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15-05-2025
- Business
- Yahoo
Q1 2025 PDS Biotechnology Corp Earnings Call
Mike Moyer; Managing Director; LifeSci Advisors, LLC Frank Bedu-Addo; President, Chief Executive Officer, Director; PDS Biotechnology Corp Lars Boesgaard; Chief Financial Officer, Principal Accounting Officer and Principal Financial Officer; PDS Biotechnology Corp Kirk Shepard; Chief Medical Officer; PDS Biotechnology Corp Mayank Mamtani; Analyst; B. Riley Securities Joe Pantginis; Analyst; H. C. Wainwright & Co James Molloy; Analyst; Alliance Global Partners Operator Greetings and welcome to the PDS Biotech first quarter in 2025 earnings conference call. (operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, lifestyle you, sir. You may begin. Mike Moyer Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first quarter 2025 results and clinical programs update call. I'm joined on the call today by the following members of the company's management team. Dr. Frank Bedu-Addo, Chief Executive Officer, Dr. Kirk Shepard, Chief Medical Officer, and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company's recent progress in its clinical development program. Mr. Boesgaard will review the financial results for the quarter ended March 31, 2025, and Dr. Shepard will then join the call to help address questions from our covering analysts. As a reminder, during this call, we will be making forward-looking. Statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10 and annual report on Form 10k, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now I'd like to turn the call over to Dr. Bedu-Addo. Frank Bedu-Addo Thank you, Mike, and good morning, our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical first quarter of 2025 in recent weeks have been a productive period for PDS Biotech, led by the initiation of our versatile 003 phase 3 clinical trial of Versamune HPV plus HPV plus pembrolizumab is a potential treatment for first line recurrence and or metastatic HPV 16 positive head and neck squamous cell carcinoma or head and neck with recurrent or metastatic HPV 16 passive head and neck cancer are difficult to treat and represent a large fast-growing population in need of targeted therapies to treat the underlying cause of the is projected that by the mid-2030s, HPV 16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the United States and Europe. Considering the strength and durability of the clinical responses observed in our versatile 002 phase 2 are excited to get the versatile 003 registrational trial underway and are confident in the potential of the combination of Versamune HPV and pembrolizumab to significantly improve outcomes for patients with recurrent and or metastatic HPV 16 positive head and neck are pleased to announce that new sites, including Mayo Clinic sites were recently added to the trial, and we continue the process of activating additional clinical sites. We look forward to the continued progression of this we announced previously, the versatile 003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go-ahead by the US Food and Drug Administration or two arms of the trial include a treatment arm of the Versamune HPV and pembrolizumab combination versus the control arm of pembrolizumab are enrolled in a two to one randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our versatile 002 clinical trial seen over the last year and a half with the most recent data presented at the European Society for Medical Oncology. ASCO Congress in encouraging patient survival and clinical responses coupled with promising tolerability as seen in the versatile 002 clinical trial will be the subject of a poster presentation of the 2025 American Society of Clinical Oncology annual Meeting, or data underscore our belief in the potential of the combination to be the first HPV-16 targeted therapy for head and neck cancer and a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck versatile 003 trial in progress is the first phase 003 trial in the high-risk HPV 16 population and has also been accepted for presentation at the 2025 ASCO annual Mayo Clinic will present the results of the MC20-O-seven 10 study investigating Versamune HPV alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV 16 positive oropharyngeal three presentations will be held on Monday, June 2, 2025, from 9 A.M. to 12 P.M. Central Daylight Time during the head and neck cancer poster in our pipeline last week we announced that at the American Association of Immunologists Immunology 2025 annual meeting, pre-clinical efficacy and immune response data in mice and ferrets with a novel infect immune-based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral studies were funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases NIA Center for Influenza Vaccine Research for high-risk collaborative approach between NIA and PDS Biotech allows PDS Biotech to focus our resources on our versatile 003 clinical March, we were pleased to announce FDA clearance of our investigational new drug IND application for the combination of Versamune M1 and our IL-12 fused antibody drug conjugate PDS01ADC to treat metastatic colorectal cancer. Several highly prevalent solid tumors are Mach one positive, including non-small cell lung cancer, ovarian cancer, breast cancer, liver cancer, and are pleased to continue our strong relationship with the National Cancer Institute; MCI and this phase 1 and phase 2 clinical trial is scheduled to be run under our collaborative research and development agreement with the MCI. PDS Biotech will continue to focus our efforts on progressing the versatile 003 phase 3 clinical I will turn it over to Lars for a review of our results for [2025], Lars. Lars Boesgaard Thanks, Frank. And good morning, for the first quarter of 2025, we reported a net loss of approximately $8.5 million or about $0.21 per basic and diluted share for the three months ended March 31. That compares to $10.6 million or $0.30 per basic and diluted share for the three months ended March 31, 2024. This decrease is due to increased benefit from income taxes as well as lower operating and development expenses were $5.8 million for the first quarter compared to $6.7 million for the prior year quarter. This decrease was primarily due to lower clinical trial expenses. General administrative expenses were $3.3 million for the first quarter compared to $3.4 million for the prior year total operating expenses were $9.1 million for the first quarter compared to approximately $10.1 million for the prior year quarter. Net interest expenses were $0.6 million for the first quarter, which compared to approximately $0.5 million for the prior year cash balance as of March 31, 2025, was $40 million compared to $41.7 million as of December 31, 2024. You'll recall that on February 27 this year, we announced that we had entered into a securities purchase agreement with new and existing healthcare focused institutional investors, as well as participation for certain directors of the company. And under that arrangement, we raised approximately $11 million upon the closing. And with an additional $11 million that may be funded upon full cash exercise of the warrants that were included in the more recently, at the end of April, we completed a refinancing of our debt with new lenders, resulting in the extension of the term to 36 months, with the first four months being interest that operator we can open the call to questions. Operator (Operator Instructions)Mayank Mamtani, B. Riley Securities. Mayank Mamtani Yes. Good morning team. Thanks for taking your questions and Congrats on getting the versatile 003 phase 3 lamping up. So, first on, the Keytruda head and neck, new achievement data we saw at ACR, could you comment on how such a standard of care, changing data set impacts enrollment expectations of your phase 3, and did we sort of learn anything. If anything, on the HPV positive, tumor set and how maybe checkpoint inhibitors, monotherapy responses, response rate looks like in SPV 16 positive, and then I have a follow up. Frank Bedu-Addo Mike you're referring to the KEYNOTE-689 trial. Mayank Mamtani That's right. Frank