Q3 2020 Cyclacel Pharmaceuticals Inc Earnings Call

Ladies and gentlemen, and this is the operator todays conference is scheduled to begin momentarily until that time your lines will again be placed on music hold thank you for your patients.

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Alright listen only mode. After today's call members of the financial community well have an opportunity to ask questions. If you would like to ask a question at that time. Please press star one on your Touchtone phone if at any point. Your question has been answered you may remove yourself from the queue.

Q I pressing the pound key in publishing your question. We ask that you. Please pick up your handset to allow optimal sound quality. The company will also be accepting a limited number of questions submitted eat submitted.

Submitted via email to the address IR at Cyclacel Dotcom lastly, if at any point during.

If you should require operator, it's Justin 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.

Thank you Erica good.

Afternoon, everyone and thank you for joining today's conference call to discuss Cyclacels financial results.

Business highlights for the third quarter, ending September 32020, 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 995 and section 21 E of the Securities Exchange Act of 934.

Sure 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 FCC, which include among other things our forms 10-Q and 10-K. These filings are available from the FCC for our web site.

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 Rombotis, President and Chief Executive Officer, Paul Mcbarron Executive Vice President Finance, and Chief operating Officer, and Dr. Mark Your found our newly appointed senior Vice President and Chief Medical Officer Spirit will be.

First an overview of our business strategy and accomplishments on Cyclacels multiple clinical programs and Paul will provide financial highlights for the third quarter of 2020, which will be followed by Q and a session. At this time I would like to turn the call over to Spiro.

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As Eric finishes introduction.

Eric is yes.

Yes, I think you got cut off just as Erik was coming through so earnings engine production over to you. Okay I apologize as I was disconnected so.

So thank you Eric and thank you everyone for joining us today for our third quarter 2020.

Business update call.

As announced earlier, we estimate that our cash.

And equivalents of $23.1 billion as of September Thirtyth 2020 will provide a cash runway for current spending plans to the end of 2022.

Before I update you on our programs I have the pleasure of introducing you to Dr., Mark Kirschbaum, who joined US two weeks ago as chief medical.

Nickoloff Sir.

He was most recently vice President Hematology oncology at Arqule, Inc., which was recently acquired by Merck, where he managed clinical development of their BTK inhibitor for Hematological indications, including CLL.

[laughter] prior to our Q he was senior medical director.

Sure with global clinical development responsibilities and three pharma companies.

Where he led clinical development of novel inhibitors of easy age to.

Hsp 90 per true and B teekay in various solid tumor and Hematological malignancies.

Before work into the Biopharma industry, Mark gained extensive hematology and oncology experience in academic clinical practice as professor of medicine at.

And director of new drug development.

Several medical centers across the United States and Israel.

Mark is completing it.

Pipeline review before making his recommendations regarding optimal allocation of clinical resources and development plans.

This is timely as recently reported fraud recite good data from ongoing phase one studies continue to show both anti tumor and anti leukemia.

Activity and also good oral bioavailability.

Turning to our programs, who will first review FID recycling or foundry for short our syndicated to nine inhibitor.

Overall fiber has demonstrated durable suppression of mcl one.

And anti cancer activity as monotherapy in heavily pretreated patients with solid tumors.

We have also observed until that give me activity consistent with the drugs mechanism and as mentioned good tolerability.

We believe these findings make far draw a leader in the race to bring tomorrow.

Market medicines that work on this cancer pathway.

Over expression of cancer resistance proteins, such as Mcl one.

Or amplification of uncle proteins, such as cycling E and or mic or so.

Associated with escape and continued growth.

Answer cells.

[noise] Mcl, one is a member of the Bcl two protein family, including Bcl, two vfl, one bcl XL et cetera.

These proteins act as pro survival mechanisms for cancer.

Cycling E April.

15 encoded by they see any gene is overexpressed in several gen ecological cancers, including breast endometrial slash shooter Rhine and ovarian.

Addiction to safely enables cancer cells to escape death after anti cancer therapy.

Suppressing this.

Proteins forces aberrant sells into apoptosis or programmed cell death.

Cyclacel therapeutic strategy with Fonterra is to suppress the expression of such proteins and reactivate the episodic machinery, leading to cancer cell death.

<unk> a differentiating feature of far draw is that it targets both the syndicate to an cdknine isoforms.

Which act as key components of the P 53 pathway.

Activity against Syndicate to result in reduction of second E.

And syndication.

Nine in reduced expression levels of Mcl, one mic and other shortly of transcripts.

Recent peer reviewed publications in peer low S. One and the journal of clinical investigation.

By scientists from Cyclacel and the Institute of Cancer Research in.

