Cyclacel Pharmaceuticals Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 13, 2023

There are 7 speakers on the call.

Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals Third Quarter 2023 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 conference call over to the company.

Operator

Please go ahead.

Speaker 1

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the Q3 of 2023. Before turning the 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 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 Rambadis, President and Chief Executive Officer Paul McFerran, Executive Vice President, Finance and Chief Operating Officer and Doctor.

Speaker 1

Mark Kirschbaum, Senior Vice President and Chief Medical Officer. Biro will begin with an overview of our business strategy and progress. Mark will provide details on Cyclacel's clinical programs and then Paul will provide financial highlights for the Q3 of 2023, which will be followed by a Q and A session. At this time, I would like to turn the call over to Spiro.

Speaker 2

Thank you, Grace, and thank you everyone for joining us today for our quarterly business update. Both our clinical stage cell cycle programs with fadraciclib or fadra and plogosertib or plogo are progressing well. We expect to shortly report complete dose escalation data with FADRA And determination of the recommended Phase 2 dose or RP2D to be used in subsequent studies. We also expect to report interim dose escalation data from the PROGO study and disclose the clinical data supporting its novel Both Fadra and Flogo have demonstrated single agent anticancer activity. With oral FADRA, we have observed complete response, partial response and stable disease In patients across a number of solid tumors and lymphoma with good tolerability.

Speaker 2

With oralcargo, we have seen stable disease in several patients with various solid tumors at low dosing levels, which is novel for this class of medicines. We believe that based on the innovative properties and demonstrated clinical activity, both Fadra and Fogo have the potential to be best in class in their respective classes. Based on encouraging results in the Fadra program, we have implemented a capsule to tablet switch With patients now receiving the more convenient tablet form of the drug, we expect that As the tablet would ultimately be used in a commercial put up of Fadra, if it reaches the market, the switch also represents strategic value to an acquirer or licensee. At the present time, Small cap biotech companies are not in favor by the investment community. However, the Cyclacel team has been hard at work Building Pharmaceutical Value for the Long Term.

Speaker 2

This is attested by the enthusiasm demonstrated by our clinical investigators across the globe and their interest in doing the clinical work and offering our medicines as clinical trial options to patients in their care. By developing 2 innovative high value medicines, both of which were discovered by Cyclacel, we hope to offer our stockholders the opportunity to realize strategic value. I will now turn the call over to Mark to review our progress in the FADRA and PLOBO studies and discuss some of the clinical results. Mark?

Speaker 3

Thank you, Spiro. In the 65,101 Phase III study with Fadra, We have enrolled 26 patients so far. FADRA has been well tolerated and anticancer activity has been observed, including PR in 2 out of 3 T cell lymphoma patients treated and stable disease in 15 solid tumor patients. Of these 15 patients, 4 out of 4 had gynecological cancer, including endometrial, ovarian and cervical, 2 out of 2 cholangiocarcinoma or biliary tract cancers, 2 out of 2 hepatocellular, 2 out of 2 prostate, 1 out of 2 head and neck, 1 out of 1 pancreatic and 1 out of 1 colorectal cancer. Padra has a unique activity profile Inhibiting both CDK2 and CDK9, which together complement one another, leading to enhanced anti tumor activity compared to either CDK2 or CDK9 alone.

Speaker 3

We have been able to maintain continuous inhibitory pressure on the tumor cells With twice daily dosing, 5 days a week without hematologic toxicity at the current dose level. We are one patient away from completing dose escalation segment of the study and expect to declare the RP2D shortly. We are also studying the PK and PD results and have identified mutational and molecular patterns on NGS and RNA Seq that may be predictive of clinical activity. This exciting data may guide patient selection for the Phase 2 segment of the study. The mutational profile we identified is frequently observed in many large tumor populations.

Speaker 3

The design of the 65,101 study provides for a rapid transition to Phase 2 and the opportunity for multiple catalysts through 2024 leading to registration pathways. As a reminder, the protocol provides for 7 independent cohorts by tumor type and an ACE Basket cohort defined by relevant biomarkers. We have added major clinical sites in the U. S. And 1 more overseas to our current Phase 1 sites in order to rapidly achieve our enrollment objectives.

Speaker 3

Let us now turn to our PLK1 inhibitor program. We are very excited that PLOGO has emerged as a new oral PLK1 inhibitor with novel epigenetic activity when given continuously at low doses. In our 14,101 study, we are evaluating CLO in escalating doses as a treatment for patients with advanced solid tumors and lymphomas. We have enrolled 14 patients so far, currently enrolling dose level 5. In dose levels 1 through 5, Plogo is administered once daily by mouth for 5 consecutive days, either for 2 weeks out of 3 or 3 weeks out of 3.