Bedu-Addo Okay. Kirk, I'll hand over to you to start if you have any comments on that. Kirk Shepard Sure, can you hear me okay. Frank Bedu-Addo Yes, we can hear you. Kirk Shepard Great. The KEYNOTE-689 trial, should not affect our versatile 003. The reason is 689 was a study of mainly HPV negative patients. That's because the eligibility criteria of the to be that the patients were eligible for surgery and most patients who are HPV positive at this stage are not eligible for surgery. So that resulted in only 3% to 4% of the patients of this study being HPV positive. So, the study was focused mainly on HPV negative patients and not positive. Frank Bedu-Addo Kirk, thanks a lot. So, that's very important because even if this does become standard of care, there is going to be very little impact on the HPV positive it may actually speed up the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. And this is something that we actually had our steering committee evaluate and give us advice on. And their feedback to PDS was Even if this new adjapan treatment is approved, since very few HPV positive patients are actually eligible for surgery at this stage, there should be negligible impact on the HPV 16 recurrent metastatic head and neck cancer population. And that's exactly what we saw as Kirk mentioned, only about 3% of the patients were actually HPV positive. Mayank that answered your question. Mayank Mamtani Yes, it you, both. And then, second on this, ask poster presentation coming up, could you talk to what we should be looking to learn on durability, incremental from what you've shown before, and maybe if you could comment on, just your durability, how might that be tracking relative to, also the emerging data from the next generation EGFR targeted therapies. Thanks again for taking your questions. Frank Bedu-Addo Thanks, my I'm not going to speak much about the EGFR inhibitors. I think they will make their presentations at ASCO. We will learn more. At this point, we can't say any more than they have currently presented to the markets. We have no additional information on how their programs are performing. But with regards to PDS Biotech, and our versatile 002 trial, as one of the key characteristics of this technology and the product is the On our corporate deck, one of the slides that shows how these patients react long term. I think one of the key things with oncology today with the current cytotoxic drugs, including cetuximab, is you get pretty good responses upfront, a good objective response rates. But what we have not seen to date in head and neck cancer, and many other cancers is once you are able to achieve these clinical you maintain these responses long term. That is the challenge, and that is exactly what we see with our adverse immune HPV plus KEYTRUDA formulation, where the patients who have clinical responses, including stable disease, partial responses, and complete responses, the majority of these patients appear to be maintaining those clinical responses long term and that has translated also to survival, which is very important. And so, as our last presentation at ASCO, as you recall, we presented a 30-month median overall survival, right. The standard today is approximately 12 months. So, really just putting that into perspective, right. Today, with the standard of care, if a patient had gone on to the standard of care, which have been KEYTRUDA or KEYTRUDA chemo. The probability of living 12 months was about 50%. You had a 50% probability of living for 12 months. However, if that patient had gone on to our versatile 002 trial, They had a 50% probability of living for 30 months or more. Right, that's the kind of durability we've seen in this HPV 16 population, which by the way, in some studies that have been public, have shown that in head and neck cancer, they found that in HPV 16 patients had the worst prognosis for survival once the disease becomes an advanced recurrent metastatic disease, to HPV negative and other types of HPV, the HPV 16 positive patients had by far the worst survival prognosis. So this is for us is an extremely encouraging result. And what we tend to do is to give an additional update on a more recent data cut on that durability and survival of these patients in the versatile 002 trial. Mayank Mamtani Thank you, Frank. Frank Bedu-Addo You're welcome. Operator Joe Pantginis, H. C. Wainwright & Co. Joe Pantginis Hi guys, good morning. Thanks for taking the question. So, I want to ask two nuanced questions regarding your two lead programs, and part of it you've already started to discuss. So first with KEYNOTE-689, when you're comparing it again, it's apples and oranges, even though I think from a perception standpoint. There are some, I guess, investor, comparing apples to oranges here, at least from a perception standpoint, so I'm just curious, how do you view the learning curve here and does it apply at all and I don't think it does, to physicians, impact and being able to want to participate in versatile 003 and then I have a follow up. Frank Bedu-Addo So, no to date and I'll ask Kirk to give his opinions on that. But to date, we have seen very strong enthusiasm from the investigators and the key opinion leaders in actually participating in the versatile 002 trial. I'll actually hand over to Kirk to give any comments before I get back to continuing my answer. Kirk, any comments on interest in the trial based on KEYNOTE-689. Kirk Shepard Yes, no, the response was very brisk and all the same from our steering committee, which are the experts in head and neck cancer, that 689 does not apply to HPV positive patients. And this is even before they saw the data broken down, which we saw at the AACR. And sure enough, when we saw the data, as Frank had mentioned, I mentioned earlier too, only 3% of the patients were HPV positive because it's not appropriate to treat these patients with surgery upfront. So, it's been discussed a lot with our investigators and especially our steering committee that this should not affect our patient accrual at all. And we're very fortunate that we have a number of versatile 002 investigators with us now who have experience with this drug and are very excited for versatile 003 to get started. Frank Bedu-Addo Thanks a lot, Joe, so along those lines, I think very importantly, I think that the oncologist and the key opinion leaders in the space really understand that this there are very few people who are going to be HPV positive who will be eligible for that new Apan treatment. And one of the things you can see in relation to that is that even at Mayo Clinic, one of the studies that we will be presenting at ASCO has to do with utilizing our Versamune HPV plus KEYTRUDA in that new adjuvan setting for HPV 16 positive patients. And one of the key things that the KOLs mentioned on our last AOL call was that their very strong recommendation for this combination based upon the tolerability that we've seen in the patients today would be to rapidly move it into that earlier stage setting, which would be locally advanced head and neck cancer. we have, we've already seen the experts in the field, based upon the promising results that we've seen in versatile 002, take that. Combination to start evaluating it in this patient population who will not be really impacted, who may not get any benefit from the KEYNOTE-689 since the HPV positive, can we take our combination and apply it now to those patients who may not be eligible for surgery, but can go on this new adjuvant/adjuvant treatment with our we see a significant opportunity for this combination there too. Joe Pantginis Great, I appreciate that added color, Frank and Kirk. So, my second nuanced question is your newly or IND approved, MUC1 program, so I wanted to do a little bit of historical perspective to where we are today and especially your program. I want to focus on the antigen itself; this has been a key target. I mean, MUC1 for immunotherapy and or cancer vaccines for more than two decades now, and there have been some, pretty high-profile failures with this target. So, I wanted to just get a little more sense again from you guys, why are you differentiated here, and I