To them strengthen the mechanistic rationale for farmers potential as an anti cancer agent.

In particular, they highlight the benefits of inhibiting both syndicate to end Cdknine and elucidate the roles of cycling the E Mcl, one and Nick over expression.

Luckily the development of cancer resistance.

More recently independent findings of synthetic LIFO screening experiments from Duke University reported at the ASCO 2020, virtual scientific program corroborated the attractiveness of this dual targeting approach again CDK to add.

And Cdknine.

Farther out what are the subject of an oral presentation last month at the plenary session of the 32nd you RTC NCR by a CR or M&A Symposium 2020.

The presentation reported data from parts too.

And three of our ongoing phase one dose escalation study evaluating single agent far Dre in patients with advanced solid tumors.

It apart to five drug is administered intravenously to 24 heavily pretreated patients with various added.

Advanced solid tumors.

This study has reached a fourth dose level.

In terms of overall efficacy to date, one confirmed partial response or PR and for stable diseases or SD have been observed.

Out of 11 patients treated at the four.

At dose level, one achieved confirmed PR and to SD.

This PR was observed after a month and a half on far Dre in a patient with mcl, one amplified endometrial cancer, who have failed seven lines of prior therapy.

The patient remains on treatment after six.

14 months.

With 92% reduction in target tumor lesions.

The two S.D. were observed in patients with secondly, amplified ovarian cancer, who achieved 29% shrinkage in target tumor lesions after two and a half months in a patient with fallopian tube and then of course.

XOMA with undetermined protein level, respectively.

In part three we enrolled five patients who were treated with an oral capsule formulation of ardra as a single agent using the same dosing schedule as the intravenously administered part two.

Analysis of bio specimens from the first three evaluable patients showed high oral bioavailability and overlapping pharmacokinetics with part two.

Based on the findings we plan to expand development of oral far Dre initially in solid tumors and later on in.

At the logical malignancies.

Let us now turn to our humor Logica Malignances program.

We have opened two phase one dose escalation studies to test the hypothesis that suppressing mcl, one and Bcl two can result in anti cancer activity against relapse.

He refractory leukemias.

We are therefore evaluating a far draw and venetoclax combination in patients with relapsed or refractory CLL in the O six five dash or two study in relapsed or refractory AML or Mds in the O six five das or three study.

The primary end.

Endpoint of each study is the termination of recommended phase two dose and safety.

And see where C O six five dash or to five patients with relapsed refractory CLL have been treated in four dose levels up to 150 milligrams per meter squared off.

Okay. The fact recycling in combination with oral venetoclax.

For recycling is administered after completion of an epic Lux ramp.

Anti leukemic activity was observed in three patients who achieved MRT negativity on the combination one in bone marrow and two in bone marrow and Peru.

I have a blood.

The latter two patients have also demonstrated continued shrinkage of lymph nodes on the combination.

In one patient all target lesions and then the other two out of four lesions have shrunk below 1.5 centimeters.

Both are waiting for confirmation of response.

Preclinical data support a dual targeting strategy of both Bcl, two and mcl one in CLL.

And see what C O six five dash or 314 heavily pretreated patients with relapsed or refractory AOL were treated in fire those.

Referrals up to 200 milligrams per meter squared of Ivy for cyclists in combination with Venetoclax.

Until the Kimi activity has been observed in four out of 12 patients available for treatment.

Preclinical data in AML suggest that targeting both EPS.

Let her one and bcl two maybe more beneficial than inhibiting either protein alone.

Both of these studies are part of our risk sharing alliance with the University of Texas, MD Anderson Cancer Center.

Whereby MD Anderson assumes patient costs for all.

Studies.

And we provide investigational drugs and other limited support.

The MD Anderson Alliance also includes clinical trials with our two other programs see we'll see 140 and Sapacitabine.

In our other mitotic program, we're evaluating.

Let's see what 40, a polo like appeal K one inhibitor.

Which like fat recyclable discovered in house.

Seven patients with advanced Leukemias have been recruited two 140 dash or won our first in human single agent those escalation study.

No.

We will dose limiting toxicities have been observed thus far.

So you will see 140 is a small molecule selective BLK one inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.

In response to innovate.

No. It's the greater demand we're progressing our plans to study see we'll see 140 in patients with solid tumors.

In our DNA damage response program succeeded to Dash 11, we're evaluating the safety and effectiveness of an oral combination of cycle ourselves newcrest.

Analog sapacitabine with another clocks in patients with relapsed or refractory AML or Mds.

This is a dose escalation study with 12 patients enrolled to date.

Two patients previously treated with combination therapies, including Hypomethylating.

The agents have achieved five and six cycles of treatment respectively.

