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14-05-2025
- Business
- Yahoo
Q1 2025 Cellectar Biosciences Inc Earnings Call
Anne Marie Fields; Investor Relations; Precision AQ James Caruso; President, Chief Executive Officer, Director; Cellectar Biosciences Inc Chad Kolean; Chief Financial Officer, Vice President; Cellectar Biosciences Inc Jarrod Longcor; Chief Operating Officer; Cellectar Biosciences Inc Aydin Huseynov; Analyst; Ladenburg Thalmann & Co. Inc. Operator Ladies and gentlemen, thank you for standing by and welcome. (Operator Instructions) Please be advised at today's conference. May be recorded. I will not like to hand the conference call over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead. Thank you. Anne Marie Fields Thank you, operator. Good morning and welcome to Cellectar Biosciences first quarter 2025 financial results and business update conference call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter and the year. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the Company's progress and plans for its promising clinical development pipeline of radio pharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's calls. A copy can be found on the investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified. Their entirety by the cautionary statements contained in today's press release and in the company's SEC filings, the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 13, 2025. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcasts are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I will now turn the call over to James Caruso. [Jim]. James Caruso Thank you and thank you all for joining us this morning as we review the progress Cellectar has made throughout the first quarter of 2025. The 2025, continued focus on our PDC platform, our radio conjugate pipeline, and finalizing the requirements from the FDA and EMA or European Medicines Agency regarding Iopofosine I 131 for the treatment of Waldenstrom's macroglobulinemia or WM. We rapidly scheduled and completed a productive meeting with the US Food and Drug Administration regarding the accelerated approval regulatory path for Iopofosine I 131and WM. The results from the Phase 2 CLOVER-WaM clinical trial of Iopofosine I 131 as a treatment for relapsed refractory WM demonstrated the drug's unique efficacy and safety product profile, which we believe represents a significant opportunity as a promising therapeutic candidate in a relapsed refractory market where no approved drugs currently exist. In parallel, we are seeking guidance from the EMA on conditional approval for Iopofosine I 131 as a treatment for WM based on the CLOVER-WaM Phase 2 study. We believe the compelling results from this study support the conditional marketing authorization strategy and will make available this critically needed new medicine to WM patients in Europe more rapidly. In addition to our Iopofosine program in WM, we continue to progress our solid tumor focused radioisotope programs which include our alpha emitter for pancreatic cancer and the Auger-emitter for evaluation in triple negative breast cancer, both of which highlight the novel utility of our delivery platform. Chad will speak further to these programs later in the call. As we explore strategic alternatives for the company, we have engaged Oppenheimer as an exclusive financial adviser to assist us. These alternatives may include but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements, or other non-diluted transactions. Now let me turn the call over to Chad for a review of our financial results, Chad. Chad Kolean Thank you, Jim, and good morning, everyone. I will address our financial results for the period ending March 31, 2025. We ended the quarter with cash and cash equivalent of $13.9 million, as compared to $23.3 million as of December 31, 2024. We expect that cash on hand is adequate to fund budgeted operations into the fourth quarter of 2025. As Jim stated, we have engaged Oppenheimer and Company to serve as our exclusive Financial Advisor. As we seek to explore strategic alternatives available to select that will allow us to maximize shareholder value moving forward. Regarding our results from operations, research and development expenses for the three months ended March 31, 2025 were approximately $3.4 million compared to approximately $7.1 million for the three months ended March 31, 2024. The overall decrease in research and development is largely driven by the reduction of patient follow-up activities for our CLOVER WaM Phase 2 clinical study in WM and a reduction in personnel costs. General and Administrative expenses for the three months ended in March 31, 2025 were $3.0 million compared to $4.9 million for the same period in 2024. The decrease in G&A was primarily driven by a reduction in pre-commercialization and personnel costs. Net loss for the three months ended March 31, 2025 was $6.6 million or $0.14 per share compared to $26.6 million or $0.91 per share during the three months ended March 31, 2024. Now I will return the call to Jarrod for an operational update, including plans for our promising pipeline of pharmaceuticals. Jarrod Longcor Thank you, Chad, and good morning everyone. I will now review the regulatory and clinical status of iopofosine and two of our exciting earlier stage radioconjugates. The first is our alpha-emitting actinium-based compound CLR 121225, and the second is CLR 121125, our lead