guess can you describe interest, from sites to participate knowing this history. Thanks a lot. Frank Bedu-Addo Really great question, Joe. Well, I'll start by saying that very similarly in HPV 16 positive head and neck cancer, cervical cancer over the last 20 years, there have also been some very high-profile failures. Right. However, with our technology, we now see that for the first time, we have a technology and product that has now has really strong data, very durable responses in moving into a pivotal registrational trial for the first time, right. There have been many failures in HPV 16, positive cancer over the last 20 years. the reason I'm giving you this analogy is it's important to recognize two things, not only the antigen. But the technology that is able to now perform the immunological function that the previous technologies have not been able to perform. That's very important in being able to activate the right immunological signaling pathways and also more effectively present those antigens into the right presentation pathways. So having a strong antigen doesn't get you very far. If it can't be effectively presented. And the right immunological pathways also activated both have to go hand in hand, now, moving from where we've demonstrated that this technology can do this effectively in head and neck cancer with the HPV antigens, we're now moving on to the Mach one after this proof of con solid proof of concept that we've generated the Mach one, these are novel antigens, agonist, what we call agonist epitopes that have been designed by the National Cancer Institute. And what they have, what they, these antigens have been designed to do is to be much more immunologically potent than the native MUC1 antigens. Therefore, having a much stronger ability to activate the immune system to recognize MUC1 as a foreign agent. And what we have now done is now taken our verse immune it with those novel or more potent antigens to facilitate their presentation to the immune system and to facilitate the training of the immune system to recognize them as foreign agents and then also activate those trained T cells to now be a lot more potent in attacking and killing the MUC1 positive And so, really, we have to look at it in the entirety of what's really happening here. The antigen alone does not do much to guarantee you or to generate an effective anti-tumor response. And what we're also doing in the study is combining it with our IL-12 anti-used antibody drug conjugate, right. And so, with the IL-12, we have demonstrated also with our HPV programs that by targeting the tumors and really driving the IL-12 away from the circulating blood, but into the tumors, which is the tumors are the required site of T cell activation, right. So, by being able to get both our T cells. And the IL-12 into the patient's tumors. We've also demonstrated significantly enhanced survival and anti-tumor responses. So, the goal is to apply this combination again to this program is being performed as part of our collaboration, collaborative research involvement agreement with the National Cancer Institute. So, this is a program where the first trial is going to be a single-site study and that's going to be done by the NCI. And this collaboration also allows us to focus our resources and efforts on running our versatile 003 program. Joe Pantginis Frank, really appreciate that detailed explanation and looking forward to see initial data thanks a lot. Frank Bedu-Addo You're welcome. Operator James Molloy, Alliance Global Partners. James Molloy Hi Frank, good you for taking my question. Just a quick, follow up on, 003. Has the first patient, have you guys announced the enrollment of the first patient yet. I, did I miss that, or what's the expectation on that. And then any anecdotal comments, from the docs on how they on enrollment and how sort of that's proceeding or how the conversations are going with the potential enrollees. Frank Bedu-Addo No, we have not made it public in how enrollment is going. So, as James, once the sites are activated, we act the sites actually have a number of internal processes they will undergo followed by screening of patients. So, the patients have to be screened that's part of the process of getting all these patients into the trial. This process is occurring as we continue to activate more sites, and the goal is to hopefully eventually get to a steady recruitment as the larger sites such as Mayo Clinic take longer to activate and get going. So our goal here is to update the markets when we have a much better idea of how enrollment is going and when we are able to approximately estimate when we're going to get to that interim data readout point. So, we will provide more updates when we have much better insight into when we, how the, what the recruitment rates should be and when we'll get to those data readout points. James Molloy That makes sense. Just starting the trial literally to try to guess that yet, I guess, and then maybe, on a mechanistic looking at the print for the OpEx for the quarter. Is this sort of the level we should anticipate going forward or expect that to kind of ramp up going through '25 or '26. Frank Bedu-Addo Lars, I'll hand over to you for that. Lars Boesgaard Yes, hi Jim. This is Las here. Yes, so we don't currently provide financial guidance, but I think it's fair to say that that we're happy the trial is, has been started well, the way it has, and as you probably are aware, right, we do tend to see a bit of a higher spend in the first couple of quarters, like we get the year up and running. So, I think without giving you any specific numbers, I think we see a relatively stable in terms of the trial spends going forward. James Molloy Okay great thank you very much for taking the questions. Operator There are no further questions at this time. I would now like to turn the floor back over to Dr. Frank do for closing comments. Frank Bedu-Addo Thank you, closing, we are very pleased to have initiated the versatile 002 registration trial this quarter. This study is the first phase 3 clinical trial specifically in the growing population of HPV 16 positive head and neck are excited based on the strong Versatile 002 results and our fast-track designation about the potential for Versamune HPV in head and neck cancer. We expect to provide updated results from our ongoing phase 2 versatile 002 study at ASCO in a couple of weeks. Our engagement with investors and clinical investigators has validated our approach and the long-term opportunity that we believe the H targeted immunotherapy presents in the HPV 16 positive head and neck cancer look forward to keeping you updated on our progress. And thank you very much again for your time and support. Thanks a lot. Operator This includes today's teleconference. You may disconnect your lines at this you for your participation. Sign in to access your portfolio
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13-05-2025
- Business
- Yahoo
Q1 2025 Relmada Therapeutics Inc Earnings Call
