this cancer type.
The sales were obtained from patients in her clinic, one of the largest in the world specializing in biliary tract cancers.
As for lymphoma, where we're excited to see monotherapy PR in.
In patients with both cutaneous and peripheral T cell lymphoma.
These included a PR.
In the NGL immunoblastic type or previous zero, which is explained by the investigator from city of hope very difficult to treat.
We also reported an exciting new findings from our 140 program.
Including early signals of clinical activity and further evidence.
Differentiated biological profile.
For those of you who are unable to join our R&D day.
Plenty of reason, including the key opinion leader presentation is available on our website.
Over the next 12 months, we expect multiple data readouts from the registration directed phase <unk> studies for <unk> and $1 40.
The dose escalation part of the progress study is approaching completion and will soon enter a phase two proof of concept stage.
Initial data from this stage with multiple cohorts by histology are expected around the middle of 2023.
Dose escalation in the 140 <unk> study is a bit earlier.
Rates are currently submitting patients four slots in dose level three.
We expect initial data from this 140 study in mid 2023 as well.
Before handing over to Mark I would like to recognize the tremendous talent pool of <unk>.
Skilled drug developers within the company and at our collaborating institutions.
The technical team is committed to our strategy of bringing our two molecules to proof of concept stage and creating shareholder value.
We are well on our way to achieving that with fiber.
And we will soon be in a position to potentially would do the same for 140.
We believe that our medicines.
Differentiated from other kinase inhibitors and their respective classes with properties, which may be best in class.
I will now turn the call over to our Chief Medical Officer, Dr. Mark <unk> to provide details on our recent clinical data.
Mark.
Thank you Spiro.
I mentioned, we are very pleased with the single agent activity Youre seeing is their own Fargo and the encouraging progress of $1 49, a phase one studies.
Let me briefly review the ongoing.
101 phase one two studies with oral sondra.
The primary objective of this study is determination of the recommended phase two dose or <unk> and <unk>.
Okay.
<unk> is determined.
That is designed to immediately move into phase II proof of concept stage.
<unk> of the drug and relevant tumor types will be the primary objective.
The phase one part will determine whether cloud was tolerated with the objective of choosing an optimal dosing schedule page.
Patients recruited into the stage generally hasnt been I don't no longer responding to treatment.
Thus referred specialized centers such as the ones participating study with you are among the top phase one in the world.
In this difficult to treat phase one population has been exciting to see early indications of broad anti cancer activity.
Two out of three patients with T cell lymphoma achieved partial response or PR, including a patient with a very aggressive.
No plastic form of T cell lymphoma, 11 of 15 patients with cervical endometrial liver ovarian cancer achieved stable disease with target lesion reductions.
Scott.
Pancreatic patient maintained stable disease for five cycles of treatment.
These are promising responses to this phase of development and predict deeper responses in the phase II study, which subjects will be treated earlier in the course of their illness.
We are pleased to report that further as well tolerated, thus far and that we were able to escalate quickly from dose level of one to five which is the 100 milligram PID Monday through Friday for four weeks out of four.
Because the 100 milligram twice daily dose on the four week schedule is completed.
Considered safe based.
Based on data collected from completed dose levels, including dose level five.
No dose limiting toxicities related to study drug.
Overall, we see primarily nausea at a manageable level as the only consistent.
Side effects of the drug.
We have also reported at <unk> 2022 results from Pharmacokinetics studies and preliminary results of molecular correlative studies, some patient 065 101.
The plasma concentrations of fab recyclable or dose proportional and cross the target engagement threshold levels for CDK to MTV canine.
At the higher dose levels, four and five for approximately five to seven hours per dose continuous dosing.
Well that Fargo goes twice daily cleanly achieve good coverage of the targets per day.
Correlative molecular studies, such as RNA seek while still preliminary show results consistent with the predicted activity of the drug.
As we near the end of the dose escalation part of the trial, we expect to identify <unk> and initiate phase II proof of concept in early 2023 to evaluate tumors of interest, which I believe to be sensitive to the activity of fungi, including breast colorectal endometrial biliary ovarian and uterine cancers.
Thomas.
With regard to our second oil fields of study there are 651 or two in patients with acute myeloid leukemia and Myelodysplastic syndrome, we are enrolling patients at dose level, four which is 100 milligrams PID Monday through Friday on weeks one through three.
The 28 day cycle.
We look forward to providing an update on the there is six five 102 trial in 2023.
And our recent R&D day, we also reported additional encouraging results from 140 101.
Phase one two study of 140 <unk> wanted to grow.
The $1 41 to one study is currently enrolled six patients with advanced solid tumors and lymphoma at dose level, one and two.
As this is the first in human study for oral <unk> hundred 40 <unk>.
Traditional <unk> started at lower doses.
