Cyclacel Prescribed drugs, Inc. (NASDAQ:CYCC) Q2 2024 Earnings Name Transcript August 14, 2024 4:30 PM ET
Firm Members
Grace Kim – IR
Spiro Rombotis – President and CEO
Brian Schwartz – CMO
Paul McBarron – EVP, Finance & COO
Convention Name Members
Ahu Demir – Ladenburg Thalmann
Grace Kim
Good afternoon, everybody. And thanks for becoming a member of at the moment’s convention name to debate Cyclacel’s monetary outcomes and enterprise highlights for the second quarter ended June 30, 2024. Earlier than turning the decision over to administration, I wish to remind everybody that in this convention name, forward-looking statements made by administration are supposed to fall inside the Protected Harbor provisions of the Non-public Securities Litigation Reform Act of 1995 and Part 21E of the Securities Alternate Act of 1934 as amended.
As set forth in our press launch, forward-looking statements contain dangers and uncertainties which will have an effect on the corporate’s enterprise and prospects, together with these mentioned in our filings with the Securities and Alternate Fee, which embrace, amongst different issues, our Varieties 10-Q and 10-Ok. All of our projections and different forward-looking statements signify our judgment as of at the moment, and Cyclacel doesn’t take any duty to replace such info.
With us at the moment are Spiro Rombotis, President and Chief Government Officer; Paul McBarron, Government Vice President, Finance and Chief Working Officer; and Dr. Brian Schwartz, Chief Medical Officer. Spiro will start with an outline of our enterprise technique and progress, Brian will present particulars on Cyclacel’s medical packages, after which Paul will present monetary highlights for the second quarter of 2024, which might be adopted by a Q&A session.
At the moment, I wish to flip the decision over to Spiro.
Spiro Rombotis
Thanks, and thanks everybody for becoming a member of us at the moment for our second quarter 2024 enterprise replace. We’re happy to report on our progress with the precision medication technique for fadraciclib or Fadra, oral CDK29 inhibitor which was highlighted on the ASCO Annual Assembly in June.
Recruitment within the enriched cohort of our 065-101 Section 2 proof-of-concept examine goes nicely. On this cohort, we’re evaluating Fadra as a monotherapy in sufferers with CDKN2A and/or CDKN2B chromosomal abnormalities, together with deep deletions or lack of perform.
There are processes we’re testing prospectively constructed on preclinical proof and the Section 1 medical knowledge offered at ASCO, which evaluated Fadra’s monotherapy from an unselected inhabitants. Medical profit was noticed in closely pre-treated sufferers with a number of tumor sorts together with endometrial, lung, ovarian, pancreatic most cancers, and T-cell lymphoma
Retrospective evaluation means that this exercise could also be related partially with alterations in sure tumor suppressor veins particularly to CDKN2A and/or CDKN2B. We imagine that there’s nice unmet medical want and business curiosity within the affected person inhabitants recognized by CDKN2A of the abnormalities, that are intently positioned from chromosome 9 and are sometimes co-deleted.
CKN2A gene deletions happen in a number of strong tumors, together with bladder, breast, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, together with squamous, melanoma, ovarian, pancreatic, and likewise in sure T-cell lymphomas.
CDKN2B deletions happen in a number of strong tumors together with bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, together with squamous and mesothelioma, melanoma, pancreatic, and others.
Based mostly on the at present accessible knowledge, we imagine that Fadra has a powerful aggressive profile in its therapeutic class. We count on to report on preliminary medical exercise from the Section 2 proof-of-concept a part of the examine beginning on the fourth quarter of this yr.
I’ll now flip the decision over to Brian to evaluation our progress and focus on a few of our medical ends in the Fadra program. Brian?
Brian Schwartz
Thanks, Spiro. As Spiro talked about, we’re recruiting nicely within the Fadra POC examine and I am very inspired by the passion of our medical investigators about enrollment of sufferers with CDKN2A B cohorts. Based mostly on the tempo of enrollments we anticipate reporting preliminary outcomes from round a dozen sufferers by the top of 2024.
We’ve additionally opened a second cohort which is recruiting sufferers with T-cell lymphoma. This was primarily based on Section 1 single productiveness, together with partial responses in two out of the three sufferers with T cell lymphoma.
As we progress with the Fadra Section 2 examine, let me summarize the info offered at ASCO and the rationale for our medical technique. The additional dataset included, 47 sufferers from the Section 1 dose escalation a part of the CYC065-101 examine, evaluating totally different additional dosing schedule as monotherapy in unselected inhabitants.
Sufferers who’re pre-treated having obtained a median of 4 prior strains of remedy, Fadra was typically nicely tolerated with good compliance between dose degree one and 5. Dose degree 5 or 100 milligrams, twice-daily, 5 days every week, 4 out of 4 weeks have been chosen for the Section 2 proof-of-concept a part of the examine. There have been no drug-related SAEs at this dose degree.
Probably the most generally reported treatment-related opposed occasions have been; nausea, vomiting, diarrhea, fatigue and hyperglycemia. A complete of 25 drug-related, SAEs have been reported in eight sufferers. Most typical have been hyperglycemia in 4 sufferers, platelet depend lower in three, and unintentional overdose in three,
A complete of 34 sufferers had measurable goal lesions at baseline. Two partial responses have been reported in sufferers with T-cell lymphoma, considered one of whom had a CDK2N2A loss. A squamous non-small cell lung most cancers affected person, with CDKN2A and CDKN2B loss achieved a 22% discount in tumor burden at 4 weeks.
As well as, medical profit was reported in two sufferers with endometrial most cancers, one every with ovarian and pancreatic most cancers. A retrospective evaluation of beforehand handled Section 1 sufferers recognized and endometrial most cancers sufferers, who achieved an entire response over three years of therapy in a earlier intravenous Fadra monotherapy examine and was discovered to have a CDKN2A CDKN2B and NCAP loss.