Brian Ritchie; Investor Relations; LifeSci Advisors Sergio Traversa; Chief Executive Officer, Director; Relmada Therapeutics Inc Maged Shenouda; Chief Financial Officer; Relmada Therapeutics Inc Uy Ear; Analyst; Mizuho Securities Yair Lotan; Professor of Urology and Chief of Urologic Oncology; UT Southwestern Medical Center Matthew Barcus; Analyst; Jefferies Operator Good afternoon. Welcome to the Relmada Therapeutics first-quarter 2025 earnings call. (Operator Instructions) As a reminder, this conference is being recorded, and will be available for replay on the location website. I would like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie. Brian Ritchie Good day, and thank you, everyone, for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 months ended March 31, 2025. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K, and today's form 10-Q for the quarter ended March 31, 2025, filed after the close today. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 12, 2025. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; and Relmada's CFO, Maged Shenouda, who will provide a review of the company's Q1 financial results. After that, we will open the line for a brief Q&A session. Now, I will hand the call over to Sergio Traversa. Sergio? Sergio Traversa Thank you, Brian as always, and good afternoon, and welcome, everyone, to the Relmada First Quarter 2025 Conference Call. 2025 is off to a good start for Relmada. We added 2 unique product candidates with very encouraging Phase II data and large addressable markets to our portfolio, NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome, Tourette syndrome and potentially other CNS indications. Reported initial proof-of-concept Phase II data for our lead product candidate, NDV-01 at the American Urology Association, and we made progress towards our objective of bringing each program to patients as soon as possible with preparation underway to begin the next set of studies for NDV-01 sepranolone. With 2 innovative product candidates that have shown promising proof-of-concept data, $27 million cash balance, clean balance sheet and a disciplined approach to development plan, we are in a good position to advance our pipeline to important clinical milestones. During today's call, I will provide a snapshot of our 2 programs, including a review of the initial Phase II data for NDV-001 at the AUA meeting 2 weeks ago. After that, Maged will review our financial results. I will make a few closing remarks, and then we will take your questions. We also invited on the call today Dr. Yair Lotan, Chief of Urology and Oncology at the University of Texas Southwestern Medical Center in Dallas, who can answer your clinical question regarding NDV-01. We are encouraged by the potential of the diversified pipeline that we are building at Relmada. Starting with NDV-01, we believe the program is an excellent fit with our strategic plan and has the potential to meaningfully improve the care of patients with bladder cancer. Our decision to in-license NDV-01 was based on strong science, strong field data and the anticipation of positive Phase II data at the upcoming American Urology Association Meeting, or AUA 2025. I'm pleased to report that positive top line proof-of-concept data presented at AUA 2025 supported our initial enthusiasm for NDV-01's potential to be the class leading bladder-sparing chemotherapy for non-muscle invasive bladder cancer. During today's call, I will touch on the market opportunity, the mechanism of action, the data and the next steps. Starting with the market, sources indicated that there are about 75,000 new cases of bladder cancer diagnosed each year in the U.S. About half or 50% of those cases have high-grade disease that has a high risk of recurrence. That is a very high recurrence rate for the 600,000 people approximately in the U.S. living with bladder cancer. Moving to mechanism of action. NDV-01 is a novel sustained-release intravesical formulation of 2 chemotherapy agents, gemcitabine and docetaxel or GEM/DOCE. NDV-01 forms a spherical soft matrix within the bladder that sequesters GEM/DOCE and releases these 2 agents as a matrix gradually disolves. The formulation was specifically designed to maximize local GEM/DOCE concentration and also provide prolonged exposure while minimizing systemic toxicity. Published clinical studies have shown that gemcitabine and docetaxel achieves a response rate and recurrence-free survival that are comparable to, or better than the historical standard of care, Bacillus Calmette-Guerin or BCG. However, the administration of conventional chemotherapy is cumbersome. The 2 chemotherapy agents require special handling and preparation in a controlled hospital pharmacy setting. In addition, the 2 chemotherapies are administered sequentially over 3 to 5 hours with limited tumor exposure time. In contrast, NDV-01 sustained release formulation is intended to be dosed in office as a ready-to-use therapy that is administered in less than 10 minutes without the need for anesthesia or new or dedicated equipment. What is really exciting about NDV-01 data is the data presented at the AUA 2025 2 weeks ago. The presentation was based on data from an ongoing single-arm, single-center ex-U.S. Phase II study evaluating NDV-01 in patients with high-grade NMIBC. 26 patients have been enrolled as of the data of the last data cutoff. The AUA presentation was based on the results for the first 20 patients. The group included 2 patients with carcinoma in situ, CIS and 18 patients with papillary disease, Ta and T1. Of the papillary disease patients, 8 were BCG naive and 12 were BCG unresponsive. The efficacy data were presented based on 3- and 6-months assessment. In addition, the highest response rate at any time point was also reported. Based on the 3-month assessment, dosing of NDV-01 resulted in overall response rate of 85% or 17 out of 20 patients. High-Grade Recurrence-Free Survival in patients with papillary disease of 83%, or 15 out of 18 patients. A complete response in carcinoma in situ patients, recognizing that the number is small, was 100% or 2 out of 2 patients. For data report at any time point, the overall response rate was 90% or 18 out of 20 patients. High-Grade Recurrence-Free Survival in papillary disease was 89% or 16 out of 18 patients. Complete response in carcinoma in situ patients remains 100% or 2 out of 2 patients. Importantly, 7 patients were evaluable at 6 months. 100% of these patients achieved disease-free status. This group include 1 patient with CIS and 6 patients with papillary disease characterized as Ta or T1. One of these patients was retreated at 3 months and responded to the second treatment. From a safety perspective, NDV-01 was well tolerated with no treatment-related adverse events greater than grade 1. We were very pleased with the reception of the data received at AUA. We believe that the results suggest that NDV-01 has the potential to significantly improve the care of patients with NMIBC. NDV-01 is currently in -- continues the Phase II single-arm study to assess safety and efficacy in patients with high-grade non-muscle invasive bladder cancer. Our goal is to bring NDV-01 to patients as soon as possible. Looking ahead to the second half of 2025, our effort will focus on securing a U.S. IND clearance. Turning briefly to sepranolone. In February, we acquired the right to sepranolone from Asarina Pharma. Our decision was based on sepranolone's broad safety database and promising Phase II results in Tourette syndrome. I would like to touch on 4 topics for sepranolone, the market opportunity, the mechanism of action, the data and the next steps. Starting with the market. We believe sepranolone is well suited to treat disorders marked by compulsive behavior and excessive activity of the GABA neurotransmitter pathway, including Prader-Willi syndrome and Tourette syndrome. This soon neurobehavioral disorder can manifest through repetitive behavior and positivity and represents sizable underserved markets. Prader-Willi syndrome or Prader-Willi is our first candidate indication for sepranolone. Prader-Willi is a complex genetic disorder, often defined by persistent anger and overheating hyperphagia. Current treatment is focused on improving obsessive compulsive behavior and other medical complications. Prader-Willi is estimated to affect approximately 350,000 people worldwide, including approximately 20,000 people in the U.S. Turning to the mechanism of action. Sepranolone is first-in-class endogenous neurosteroid. It's a member of a new subgroup of neurosteroid called GAMSAs or GABAA modulating steroid antagonist. GAMSAs selectively act on GABAA to alleviate the repetitive symptom of compulsive disorder. We were attracted to sepranolone because of its unique mechanism of action and promising proof-of-concept data. The Phase II results from the originator Asarina showed that sepranolone demonstrated a competitive peak reduction of 28% with a p-value of 0.051 in its primary clinical endpoint as measured by the YGTSS, a standardized Tourette scale. The data also showed that sepranolone treatment produced an improved quality of life without any off-target CNS effects. These data provide a strong foundation to study sepranolone in compulsion-related disorders such as PWS or Prader-Willi syndrome. Our effort