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3 days ago
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Memo Therapeutics AG Publishes Study in Frontiers in Pharmacology Demonstrating Therapeutic Antibody Transcytosis Across the Kidney Barrier After Intravenous Administration
Results demonstrate that intravenously administered therapeutic IgG antibodies can be detected in urine, supporting the conclusion that these antibodies are capable of crossing the kidney endothelial barrier This proof-of-concept study provides compelling support for the selected dosing regimen of MTx's investigational BK polyomavirus-neutralizing antibody Schlieren / Zurich, Switzerland, 11 June, 2025 – Memo Therapeutics AG (or 'MTx'), a late-stage biotechnology company developing antibody-based therapies for viral infections and cancer, has published a study in Frontiers in Pharmacology detailing the transport of therapeutic IgG1 antibodies across the kidney endothelial barrier. This quantitative analysis provides a scientific basis for the selected dosing strategy of MTx's highly potent human anti-BKV IgG1 therapeutic antibody, potravitug, currently in Phase II clinical development. The study reports that, 0.015% (median) of the serum concentration of therapeutic antibody rituximab is found in the urine, with levels reaching up to 4.2%. These findings suggest that therapeutic IgG antibodies can cross the kidney filtration barrier in measurable amounts, challenging prior assumptions about size-exclusion limitations and supporting the feasibility of antibody-based interventions for renal infections. Christoph Esslinger, CSO of MTx, commented: 'This data reinforces the notion that potravitug can access infected renal tissue and supports the continued development of this first-in-class candidate for the treatment of BK viremia in kidney transplant recipients.' BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term graft survival. Despite this, therapeutic options remain limited, partly due to the prevailing belief that large-molecule biologics cannot effectively penetrate kidney tissue. This study contributes to a growing body of evidence suggesting otherwise. MTx is currently conducting a Phase II double-blind, randomized, placebo-controlled trial with 90 patients in the USA for the treatment of BK viremia in kidney transplant recipients, with top line results anticipated later in 2025. The full publication can be accessed here. -Ends- Contacts Memo Therapeutics AG info@ ICR Healthcare Amber Fennell, Ashley Tapp memotx@ +44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG ('MTx') is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company's lead program, potravitug, is in Phase II development targeting BK viremia in kidney transplant recipients, an infection which can result in decreased kidney functionality and longevity and reduced patient survival. Potravitug has the potential to become a first-in-class BKV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn. Alongside potravitug, MTx is focused on discovering novel oncology targets. Underpinning MTx's core assets is its proprietary DROPZYLLA® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at and on in to access your portfolio
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3 days ago
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Memo Therapeutics AG Publishes Study in Frontiers in Pharmacology Demonstrating Therapeutic Antibody Transcytosis Across the Kidney Barrier After Intravenous Administration
Results demonstrate that intravenously administered therapeutic IgG antibodies can be detected in urine, supporting the conclusion that these antibodies are capable of crossing the kidney endothelial barrier This proof-of-concept study provides compelling support for the selected dosing regimen of MTx's investigational BK polyomavirus-neutralizing antibody Schlieren / Zurich, Switzerland, 11 June, 2025 – Memo Therapeutics AG (or 'MTx'), a late-stage biotechnology company developing antibody-based therapies for viral infections and cancer, has published a study in Frontiers in Pharmacology detailing the transport of therapeutic IgG1 antibodies across the kidney endothelial barrier. This quantitative analysis provides a scientific basis for the selected dosing strategy of MTx's highly potent human anti-BKV IgG1 therapeutic antibody, potravitug, currently in Phase II clinical development. The study reports that, 0.015% (median) of the serum concentration of therapeutic antibody rituximab is found in the urine, with levels reaching up to 4.2%. These findings suggest that therapeutic IgG antibodies can cross the kidney filtration barrier in measurable amounts, challenging prior assumptions about size-exclusion limitations and supporting the feasibility of antibody-based interventions for renal infections. Christoph Esslinger, CSO of MTx, commented: 'This data reinforces the notion that potravitug can access infected renal tissue and supports the continued development of this first-in-class candidate for the treatment of BK viremia in kidney transplant recipients.' BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term graft survival. Despite this, therapeutic options remain limited, partly due to the prevailing belief that large-molecule biologics cannot effectively penetrate kidney tissue. This study contributes to a growing body of evidence suggesting otherwise. MTx is currently conducting a Phase II double-blind, randomized, placebo-controlled trial with 90 patients in the USA for the treatment of BK viremia in kidney transplant recipients, with top line results anticipated later in 2025. The full publication can be accessed here. -Ends- Contacts Memo Therapeutics AG info@ ICR Healthcare Amber Fennell, Ashley Tapp memotx@ +44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG ('MTx') is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company's lead program, potravitug, is in Phase II development targeting BK viremia in kidney transplant recipients, an infection which can result in decreased kidney functionality and longevity and reduced patient survival. Potravitug has the potential to become a first-in-class BKV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn. Alongside potravitug, MTx is focused on discovering novel oncology targets. Underpinning MTx's core assets is its proprietary DROPZYLLA® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at and on in to access your portfolio
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15-05-2025
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Q1 2025 Celcuity Inc Earnings Call
Apoorva Chaloori; Investor Relations; ICR Healthcare Brian Sullivan; Chairman of the Board, Chief Executive Officer, Co-Founder; Celcuity Inc Vicky Hahne; Chief Financial Officer; Celcuity Inc Maury Raycroft; Analyst; Jefferies Unidentified Participant Tara Bancroft; Analyst; TD Cowen Gil Blum; Analyst; Needham & Company Oliver McCammon; Analyst; LifeSci Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity first-quarter 2025 financial results webcast conference call. (Operator Instructions)I would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead. Apoorva Chaloori Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's First Quarter 2025 Financial Results and Business Update. Earlier today, Celcuity Inc. released financial results for the first quarter ended March 31, 2025. The press release can be found on the Investors section of Celcuity's me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results and evaluate the company's current performance. Management believes that the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead. Brian Sullivan Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our first quarter financial results conference call. We have an exciting year ahead of us with multiple upcoming clinical data readouts. We expect to report top line data from the PIK3CA wild-type patient cohort of our Phase III VIKTORIA-1 trial in Q3 2025 and from the PIK3CA mutated patient cohort in Q4 2025. We also anticipate reporting preliminary top line data for the Phase Ib portion of our Phase Ib/II trial in prostate cancer in late second finally, we made great progress activating trial sites for our Phase III first-line VIKTORIA-2 trial over the past few months. In our view, each of our 3 programs has the potential to generate significant levels of revenue. If these programs ultimately result in regulatory approvals, we estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with gedatolisib. Let's turn now to our VIKTORIA-1 trial. Our Phase III VIKTORIA-1 trial is designed to evaluate gedatolisib in combination with fulvestrant with and without palbociclib in patients with hormone receptor positive HER2-negative advanced breast cancer, whose disease has progressed on or after treatment with a CDK4/6 VIKTORIA-1 trial includes 2 patient cohorts with independent statistical analysis plans and primary endpoints. The primary endpoints for VIKTORIA-1 are progression-free survival or PFS as assessed by blinded independent central review. Study is designed to independently evaluate a PIK3CA wild-type cohort and a PIK3CA mutant cohort. For the PIK3CA wild-type cohort, there are 2 primary endpoints that will be tested hierarchically, whereas the PIK3CA mutant patient cohort has a single primary endpoint. The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression based on the current blinded event rates, we anticipate the primary completion of the PIK3CA wild-type patient cohort will occur in June, which would allow us to announce in a press release top line data in the third quarter and to present full results from this patient cohort at a medical conference later in 2025. If positive, we expect the data will support our first new drug application and if approved, our