In addition, an investigator sponsored trial or ice tea is enrolling at the Dana Farber Cancer Institute.

Evaluating in combination of Sapacitabine will elaborate after.

I suppose anikas lynparza in patients with Bracken.

Mutant breast cancer.

Seven patients have been enrolled with two partial responses and prolonged stable disease is observed.

Turning to our other eye Estes, we're collaborating with an international cooperative group to evaluate far dry and be aggressive childhood cancer in Europe.

Blastoma, we're mic over expression is prevalent.

We will provide updates once the study is open for enrollment.

During the quarter, we continue to move our programs forward to multiple data outcomes over the next two years.

Our upcoming key milestones.

Includes.

Treat the first patient with orally administered pharmacyclics.

In phase ones last two advanced solid tumor study.

Report initial data from Pharmacyclics medical X. phase one study in relapsed refractory AML or Mds and CLL.

Right.

Report safety and PK data from Phase one study of motorcyclists oral formulation.

Report initial data from see we'll see 140 phase one first in human study in relapsed refractory leukemias.

And report initial data from Sapacitabine Venetoclax phase one study in.

<unk> refractory AML or Mds.

Well the capital on hand estimated to the end of 2022, we have the resources to deliver a key milestones in our clinical studies.

I would now like to turn the call over to Paul to review, our second quarter 2020 financials Paul.

Thank you very much spirit as I outlined in today's press release for the quarter ended September 30th Twentytwenty.

Cash and cash equivalents totaled $23.1 million compared to 11.9 million as of December 31st 2019.

The increase of 11.2 million was primarily.

Finally, due to net proceeds of 18.3 million from an equity financing in a full 2020 or.

Offset by net net cash used in operating activities was.

6.8 million.

We estimate that cash resources as of September 30, EPS will fund currently planned programs to the end of.

2022.

Research and development expenses were 1.1 million for each of the three months ended September Thirtyth 2020 and 2019.

Research and development expenses raising to the transcriptional regulation.

Okay increased by almost 2.1 million for the three months ended.

September Thirtyth 2020, as we continue to progress the clinical evaluation of side recyclable.

General and administrative expenses for the three months ended September Thirtyth, Twentytwenty 1.5 million compared to 1.3 million for the same period of the previous year.

Hi, Chris.

<unk> point 2 million for the three months ended September Thirtyth Twentytwenty is due to increased professional costs.

Total other income net for the three months ended September Thirtyth Twentytwenty was $35000.

Compare to 174000 for the same period over the previous year.

The decrease of approximately hundred 40000.

<unk> for the three months ended September 32020.

It's primarily related to a reduction in foreign exchange gains and interest income.

United Kingdom Research and development tax credits were point Threemillion for each of the three months ended September Thirtyth 20 and 2019.

Our net loss for the three.

The months ended September if only 20 was 2.3 million compared to $1.9 million for the same period.

I'm 2019.

Operator, we're now ready to take questions. Please.

As a reminder to ask a question you won't need to press star one on your attach.

Well move your question press the pound.

Thank you and your first question is from Jonathan Aschoff.

With Roth capital partners.

Thank you.

No. It's all Senator second.

Yeah.

Her like intravenous dosing.

Pointing you switched completely to oral will you start a new intravenous trial given a similar PK between hall in R&D that was at least showing at 115 heavy compared doses higher than 150 or versus anything.

Thank you gentlemen.

I. Appreciate your question. The short answer is that we are very much aware of the value of the patients and physicians ascribe to oral therapy, especially during an unveiling a global pandemic still evolving and were therefore very keen to begin a harley evaluation of hard recycling.

In regard to the dosing schedule.

A little clearly as an oral drug that gives us more flexibility in being able to dose at different dosing schedules on Ivy therapy would permit and therefore, we treat the results of the IB program as supportive, but not a relevant necessarily dwell could achieve with oral dosing are there once or twice a day.

Our continuous days.

Yes.

That schedule is yet to be refined upon initiation of relevant studies, but were clearly responding to also clinicians requests for oral therapy to become the drug has high overlapping teekay was clearly does.

Thank you Ben and said that there were no deal.

With oral does that mean.

There was also no.

Exactly.

Well, we are still early in escalation in the oral therapy and therefore, it's too early to call, where we'll might Max out.

The ongoing phase one program one form probably in the next.

Two to three months.

Well my Max out we're we're clearly close to the upper then those and other scheduled after that so far so we don't expect it will take very long to get a clear idea, but again as with those sequentially.

On daily schedules with the oral therapy may be that these observations or not necessarily.

Relevant because we may find anticancer activity sooner. So this is still the work in progress.