to progress sepranolone are expected to include planned FDA interaction and further development of product supply with plans to advance into clinical development in early 2026. Now I would like to turn the call over to our Chief Financial Officer, Maged Shenouda, to talk about our financial results. Maged? Maged Shenouda Thanks, Sergio. With 2 innovative product candidates that have shown promising proof-of-concept data, a $27.1 million cash balance, a clean balance sheet and a disciplined development plan, we are in a good position to advance our pipeline to important clinical milestones. Turning to our financial results. As noted by Brian, this afternoon, we issued a press release announcing our business and financial results for the first quarter ended March 31, 2025. As of March 31, 2025, Relmada had cash, cash equivalents and short-term investments of approximately $27.1 million, compared to $44.9 million as of December 31, 2024. Cash used in operations in the first quarter ended March 31, 2025, was $18.1 million, compared to $13 million for the same period in 2024. Our efforts in 2025 are dedicated to advancing NDV-01 and sepranolone through key development milestones. Over the coming months, as we finalize our clinical and regulatory strategy for each program, we expect to have better visibility into our requirements and runway. Moving through our first quarter 2025 financial results. Research and development expense for the first quarter of 2025 totaled $12 million, compared to $13.3 million for the first quarter of 2024, a decrease of $1.3 million. The lower spend was primarily driven by lower study costs with the completion of clinical trials for REL-1017 for major depressive disorder, offset by payments for the sepranolone acquisition and the NDV-01 in-licensing. General and administrative expense for the first quarter of 2025 totaled $6.3 million, compared to $9.7 million for the first quarter of 2024, a decrease of approximately $3.4 million. The decrease was primarily driven by a decrease in stock-based compensation expense. The net loss for the first quarter of 2025 was $17.6 million, or $0.58 per basic and diluted share, compared with a net loss of $21.8 million, or $0.72 per basic and diluted share for the first quarter of 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio? Sergio Traversa Thank you, Maged. I would like to leave you with these key messages from today's call before we enter the Q&A section. 2025 is off to a strong start with the addition of 2 unique product candidates with proof-of-concept Phase II data and large addressable market to our portfolio, NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome and Tourette syndrome. Reported positive initial proof-of-concept Phase II data for our lead product candidate, NDV-01 at AUA, and we made progress toward our objective of bringing each program to patients as soon as possible with preparation underway to begin the next set of studies for NDV-01 and sepranolone. With 2 innovative product candidates that have shown promising proof-of-concept data, $27 million cash balance, a clean balance sheet and a disciplined approach to development plan, we are in a good position to advance our pipeline to important clinical milestones. As we prepare to advance our 2 clinical program, we want to thank our investors for your support and for taking time to join today's call. Operator, I would like now to open the call for questions. Operator (Operator Instructions) Uy Ear, Mizuho Securities. Uy Ear And congrats on the quarter, the recent data. So maybe the first question from us is, you indicate you'll be approaching the FDA to speak with them in order to move forward. I guess what gives you confidence that the current data from the Phase II study would be sufficient for the FDA to agree for NDV-01 to move into registrational studies. And I guess -- the second question maybe is you indicate that you're going to scale up supply. Could you sort of elaborate what you mean by that? Is this -- are they commercial products? Are they scaling up for clinical study only? Sergio Traversa Thank you, Uy for the question. Let me answer the first one, and I believe Dr. Lotan should have joined the call. And anything you would like to add would be very welcome. But what makes us confident that the conversation with the FDA will drive like the beginning or the start of registrational of product and a program. But a couple of things. One is the combination of drug itself, right? gemcitabine plus docetaxel has been used -- has been currently used and has been used for some time by many, many urologists everywhere, and everybody is convinced about the efficacy and the safety of the local administration of the 2 drugs. The reason that has not been more widely used is the limitation in the practicality. The very few doctor office can prepare the solution. So it has to be prepared by pharmacists authorized, used to handle chemotherapy, most of the cases in clinics. So -- and the administration that requires a sequential gemcitabine and docetaxel one after the other, and it takes time. So you have to keep the doctor office or the clinic occupied for 3, 4, 5 hours and for the patient, too, because you have to see it in the clinic holding and for 1 or 2 hours, each of the 2 preparations. That's -- even if a patient affected bladder cancer is willing to go through a lot to avoid to take the bladder off is still a convoluted process. And so that's one of the reasons that we feel confident that the combination of chemotherapy is not new. It's well known, has been -- is in use and is recognized as one of the most effective, if not the most effective pharmacological treatment of bladder cancer. The second one that comes from this data and is the safety of the formulation. We have no one single patient interrupting the study for side effect. And all the side effects registered are all grade 1. So it seems it's very, very well tolerated. And so you put the 2 things together and the advantage also of the administration in the doctor office, non-anesthesia, less than 10 minutes is a prefilled syringe that doesn't need any handling. So, all the things together should make the FDA willing to let us go into a larger registration study. Of course, there is always like until we get the direct -- the minutes from the FDA, you cannot -- never be sure, but we believe there is a very good chance they will be okay with that. And I don't know if Dr. Lotan has been able to join the call. He was in the surgery, so. Yair Lotan Yes. Good afternoon. Can you hear me okay? Sergio Traversa Yes, absolutely. Very well. Go ahead. Yair Lotan So I think I can address the issue to some degree. First of all, intravesical chemotherapy has been routinely used for treating both intermediate risk and high-risk bladder cancer for decades. Now it's interesting because the therapies that are currently used, mitomycin, gemcitabine, docetaxel are all being used as off-label use, but they are reimbursed and commonly utilized. The biggest challenge for urologists, though, is that you need a hood to mix these formulations. And unless you have a cancer pharmacy, you can't give it in your office. Immune therapies like BCG come in a vial and a powder that you can reformulate, but intravesical chemotherapy, you can't. And medical oncologists who give IV doses of the chemotherapy are not typically giving intravesical therapies in their offices. They're not familiar with placing catheters. There's little reimbursement. And so you have a bit of a catching too. If you're a patient, you can't really get it in your urologist's office and you can't get it at your medical oncologist office. Now the formulation of gemcitabine and docetaxel is actually one of the more commonly used drugs in BCG-unresponsive, which is a space with a lot of development between nadofaragene and KEYTRUDA and TAR-200 and cretostimogene and ANKTIVA, there's a lot of drugs being developed in this space. And yet many people are still using gemcitabine and docetaxel because the other drugs have -- well, some of them are not approved yet. Some of them are more problematic to give in the clinic. But many patients are kind