Speaker 3

With this novel dosing approach, we have observed anticancer activity in patients with biliary tract, non small cell lung, ovarian and other tumor types with no drug related SAEs thus far. In our preclinical program, we have identified that Togo acts through a novel epigenetic mechanism. This epigenetic activity may have a crucial role in the presence of certain common tumor mutations. Patients carrying these mutations are frequent in several large Following these findings, we have entered into scientific collaborations with major global research to help further characterize this novel activity of Clogo and define the tumor subsets that will benefit the most from this approach. As additional data corroborate these findings, we may enroll in the future possibly as an expansion of our current Phase III study, 1 or more patient cohorts specifically selected on the basis of such biomarkers.

Speaker 3

I will now turn the call over to Paul to review our Q2 and financial

Speaker 4

results. Thank you, Mark. As of September 30, 2023, Cash equivalents totaled $5,900,000 compared to $18,300,000 as of December 31, 2022. Net cash used in operating activities was $12,200,000 for the 9 months ended September 30, 2023, compared to $15,700,000 for the same period of 2022. The company estimates that its available cash We'll fund currently planned programs through the end of 2023.

Speaker 4

The operating plan includes discretionary expenditures, which have not incurred And taken together with the anticipated receipt of research and development tax credits of approximately $3,100,000 in the Q1 of 2024 could extend available cash into the 2nd quarter. Research and development or R and D expenses were $5,200,000 for the 3 months ended September 30, 2023, as compared to $4,400,000 for the same period in

Speaker 5

2022. R and

Speaker 4

D expenses relating to FILDA were $3,600,000 for the 3 months ended September 30, 2023, as compared to $2,500,000 for the same period in 2022 due to increased costs associated with manufacturer scale up an introduction of the tablet form. R and D expenses related to Plogo were $1,500,000 for the 3 months ended September 30, 2023 as compared to $1,700,000 for the same period in 2022. General and administrative expenses for the 3 months ended September 30, 2023 were $1,600,000 as compared to $2,100,000 for the same period in 2022 Due to non recurring professional fees of $400,000 last year. Total other income net For the 3 months ended September 30, 2023 was $100,000 compared to an income of $400,000 for the same period of the previous year. United Kingdom research and development tax credits for the 3 months ended September 30, 2023 were 600,000 compared to $1,000,000 for the same period of the previous year.

Speaker 4

The decrease is due to legislative changes that took effect in April 2023, which reduced the amount of tax credit which could be claimed. The R and D tax credits are directly correlated to qualifying research and development expenditure. Net loss for the 3 months ended September 30, 2023 was $6,100,000 compared to $5,100,000 for the same period in 2022. Operator, we're now ready to take questions.

Operator

Thank you. Our first question comes from Ahu Pinar, Ladenburg Thalmann.

Speaker 6

Good evening. Thank you so much for taking my questions. I have Three questions. First one is regarding the biomarker studies. What type of biomarkers are they novel targets or are they known Therefore, are they known biomarkers that we have seen before?

Speaker 6

And when do you plan to disclose and Report on the biomarker studies.

Speaker 2

Thank you for your question, Ahu. These are known biomarkers in terms of appearance on Next gen sequencing scans and path reports and so forth. However, they are novel for the CDK class. We believe we made a That has not been reported previously for this class, and we think that there is sufficient clinical support for this hypothesis to be pursued further in the clinic. Disclosure should occur, as we said, when we give the full Phase 1 update.

Speaker 2

We're obviously hoping to present this data at upcoming medical meetings, And that would be important as far as deadlines are concerned as to when we make the announcement. But I would expect probably around the end of the year or early next year.

Speaker 6

Thank you, Spiron. My second question is on the PLODO program. We know the epigenetic aspect is very unique, Unlike any other TLK inhibitors, I am curious given that you already dosed 12 patients, What type of activity do you observe? Is there anything that's so unique that you see activity in certain indications given that the genetic Agent targeting, so just curious on the clinical activity.

Speaker 2

Yes. I think it's a question for Mark, who's also an expert in epigenetics. Mark?

Speaker 3

Well, some of it is still a little early to disclose, but we have been seeing at these low dose levels Very prolonged stable disease in a number of very bad tumors. So that led the search for the mechanism of why this would be happening at these low doses. And it turns out to be a really interesting story. I think there'll be some abstracts and some things in the near future. And As Spiro said, at the disclosure times, we'll reveal all of that.