Therefore suddenly surprised in this early stage in the study to observe stable disease at dose level, one and two patients with metastatic non small cell lung cancer for six Michaels and one was metastatic ovarian cancer, who went through five cycles.
Published preclinical evidence.
Yes.
Dose continuous administration may be an effective strategy for plc, one inhibitors as well as the more documented higher dose pulse type strategy.
Particularly true for 140, given that it has a favorable PK inhibitor inhibitory profile.
And the shorter half life potentially minimizing as.
As well as loan animal level inhibition of <unk> four.
<unk> before is a central epigenetic target, which plays an important role in the regulation of many oncogene involved process.
Our ongoing phase one two trial of 140 is designed to target several important tumor types with the drugs activity may show broad single agent activity.
This was observed across multiple preclinical models, including breast esophageal gastric non small cell lung ovarian and squamous cell carcinoma.
Our study efficiently evaluates both dose and schedule for the best dose and schedule can be chosen for the efficacy or cohort stage of the study in these tumor types.
I will now turn the call over to Paul to review, our third quarter financial results.
Thank you Mark.
As of September 32022, cash and cash equivalents totaled $23 $7 million.
Compared to $36 6 million as of December 31, 2021.
Net cash used in operating activities was $15 7 million for the nine months ended September 32022.
Compared to $14 million for the same period of 2021.
The company estimates that its available cash will fund currently planned programs through the end of 2023.
Research and development or R&D expenses were $4 4 million for the three months ended September 32022.
As compared to $4 2 million for the same period in 2021.
R&D expenses relating to the cycle with $2 5 million for the three months ended September 32022.
As compared to $3 3 million for the same period in 2021.
Due to a decrease in clinical trial costs $3 million associated with the ongoing phase one two studies and.
And a reduction of <unk> 5 million in non clinical expenditures.
R&D expenses related to <unk> $141 7 million for the three months ended September 32022.
As compared to <unk> 7 million for the same period in 2021.
The clinical trial costs associated with the $1 40, that's 101 phase one two study.
General and administrative expenses for the three months ended September 32022, with $2 1 million compared to $1 8 million for the same period of the previous year due to an increase in professional and legal costs.
Total other income net for three.
Three months ended September 32022 was <unk> 4 million.
Third to $13000 for the same period of the previous year.
The increase of <unk> 3 million for the three months ended September 32022 is primarily related to foreign exchange gains.
The United Kingdom Research and development tax credits were $1 million to each of the three months ended September 32022 and September 32021.
Not directly correlated to qualifying research and development expenditure.
Net loss for the three months ended September 32022 was $5 1 million compared to 5 million for the same period in 2021.
Operator, we are now ready to take questions.
If you would like to ask a question at this 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 to you.
Posing your question, we ask that you. Please pickup your handset to allow optimal sound quality.
And our first question comes from Bahu Gamer.
From Ladenburg.
Good evening. Thank you so much for taking my question.
Also congrats on the progress you have made over the course thoughts.
At last months My first question will be on the sludge program.
There are multiple combinations and indications you plan to proceed for the proof of concept stage.
Are there any indications that you are particularly interested or you will be prioritizing for the first half of 2020.
Thank you I hope all your question, we are not prioritizing any one indication because they all come at the same time. However, it is obvious that the investigators have highest interest based on the initial dialogue with phase III sites abutments, Homer and women's cancers. That's always the case, we have seen clinical activity so far.
But obviously as the study starts to enroll we'll get people voting with their feet and reflecting both unmet medical needs as well as the relevance of the drug for the disease States.
Our cost for steel second question will be on day, one for these programs.
<unk> four inhibition is that new information to the public.
Would be curious to know what potential combinations and indications.
And then you will be close I know, it's not yet publicly known.
Any any information you provided in the timeline for it.
Yes, let me ask Mark to address the scientific and medical aspects of your question I'll come back on the timelines Mark over to you.
Yes, hi.
We're very early in the study.
We're still assuming the dosing schedule, so it's hard to really.
What kind of combinations, where can I go ahead.
Tumor types in the past have been responsive to single agent.
Therapy and were hoping to replicate that kind of activity so far.
First step.
Thank you Mark so on the question of timing. This is a phase one dose escalation study normally we would not expect to see activity at the first dose level, which typically is below the expected therapeutic window. It's clear that we were wrong in that assumption that the drug is active at a low level that mark has provided an explanation for that.
The R&D day, which some of you may have already heard.
Essentially we need to complete the escalation we need to go up perhaps three or four 5% demand levels.
The answer we expect this to happen within the first half of 2023 and need to continue to see activity that of course does that could speed up things and entry into phase III.
In addition to BRD for activity, which you highlighted who I would like to turn people's attention to the chaos due to a <unk> mutation that we have recently discovered was registered with the patients who have non small cell lung cancer is still on study after six cycles. So very encouraging that the first dose level as we know the <unk> inhibitors.