of out in the cold. They're not able to get access to these drugs, either the newer drugs or drugs like gemcitabine and docetaxel. Now in terms of efficacy, as mentioned, there are many studies looking at intravesical chemotherapy and demonstrating efficacy. However, we know that formulations like TAR-200, which allude over 3 weeks work better than single agents. And I think that this combination, which has the advantage of both being easy to deliver and sustainable release in the bladder over 2 weeks will be superior potentially over agents that stay in your bladder for just 1 hour. So there are several potential advantages for this, both in terms of ease of use and the potential increased efficacy. Sergio Traversa Thank you, Dr. Lotan. Uy, did that answer your question? Uy Ear Yes. So maybe just a follow-up on what you guys said in response to potential differentiation. So maybe Dr. Lotan, if you're still there, maybe one of the feedbacks that we've gotten from investors is that this is kind of a crowded market. So maybe just help us understand how you see NDV-01 fit in the treatment paradigm when it comes to market, you have BCG, you have CG Oncology and other potential competitors who could be ahead. Yair Lotan Right. I think -- I'm happy to respond. First of all, I think that if you ask patients, they want to keep their bladder. And in the BCG-unresponsive space, which I completely agree, there's probably 3 or 4 potential treatments, TAR-200 and cretostimogene both will likely be accepted by the FDA. But nonetheless, patients are frequently going to want 2 or 3 lines of therapy, and they're going to want to get sort of the most effective treatment. I don't necessarily think that, that's going to be the best first place to go with this drug, mainly because as you say, it's going to be a bit of a busy space, even though I suspect that since many people are already using gemcitabine, docetaxel as their main treatment off-label, if they actually have an approved compound that they're familiar with, with durable excretion of drug and an easier mechanism of delivery, then they'll be very open to giving that drug that they're familiar with over some of the other agents. But on the other hand, in the intermediate risk space, which is -- has a higher prevalence by far than the BCG unresponsive place, there really aren't drugs that are commonly used. Intravesical gemcitabine is available, not approved, but available. But as I said, it's hard to get access to. So in academic centers, we give intravesical chemotherapy, but many community sites don't. And so it would be a very natural fit to give intravesical chemotherapy such as this formulation for intermediate risk patients. It has potential in the chemoablative space as well, which even though that's not sort of a place that we commonly use drugs, but UGN-102 is doing -- did a chemoablation trial and it's going to FDA. And it's a single drug, mitomycin. This is actually a combination, which I think could potentially compete nicely, if they had a good performance. And there's a BRIDGE trial comparing GEM/DOCE to BCG that's being enrolled right now. And if it shows equivalence or superiority, then this drug could fit in the BCG naive space. And the other drugs that you're mentioning, TAR-200, cretostimogene are not competing in that space. And the trials that have been completed with BCG and checkpoint inhibitors have shown CREST has been reported, had about a 7% increase -- reduction in recurrence at 18 months, but about a 15% rate of Grade 3 SAEs and no improvement in progression, no improvement in survival. So I don't think any of the checkpoint inhibitors are going to compete in the BCG naive space. But if the BRIDGE trial shows equivalence of efficacy, this drug could actually fit in the BCG naive space without much competition from some of these newer agents. So I see many potential uses right now. Sergio Traversa Thank you, Dr. Lotan. And your second question was regarding the manufacturing and -- sorry, was for sepranolone or for NDV-01 for the NDV-01, right. Uy Ear NDV-01. Sergio Traversa Right. Yes. The -- clearly, the quantity needed for commercial will be large. So like we will -- and we always want to have 2 manufacturer at minimum. So we are looking for like capacity and a second manufacturer for like risk management. It's not a complicated product to make. It's gel and so they all known components. Operator Andrew Tsai, Jefferies. Matthew Barcus This is Matt Barcus on for Andrew. I guess, regarding the latest data set for NDV-01presented at the AUA meeting earlier, when should we look forward to sharing the complete response rate for the entire population? And how do you anticipate sharing the future updates from the program? Like what more can we look forward to in those data sets throughout the year? And what are your expectations for success? Sergio Traversa Well, the -- I can answer part of it and maybe Dr. Lotan can expand. So the next data point will be the 6 months. We had 7 patients now at the AUA with a 100% complete response. We'll have 6 months data of the 20 patients somewhere around end of June, July. We'll present that and then that -- and then we'll give 9 and 12 months of this -- of the 20 patients. And so these are the expectations. Look, the data, the -- we can only look at what we have now that is like 90% at 3 months and 100% of the 7 patients at 6 months, but they look pretty good. And not surprising because it's known that the combination GEM/DOCE is very efficacious. And even if like with the duration of tumor contact of a couple of hours, we use the same dose and it stays there for 10 days and is done 6 times in 3 months. So the expectation that the results are good are definitely there. And do you want to add something, Dr. Lotan? Yair Lotan No, I think this is obviously an interesting cohort from an efficacy standpoint. I actually think the more important aspect of it is actually the safety standpoint because a lot of -- there's a lot of data about efficacy of GEM/DOCE formulations. And we know that you could look even at TAR-200 data and see what happens when you give gemcitabine over a sustained period of time. But the safety is actually the more important component because you worry whether or not prolonged exposure of the bladder to the chemotherapy might cause irritation, frequency, urgency, pain. And so far, we haven't seen that. And that's probably -- if you had asked me at the beginning of this, what would be my biggest concern, it would not have been an efficacy concern, it would have been a safety concern. And so that's probably the most reassuring aspect of this. It's a heterogeneous population. So it's going to be a little challenging to compare this to some of the mature trials like SunRISe-1 or BOND-3 in terms of efficacy because only some of these patients have CIS, BCG unresponsive CIS. This is still Phase II with a heterogeneous population. But at some point, obviously, once -- after conversation with the FDA, we can decide on which indication to actually do a larger cohort. But the safety profile is obviously quite reassuring. Sergio Traversa Thank you, Dr. Lotan. Did I answer your question? There was the first part that I didn't catch entirely. Matthew Barcus No, yes, yes, you caught it. And then I guess, like as you're thinking about talking with FDA on -- with these data and the design of the Phase III, I guess, what would you want the Phase III to look like in terms of time points, endpoints and the types of patients you're thinking about enrolling? Sergio Traversa Dr. Laton, that here, you can add a lot of value because Dr. Laton is helping us very closely to design the Phase III program. Do you want to answer that? Yair Lotan Sure. I think there's -- there are easier routes and there are harder routes. I think somebody highlighted the challenge with the BCG unresponsive route. The benefits of that route are -- that the FDA has approved single-arm Phase II trials for approval in CIS alone to look at efficacy. The challenge is that these patients are relatively rare, and it takes many sites and quite a bit of time to enroll. I think there's 2 easier routes. One route would