transition to a commercial stage company. If proven effective, gedatolisib in combination with fulvestrant and palbociclib could offer a new standard of care for patients with HR-positive/HER2-negative advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. For the PIK3CA mutant patient cohort, we anticipate reporting top line data in the fourth quarter of 2025. The current second-line treatment paradigm for HR-positive/HER2-negative patients with advanced breast cancer includes selective estrogen receptor degraders or SERDs, like fulvestrant or elacestrant as single agents or 1 of 3 approved PAM inhibitors combined with endocrine each of the PAM inhibitors only targets a single PAM node, such as PI3K alpha, AKT or mTORC1, which is suboptimal because the uninhibited PAM nodes can induce compensatory resistance. In patients who've received prior treatment with the CDK4/6 inhibitor, none of these single node PAM inhibitors have demonstrated efficacy in patients who have PIK3CA wild-type tumors, while only the PIK3CA alpha and AKT inhibitor have reported benefit in patients with PIK3CA mutations. And these results are consistent with the nonclinical data that shows these single node inhibitors are 3 to 4 times less potent in breast cancer cells without PIK3CA mutations than in those with them. Of course, we recognize the foundation of gedatolisib's role in this treatment landscape will require that gedatolisib be well tolerated and report a clinically meaningful result measured in terms of the incremental improvement in both PFS and the hazard ratio relative to standard of care. Breast cancer KOLs and regulators generally consider an incremental improvement in PFS of 3 months relative to its control to be clinically MPFS or median progression-free survival benchmarks for patients pretreated with a CDK4/6 inhibitor patient population we're evaluating are modest. Only 2 non-chemo-related therapies have been evaluated in this patient population and received approval. One reported a 1.9 months incremental median PFS improvement relative to its comparator in patients with ESR1 mutations. The other did not report median progression-free survival improvement relative to current standard of care, but it did report a more favorable safety profile in patients with PIK3CA mutations. Despite the modest or no efficacy improvements on this benchmark, both of these recently approved drugs has experienced rapid market adoption and drug reached revenue run rates within the first 12 months of launch estimated to be nearly $0.5 billion despite approvals that only address 30% to 40% of the eligible second-line patient population. We believe this demonstrates the significant interest amongst oncologists for new treatment options for these patients and the relatively low bar required to obtain adoption and market penetration. A potentially more important data point than incremental PFS benefit to consider in advanced breast cancer when assessing the clinical benefit of one therapeutic regimen relative to another is the hazard ratio. And this is because recent randomized studies evaluating therapies for patients with HR-positive/HER2-negative advanced breast cancer have enrolled widely heterogeneous patient populations. Since physicians make different treatment decisions for patients depending on, among other factors, how many lines of therapy, how well they respond to the prior therapy and which type of therapy they may have received, results from these studies can be hard to interpret using absolute median PFS for incremental PFS benefit a result, top line and PFS results from these studies don't provide sufficient clarity about the actual benefit a particular patient population may receive. The hazard ratio essentially factors out the differences in study populations and thus provides physicians with a more objective benchmark. We not only hope to report a hazard ratio that is statistically significant, but one that compares favorably to the hazard ratio reported for other therapies available for second-line patients whose disease progressed while receiving a CDK4/6 inhibitor. If gedatolisib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for the second-line indication could exceed $2 billion with just 40% market penetration. I'd like now to turn to our first-line breast cancer program and our VIKTORIA-2 VIKTORIA-2 study is a global Phase III open-label randomized clinical trial, evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus investigator's choice of either ribociclib or palbociclib as a first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer, and these patients are endocrine therapy resistant. Approximately 638 subjects will be assigned to a cohort based on their PIK3CA mutation status. The primary PFS endpoint for each of the cohorts will be evaluated independently. Prior to initiation of the Phase III portion of the trial, a safety run-in study will be conducted in 12 to 36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant. And during the first quarter, we completed our site qualification activities, and we're now focused on activating the nearly 200 sites we've qualified across North America, Europe, Latin America and Asia also begun screening patients and expect to dose our first patient during the second quarter. Current standard of care first-line treatment for most endocrine therapy-resistant patients includes any of the 3 approved CDK4/6 inhibitors combined with fulvestrant. Results from a recent trial suggest that the median PFS period for patients receiving 1 of these 3 regimens is only 7 to 8 months. And these results compare poorly to the median PFS of 25 to 27 months reported for patients who are sensitive to endocrine therapy and who receive a similar regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy. Now I'd like to turn to our Phase Ib/II trial that's evaluating the safety and efficacy of gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer whose disease progressed while receiving a next-generation androgen receptor Phase Ib/II study evaluates gedatolisib in combination with darolutamide, which is an androgen receptor signaling inhibitor in patients with metastatic castration-resistant prostate cancer. We've completed enrollment of the Phase Ib dose escalation portion of the study and anticipate reporting top line data by the end of the second quarter this year. Since we're at an earlier phase in this program, our focus is optimizing the dose and schedule for this tumor type and drug combination. This data set will include approximately 36 patients, half of whom will have received a 120-milligram dose of gedatolisib, the other half a 180-milligram dose. Each are administered on a 3-week on, 1-week off we're comparing both the landmark PFS at 6 months and safety profile of these 2 arms to each other and to historical control data for second-line metastatic castration-resistant prostate cancer patients who are retreated with an androgen receptor inhibitor. And finally, we're excited about the opportunity we announced today to collaborate with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer. The rationale to initiate the study is based on compelling historical clinical data that indicates women with ER-positive or type 1 endometrial cancer may benefit from treatment with a PI3K/AKT/ mTOR inhibitor like gedatolisib in combination with endocrine therapy. Additionally, results from a prior Phase II clinical study evaluated gedatolisib as a monotherapy in patients with either type 1 or type 2 endometrial cancer, and these results were encouraging. So I'd like now to turn the call over to Vicky to review our finances. Vicky Hahne Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the first quarter of 2025. Our first quarter net loss was $37 million or $0.86 per share compared to $21.6 million net loss or $0.6 per share for the first quarter of 2024. Our non-GAAP adjusted net loss was $34.7 million or $0.81 per share for the first quarter of 2025 compared to non-GAAP adjusted net loss of $19.9 million or $0.59 per share for the first quarter of 2024. Research and development expenses were $32.2 million for the first quarter of 2025 compared to $20.6 million for the first quarter of the approximately $11.6 million increase in R&D expenses, $5.9 million was related to increased employee and consulting expenses and $5.7 million primarily related to activities supporting our ongoing clinical trials. General and administrative expenses were $3.9 million for the first quarter of '25 compared to $1.8 million for the first quarter of 2024. Increased employee and consulting-related expenses accounted for $1.6 million of the increase. Professional fees, expanding infrastructure and other administrative expenses accounted for the remaining increase of approximately $0.5 million. Net cash used in operating activities for the first quarter of 2025 was $35.9 million compared to $17.1 million for the first quarter of ended the quarter with approximately $205.7 million of cash, cash equivalents and short-term investments. We expect this cash, cash equivalents and short-term investments and drawdowns on our debt facility to fund current clinical development program activities through 2026. I will now hand the call back to Brian. Brian Sullivan We're now ready to turn the call over for questions. Operator (Operator Instructions) Maury Raycroft, Jefferies. Maury Raycroft Congrats on the progress. was going to ask one on VIKTORIA-1. You're using the blinded independent central review analysis, which can take a longer amount of time to analyze versus investigator assessed. And so just wondering if you can provide more perspective on how long you think it will take to lock the data set sometime in June and then to get to the actual results in 3Q. Just wondering if you can give