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spk01: Good morning and welcome to Cirrus Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen only mode. This call is being webcast live on the investors and media section of Cirrus website at www.cirrus.com. Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Karen Unity, Director of Investor Relations and Corporate Communications at Cirrus.
spk00: Thank you. This morning, we issued a press release announcing our first quarter 2024 financial results. The full release is available on the Investor and Media section of Cirrus' website at www.cirrus.com. We will begin the call with prepared remarks by Conley Chee, our Chief Executive Officer, Dr. David Roth, our Chief Medical Officer, and Jason Haas, our Chief Financial Officer. We will then open the call for questions. Kristen Stevens, our Chief Development Officer, is also on the call and will be available for Q&A. Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements. Actual events or results could differ materially than those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factors section of our quarterly report on Form 10-Q that we filed this morning, our annual report on Form 10-K that we filed earlier in the year, and any other filings that we may make with the SEC in the future. Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. I would now like to turn the call over to Conley. Conley?
spk05: Thanks, Karen. And thank you, everyone, for joining this morning. 2024 marks an important year for Xerox. We're acutely focused on execution across our clinical development programs and pre-commercial activities as we continue to advance tamiberitine, a potential new standard of care for the frontline treatment of hematologic malignancies. We are very encouraged by recent progress of our programs in higher risk MDS and unfit AML. As David will discuss shortly, our phase three select MDS one trial recently passed a pre-specified interim futility analysis. This is a meaningful milestone for our program. The interim futility analysis was designed to evaluate the primary endpoint of complete response. And as a reminder, we remain blinded to the data that was reviewed by the Independent Data Monitoring Committee. They recommended that our study continue without modification, and while that result was anticipated, this is an important step to pass as we look forward to reporting our pivotal data by mid-Q4 of this year. Also in April, the FDA granted fast-track designation for tamibericaine in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit AML with RARA overexpression. As you know, fast track designation is granted to compounds that are intended to treat serious conditions and for which non-clinical or clinical data demonstrated the potential to address unmet medical needs. We believe that this designation not only reflects the need for a new therapeutic option in AML, but speaks to the strength of our initial data from select AML1, which we reported at the end of last year. This is the second FDA fast track designation that we received for Tamiviratine. Previously, the FDA granted this designation to Tamiviratine in combination with azacitidine for the treatment of higher risk MDS with rama overexpression. Together, the progress that I described continues to reinforce our confidence and the potential for camiberitine to provide a safe and efficacious therapy for MDS and AML patients with raw, raw overexpression. We look forward to important data readouts ahead, including additional data from our Phase II Select AML-1 trial, expected in the third quarter of this year, and as I mentioned before, pivotal data from our Phase III Select MDS-1 trial, expected by mid-Q4. As we approach these readouts, I'm also really pleased by our progress in advancing our launch readiness activities so we can effectively deliver Tamivaritine to patients in the U.S. following approval. We look forward to sharing details of our launch preparations as we move closer to a potential NDA filing. With that, I'll now turn it over to David to review our programs and upcoming milestones in more detail. David?
spk03: Thank you, Conley. We're excited with the continued progress in advancing Tamivaritine through late stage development. As we announced in March, we completed enrollment of the 190 patients necessary to support the complete response rate primary endpoint analysis. And we remain on track to report pivotal CR data by the middle of the fourth quarter of this year. And as Conley mentioned, we are highly encouraged by the recently completed pre-specified select MDS-1 interim futility analysis, which was conducted by an independent data monitoring committee who recommended that the trial continue without modification. The analysis looked at CR data across the two arms of the trial, data that remains blinded to cirrhosis, and it passed. In addition, no concerning safety signals were noted. This is a meaningful milestone, particularly in the higher-risk MDS setting, where passing a futility analysis in a pivotal registration trial cannot be taken for granted. Over the past several years, the competitive landscape in higher-risk MDS has become narrower and narrower as compounds have failed interim futility analyses or primary analyses for reasons related to efficacy and or safety. This encouraging outcome, based on an evaluation of half of the enrolled patients needed for our primary analysis, underscores the potential for Tamibaratine to provide profound benefit to patients, and we look forward to pivotal data later this year. As a reminder, the ongoing SELECT-MDS-1 trial is a randomized, double-blind, placebo-controlled trial evaluating the combination of tamobarotene and azacitidine versus placebo and azacitidine in newly diagnosed, higher-risk MDS patients with RARA overexpression. The existing standard of care for higher-risk MDS patients provides limited efficacy with a 17% complete response rate and a median overall survival of just 18.6 months. No new therapies beyond hypomethylating agents have been approved in newly diagnosed higher-risk MDS in well over a decade, which provides the opportunity for our biologically targeted approach with Tamubaratin to improve the care and treatment of patients with RARA overexpression who can be readily identified using a simple blood test. To date, studies of Tamibaratine have demonstrated a generally well-tolerated safety profile, which is particularly important in patients with higher risk MDS who are commonly elderly and with underlying comorbidities that preclude intensive treatment options. To provide additional perspective on our higher risk MDS program, We will be hosting a webcast event on June 25th to discuss MDS disease biology and the current treatment landscape in higher risk MDS, as well as the design of the ongoing pivotal phased-free select MDS1 trial and the opportunity for Tammy Baratie. We're excited to have medical experts and disease specialists join Cirrus to discuss and present on these topics. Now, turning to AML. we continue to advance Tamubaritin in the randomized select AML1 Phase II clinical trial in unfit AML patients with RARA overexpression. In April, we were pleased to announce the FDA decision to grant a fast-track designation for Tamubaritin in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit AML patients with RARA gene overexpression as detected by an FDA-approved test. This designation reflects the tremendous need for a safe and effective therapy for AML patients, many of whom are unable to tolerate intensive treatment. We are especially encouraged that this designation was given based on an FDA review that included the initial interim data from a pre-specified analysis of the randomized portion of the select AML-1 study, in which we saw encouraging CR and CR-CRI rates in the triplet with tamibaratine compared to the standard of care. These results were also bolstered by safety data that demonstrated no additive toxicity. Overall, the data continued to support the potential for tamibaratine in combination with standard of care in the frontline treatment of AML patients with RARA overexpression. We also believe these results in AML increase our confidence in the ongoing evaluation of tamibaratine in combination with azacitidine in higher-risk MDS. Based on data to date, we believe Tamivaratine is uniquely positioned to improve upon the standard of care in higher-risk MDS and in AML, and we look forward to reporting clinical activity and tolerability data from a pre-specified analysis of over 40 patients from the randomized portion of the Select AML-1 trial in the third quarter of this year and the pivotal data readout from the Phase III Select MDS-1 trial by the middle of Q4 of this year. I would now like to turn the call over to Jason, our Chief Financial Officer, to review our first quarter financial results. Jason?