be to go through a single-arm chemoablation route, similar to what UroGen with the ENVISION trial. I think we're going to learn a lot later on this month when it goes to ODAC. And if the drug -- their combination gets approved with a single-agent mitomycin that stays in your bladder about 4 hours, then a single-arm trial in that setting with our formulation makes a lot of sense. It would be probably the quickest route to approval. And if that doesn't -- if there is reasonable rationale from the FDA that they won't approve such an approach, then a randomized trial like PIVOT-6 in intermediate risk, randomizing NDV-01 to placebo or observation would probably be the next quickest route. That trial actually enrolled extremely quickly in the U.S. I think that, this formulation would actually be more attractive than an oncolytic virus. But that type of trial design was enrolling very rapidly. They're almost done with enrollment. And I think somewhere around 15 to 18 months. And I think that would be the next approach, especially since the FDA approved a randomization against placebo, which is easy to do a superiority trial against nothing in a population of patients who have high risk for recurrence. Operator There are no further questions at this time. So this will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation. Sergio Traversa Thank you all. Thank you very much. Thank you, Dr. Lotan. Yair Lotan Thank you. 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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13-05-2025
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Q1 2025 FibroGen Inc Earnings Call
Joanne Geller; Investor Relations; LifeSci Advisors Thane Wettig; Chief Executive Officer; FibroGen Inc David DeLucia; Chief Financial Officer; FibroGen Inc Andy Hsieh; Analyst; William Blair Matthew Keller; Analyst; H.C. Wainwright & Co Operator Good day, and thank you for standing by. Welcome to FibroGen first quarter 2025 earnings conference call. (Operator Instructions). Please be advised today's conference is being recorded. I would not like to end the conference over to your speaker today, Joanne Geller. Please, go ahead. Joanne Geller Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's first quarter 2025 financial and business results. I'm Joanne Geller from LifeSci Advisors. Joining me on today's call are Thane Wettig, our Chief Executive Officer; and David DeLucia, our Chief Financial Officer. Following the prepared remarks, we will open the call to your questions. I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include, but are not limited to, our collaborations with AstraZeneca and Astellas, financial guidance, initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results, and results of operations, risks related to our business, and certain other business matters. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in FibroGen's filings with the SEC, including our most recent Form 10-K and Form 10-Q. FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting the company's financial results and business update, and a webcast of today's conference call, can be found on the investor section of FibroGen's website at With that, I'd like to turn the call over to CEO, Thane Wettig. Thane? Thane Wettig Thank you, Joanne. Good afternoon, everyone, and welcome to our first quarter 2025 earnings call. On today's call, I will provide a status update on the transformation of FibroGen, which includes the divestiture of FibroGen China and a laser focus on our US pipeline opportunities, specifically the exciting prospects for FG-3246 and FG-3180, our potential first-in-class antibody drug conjugate targeted in CD46, and our PET imaging agent in metastatic castration-resistant prostate cancer. And for roxadustat in the treatment of anemia due to lower-risk myelodysplastic syndrome. Then, David DeLucia, our CFO, will review the financials, after which we will open the call for your questions. On slide 3, I would like to highlight the strategic priorities we've set forth for FibroGen this year. I'll begin by providing an update on the sale of FibroGen China to AstraZeneca. As we've stated previously, this is a truly transformative transaction for FibroGen as it simplifies our operations, allows for the payoff of our term loan facility with Morgan Stanley Tactical Value, and provides the most efficient pathway to access the company's net cash held in China. At the time of the announcement in February, the total consideration for the sale was expected to be approximately $160 million, which included an equity value of $85 million and expected net cash in China of approximately $75 million. We are pleased to share that we expect the total consideration to now be approximately $185 million, which is a $25 million increase from our initial guidance due to greater than expected net cash in China at closing. Importantly, the increase in expected proceeds extends the company's cash runway into the second half of 2027. We now expect the transaction to close in the third quarter of this year. Second, we remain hyper-focused on advancing FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer or mCRPC, in which we continue to make important progress. We recently announced in March the publication of the full trial results from the Phase 1 monotherapy study of FG-3246 in patients with mCRPC in the Journal of Clinical Oncology, which highlights the promising potential of its anti-cancer activity, especially when considering the unselected, heavily pretreated patient population. We believe the trial results demonstrate that the CD46 target is active and provide key insights into the potential clinical impact of targeting CD46-expressing tumors. We are excited to share that we recently received notification from the FDA clearing the IND for FG-3180, our companion PET imaging agent. This marks an important achievement for FibroGen as it paves the pathway for FG-3180 to be used alongside FG-3246 in the upcoming Phase 2 dose optimization monotherapy trial, which is expected to start in the third quarter. Third, for roxadustat, FibroGen recently filed a type C meeting request with the FDA to gain feedback on the potential path forward for roxadustat in anemia associated with lower-risk myelodysplastic syndromes, an indication with significant unmet medical need. In the post hoc subgroup analysis from the MATTERHORN Phase 3 trial, roxadustat showed promise in reducing transfusion dependence in patients with a higher transfusion burden at baseline. We expect FDA feedback in the third quarter that will provide important clarity on the path forward for roxadustat in the US, with the aim of realizing additional value for this wholly owned asset. Altogether, we are confident that our refined focus, multiple near-term catalysts across both clinical programs, and our existing strong foundation position us well to create value for shareholders now and in the future. I will now provide a brief overview of our FG-3246 and FG-3180 programs in mCRPC. Slide 5 highlights the high unmet need in late-stage prostate cancer. There are approximately 290,000 men diagnosed with prostate cancer each year in the US. Of these, there are 65,000 drug-treatable patients where the cancer has metastasized and become castrate-resistant, resulting in a grim five-year survival rate of approximately 30%. There remains a significant opportunity for new treatments that can extend survival for these men, with a total addressable market of well over $5 billion in annual sales. FG-3246 could become a non-PSMA treatment option that is so desperately needed given the significant unmet need in mCRPC. Turning to slide 6, we highlight the novelty of our target, a tumor-selective epitope of CD46. CD46 and this specific CD46 epitope have several distinguishing features. First, CD46 is upregulated during tumorigenesis and helps tumors evade complement-dependent cytotoxicity. The CD46 epitope is highly expressed in mCRPC tissues with lower interpatient variability and higher median expression compared with PSMA, as depicted in the graph on the right-hand portion of the slide. Importantly, the expression of CD46 is upregulated in