more perspective on the amount of time there. Brian Sullivan Sure the primary completion date essentially is referencing the data cutoff date when you stop collecting data, and that's typically done and in our case, will be done when you've achieved the prescribed event threshold. And so from there, you are engaged in the data cleaning process and ultimately, at that point, you lock the database. So we expect that in Q3, and we're -- if we achieve what we're very confident about achieving with completing the -- achieving the primary completion date, we think that Q3 is absolutely certain time when we would have the data available. And we're not going to get into more specificity in terms of month. But again, I think there's no further risk of delay at this point in the trial of being able to report these results. Maury Raycroft Understood. But I guess for that amount of time from locking the database to reporting the data, any general estimate on how long that could take? Brian Sullivan I mean, typically, you would see no more than 3 months and typically less than that. Maury Raycroft Got it. Okay. And then understanding that overall survival might not be fully mature at the top line, do you think you would be able to provide some sort of an update on just the directionality of survival trend that you're seeing between the 3 arms at the data readout? Brian Sullivan The data readout that we expect to make in a press release will only include the median PFS and the hazard ratios for the 2 primary analyses. The subsequent data will be analyzed rather presented at the medical conference later in the year. Operator Andrew Berens, Leerink. Unidentified Participant This is [Elison] on for Andy. I wanted to get your thoughts on the potential impact of SERENA-6 on the second-line setting for HR-positive patients. Just curious what could broad adoption from this need for GEA in the wild-type population? And also kind of a similar question, what could the potential impact be to GA in the mutant patient population as well? Brian Sullivan Sure. Well, we don't think that would affect us at all. These are still essentially first-line CDK4/6 patients. It's actually current practice amongst many doctors, depending on the profile of their patients to transition them off letrozole to fulvestrant depending on how they believe their patients are progressing. So this trial essentially identified a more precise way of determining the timing and what appears to be a very effective way of doing the patients in our trial are essentially consistent with the patients that this trial evaluated, which are patients who received CDK4/6 and eventually progressed. And so if our data is favorable, we would expect physicians to then seek to continue treatment with the CDK4/6 inhibitor with one that includes gedatolisib. And I don't think the practice will vary between those patients who lack PIK3CA mutations versus those who do have PIK3CA mutations. I think the primary effect may be on how other CDK4/6 plus oral SERD combinations get Operator Tara Bancroft, TD Cowen. Tara Bancroft So I was wondering if you could provide any updated thoughts on what minimum HR you would consider to be good data in the wild-type update, not just for hitting stats, but in relation to other data sets and indication like SERENA-6 that was just mentioned and other marketed products? And what do KOLs want to see in order to use it? Brian Sullivan No, I appreciate the question. At this time, with the data fairly imminent, we're not going to comment specificity about those types of projections. We've commented because the analysis is easier to do that an incremental 3 months would be considered clinically meaningful. Certainly, any statistically significant hazard ratio that's consistent with 3 months would also be considered clinically meaningful. How the regimen and the results specifically stack up against other regimens will just be a function of how those 2 sets of data compare. Operator (Operator Instructions) Gil Blum, Needham & Company. Gil Blum So just to fully clarify this, what exactly drove the slight change in timing for the wild-type readout? And should we expect to see no change in the PIK3CA time line? And as a follow-on, what investment, if any, would you need to do to support the endometrial cancer collaboration? Brian Sullivan Sure. As far as what drove it, again, I think we've indicated on prior calls that because this is a 3-arm trial and the primary analysis is driven by reaching an event threshold in each of 2 different analyses, it's imprecise for us to estimate the timing. I think there's this variance in how those results are distributed within the aggregate total of events for all 3 arms. And we're now at a point where the potential for variability is de minimis. And so that's why we have confidence about being able to establish a data cutoff in as far as Q4 for the PIK3CA mutant, we're confident about that. It's a less complicated tracking of event threshold because even though the 3 arms, the third arm comprises only about 15% of the total. So the primary analysis event threshold is much more closely aligned to the aggregate of the 3 arms. And as far as the endometrial study that we announced, we are supplying drug product and providing clinical support to that study. So we don't think we'll have any incremental financial effect on the Operator Oliver McCammon, LifeSci Capital. Oliver McCammon Maybe we'll take a break from VIKTORIA-1 for a moment. I'm curious if you can just remind us on some of the prior proof-of-concept data for targeting the PI3K/AKT/MO4 pathway in prostate cancer. And more specifically, what you think the potential is for multi-node inhibition versus single node inhibitors like capivasertib. And then I'm also curious if you plan to share PSA data at the time of the update late in the second quarter. Brian Sullivan Sure. And so the data that's been reported with either in particular, AKT inhibitors, those have been the inhibitors from this general class of drugs that have been evaluated in patients with metastatic castration-resistant prostate cancer. Now capivasertib reported positive data with patients who have hormone-sensitive prostate cancer that was favorable in patients who have P10 mutations, and so a subgroup of the total population. The nonclinical data that we've reported and published indicate the GE is equally active independent of the status of P10, which is the primary mutation in prostate cancer. And capivasertib hasn't demonstrated activity or it's significantly less active in tumor cells, prostate tumor cells that lack P10 so we think that data is encouraging because it demonstrates the role the pathway plays. And similar to breast cancer, gedatolisib in nonclinical models has shown to be significantly more potent and cytotoxic than, let's say, an AKT inhibitor like capivasertib or the other drugs that have been approved that address the PAM pathway. And so that was a major part of the rationale for evaluating GEA in this setting that, a, the pathway has been demonstrated to be approved; and b, the drugs that have demonstrated activity are at least nonclinically, less active than GEA, which we think creates a very strong rationale for the trial. As far as the update, the update will really just focus on the primary analysis and safety data. And then the rest of the data, we would expect to report at a medical meeting in 2025. Operator There are no further questions at this time. Please continue, Mr. Brian Sullivan. Brian Sullivan Well, thank you. We appreciate your interest in Celcuity, and we'll be attending and presenting at several investor conferences over the next few weeks. So I look forward to seeing some of you there. Goodbye. Operator Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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15-05-2025
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Q1 2025 Cytosorbents Corp Earnings Call
Adanna Alexander; Investor Relations; ICR Healthcare Phillip Chan; Chief Executive Officer, Director; Cytosorbents Corp Efthymios Deliargyris; Chief Medical Officer; Cytosorbents Corp Peter Mariani; Chief Financial Officer; Cytosorbents Corp Michael Sarcone; Analyst; Jefferies Sean Lee; Analyst; H.C. Wainwright Michael Kim; Analyst; Zacks Small-Capital Research Operator Good afternoon, ladies and gentlemen, and welcome to the CytoSorbents' first-quarter 2025 earnings conference call. (Operator Instructions) This call is being recorded on Thursday, May 8, 2025. I would now like to turn the conference over to Mr. Adanna Alexander. Please go ahead. Adanna Alexander Thank you, Constantine, and good afternoon, everyone. Welcome to CytoSorbents' First Quarter 2025 Financial Results and recent Business Highlights Conference Call. Joining me today from the company for prepared remarks are Dr. Phillip Chan, Chief Executive Officer; Dr. Makis Deliargyris, Chief Medical Officer; and Pete Mariani, Chief Financial Officer. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements, which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today. The forward-looking statements we make reflect our views and estimates as of today, May 14, 2025 and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for the first quarter 2025. Following the presentation, we will open the line to analysts for their questions. And now it is my pleasure to turn the call over to Dr. Phillip Chan. Phil? Phillip Chan Thank you very much, Adanna. Good afternoon, and welcome, everyone, to our first quarter 2025 earnings call. As a quick summary for those who are new to the company, CytoSorbents is a leader in the treatment of life-threatening conditions in the intensive care unit in cardiac surgery through blood purification and the removal of harmful substances from blood with our proprietary sorbent bead technology. Cartridges filled with these beads are high-margin single-use disposables that are plug-and-play compatible with existing blood pump machines in the hospital, such as dialysis, ECMO and heart-lung machines. Our technologies are used in a broad number of blood purification applications, specifically CytoSorb, our flagship product, which is approved in the European Union, is used primarily to treat life-threatening conditions in the ICU and cardiac surgery such as sepsis, acute respiratory distress syndrome, liver failure, blood thinner removal and infective endocarditis. CytoSorb is the anchor of our core international business with over 270,000 devices utilized to-date in more than 70 countries worldwide and drove $35.6 million in core product sales in 2024. Our second product, DrugSorb ATR is an investigational FDA breakthrough designated medical device intended to reduce the severity of perioperative bleeding in patients undergoing cardiac surgery due to blood thinning drugs. We are focused initially on the blood thinner Brilinta in patients undergoing coronary artery bypass grafting or CABG surgery. And in September and November of 2024, we submitted marketing applications to both FDA and Health Canada, respectively. Makis will have some updates on the status of these applications later. Given that we just had a broader update on the company in our end of year earnings call 1.5 months ago, today's agenda will just focus on the three main areas where we are concentrating our efforts. I will discuss our core CytoSorb business and highlight key catalysts for growth. Makis and I will then cover the regulatory status and activity of DrugSorb ATR in the U.S. and Canada to outline our plans going forward. And then Pete will go over our progress and our goal to have our core business near breakeven by the end of this year with sufficient cash to fund our company initiatives. Let's turn to CytoSorb. In the first quarter of 2025, we reported product sales of $8.7 million, representing a 3% year-over-year decline. However, when adjusted for constant currency, sales were approximately the same compared to the same period last year. International distribution and other direct sales markets delivered strong performances, helping to offset temporary disruptions in our German direct sales segment. These disruptions were anticipated as they stem from the strategic reorganization and realignment of our German sales team and the go-to-market approach, initiatives we believe are essential for positioning this critical market for renewed growth. Our goal is to return Germany to growth in the second half of 2025 following two years of flat annual performance. We are confident that the changes underway will yield long-term benefits. Meanwhile, gross margin performance remained solid, holding steady at 71%, blending higher-margin direct sales with lower margin distributor sales, which is consistent with the 2024 average, reflecting ongoing discipline in our end-user pricing and manufacturing cost controls. We expect gross margin expansion this year with smoother manufacturing operations and increased production volume. Importantly, as Pete will discuss later, we continue to make meaningful operational progress across the organization, moving steadily towards our goal of reaching near breakeven by the second half of 2025. CytoSorb is a powerful blood purification technology designed to remove a wide range of harmful substances that can severely damage the body. It is particularly effective in treating critically ill patients by targeting the overwhelming inflammatory response, often referred to as a cytokine storm that drives many life-threatening conditions. This uncontrolled inflammation is a major cause of patient instability, organ failure and death and is estimated to affect 40% to 60% of ICU patients suffering from conditions that we talked about before, such as septic shock, severe infections, including COVID-19, flu, pneumonia and postsurgical infections, ARDS, trauma, burns, pancreatitis and many others. Caring for critically ill patients is complex with many variables influencing outcomes. However, one thing is certain, if severe inflammation is not addressed quickly and aggressively, it can spread like wildfire throughout the body, becoming nearly impossible to control. That is why CytoSorb is focused on early targeted intervention, what we call treating the right patient at the right time with the right dose. By intervening early in patients with signs of severe inflammation, CytoSorb helps break the vicious cycle of runaway immune activation, stabilizes patients in shock, supports organ function and removes other harmful substances from the blood. This proactive approach offers a powerful tool in the fight against some of the most challenging and deadly conditions in the intensive care unit. In fact, the use of CytoSorb in treating critical illness closely parallels treatment guidelines for antibiotics. For the best clinical outcomes, CytoSorb must be used early, aggressively and consistently just like antibiotics. Even if a patient shows signs of improvement, it's crucial to continue therapy until the full course is complete. The objective is not just to control inflammation, but to reduce it to a safe level, much like extinguishing a wildfire, which can take days to fully subside. We believe strongly this new simplified messaging will help drive broader adoption of CytoSorb by driving more effective patient treatment. This is expected to strengthen physician confidence, generate more positive word of mouth in clinical publications and ultimately support the development of standard treatment guidelines and broad global uptake. There are clearly many catalysts for future growth, but some of the ones that we are focused on now are: one, publicizing compelling new data in core applications. New clinical and real-world data strengthens our value proposition, drives adoption and supports guideline inclusion, positioning us for accelerated growth in key markets. In particular, in the near future, we will be discussing a number of powerful studies highlighting the successful use of CytoSorb in one of our largest markets, the treatment of septic shock. Second is simplified impactful customer messaging. As stated just before, easy to remember impactful guidance to users can yield many benefits, including better patient outcomes, greater physician confidence and broader adoption. Third is returning German sales to growth. Germany is the largest medical device market in the European Union with high strategic importance and accounts for approximately 40% of our sales. At flat growth over the past several years, this has held back our growth overall despite strong gains in other parts of our business. Although there are a number of macro factors that have impacted this market since the pandemic, we believe our efforts to better optimize our German sales team, our sales strategy and our medical messaging is under our direct control and can reinvigorate sales in the country to contribute to our growth overall. And lastly, expansion via our Dubai subsidiary. Dubai is a vibrant epicenter of healthcare business in the Middle East. Establishing this hub is expected to accelerate access to high-growth markets in the Middle East and Africa, enabling faster market entry, stronger partnerships and regional revenue diversification. With that, I would like to transition now to discuss DrugSorb ATR. Acute heart attack patients are routinely treated with blood thinners like Brilinta, also known as ticagrelor to improve clinical outcomes. However, while these medications save lives, they also present a significant challenge when patients require urgent CABG surgery. Brilinta can lead to serious and potentially life-threatening bleeding complications during and after surgery. The only current solution is a drug washout period of 3 to 5 days to reduce bleeding risk. Unfortunately, time is a luxury many of these patients do not have. Rushing to surgery can lead to major bleeding if performed too soon, while delayed surgery can result in devastating complications such as sudden death if the procedure is postponed while the patient is still experiencing a heart attack. These delays are also costly and strain hospital resources. To address this critical and widespread clinical problem, we have developed DrugSorb ATR, an FDA breakthrough designated device. DrugSorb ATR is specifically designed to remove blood thinners like Brilinta from the bloodstream, enabling safer timelier surgeries. This innovation targets a serious unmet medical need affecting tens of thousands of patients each year in the United States and Canada, representing an initial market opportunity of over $300 million, one we estimate could grow to more than $1 billion if approved and used in different indications. To give you an update on the regulatory status of DrugSorb in the United States and Canada, I've asked our Chief Medical Officer, Dr. Makis Delagiris, to provide additional clarity on the strength and status of our application and path moving forward. Makis? Efthymios Deliargyris Thank you, Phil, and good afternoon to everyone on the call. As most of you know, in the second half of last year, we submitted a de novo application to FDA and a medical device license application to Health Canada, supported by the STAR-T randomized clinical trial data and real-world evidence from the STAR registry. The FDA review process has been interactive with many issues discussed and resolved. However, on April 25, 2025, the FDA issued a denial letter citing remaining open issues. Following the issuance of the letter, we met with the FDA and had the opportunity to discuss these remaining issues and gain better clarity. We continue