Bio Green Med Solution, Inc. (BGMS) Q2 2024 Earnings Report, Transcript and Summary

Good afternoon, everyone. And thank you for joining today's conference call to discuss Cyclacel’s financial results and business highlights for the second quarter ended June 30, 2024. 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 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, 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. 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 second quarter of 2024, which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.

Thank you, and thank you everyone for joining us today for our second quarter 2024 business update. We are pleased to report on our progress with the precision medicine strategy for fadraciclib or Fadra, oral CDK29 inhibitor which was highlighted at the ASCO Annual Meeting in June. Recruitment in the enriched cohort of our 065-101 Phase 2 proof-of-concept study is going well. In this cohort, we’re evaluating Fadra as a monotherapy in patients with CDKN2A and/or CDKN2B chromosomal abnormalities, including deep deletions or loss of function. There are processes we are testing prospectively built on preclinical evidence and the Phase 1 clinical data presented at ASCO, which evaluated Fadra’s monotherapy from an unselected population. Clinical benefit was observed in heavily pre-treated patients with several tumor types including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma Retrospective analysis suggests that this activity may be associated in part with alterations in certain tumor suppressor veins specifically to CDKN2A and/or CDKN2B. We believe that there is great unmet medical need and industry interest in the patient population identified by CDKN2A of the abnormalities, which are closely located from chromosome 9 and are often co-deleted. CKN2A 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. CDKN2B 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. Based on the currently available data, we believe that Fadra has a strong competitive profile in its therapeutic class. We expect to report on initial clinical activity from the Phase 2 proof-of-concept part of the study starting at the fourth quarter of this year. I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the Fadra program. Brian?

Thank you, Spiro. As Spiro mentioned, we are recruiting well in the Fadra POC study and I'm very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDKN2A B cohorts. Based on the pace of enrollments we anticipate reporting initial results from around a dozen patients by the end of 2024. We have also opened a second cohort which is recruiting patients with T-cell lymphoma. This was based on Phase 1 single productivity, including partial responses in two out of the three patients with T cell lymphoma. As we progress with the Fadra Phase 2 study, let me summarize the data presented at ASCO and the rationale for our clinical strategy. The extra dataset included, 47 patients from the Phase 1 dose escalation part of the CYC065-101 study, evaluating different further dosing schedule as monotherapy in unselected population. Patients who are pre-treated having received a median of four prior lines of therapy, Fadra was generally well tolerated with good compliance between dose level one and five. Dose level five or a hundred milligrams, twice-daily, five days a week, four out of four weeks were selected for the Phase 2 proof-of-concept part of the study. There were no drug-related SAEs at this dose level. The most commonly reported treatment-related adverse events were; nausea, vomiting, diarrhea, fatigue and hyperglycemia. A total of 25 drug-related, SAEs were reported in eight patients. Most common were hyperglycemia in four patients, platelet count decrease in three, and accidental overdose in three, A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with T-cell lymphoma, one of whom had a CDK2N2A loss. A squamous non-small cell lung cancer patient, with CDKN2A and CDKN2B loss achieved a 22% reduction in tumor burden at four weeks. In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer. A retrospective analysis of previously treated Phase 1 patients identified and endometrial cancer patients, who achieved a complete response over three years of treatment in a previous intravenous Fadra monotherapy study and was found to have a CDKN2A CDKN2B and NCAP loss. Although the Phase 1 hypothesis generating data are limited and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific cancer types in the Phase 2 POC part of the study. We look forward to reporting initial data in the upcoming months. I will now turn the call over to Paul to review the second quarter results.