Auger-emitting radiotherapeutic. The path to achieve conditional approval iopofosine I 131 is based on major response rating or MRR and to obtain full approval based on Progression free survival or PFS. In a randomized controlled Phase 3 study evaluating the activity of iopofosine I 131 versus an investigative choice comparator arm which will provide the study investigators a choice between one of two NCCN approved treatment options. The primary endpoint for accelerated conditional approval is superiority based upon the MRR. Progression pre survival from the same patients will be used to receive full approval. This trial is expected to enroll approximately 100 patients per arm. Hence there is no data available for efficacy of any competitor in this patient population. Cellectar is working with the FDA to utilize claims data demonstrating. The current utilization patterns by physicians to select the two NCCN guideline listed drugs for the comparator arm. As our earlier stage pipeline, as for our earlier stage pipeline, CLR 121225 is our lead alpha emitting radioconjugate product candidate to date it has shown excellent bio distribution and uptake into cell tumors with demonstrated activity across multiple solid tumor animal models, including challenging to treat pancreatic and refractory colorectal cancers. CLR 121225 has been observed to be well tolerated for these experiments. The Phase 1 trial for CLR 121225 is designed to comprehensively evaluate the compounds bio distribution, safety, and tolerability in patients with Pancreatic adenocarcinoma. The study will commence with a [duo-symmetry] Phase, aimed at determining the absorbed dose in both normal and tumor tissues, this initial assessment will provide valuable insights into the compound's biodistribution and potential therapeutic window lay the foundation for subsequent phases of the trial and future development. Following those symmetry, the study will progress to a dose escalation phase, systematically evaluating increasing doses of CLR 121225 to establish the maximum tolerated dose. This approach offers an opportunity to demonstrate proof of concept for our innovative combination of phospholipids or POE technology with alpha emitters, potentially showcasing this radioconjugate's unique ability to safely treat large bulky, solid tumors. Our Auger-emitting radioconjugate product candidate CLR 121125 represents the peak of precision in targeted radiotherapy with its emissions traveling only a few nanometers. With our delivery mechanism providing the necessary targeting to the tumor, entry into the cell and transport to the nucleus as validated through pre-clinical studies, we have seen CLR 121125 demonstrate significant tumor uptake and activity with enhanced tolerability across multiple challenging animal models, including triple negative breast cancer and metastatic breast cancer. We are preparing CLR 121,125 for a Phase 1B study in triple negative breast cancer. This trial will evaluate three distinct doses and dosing regimens and the primary objective of identifying the optimal recommended Phase 2 dose. The study will include an imaging component to further elucidate the biodistribution of CLR 121125, providing crucial insights into its targeting and potential efficacy. It is important to note that the initiation and timing of these trials is dependent on the company obtaining the necessary funding. With that, let me turn the back the call back to Jim for closing remarks. Jim. James Caruso Thank you, Chad and Jarrod. Before opening the call to questions, I would like to thank our dedicated and talented select our team to continue to work with tremendous determination to move these important programs and our Company forward. We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance iopofosine I 131 market. Operator, we are ready to open the call for questions. Operator Thank you, ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Aydin Huseyenov, Ladenburg. Aydin Huseynov Good morning everyone. Thank you for taking the questions and I appreciate the updates this morning regarding application for conditional approval in Europe. So I want to ask a question regarding a hypothetical match of Iopofosine I 131 against rituximab in early line. So, since you're going to run the trial anyways and going to take more than perhaps two years to reach this out. Would it make sense to run against rituximab in early lines of therapy just to get the bigger market and what do you think about the hypothetical efficacy against rituximab in early lines? Thank you. James Caruso Yeah, thank you, Aydin. I appreciate your participation today and certainly the question, as you would imagine, we've evaluated, a number of different study designs and opportunities for Iopofosine, not only in the relapse refractory setting, which would be our initial to market play, but obviously in earlier lines of therapy there could be a real benefit for patients that either do not tolerate BTKis. BTKis, are not effective, and in your particular case, rituximab or rituximab combinations as well. I will say that you know for the US FDA, the team has done a really nice job based on our November discussion to very rapidly secure an additional meeting with the FDA that occurred in March and as part of that, we have, we believe very clear line of sight on what a pivotal study would look like certainly in the US with based on the FDA's guidance. And one of those comparator