Okay. Thank you and there's no updates at Ash correct.

Well, we do not have any submission on the cut off rash was in August and the studies are still enrolling.

Okay. Thank you.

Thank you gentlemen.

Your next question is from.

Good morning, Roger.

Claim capital.

Hi, Thanks for taking my questions.

With regard to the dose escalation study.

With regard to the analysis with that.

White blood cells.

A large proteins are being analyzed there what is the timeline to get data from those.

And how do you think that is going to help the dosing in the clinical study.

Right first of all we have said that I'm very interested and three relevant.

Proteins with the drugs mechanism, which are and to a one mic and 70. So we're certainly want to get that information from future studies and perhaps ongoing studies. If it is available if patients are willing to give specimens I think the question on web blood serum levels is clearly important or we have seen.

At legacy license early after for the sake of treatment, but there appears to be a phenomenon where continued therapy as possible and this phenomenon declines evidently one patients that achieve the PR is on therapy on single agents that are selling for more than a year and a half which also makes the point is well tolerated. So this is still the work.

The progress clearly in solid tumor patients WBC lysis. If it is a short term phenomenon could lead to eventually turnover of cancer cells, but at this point. This is an unknown Kumar I wanted to oversee.

Find out more as we escalate further in the ongoing phase one or additional studies that arent planning.

Okay are you mainframe.

I can about it a little bit in your remarks with regard to the studies being done at view. They went recently a paper published with regard to.

Really get to nine in colorectal cancer.

Are you guys planning to conduct some studies based on.

We're now at the results from that you can you will see.

Yes, you are correct dimension the professor David Suze teams work in this field, especially what they have done in models of colorectal cancers are synthetic leasehold screen whether.

Weather look the effect of the different.

Inhibitors.

On a different city case and it came to the conclusion that inhibiting both the syndicate to end Citigroup. Your line is important I'm not sure that we can necessarily use. These preclinical experiments is predictive of human disease activity such as in specific tumor histologies.

But we are certainly interested in certain solid tumors and we intend to explore.

Of course in the upcoming solid tumor studies, we have not yet made a decision whether metastatic CRC now will be one of them.

Your next question is from long Sealy.

Yes.

Mr. Lee your line is open.

Hello can you hear me.

We can hear you now ones.

Hey, thanks.

So my question is about how this accolade.

You recently presented data and looks.

Thanks Nike.

Excluding the 160 milligram dose and just wondering.

Any color on that dose do you think it would be.

Sufficient or you could still pressuring the wondrous three milligram dose.

I think you're referring first of all to make sure. Our audience is able to follow the question correct me, if I'm wrong, but I think you're speaking about the ongoing phase one study where 160 milligrams per meter squared was considered is that correct.

Yes.

Right. So first of all it's a flat those and first of all we.

Sure that this schedule, which was designed as a proxy for the oral drugs to test PK and an apples to apples comparison is going to be the one that with the commotion relevant for the strike if it reaches the market.

As I mentioned the recent results with good oral bioavailability have motivated us to move our program into the all.

We're not formulation.

And that will therefore as I mentioned previously a remarkable other line a few minutes ago would require the oral drug to be developed and perhaps different strategies that will might use for navy agent in the middle of pandemic. Our goal is to use the oral formulation on a daily schedule to the extent this is Tyler.

But we intend to find that out in the immediate next program that we intend to begin and this would therefore make the question aware the Ivy day, one to eight and nine schedule ends up in terms of our Peter de largely not relevant.

I hope I've given you some color on our thinking.

Well, yeah you there.

Okay.

There are no I didn't hear a response I don't know if we asked.

I don't know if we ask one of his question.

There are no further questions at this time I could ask Dr. Curt.

Farm to maybe say a few words about what discovered upon joining the company and what his thoughts.

For our plans for the future Mark over to you.

Hi, everyone.

I just joined the company.

Roughly three weeks ago.

I can say at this point.

It is a great honor to have joined cycle, so as to be working with a strong executive group.

Unlike the full potential of its promising pipeline.

That recycling.

He was the one for our agents with a strong preclinical story.

A question is not whether they will be effective but how to make the most effective in the clinical setting.

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I look forward to working with the team.

And our investigators in taking our compound forward. Thank.

Thank you very much.

Thank you Mark and thank you all for participating and cycle ourselves third quarter 2020 earnings call.

We appreciate your support of our efforts.

To fulfill our strategy and realize stockholder value by demonstrating safety efficacy and cost effectiveness of our medicines.

We look forward to updating you on our progress and meeting some of you at upcoming conferences are the virtual you're hopeful in person.

Please stay safe and well operator at this time you may.

On the call.

And ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.

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