to believe that our submission package and data are strong and that the remaining issues can be resolved. After consulting with our regulatory counsel, we concluded that the most direct path forward is the filing of a formal appeal, which needs to happen within 60 days of receipt of the FDA letter. Once the appeal is filed, the process is prescribed and includes a formal hearing that will be attended by the company and our regulatory counsel, DuVal & Associates, the FDA review team, additional FDA senior officials and external clinical experts such as cardiac surgeons to provide expert testimony. The appeal decision is estimated approximately 60 days after the filing date, and there are three potential outcomes. First, the original decision is upheld and the de novo authorization is denied. Second, the original decision is reversed and the de novo authorization is granted. And finally, a third option where the original decision is reversed and the de novo authorization is granted, but under certain conditions that will need to be satisfied. Switching now to Canada, our medical device license application remains in advanced review. Health Canada recently indicated that they're experiencing delays and the review times are extending beyond their target timelines. They did reaffirm, however, the commitment to issue a decision to our application as soon as possible. We, therefore, continue to expect final regulatory decisions, both in the U.S. and Canada in 2025. The evidence based on blood thinner removal during cardiac surgery continues to grow. Our international STAR registry now has 28 heart centers actively recruiting in 6 countries, including Germany, the United Kingdom, Belgium, Austria, Sweden and Switzerland and has enrolled over 600 subjects to-date. The registry includes many types of surgeries, but we have focused our initial analysis on CABG. Last year, we presented data at EuroPCR on 102 CABG patients on ticagrelor and showed that device use resulted in fewer severe bleeding events compared with what would be expected according to historical benchmarks. These results were published earlier this year, and the paper is available online and with open access, so anyone can download it for free. This year, again at EuroPCR, which is taking place in Paris next week, we are presenting another real-world analysis this time comparing bleeding rates after CABG between patients on ticagrelor operated with the device and patients on ticagrelor operated without the device. Details of the data are embargoed until the time of presentation, but what we can say is that we are very excited that we now have very compelling evidence of the device's effectiveness in reducing ticagrelor-related CABG bleeding in the real world. We also have a new publication this year on the removal of direct oral anticoagulants or DOACs for short, during CABG that also showed lower-than-expected bleeding rates. This paper is also available online with open access, so anyone can download it for free. Overall, our real-world results consistently show that the device is effective in reducing severe bleeding complications in patients on blood thinners undergoing CABG. Importantly, the device is also safe for patients and easy to use by surgical teams. To-date, we have zero device-related adverse events and zero device deficiencies reported in the STAR registry, results that echo the clean safety we observed in STAR-T to everyday use in the real world. We continue to believe that our technology that enables blood thinner removal during cardiac surgery has a powerful value proposition for patients, surgeons and hospitals, and we are very encouraged by the growing adoption of the device as part of standard care at heart centers around the world. With that, I would like to turn it back to Phil now. Phillip Chan Thanks, Makis. As we await regulatory decisions from both the FDA and Health Canada, we're proactively preparing for the potential commercial launch of DrugSorb ATR in the U.S. and Canada. With the FDA's breakthrough device designation, DrugSorb ATR is uniquely positioned to help address the critical challenge of perioperative bleeding in patients on blood thinners like Brilinta undergoing CABG surgery. Upon potential approval or authorization, our initial focus will be a controlled market introduction at select clinical trial centers. This phased approach will enable us to gather real-world data and valuable insights; confirm key assumptions and optimize our commercialization strategy ahead of a broader national rollout. We remain deeply committed to bringing DrugSorb ATR to the North American market, where it represents a meaningful advance in the care of CABG patients facing life-threatening bleeding while on Brilinta. Momentum continues to build on the technology with growing awareness of DrugSorb ATR's potential and compelling new European data emerging in 2025. As Makis has highlighted, these real-world findings consistently demonstrate reduced bleeding and highlight the device's promise in helping surgeons address a significant and persistent clinical challenge. We are thrilled to welcome Tom Shannon to the CytoSorbents team as Vice President of Marketing for North America, a big move as the company gears up for the potential launch of DrugSorb ATR in the United States and Canada, pending market authorization. Tom is a global strategic marketing executive with over 25 years of experience bringing cutting-edge cardiovascular and critical care technologies to market and knows how to build momentum around major product launches. Tom has held leadership roles at multinational corporations like Medtronic, Fresenius and Getinge as well as Genesee Biomedical, where he helped launch dozens of products and drove consistent growth. For example, he helped launch the market-leading CardioHelp ECMO platform used around the world at Getinge in patients with refractory lung failure that was also used routinely with CytoSorb during the pandemic to salvage patients who otherwise would have died of COVID-19. Tom also brings hands-on clinical experience, having worked for over a decade as a cardiovascular perfusionist. Tom will be leading the marketing strategy for DrugSorb ATR, which is designed to help reduce serious bleeding risks in heart surgery patients taking Brilinta. In the very short time he has been with the company, we have already been impressed with his deep expertise and operational efficiency that we believe makes him the right person to help CytoSorbents successfully enter the North American market with this important new therapy when the time comes. Now I'll turn it over to Pete to give a financial update. Pete? Peter Mariani Thank you, Phil, and good afternoon, everyone. Today I will be reviewing our Q1 financial performance, including the strengthening of our balance sheet and our outlook for 2025. Revenue was $8.7 million, a decrease of 3% and flat on a constant currency basis compared to $9 million in Q1 of 2024. As Phil noted, we had strong revenue growth in our distributor and other direct European markets, and that growth was offset by declines in our largest market in Germany. The realignment of our German commercial team and approach is a key strategic initiative, and we are pleased with the progress we're making and expect these actions will drive improved execution and results in the second half of the year. Gross margin for the quarter was 71%, which is consistent with our full year '24 and lower than the 76% in Q1 of 2024. The year-over-year decrease was primarily due to a 23% reduction in the number of units produced in Q1 of this year compared to 2024 and partially offset by an 11% reduction in production costs year-over-year. We expect that production volumes to increase across the year to support growth in our core business and to prepare for the anticipated launch of DrugSorb ATR in the U.S. and Canada later this year. Q1 operating loss improved by 17% to $3.9 million in the current year compared to $4.7 million in 2024, driven primarily by a 12% reduction in operating expenses to $10.1 million in Q1 of this year compared to $11.5 million last year. The decrease was driven by a 26% reduction in R&D expenses following the completion of our STAR-T trial as well as lower spend in other clinical projects and the impact of cost-cutting efforts implemented over the previous year, including a 15% reduction in headcount. Net loss for the quarter was $1.5 million or $0.02 per share compared to $6.1 million or $0.11 per share in the prior year. Eliminating the impact of foreign currency changes and noncash stock compensation in both periods, adjusted net loss in the quarter was $3.7 million or $0.06 per share, which is consistent with an adjusted net loss of $3.7 million or $0.07 per share in the prior year. Adjusted EBITDA loss for the quarter, which also excludes the impact of noncash stock compensation and changes in foreign currency, improved by 17% to a loss of $2.7 million compared to adjusted net loss of $3.3 million in the prior year, driven by the reduction in operating expenses. Now we're pleased to have successfully executed our shareholder rights offering, inclusive of the exercise of the Series A right warrant, which raised total proceeds of $6.8 million, net of all related expenses, including banking, legal and transfer agent fees. This raise also allowed for the release of $5 million of restricted cash on our balance sheet. And combined, the raise increased our available liquidity by $11.8 million. And as a reminder, in early April, we provided a 60-day extension of the Series B right warrant, which will now expire on June 10 of this year. Our total cash, cash equivalents and restricted cash was $13.1 million on March 31 compared to $9.8 million at the end of the year. The increase