arms in the relapse refractory setting, will most likely be the rituximab. Based on data there in these later lines of therapy, rituximab certainly in third line or greater is in this kind of 10% to 20% range based on the data that we can we have observed using data and claims in the US. In earlier lines of therapy, there are clinical studies available, and I'll have Jarrod speak to our thinking around that. Jarrod Longcor Yeah, we, as Jim said, Aydin, we did look at going to an early line. The challenge with going to an early line is the size of the study becomes much larger, as you might imagine, looking at differentials in major response rates or progression free survival in earlier lines with going against rituximab, where there is a relatively higher rate of responses, as opposed to the 20%, approximate 20% that Jim just quoted for major response rate in later lines. It jumps up to 60%, 70% or 80% depending on exactly what you're looking at that then alters your patient population sizing, so the number of patients required to execute that study goes up pretty quickly and pretty significantly, making the cost of the study considerably more than what we're looking at right now. So we've hesitated on that. Aydin Huseynov Yeah, makes sense. And regarding the Phase 3 trial design, the investigator choice out of the all possible sort of sincere and recommended choices, what is the weakest essentially comparator hypothetical comparator arm you would choose or sort of compel physicians to choose in order to improve the chances of 131 in this trial and are they--any, eligibility criteria, where 131 would be the best suitable option versus other potential options that NCCN recommends. James Caruso Yeah, it's a great question, and before I hand this off to Jarrod, as you think about this, there's little to no data available relative to most of those treatments that are identified in NCCN guidelines. They're there because they're treating other hematologic malignancies and oftentimes in WM in second line you can already be in a salvage therapy mode in some form of a combination. Chemotherapeutic soup, etcetera keeping in mind this is a much older patient population that you know may already have been treated with multiple lines of therapy prior from an adverse event perspective. It could be a challenge for these patients. And so there's clearly, to your point, a dearth of information relative to the performance of these drugs certainly. And second line and beyond and clearly in a relaxed refractory setting. So there's high unmet medical need there based on the data claims and utilizing information from third party community-based, integrated oncology delivery networks typically see a third line or greater this kind of a 10% to 20% response rate based on the data that we're able to garner. Jarrod Longcor Yeah, and if I may, follow up a little bit. So, the interesting piece and I'll put it back into the hypothetical, the interesting piece of your question is the hypothetical piece is can you identify essentially the weakest drug to go against to ensure success. And I'll come to why we don't really care in a moment, I think it'll make a lot more sense, but at the end of the no matter what drug you pick or pair of drugs you pick, whatever you pick as the investigator choice, you obviously have the FDA to approve those choices, and the FDA wants to stick to what is the most common treatment paradigm that is ongoing right now. Obviously, physicians aren't likely to be prescribing drugs that they know are failing rapidly. That said, one of the things that that I think leads to this is when you get into the second line and the third line like Jim said, and you're in this sort of already coming into a salvage therapy, frequently what you actually see is physicians are just satisfied with patients not having a major response but achieving stable disease or suppression of the [sequela] associated with the disease, so peripheral neuropathy, maybe reduction in their fatigue, what have you. And that's what they're really trying to do. They're not actually trying to alter the disease course. They're just trying to ameliorate symptoms and signs of the disease, essentially. What's interesting is, what does that mean? That means, as Jim said, most of these other drugs, at least from what we're seeing, have a very, have very low major response rates and very short progression free survival. So as we said, rituximab or even some of the rituximab combinations. A range in and around this 10% to 30% maximum major response rate and sub six months of aggression pre-survival. And so we feel very confident that with our near 60% major response rate, which I think was 58.2% in the overall patient population that we will easily be able to demonstrate with major response rate the potential of iopofosine. And then when you look at the PFS again, if you're looking at sub six months and you look at what our ongoing PFS was in the study, the last time we reported, which was north of 11 months, again, we think we have a very strong compelling position as it relates to any comparative that we will select. And we do think, with the discussions with the agency, the selection here is really about a fixed course therapy that compares with our fixed course therapy, and so that means, you're basically rituximab and rituximab combinations only as your alternative. I think on the other piece when you think about eligibility. You ask