spk04: Thank you, David. Now we'll turn to our first quarter financial results. We did not recognize any revenue in the first quarter of 2024 as compared to $3 million for the first quarter of 2023. The decrease reflects the termination of Cirrus' collaboration agreement with Pfizer late last year. R&D expenses were $24.7 million this quarter, compared to $28.8 million for the first quarter of 2023. The decrease was primarily due to the reduction in external R&D consulting, contract manufacturing, and a reduction in headcounts and related expenses. Our R&D expenditures are now principally focused on the advancement of Tamavera team. G&A expenses were $6.3 million in the first quarter of 2024, as compared to $7.4 million in the same quarter last year. The decrease was primarily due to a reduction in headcount and related expenses, consulting, and facilities expenses. We reported a net loss for the first quarter of $3.7 million, or 10 cents per share, compared to a net loss of $23.8 million, or 85 cents per share, for the same period in 2023. Cash, cash equivalents and marketable securities as of March 31st, 2024 were $108.3 million as compared with $139.5 million on December 31st, 2023. On May 9th, we agreed to amend our loan agreement with Oxford. The amendment will provide us with more financial flexibility by extending the interest-only period from September 1st, 2024 to November 1, 2025, with further extensions to as late as November 1, 2026, upon the achievement of certain milestones. In addition, the amendment will allow us to increase the amount of term loans available to us from $40 million to $100 million, with two tranches totaling $40 million becoming available upon the achievement of certain milestones, and an additional $20 million becoming available at Oxford's discretion. With the Oxford Amendment, which extends our interest-only period to November 2025, we believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into the third quarter of 2025, beyond pivotal Phase III data from the Select MDS-1 trial and additional data from the randomized portion of the Select AML-1 trial. With that, I will turn the call over to the operator for questions.
spk01: We will now begin the question and answer session. Should you have a question, please press star followed by one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. Your first question comes from the line of Phil Nadeau from TD Cowan. Your line is open.
spk02: Good morning, congrats on the progress. Thanks for taking our questions. Two from us. First, on the interim analysis in select MDS1, I think you said the analysis looked at 50% of the patients who will be involved in the primary endpoint. Is that correct? And could you give us any additional information on the statistical bar for the futility analysis? And then second question in AML, do you think you'll have enough information post that Q3 update to make a go, no-go decision on pivotal development in AML? If not, when could that decision ultimately come? Thank you.
spk03: Thanks, Phil. It's David here. We appreciate the questions. So the interim, you did hear correctly, the interim analysis was a pre-specified futility analysis, and the futility analysis was triggered based on when 50% of the patients who were going to be contributing to the the final primary analysis had a sufficient time on study. The data were reviewed in a blinded fashion by an independent data monitoring committee. They looked at the complete response rates across the two arms. We remain blinded to that information, so we have no information specifically about what those results showed. However, we were told that we passed. And we were also told that there were no new safety signals or anything of concern and that we should continue the trial without any modification. So, of course, we were very excited about that. We haven't specifically shared the details on the statistical bars that one had to achieve. I just think it's an important point to take home that it's very encouraging that we passed. And it's an important and requisite milestone to achieve such that we can now look forward to reporting the final data on the primary endpoint by the middle of the fourth quarter of this year. So that's exciting. And then with regard to your AML question, at this point, we're anticipating reporting out another pre-specified analysis from that study in the third quarter. That will be based on including at least 40 of the patients. So that will be at least half the trial will have outcomes. And I think it would be important to realize that without having seen the data, the actual analysis that we're going to be sharing hasn't been seen yet. It's hard to project when we would have a go, no go. And that's the kind of thing where we could provide you with an update in the future. That's very helpful. Thanks for taking our questions.
spk01: Again, if you wish to ask a question, please press star 1 on your touch-down phone. There are no further questions at this time. I will turn the call to Conley Chee for giving closing remarks.
spk05: Great. Thanks, operator, and thanks, everyone, for joining us today and for your continued support of Cirrus. Please reach out to the team if you have further questions. Have a great day.
spk01: Ladies and gentlemen, thank you for participating. You may now disconnect.
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