reflects the net $6.8 million raised in the offering and is net of cash used in the quarter of $3.7 million, which includes disbursements that are unique to the first quarter of approximately $900,000. Additionally, as previously announced, on April 21, we received an additional $1.7 million from the sale of our 2023 and amended 2022 NOLs and R&D credits from the technology business tax transfer program sponsored by the New Jersey Economic Development Authority. The program allows technology and biotech businesses with net operating losses to turn their tax losses and credits into cash to buy equipment or facilities or other allowable expenditures. We intend to utilize the funding to help drive ongoing growth, including preparations for the anticipated launch of DrugSorb ATR in the U.S. and Canada, scaling up manufacturing in our Princeton facility and supporting other key strategic initiatives. Additionally, our loan agreement provides for a second tranche of $5 million, which may be drawn at our request in the second half of 2025, provided the company receives FDA marketing approval of its DrugSorb ATR application. The strengthening of our balance sheet, together with our initiatives to reduce cost, manage cash has provided a solid foundation where we will drive continued growth and further cost efficiencies that we believe will result in our core business approaching cash flow breakeven in the second half of the year, allowing for investment in our North American commercial launch of DrugSorb ATR later this year and into 2026. Now additionally, I wanted to introduce you to Melanie Grossman, our new Vice President and Corporate Controller. Melanie joined us in April and brings over 25 years of accomplished finance and accounting leadership in global publicly traded and private companies. She began her career as an auditor with E&Y, and her healthcare experience includes roles with Stryker, Byram Healthcare and Vaxxinity. She has excellent experience across areas -- all areas of finance and accounting, including SEC reporting, systems, processes and controls as well as financial planning, analysis and strategy. We're pleased to welcome Melanie to the team and are looking forward to her many contributions as we continue to scale our operations for profitable growth across the organization. And now let me turn the call back over to Phil. Phillip Chan Thanks, Pete. We believe our value proposition is both strong and highly differentiated. With CytoSorb, we have built a robust high-margin international business in critical care and cardiac surgery, markets with vast unmet needs and enormous potential for growth. Our foundation is solid, and we are now focused on generating new clinical data to help guide physicians in optimizing CytoSorb use, treating the right patient at the right time with the right dose. We believe that improving clinical outcomes will drive broader adoption across a range of indications, ultimately accelerating product utilization and revenue growth. Last year, we saw encouraging momentum, particularly from strong direct sales outside of Germany and solid performance by our distributor and partner network. We are also taking proactive steps to reignite growth in Germany. If successful, this could significantly strengthen our overall financial performance. Importantly, continued growth in product sales brings us closer to our goal of near breakeven by the end of 2025 and sets the stage for long-term financial independence. What is not yet fully reflected in our growth story is the exciting potential of DrugSorb ATR. We are working diligently on driving positive regulatory decisions from both FDA and Health Canada this year. In the meantime, we are actively preparing for launch, building awareness with positive real-world clinical data, corroborating the significant reduction in serious bleeding events in CABG patients on Brilinta seen in our pivotal trial and presenting at major cardiovascular conferences. While we await regulatory decisions from FDA and Health Canada, a positive outcome could unlock our first commercial access to the United States and Canadian markets. We expect to begin with a controlled market release and scale up from there. The initial addressable market, again, is estimated at $300 million for Brilinta in CABG surgery that could eventually exceed $1 billion with broader indications for use. With that, on behalf of the team at CytoSorbents, we thank you for your attention and continued support. That concludes our prepared remarks. Operator, please open the line for questions. Thank you. Operator (Operator Instructions) Michael Sarcone, Jefferies. Michael Sarcone Just to start, Phil, understanding you're going to submit for an appeal of the FDA letter. I guess can you talk about your level of confidence that we can get this over the finish line and get clearance? And then as my follow-up to that, just when you think about the various scenarios, in the worst case, if you appeal and it gets denied, where do we go from there? Phillip Chan Sure. Makis, why don't you take that question? Efthymios Deliargyris Yes. Thanks, Michael. So as we stated in our prepared remarks, we feel very strongly about the strength of our submission. We feel that the data in CABG from the STAR-T trial are compelling. And as I showed you and discussed previously, our real-world performance of the device has been excellent so far and very well-received by practicing clinicians. We, therefore, believe that our chances during this appeal process are good, and we discussed this with our regulatory council who agree with us, and therefore, we're taking this path as the most expedited way to resolve this. Now on your second part of your question, what we can tell you is that there's always an opportunity should the appeal process not be successful to continue with a new de novo submission utilizing a very large portion of the original submission and therefore, resulting in a much more truncated review time and review items that are remaining since many of the items were resolved during the initial submission. Michael Sarcone Got it. That's very helpful. And I guess in that latter scenario, Makis, would you have to run another trial and generate more data or would you not have to do that? Efthymios Deliargyris Although in general, we have not discussed the details of the remaining deficiencies outlined on the letter we received from FDA, I think we can announce that we have not received a request for an additional trial. So we believe that the remaining issues can be resolved with the existing data at hand. Operator Sean Lee, H.C. Wainwright. Sean Lee My first one is on the various -- registry as well as the data that you've been presenting. Will these results help in any way with your marketing or reimbursement in Europe? Efthymios Deliargyris The clinical data is always the core of the discussion around the value of any introduced medical technology, the drugs or devices. So the strongest your clinical proposition, the more powerful your value proposition. So absolutely, we plan to leverage this clinical data to support reimbursement and health technology assessment decisions over in the EU. Sean Lee Are there any current discussions going on in countries outside of Germany? Efthymios Deliargyris In relation to? Sean Lee Reimbursements, I mean. I know that your -- the reimbursement is mostly focused on Germany and surrounding countries. I was wondering for the broader reimbursement you use, especially during cardiac surgery, is there broader discussions on that? Phillip Chan Yeah. I think that cardiac surgery is where the data are simpler and clearer, and we absolutely have active discussions going on to try to obtain reimbursement in that area. In fact, in places like the United Kingdom, cardiac surgery is one of the top applications that's driving revenue in that territory, for example. Operator (Operator Instructions) Tom Kerr, Zacks Small-Capital Research. Michael Kim This is Michael Kim filling in for Tom Kerr. Some of our questions have been asked and answered, but we did have a couple more. Just first, curious if there are any other European markets that might be showing promise for the CytoSorbent device besides Germany? Phillip Chan Yeah. I think that we're making good progress in the Big 5. We go direct in the U.K., we go direct in Germany. We work through distributors in Italy and Spain/Portugal. And in France, it's kind of a hybrid approach with partners and our own direct sales. So from that standpoint, I think our progress is going actually quite well. And then obviously, in the other European territories, I think that we're making good progress as well. We have decided to pull back in Scandinavia, favoring a distributor-focused approach in that territory, given the types of volumes in that part of the world. But that being said we are seeing good momentum in other countries around the EU as well as outside of the EU. Michael Kim Got it. That's helpful. And then any updates on other products in development besides CytoSorbents and DrugSorb ATR? Phillip Chan Well, right now, the big fish on the plate is DrugSorb ATR. And so we're uniquely and solely focused on driving that to the finish line. So I think that when we -- we obviously have other technologies like HemoDefend-BGA that we'll hopefully be talking about in the future. But for right now, we are uniquely and singularly focused on DrugSorb ATR. Operator Michael Sarcone, Jefferies. Michael Sarcone Just had a follow-up on Germany. You talked about aiming to accelerate or get back to growth in the second half. I guess what kind of visibility do you have into the conditions there? And again, we would just like to hear how you're thinking about your level of confidence in being able to reaccelerate growth in Germany. Phillip