Sensitive to Trs mutations.
As many of you know there is one approved drug for chaos G 12, see but there is no approved drug in a huge unmet medical need for other mutations, including <unk>, which is the one that outpatient past. So this is going to be a very exciting Avenue of investigation and I would expect to see patients with lung potentially call on another chaos relevant tumors.
Wishing to earn slots in our study as we move forward the dose escalation.
Very helpful. Thank you so much for taking my question.
Thank you.
Our next question comes from Schuff, Hindu summary from Brooklyn capital markets.
Yeah.
Alright, Thank you for taking my question.
So with regards to the fabric product how many patients have been dosed in those logistics.
And are you planning or you're also enrolling a dose level seven.
How are you thinking about it thank you.
Yes.
But I think this is a question for Mark.
Yes, hi.
We are just ongoing with those little six so it's way too early to really disclose that information.
But it's accruing now I mean, we're in that's.
That's in process in real time, now so we will update that in a short while.
Okay. Thanks.
I wanted to the 140 <unk>.
Until you are in those two and enrolling for those 83. So how are you planning to escalate.
Please elaborate on the schedule there.
Yes sure Mark.
Yes, so certainly so the.
It's pretty straight ahead.
It's a five milligram increase essentially each for each dose level.
Scientific evidence that shows that low dose and a continuous dosing schedule and then higher doses and a pulse type schedule both hubs.
Activity pre clinically.
So we're looking at both both of these dosing regimens and schedules as we go along so we started with five milligrams three weeks contingencies with Monday through Monday through Friday, five days a week.
For three weeks out of four.
Now that we're at 10 milligrams a week on week off and then the next the next dose level will be three weeks continuously color.
Color is it so that's kind of how the how the drug will go alone.
We're taking doing it slow.
Because these drugs have.
In the past so Fortunately, we're not seeing any of this kind of flexibility at this point in time.
And as you heard.
Great Joy actually to the first three patients.
Clinical activity.
We think this.
This ultimate schedule kind of story they give us.
Multiple ways to treat patients as we go forward.
Yes.
I will take the various combinations.
Okay, Thanks relation with color.
Finally, if I may with 140 <unk> what are your thoughts about possible combinations with maybe with targeted therapies like <unk>.
In addition, our immunotherapies.
Thinking about that.
Mark.
Yeah.
Think about it as a loss.
Yes.
Again, the major thing that we have to do is see.
C where we are with this.
Obviously, if this low dose kind of approach holds up a little.
A lot of these kind of.
<unk> is a very simple fashion, because it'll be a nontoxic active regimen, but it's really too early to.
Really predict exactly.
Where we would go with us I think.
Just getting going.
This may be a good time, unless you've been good too.
Support of marks explanation to also remind the audience that we are going for single agent activity as our default strategy.
Combinations are an important part of the molecular profile of this drug as you correctly asked.
We think that he hasnt enhanced jobs compared to other <unk> inhibitors in the clinic, we show single agent activity to this end the BRD for discovery is very important it gives us a higher chance of single agent response, so from a business perspective allocating capital to test it in phase one as a single agent is very important to provide access to <unk>.
Discretionary opportunities and of course, if we have a safe and combinable drug as Mark pointed out we will certainly be exploring combinations, where its mechanistic rationale.
Bias is to look for single agent activity, if we can.
Excellent. Thank you so much for taking my question.
Thank you Samantha.
Once again another scarring one to ask a question we'll take our next question from Jonathan Aschoff from Roth Capital Partners.
Thank you guys that just a brief housekeeping should we grow G&A from this roughly $2 million number or was that a little bit of an outlier.
Paul.
Okay.
<unk> been Apple Jonathan So I would stay with the trend that we've had in the prior quarter.
That sounds great. Thank you very much guys.
Welcome.
Thank you Jonathan.
Yes.
And it appears we have no further questions at this time I will now turn the call back over to the company for any additional or closing remarks.
Thank you Kristian and thanks to all of you for joining <unk> third quarter earnings call will.
We began 2022 with tremendous promise largely based on the earlier clinical work with IV cadre.
The new clinical data, we recently reported for oral Fabra, a highly promising and may translate into clinical success as we execute our clinical development plan.
Our second pipeline asset <unk> is following a similar clinical trajectory to our fiber <unk>.
By means of the early signs of single agent activity at low doses in heavily pretreated patients with solid tumors and lymphoma.
The key takeaway is that as momentum builds with our two clinical programs the potential of becoming an important anti cancer therapeutics in solid tumors and lymphoma is becoming apparent in medical and industry circles.
We look forward to providing further updates on our clinical progress throughout 2023 and hope to meet some of you at upcoming conferences.
Operator at this time you may end the call.
Thank you ladies and gentlemen. This concludes today's conference you may now disconnect.
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