Though the Section 1 speculation producing knowledge are restricted and can’t be generalized, we imagine that the info helps evaluating the 2 affected person cohorts with particular most cancers sorts within the Section 2 POC a part of the examine. We stay up for reporting preliminary knowledge within the upcoming months.
I’ll now flip the decision over to Paul to evaluation the second quarter outcomes.
Paul McBarron
Thanks, Brian. As of June 30, 2024, money equivalents totaled $6 million, in comparison with $3.4 million as of December, 31 2023. Web money utilized in working actions was $3.6 million for the six months ended June 30, 2024, in comparison with $8.2 million for a similar interval of 2023.
Web money supplied by financing actions was $6.3 million for the six month ended June 30 2024 because of receiving roughly $6.3 million internet of bills from the difficulty of frequent inventory and warrants beneath securities buy settlement.
The corporate estimates that its present money sources will fund deliberate packages into the fourth quarter of 2024. Analysis and growth or R&D bills have been $2 million for the three months ended June 30, 2024, as in comparison with $4.7 million for a similar interval in 2023. R&D bills referring to Fadra have been $1.5 million for the three months ended June 30, 2024 as in comparison with $3 million for a similar interval in 2023 because of the lower in medical trial and different non-clinical expenditures. R&D bills relative to plogosertib, our PLK1 inhibitor have been $0.5 million for the three months ended June 30, 2024 as in comparison with $1.4 million for a similar interval in 2023, on account of a lower in manufacturing prices and different non-clinical expenditures.
Basic, and administrative bills stay flat at roughly $1.6 million for every of the three months ended of June 3024 and 2023. Whole different bills internet have been $0.1 million for every of the three months ended June 3024 and 2023.
The UK analysis and growth tax credit for the three months ended June 30, 2024, have been $0.4 million, in comparison with $6 million for a similar interval within the earlier yr and are straight correlated to qualifying R&D expenditure.
Web loss for the three months June, 30 2024 was $3.3 million, together with stock-based compensation expense of $0.2 million, in comparison with $5.5 million together with stock-based compensation expense of $0.4 million for a similar interval in 2023.
Operator, we are actually able to take questions.
Query-And-Reply Session
Operator
[Operator Instructions]
Thanks, Mr. McBarron [Operator Instructions]. We’ll go first to Ahu Demir at Ladenburg Thalmann.
Ahu Demir
Good afternoon. Thanks very a lot for taking my questions. We’ve couple. First query is, what’s the enrollment goal for the CDKN2A and 2B program? And different a part of the query is, what could be the – what are the situations for this program? And what could be the benchmark and success that you’d think about primarily based on the info that you just plan to reveal within the second half of this yr?
Spiro Rombotis
Ahu, thanks in your query. I believe that is for Brian. Flip over to you.
Brian Schwartz
Hello, Ahu. So, the primary query is it is a type of a two-stage course of. At stage one, is to take a look at roughly 12 to 14 sufferers, the place it is advisable see greater than two responses. And then you definately would transfer on to the following part of the examine. The success for the primary half might be a minimum of two analysis responses within the first 12 to 14 sufferers.
I hope that clarifies and the following part might be to substantiate that dose responses simply verify within the greatest cohorts.
Ahu Demir
Sure, that is useful, Brian. And what number of sufferers are you planning to point out knowledge within the second half of this yr? And what’s the goal enrollment for this program?
Brian Schwartz
Accrual has been good and the sufferers required have this, that we want have been screened. So, we anticipate that is why we’re moderately assured we will current a minimum of simply round a dozen sufferers price of response knowledge by the top of the yr. Only a reminder everybody, we scan right here each two months. So, we’re already in August. This might be type of two months for the primary scan, two months for the second to get the efficacy in a while that group.
Ahu Demir
If I may ask yet another query, Brian, I believe I might analysis that query to you, as nicely. By way of the alteration, is there any purpose to vary the native CDKN2B, 2A and 2B could be stronger kind as a substitute of the mutations and different alterations? Or it might be any of those and with the info disclosure within the second half would we be capable of see what’s the standing of this totally different alterations?
Brian Schwartz
You deliver up a very fascinating level by way of the totally different both deletions or totally different mutations which are which are current. I believe from what we have seen thus far is WE will be capable of get a minimum of a really feel from our outdated handled sufferers plus the muted which might be approach over 20, 25 individuals to see is there particular alteration that is principally into the medicine. So we’ll get an concept. There are quite a few totally different ones after which hopefully from that evaluation we will maintain it down, even a bit bit extra.
Ahu Demir
Nice. Thanks a lot for answering my questions.
Operator
Thanks. [Operator Instructions]
And gents, it seems, now we have no additional questions this afternoon. Mr. Rombotis, I’ll flip issues again to you sir for any closing feedback.
Spiro Rombotis
Thanks, Bo. And due to all of you for becoming a member of Cyclacel’s second quarter 2024 earnings name. We’ve achieved key milestones for Fadra with a number of sufferers dosed within the Section 2 proof-of-concept stage and stay up for essential catalysts in 2024. These embrace, reporting interim knowledge from preliminary cohorts within the Section 2 proof-of-concept stage of the 065-11 examine with oral Fadra in sufferers with superior strong tumors and lymphoma.
We stay up for offering you with additional updates. I hope to fulfill a few of you at upcoming conferences. Operator, right now chances are you’ll finish the decision.
Operator
Thanks, Mr. Rombotis. Once more girls and gents, that can conclude Cyclacel’s monetary outcomes convention name. Once more, thanks a lot for becoming a member of us everybody. And we want you all an ideal the rest of the day. Goodbye.