the question about, is there a way to enhance the eligibility to ensure again better patient population for iopofosine, and we think we've done that fundamentally, this post BTKi patient population that we're pursuing, keeping in mind that now with rituximab approved in the first line you're seeing a lot more utilization of BTKi in combination we're talking about in that first line setting. What does that mean and why is that important? What we've seen through both anecdotally and then also through the claims data that Jim referred to, what you see is that patients who've had a BTKi tend to fail almost every subsequent treatment after that. However, as you will note from our study and our press release, I think this morning, when we look at the post-BTKi population with iopofosine, you're looking at a 15.9% or essentially a 60% or 59%, 59% major response rate in that patient population. So again, we don't see a change, and we think, that just select that patient population enriches. A true separation and really identifies the need for iopofosine. James Caruso The only other thing that was very comprehensive, Jarrod, thank you. The only other thought that I would, provide to Aydin is this concept of re-challenging. Where what you typically see is rituximab or some rituximab combination being used in multiple lines of therapy hypothetically, if it was used in first, you may see it in third and fourth, and you know it's in this kind of, I think 30% to 40% range for treatments used and in the second, third, fourth, fifth lines of therapy, and that's really a fun and each time it's used. Typically, it becomes less and less effective by line of therapy as you use it to rechallenge patients and as a result of that, just really talks to the high unmet medical needs that exist here in this patient population. Aydin Huseynov Yeah, makes a lot of sense. One additional question I have regarding the conditional marking application in Europe. So this is, I think there's a 10 year report from EMA that says 6 out of 10 drugs that were submitted got approved. Conditioner first and some of them actually got full approval after that. But how do you assess the commercial opportunity in Europe after you will hear back from EMA, I think you mentioned third quarter 2026. So how do you assess the commercial opportunity given the pricing environment there, given the market size environment there? Just curious your thoughts on to hear your thoughts on this. James Caruso Sure, I think first perhaps an update in terms of where we sit with the EU in terms of the potential for conditional approval there and how we're thinking about the regulatory pathway, and we also aid in view that market as a very rich one as well. Jarrod Longcor Yeah, so to your point. 6 out of 10 drugs that seek conditional approval in Europe receive it, which is a nice percentage, 60% of the time you're going to get it. We think that our possibilities there may be enhanced because we have the prime designation. And the data set that we have is so strong. We did have a meeting, scientific advice meeting with the EMA previously during that meeting. It was commented by them about the study design on sort of separate from the US, they were much more focused on a single trial design approach for the drug. And they were very impressed with the data they were looking at that point from the CLOVER WaM study. They did not have all of the data, so they are looking forward to receiving that. So we expect that, as you sort of said that we will have the meeting with them to discuss that pathway and to, basically ensure that we are eligible and that we should seek the approval on that study. We also think because you know where we sit right now is with the new Phase 3 study design that we come with the FDA, we'll be sharing that with EMA as essentially the confirmatory study for full approval in Europe, and we think that that study as it is designed, will ensure that they are more amenable to the conditional approval because obviously it does then address several of their traditionally desired things a comparative controlled trial, a comparative is widely used throughout Europe, one that you can then use from a pricing perspective as well. So all of these things will help them to be in a position to grant the conditional approval. And then I think, as you ask the question on the commercial side. Yes, pricing is different in Europe and yes, it is significantly lower than here in the US. However, one of the new regulations, new approaches there is you have to do a comparative control trial so that you can get appropriate pricing and justify. In a rare disease like this, you get some benefit. Keeping in mind that you know this disease is predominantly a disease of older northern European descendants, it is more common or equally as common in Europe, even though the population size is a bit lower. It is relatively common, and I would say that the other key component there is, we do believe that rituximab will be one of the comparator arms as that is much more highly utilized in Europe than it is here in the US, I think Jim, as Jim quoted a little bit ago, rituximab generally in the US, irrespective o the line of therapy is being given at 30% to 40% of the time, and Europe's almost double that. So now you're taking out one of the leading utilized drugs across Europe, and if you're demonstrating that you can beat it with a superiority study. You should be