Speaker 6

Sounds good. Thanks, Mark. And my last question is on the Financials. Paul, it looks like there is an increase as you pointed out on the given the manufacturing and the clinical activity. So curious how much increase are we expecting in the next quarters?

Speaker 6

Is the manufacturing going to continue to increase? So how should we Model forecast.

Speaker 4

No, exactly, thanks for the question. So the manufacturing cost was, as Spiro mentioned, as we move From a capsule form to the tablet form. So that was the active ingredient manufacturing, Which happened in Q3, so that should decline in Q4.

Speaker 6

Helpful. Okay. Thank you so much. Thanks for answering my questions. Welcome.

Speaker 5

Thank

Operator

you. Our next question comes from Jonathan Aschoff, ROTH MKM.

Speaker 5

Thank you. Hi, guys. I was wondering if you could say anything about the Fadrus cyclops strategic options that you're looking at. Can you give us any clarity there as to the level of What's a real gating factor to move a conversation forward from where it is now?

Speaker 2

Thank you, Jonathan. This is a topic we have discussed before in these calls. There is strategic interest In next gen CDKs and fadrocitlib in particular, this interest comes from multiple parties at different points in time. We have different hurdle rates. I think the disclosure in the very near future of the biomarkers, as I mentioned to the previous questioner, It's an important catalyst that will bring home much of our interest, which was preliminary.

Speaker 2

But now I think we have not only Evidence of single agent activity, including CRPR and stable disease, but we also know now possibly which patient population to target future trials. So I would expect that this would capitalize further strategic interest and we look forward to continue those discussions with relevant parties.

Speaker 5

Also lastly, you don't want to tell us if you're finishing off the Phase 1 PHYRA at dose 5 or 6A, right?

Speaker 2

Well, I think it's a question for Mark and then I can come back and give a bit more color. But Mark, why don't you take that? What's your guess about the RP2D?

Speaker 3

Well, we're one patient away from finishing 6a. So I'm hoping that that will be it. We have the day looks very good. We have shown it. It seems to be doing what we want at those levels.

Speaker 3

So I'm hoping that this last stage will conclude and we'll be able to formally announce. But until then, we don't know.

Speaker 5

Okay. And Mark, there's nothing telling you that you need to do any sort of slightly different dosing schedule, correct? No. Okay. Thank you.

Speaker 3

No, we're very happy as it stands right now, but we can't say anything until it is complete.

Operator

We have no further questions in the queue at this time. I would now like to turn the call back over to the company for closing remarks.

Speaker 2

Thank you, operator, and our thanks to all of you for joining Cyclacel's 3rd quarter earnings call. Both our programs are approaching important catalysts such as starting Phase 2 proof of concept stage with a strong competitive profile in the therapeutic classes. As a reminder, our upcoming key milestones are report Final data from dose escalation stage and RP2D determination from the 65-one hundred and one study of oral FODRA in patients with advanced solid tumors and lymphoma. 1st patient dosed with oral FAGRA In Phase 2 stage of 65-one hundred and one study in patients with advanced solid tumors and lymphoma. Report Phase 1 data from 140-one hundred and one study of oral globosretib in patients with advanced So the tumors on lymphoma and elaborate the novel mechanism of action of Plovo.

Speaker 2

We look forward to providing you with further updates and hope to meet some of you at upcoming conferences. Operator, at this time, you may end the call.

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Key Takeaways

  • Both FADRA (fadraciclib) and PLOGO (plogosertib) programs are advancing with expected near‐term dose escalation data readouts and RP2D determination to support Phase 2 studies across solid tumors and lymphomas.
  • FADRA has shown complete and partial responses plus stable disease in various tumor types with good tolerability, and the company is switching to a tablet formulation to support future commercialization and strategic partnerships.
  • PLOGO, as a novel oral PLK1 inhibitor administered continuously at low doses, has elicited stable disease in biliary tract, non–small cell lung, ovarian cancers and others with no drug-related SAEs, and its unique epigenetic mechanism is being further characterized with global research collaborations.
  • Cash and cash equivalents stood at $5.9 million at quarter end, providing a cash runway through Q4 2023 with potential extension into Q2 2024 via expected R&D tax credits, while net loss was $6.1 million for Q3 2023 driven by increased R&D spend.
  • The company plans to disclose biomarker findings that may guide patient selection for FADRA trials by year‐end or early next year, which it believes will catalyze strategic interest from potential partners and acquirers.
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Earnings Conference Call
Cyclacel Pharmaceuticals Q3 2023
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