Thank you, Brian. As of June 30, 2024, cash equivalents totaled $6 million, compared to $3.4 million as of December, 31 2023. Net cash used in operating activities was $3.6 million for the six months ended June 30, 2024, compared to $8.2 million for the same period of 2023. Net cash provided by financing activities was $6.3 million for the six month ended June 30 2024 as a result of receiving approximately $6.3 million net of expenses from the issue of common stock and warrants under securities purchase agreement. The company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024. Research and development or R&D expenses were $2 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023. R&D expenses relating to Fadra were $1.5 million for the three months ended June 30, 2024 as compared to $3 million for the same period in 2023 due to the decrease in clinical trial and other non-clinical expenditures. R&D expenses relative to plogosertib, our PLK1 inhibitor were $0.5 million for the three months ended June 30, 2024 as compared to $1.4 million for the same period in 2023, due to a decrease in manufacturing costs and other non-clinical expenditures. General, and administrative expenses remain flat at approximately $1.6 million for each of the three months ended of June 3024 and 2023. Total other expenses net were $0.1 million for each of the three months ended June 3024 and 2023. The United Kingdom research and development tax credits for the three months ended June 30, 2024, were $0.4 million, compared to $6 million for the same period in the previous year and are directly correlated to qualifying R&D expenditure. Net loss for the three months June, 30 2024 was $3.3 million, including stock-based compensation expense of $0.2 million, compared to $5.5 million including stock-based compensation expense of $0.4 million for the same period in 2023. Operator, we are now ready to take questions.

[Operator Instructions] Thank you, Mr. McBarron [Operator Instructions]. We'll go first to Ahu Demir at Ladenburg Thalmann.

Good afternoon. Thank you very much for taking my questions. We have couple. First question is, what is the enrollment target for the CDKN2A and 2B program? And other part of the question is, what would be the - what are the scenarios for this program? And what would be the benchmark and success that you would consider based on the data that you plan to disclose in the second half of this year?

Ahu, thank you for your question. I think this is for Brian. Turn over to you.

Hi, Ahu. So, the first question is it's a sort of a two-stage process. At stage one, is to look at approximately 12 to 14 patients, where you need to see more than two responses. And then you would move on to the next phase of the study. The success for the first part will be at least two research responses in the first 12 to 14 patients. I hope that clarifies and the next phase will be to confirm that dose responses just confirm in the biggest cohorts.

Yes, that's helpful, Brian. And how many patients are you planning to show data in the second half of this year? And what is the target enrollment for this program?

Accrual has been good and the patients required have this, that we need have been screened. So, we anticipate that's why we are reasonably confident we will be able to present at least just around a dozen patients worth of response data by the end of the year. Just a reminder everyone, we scan here every two months. So, we are already in August. This would be sort of two months for the first scan, two months for the second to get the efficacy later on that group.

If I could ask one more question, Brian, I think I would research that question to you, as well. In terms of the alteration, is there any reason to change the local CDKN2B, 2A and 2B would be more potent form instead of the mutations and other alterations? Or it could be any of these and with the data disclosure in the second half would we be able to see what is the status of this different alterations?

You bring up a really interesting point in terms of the different either deletions or different mutations that are that are present. I think from what we've seen so far is WE will be able to get at least a feel from our old treated patients plus the muted which would be way over 20, 25 persons to see is there specific alteration that's mostly into the drugs. So we'll get an idea. There are numerous different ones and then hopefully from that analysis we will be able to hold it down, even a little bit more.

Great. Thank you so much for answering my questions.

Thank you. [Operator Instructions] And gentlemen, it appears, we have no further questions this afternoon. Mr. Rombotis, I’ll turn things back to you sir for any closing comments.

Thank you, Bo. And thanks to all of you for joining Cyclacel’s second quarter 2024 earnings call. We have achieved key milestones for Fadra with multiple patients dosed in the Phase 2 proof-of-concept stage and look forward to important catalysts in 2024. These include, reporting interim data from initial cohorts in the Phase 2 proof-of-concept stage of the 065-11 study with oral Fadra in patients with advanced solid tumors and lymphoma. We look forward to providing you with further updates. I hope to meet some of you at upcoming conferences. Operator, at this time you may end the call.

Thank you, Mr. Rombotis. Again ladies and gentlemen, that will conclude Cyclacel’s financial results conference call. Again, thanks so much for joining us everyone. And we wish you all a great remainder of the day. Goodbye.