instantly placed in front of it as utilization across Europe. While the price might be different, you actually will likely see an increase in total volume while setting that price differential. James Caruso And Jarrod, for clarity relative to the conditional approval timeline, we will know from our friends at the EMA in the third quarter of this year as to whether or not a conditional regulatory pathway with conditional approval would be acceptable. Jarrod Longcor And then it would essentially from there it's approximately, the filing would go in and then it's 12 months from the filing generally for EMA. Aydin Huseynov Right. Okay. Thank you. Thanks so much for taking the questions and I appreciate the discussion. James Caruso Of course. Thank you, Aydin. Aydin Huseynov Thank you. Operator (Operator Instructions) There are no further questions at this time. I will now turn the call over to the select your team for closing remarks. Please go ahead. James Caruso Operator, thank you for facilitating the call and also thank you to everyone participating today. This does conclude our call, and you may disconnect. Thank you. Operator Ladies and gentlemen, this concludes this conference call. Thank you for your participation. You may now disconnect. Sign in to access your portfolio Error in retrieving data
Associated Press
31-03-2025
- Business
- Associated Press
Precision AQ Earns HITRUST Implemented, 1-year i1 Certification for Data Protection and Cybersecurity Risk Management
HITRUST i1 certification confirms Precision AQ's commitment to protecting sensitive data with leading security practices. NEW YORK, March 31, 2025 /PRNewswire/ -- Precision AQ, a leader in guiding life science organizations through the complexities of product commercialization and empowering access to life-changing medicines for all, announced today that its PatientLens platform has achieved HITRUST certification for system and information security. PatientLens transforms healthcare insights and patient program design by reducing friction in patient services and by delivering timely, actionable information to support decision-making. The platform offers a detailed view of insurance coverage, out-of-pocket costs, and medical or medication history. By leveraging tokenized patient data and advanced analytics, PatientLens helps healthcare organizations optimize patient outreach, prioritize cases, and ensure compliance, driving improved outcomes and operational efficiency. The HITRUST Implemented, 1-Year i1 validated assessment and certification process confirms that the PatientLens platform applies a robust set of HITRUST-curated controls. These controls ensure the organization follows leading security practices and maintains a comprehensive cybersecurity program to defend against cyber threats. HITRUST continuously analyzes cyber threat intelligence to keep its control requirements relevant, helping organizations mitigate emerging risks like phishing, brute force attacks, and ransomware, and supporting organizational resilience. 'The HITRUST i1 validated assessment is a powerful tool for cyber-aware organizations, such as Precision AQ,' said Robert Booker, Chief Strategy Officer at HITRUST. 'This certification assures the measurement, implementation, and performance of robust information security controls. Congratulations to Precision AQ on achieving HITRUST i1 certification for their PatientLens platform, showcasing the operational maturity of their cybersecurity program.' Precision AQ successfully achieved HITRUST CSF certification through a strategic partnership with Coalfire Systems, a leading provider of cybersecurity and compliance solutions. By leveraging Coalfire's deep expertise and proven methodologies, Precision AQ navigated the rigorous certification process with confidence and efficiency. 'Healthcare data reveal some of the most intimate aspects of our lives,' said Aaron Reynolds, Vice President, Security, Data & Consumer Services at Coalfire. 'We are privileged to collaborate with Precision AQ, an organization devoted to advancing access to transformative medical solutions. Our evaluation of their cybersecurity program against HITRUST's rigorous criteria underscores Precision AQ's dedication to mitigating cyber threats and safeguarding sensitive healthcare information. Securing HITRUST i1 certification highlights their unwavering focus on data protection and fostering trust with patients.' To learn more about how Precision AQ is advancing data security and patient-centric solutions, visit About Precision AQ Precision AQ, formerly known as Precision Value & Health, is a trusted partner for life sciences companies, guiding them through the complexities of commercialization across a product's life cycle. With a team of life science experts, advisors, and creative professionals, Precision AQ is dedicated to ensuring patient access to transformative therapies. The company provides a comprehensive range of services, including global pricing and market access strategy, healthcare advertising and marketing, health economics and outcomes research, medical communications and medical affairs, managed markets marketing, market access and data-driven technology solutions, investor relations and external communications, international brand strategy, medical education, learning and development, public relations, patient insights services, and omnichannel engagement strategy and product solutions. For more information, visit