Chan Yeah. As I mentioned in my remarks, and I mentioned last time that Germany faces -- is the largest market -- medical device market in the European Union, but as such, faces some unique challenges. And so there's been issues related to the pandemic and the pandemic hangover that we've talked about extensively in the past. There is the new issue of hospital reform that is happening. And this is being slowly rolled out throughout Europe, where they're going to be focused more on quality measures to drive reimbursement rather than pay for procedure measures to pay for reimbursement. And that, again, we believe, favors our technology given that our technology is designed to get patients -- to keep patients from getting so sick and getting them out of the hospital as quickly as possible, which I think is the major tenet of the hospital reform that's taking place in Germany. But that being said, we can always be doing better in our own execution of sales. And I think that is what our reorganization and new efforts at trying to drive operational efficiency at our German subsidiary. And I think that these changes are something that we can control that we have -- are actively implementing. And we believe that the results of these changes that started at the beginning of the first quarter will flow through and ultimately, we'll see benefits in the second half of this year. Already in Q2, we're seeing promises -- promising developments that would suggest that we're making progress. Operator There are no further questions at this time. I'd like to turn the call over to Dr. Phil Chan for closing comments. Sir, please go ahead. Phillip Chan Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to us at ir@ We look forward to updating you in the future. Have a good evening, everyone, and thank you very much. Have a great night. Operator This concludes today's conference call. Thank you very much for your participation. You may now disconnect. 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Yahoo
13-05-2025
- Business
- Yahoo
Q1 2025 Imunon Inc Earnings Call
Stacy Lindborg; President, Chief Executive Officer and Board Director; Imunon Inc Operator Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Imunon's first quarter 2025 financial results conference call. (Operator Instructions) I would now like to turn your call over to Peter Vozzo of ICR Healthcare Investor Relations, representative for Imunon. Please go ahead. Thank you, Dave. Good morning, everyone, and welcome to Imunon's first quarter 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, beliefs or other similar expressions. These statements are based on current expectations that are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as the date of this live broadcast, May 12, 2025. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Dr. Stacy Lindborg, President and Chief Executive Officer. Stacy? Stacy Lindborg Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas V. Faller, Imunon's, Chief Medical Officer: and Dave Gaiero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardugno, the Executive Chairman of our Board and Khursheed Anwer, our Chief Scientific Officer are also both on the line and will be available for Q&A. I want to start by saying that we may be close for the first time to unlocking the power of interleukin-12 to effectively treat cancer in one of the worst forms, ovarian cancer. Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientists and clinicians and researchers, underscores our commitment to addressing unmet medical needs and driving long-term value. I'm amazed at the number of discussions I've had since joining Imunon in both personal and professional settings where people have shared impact from ovarian cancer at a close and personal level. Its devastation has no limits in taking the lives of women, young and old, in their prime. We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer. To that end, I'm pleased to report that we have initiated the first clinical site in our Phase 3 pivotal study of Imunon-001. If the results from our highly successful Phase 2 study are replicated in Phase 3, patients and doctors may potentially have a meaningful life extending therapy that recruits and empowers body's immune system to effectively target this disease. Our Phase 3 study, known as OVATION 3, is being recognized by the medical community as a critical step towards the goal of delivering a new frontline treatment for women with limited options and unmet urgent medical needs. This recognition is exemplified by the acceptance of our new OVATION 2 results for an oral presentation at the upcoming ASCO Annual Meeting and for publication in the peer-reviewed journal Gynecologic Oncology. It also underscores the scientific community's strong and historic evidence of Imunon-001's anti-cancer potential. We believe we have much to offer the future of oncology treatment, and I hope you are as excited as we are. Now, I'd like to report on our recent progress and review our clinical and regulatory status of Imunon-001. We continue to work with our trial investigators to begin enrolling participants, all of whom have shown unwavering interest in the Phase 3 trial and are committed to advancing the study. The confirmatory Phase 3 trial OVATION 3 will assess the efficacy of Imunon-001, plus the standard-of-care versus the standard-of-care, which is neoadjuvant and adjuvant chemotherapy alone. The standard-of-care for women who are newly diagnosed and treatment naive is paclitaxel and carboplatin chemotherapy, both neoadjuvant and adjuvant to interval debulking surgery. The study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer. Study participants will be randomized 1:1, and there will be a subgroup of women positive for homologous recombination deficiency, HRD, which, as many of you will know, includes the familiar mutations BRCA1 or BRCA2. Participants within this sub-group will receive PARP inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival or OS. Secondary endpoints include surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints including quality of life measures, which will aid as we engage in payer and pricing discussions in the future, as we entertain approvals and access around the world. The advantage of overall survival as the primary endpoint is that it is a definitive endpoint. There will be no need for a second confirmational study to support approval. And if results are positive, the Phase 3 trial is also expected to support EU registration as a direct result of the selection of the overall survival of the primary endpoint. And you'll recall that we have orphan status established in Europe along with US Orphan Drug Designation. The initial core set of clinical trial sites currently activating are highly encouraged by Imunon-001's data and are enthusiastic about OVATION 3. These include sites that were part of both the Phase 1 OVATION 1 study and the Phase 1/2 OVATION 2 study. And we're excited to bring new sites on board to accelerate enrollment of the trial. The strength of our data is the key point of discussion, and we believe it will drive surgeons' interest and patient recruitment. There is optimism that Imunon-001 could potentially be a new product on the horizon and reset the standard-of-care for the frontline treatment of women newly diagnosed with advanced ovarian cancer if the safety and efficacy from OVATION 2 are confirmed in Phase 3. We have a strategy and statistical plan which allows for a 500-patient trial in an all-comer population of newly diagnosed patients, as well as a plan to focus on a 250-patient sub-group defined by a biomarker identifying patients who are HRD positive. Both are strong options and have 95% power or higher, and both are capable of supporting an FDA approval for Imunon-001. As we shared in our last call, we will focus initially on the HRD positive sub-group defined by a biomarker through a central lab. This highly cost-effective strategy allows us to enroll half the number of patients with an opportunity to achieve a readout sooner. We expect the study budget will be approximately 40% lower than the full study budget and could read out two years earlier. This population represents one half of the neoadjuvant ovarian cancer market and would be an important advancement for patients. We would likely trigger a broadening of the inclusion criteria at a later date budget permitting to reach the 500 patient all-commerce trial. Our strategy includes an interim analysis at high probability for success milestones. As we advance Imunon-001 in the Phase 3 OVATION 3 trial, we do not want its achievements in OVATION 2 to go unnoticed. As previously announced, data from the OVATION 2 study will be reviewed in an oral presentation during ASCO's Annual Meeting next month. Dr. Premal Thaker, who is Interim Chief of Gynecologic Oncology. David & Lynn Mutch, Distinguished Professor of Obstetrics & Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington University School of Medicine. She will lead the discussion in the oral presentation. As I mentioned earlier, review of the full data from OVATION 2 will be published in the highly esteemed journal Gynecologic Oncology on June 3, being released simultaneous to the ASCO presentation. Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer as well as the strength and potential of Imunon's TheraPlas platform technology. With that, I'd like to turn the call over to Dr. Douglas Faller, who will discuss the Phase 3 OVATION 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas? Thank you, Stacy. This is clearly a very exciting time for Imunon. In addition to the presentation of the results from our OVATION 2 trial at an oral session of ASCO in a few weeks and the simultaneous journal publication which Stacy mentioned, we've also been invited to present new translational data from the OVATION 2 trial at the International ESMO Gynecological Conference in June. The new data that we will present demonstrate that Imunon-001 technology performs exactly as it was designed, delivering highly potent IL-12 gene therapy directly to the site of the tumor while keeping systemic exposure to IL-12 extremely low. This is the proprietary biochemical basis for both Imunon's anti-cancer activity and just as important, its safety. We initiated the first clinical site in our registrational OVATION 3 trial last week with the second site to be initiated in two days. More site initiations are planned in the coming weeks. It is gratifying to me as a clinician and informative to note that these leading hospitals and internationally known principal investigators were also major participants in OVATION 2. Their enthusiasm actually their insistence for joining OVATION 3 speaks to their belief in the safety and potential benefit of Imunon-001 in the women they care for. They want to join with us in this crucial step towards bringing Imunon-001 forward as a novel and innovative therapeutic in ovarian cancer. Our highly experienced clinical development team is excited to have initiated the OVATION 3 trial and is eagerly planning the expansion of the trial over the next six months. I'll now turn the call back to Stacy. Stacy Lindborg Thanks, Douglas. As we look towards financing our Phase 3 clinical trial, our goal is twofold: one is to ensure that we have done the best possible job for all stakeholders including our shareholders; and two, to raise capital in an amount that allows us to achieve our product development goals. And dilution is top-of-mind as we consider these options. Moreover and importantly, we have taken steps to conserve cash and align our critical needs with available capital on hand, while adding to the balance sheet through optimal opportunities. We're actively working on value-added financing and partnerships which will help secure a cash runway that supports our clinical timelines and long-term strategic objectives. Focusing on both technologies, TheraPlas and PlaCCine, we are having discussions with potential partners that have significant investment in oncology as well as vaccine development, some of these under CDA. We are also exploring geographic partnerships and ways to accelerate development of Imunon-001 in other parts of the world. And finally, we intend to leverage the data from the proof-of-concept trial, using our novel PlaCCine vaccine technology to sell or license that technology. Our PlaCCine technology offers several advantages and strong advantages over other vaccine platforms such as exceptional stability being viable for one year at 4-degree centigrade refrigerated temperatures and one month at 37 degree Celsius. The platform also has the ability for rapid adaptation to new pathogens or variants, longer lasting protection or durability, meaning it could be less frequent booster shots and cost-effective manufacturing. We shared insights from the PlaCCine proof-of-concept trial and the preclinical trials in this month, this last month April 2025 at both the AACR Annual Meeting and at the World Vaccine Congress and are following up with companies in the vaccine space. We are actively working on value-added financing and partnerships, which will help secure a cash runway. We will provide updates when we're able, and our goal is to cover OVATION 3 trial cost through corporate partnerships and equity. I'd now like to turn the call over to Dave Gaiero to review our financial results for the first quarter. Dave? Thank you, Stacy. Details of Imunon's first quarter 2025 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed before the market opened this morning. As of March 31, 2025, Imunon had $2.9 million in cash and cash equivalents. We remain focused on securing near-term financing to strengthen the company's financial condition and advance OVATION 3. Research & development costs were $2.2 million for the first quarter of 2025, compared with $3.3 million for the same period in 2024. The decrease was due primarily to lower costs associated with the Phase 1 proof-of-concept PlaCCine DNA vaccine trial and the development of PlaCCine DNA vaccine technology platform. General & administrative expenses were $2 million for the first quarter of 2025 compared to $1.7 million for the same period in 2024. The increase was primarily due to higher employee-related expenses. Net loss for the first quarter of 2025 was $4.1 million or $0.28 per share compared to a net loss of $4.9 million or $0.52 per share for the same period in 2024. With that financial review, I turned the call back to Stacy. Stacy Lindborg Thank you, Dave. With that, I'd like to open the call to your questions. Operator? Operator (Operator Instructions) Emily Bodnar, HC Wainwright. Stacy Lindborg Hello, Emily. Hi. Thanks for taking the questions. Hello, and congrats on the progress. I guess first one I'll ask about the ASCO presentation, so congrats, obviously on getting an oral presentation. Is there anything new in terms of like sub-group analysis or any new data analysis that we should be expecting at the ASCO presentation? And will you potentially have the median OS for the HRD positive patients by then? Stacy Lindborg So we are by nature of ASCO's embargo, Emily, I know you'll understand that not able to talk about the content of the presentation. They're very careful with what is shared in advance. We will be sharing new information and that I think is really quite central to being accepted as an oral presentation. Although I think the full body of evidence that we've been discussing merits a view at this level and at a platform like ASCO. So we're incredibly excited for the presentation and look forward to hearing Dr. Thaker's perspective on the data. Okay. Makes sense. And then, maybe just follow-up on the Phase 3 design. How many sites are you expecting to have in total for the trial for that, I guess, first half portion that you were discussing? And then are you having OS as a dual primary endpoint for HRD positive and the ITT population or how are you kind of splitting up the statistical plan? Thanks. Stacy Lindborg I'll have -- Doug, why don't you take a step in. Sure. The analysis for the Phase 3 has always been predicated on analyzing the HRD population first. This is the population in which we think from OVATION 2 data including data that will be presented at ASCO in which we have the highest effect in terms of activity. And so the population that would be read out first whether we proceed it with the entire HRD and HRP or whether we focus on HRD alone, as Stacy mentioned, the readout does not change. There are two interim analyses and a final analysis if needed all based on HRD events. You asked the question -- Stacy Lindborg A number of sites. A number of sites. We are projecting about 45 sites at this point. Stacy Lindborg Yeah. Emily, just to recap, so the overall survival of the primary is not dual and it is consistent for all populations as the primary. Got it. Okay. Thank you. Operator James Molloy, Alliance Global Partners. Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking my questions and congrats on the progress. So for OVATION 3, what's the current status that you have on like the inventory and the manufacturing capabilities for this trial especially with the 250 to 500 patient enrollment plan that you have set up? Stacy Lindborg Yeah. Great question and I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in-house. And we are prepared and are monitoring various enrollment plans and ensuring that we have and will have continue to have product available. So we have had product that has passed all of the release specifications and has been ready to sit for weeks now and are well prepared for the weeks and months ahead. Got it. Thank you. And then also the clinical trial that you have in collaboration with the Breakthrough Cancer Foundation, what's the current status of this trial here? And are you still on track to have preliminary results announced later on this year? Stacy Lindborg You just had a call with the PIs, can you just give some insight from that? We have a meeting with the principal investigators every two weeks. And the last one was a couple of days ago on Friday. We've initiated another site, University of Oklahoma and very excited about that. Johns Hopkins has managed to re-staff its clinical research group. And so they're excited about starting to screen patients. We are expecting to have data at the end of this year, yes. All right. Thank you for the answers. Thanks for taking the questions. Stacy Lindborg Thank you. Operator This concludes our question-and-answer session of the call. I now want to turn the call back over to Imunon's President and CEO for including remarks, Dr. Lindborg. Stacy Lindborg Thank you. I want to reiterate our near-term focus, which is on securing funds to strengthen the company's financial condition and advancing our Phase 3 trial and in the process, advancing Imunon-001. We expect to have an update on this front by the end of this quarter. And as referenced earlier, our goal is to cover the OVATION 3 trial cost, and we want to and will be seeking corporate partnering and equity financing. We expect this will be an iterative process driven by catalysts to further investor confidence and follow-on financings. And as our work in providing a new treatment option for women with ovarian cancer progresses and as the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the months ahead. We look forward to keeping you appraised of our progress and thanks again for joining us today and for your interest in Imunon. Operator The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