the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer and further overexpressed following treatment with androgen signaling inhibitors. The CD46 epitope is also overexpressed in colorectal cancer and other solid tumors. Turning to slide 7, FG-3246 is a potential first-in-class ADC in development for mCRPC with a novel targeting antibody YS5, which binds to the tumor-selective epitope of CD46 along with an MMAE payload. MMAE is a validated payload that is approved as part of a number of ADCs and other oncology indications. FG-3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development. A companion PET imaging agent, FG-3180, utilizes the same YS5 targeting antibody as FG-3246 and is also under clinical development. In preclinical studies, the PET imaging agent has demonstrated specific targeting of and uptake by CD46-positive tumor cells. We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in the Phase 3 portion of the clinical development program, but it would also enable differentiation for FG-3246 in the prostate cancer treatment paradigm. In addition, FG-3180 could represent an important commercial opportunity as a companion diagnostic to FG-3246, similar to the existing PSMA PET agents such as PYLARIFY. We are excited to announce that we have recently received IND clearance for FG-3180, paving the way for FG-3180 to be an important component for the upcoming Phase 2 dose optimization study that I will touch on in a moment. Slide 8 recaps the top-line results from the Phase 1 monotherapy study with full details published in the peer-reviewed Journal of Clinical Oncology in March of this year. The completed monotherapy study included a total of 56 metastatic castration-resistant prostate cancer patients who were biomarker unselected and were heavily pre-treated, receiving a median of five lines of therapy prior to FG-3246. In the efficacy evaluable population of 40 patients, a median radiographic progression-free survival of 8.7 months was observed. There was an overall response rate of 20% confirmed by RECIST 1.1, and PSA reductions of greater than 50% were achieved in 36% of patients. Adverse events were consistent with those observed with other MMAE-based ADC therapies. Additional highlights from the JCO publication include the expression of CD46 being observed in 80% of evaluable biopsies in patients enrolled during the dose expansion phase, which is consistent with results previously reported from a prospectively obtained cohort of patients who underwent metastatic CRPC biopsy. 20 patients had evaluable circulating tumor DNA at baseline, on treatment defined as before the cycle 2 day 1 dose, and at the end of treatment or disease progression. In 9 of these 20 patients, or 45% of those evaluable, there was a greater than 50% decline from baseline in ctDNA fraction after just one cycle of treatment. A tighter dose-response relationship appeared to be observed for objective tumor response by imaging as opposed to serum PSA decline, which may be related to the independence of CD46 from the androgen signaling pathway and expression of CD46 in androgen receptor-independent tumor clones. Finally, anti-tumor activity was observed in patients who had received more than one previous line of ARPI therapy, as well as those who had received taxane chemotherapy in the metastatic castration-sensitive setting, the latter being notable given similar mechanisms of action of taxane and MMAE. Based on the totality of the data from the Phase 1 monotherapy trial, we are encouraged by the clinical activity of FG-3246 in targeting CD46 in mCRPC. On slide 9, we highlight the rPFS results of FG-3246 in its Phase 1 study versus other comparable early-stage studies. As covered on the previous slide, the Phase 1 study of FG-3246 demonstrated an rPFS of 8.7 months across a robust sample size of 40 heavily pre-treated patients. While we cannot make direct comparisons to these trials due to the differences in study design and prior prostate cancer treatments, we are encouraged by these rPFS results, which is a recognized regulatory endpoint in prostate cancer trials. On slide 10, we highlight previously reported preliminary efficacy data from the Phase 1b portion of the ongoing investigator-sponsored combination study with enzalutamide. These interim results included data on 17 biomarker unselected patients, 70% of whom were pre-treated with at least two prior ARSIs. In addition to establishing the Phase 2 dose of FG-3246, the IST also demonstrated an encouraging 10.2 months of radiographic progression-free survival, with PSA declines observed in 71% of evaluable patients. We expect to report the Phase 2 top-line results in the fourth quarter of this year, which will also include data on CD46 expression in patients treated with FG-3180, our PET biomarker, during the Phase 2 portion of the IST. On slide 11, we depict a comparison of the initial results from the monotherapy trial in heavily pre-treated patients and the combination trial for FG-3246 versus the rPFS results from second-line therapies in late-stage trials. Again, while we cannot make direct comparisons to these trials due to the differences in study design and previous prostate cancer treatments, we are encouraged that FG-3246 demonstrates what we believe to be competitive rPFS results. Slide 12 highlights the Phase 2 monotherapy dose optimization trial design that is based on our discussion with the FDA. We plan to initiate the study next quarter and expect to enroll 75 patients in the post-ARSI pre-chemo setting across three dose levels to determine the optimal dose for Phase 3 based on efficacy, safety, and PK parameters. It is important to note that FG-3180 will be an integral part of the study as we seek to demonstrate the correlation between CD46 expression and response to the ADC in this all-comers population. One other important design element is the use of UCSF as primary prophylaxis to mitigate Grade 3 or greater adverse events associated with neutropenia commonly seen with MMAE payloads. The addition of UCSF may enable a better tolerated and more consistent treatment with the ADC, minimizing dose interruptions or dose reductions, extending duration of therapy, and potentially enhancing the efficacy of the ADC. We are planning an interim analysis in the second half of 2026, which will include efficacy, safety, PK, and exposure-response data, and we intend to share relevant data with all stakeholders as they become available, given the open-label design. Slide 13 highlights why we are so optimistic about the potential for the Phase 2 study to further build upon the strong efficacy seen in the Phase 1 study. We believe there are three factors that could drive our PFS even higher than the 8.7 months observed in the Phase 1 monotherapy trial. First, preliminary evidence of an exposure-response relationship allows us to focus our Phase 2 study on three of the highest tolerated doses from the Phase 1 dose escalation and expansion study. Second, utilizing primary prophylaxis with UCSF to combat neutropenia potentially allows patients more consistent exposure to the ADC with fewer dose interruptions or adjustments. Third, enrolling patients in earlier lines of therapy versus the median five prior lines of therapy in the Phase 1 trial. We believe that these design elements have the potential to improve upon the Phase 1 results and achieve an rPFS in the 10 to 12-month range, which we believe is the benchmark for commercial competitiveness. On slide 14. We show our long-term development strategy for FG-3246 and FG-3180, which we believe provides significant optionality in prostate cancer. We have a robust Phase 2 monotherapy trial in the pre-chemo setting in mCRPC to further build upon the compelling efficacy data of 8.7 months of rPFS in 40 heavily pretreated biomarker-unselected patients from the Phase 1 monotherapy study. In addition, this study will explore the correlation between CD46 expression and response to the ADC, potentially validating FG-3180 as a predictive patient selection biomarker in future studies. We are confident that our development pathway for FG-3246 unlocks sequential or parallel registration pathways, as FG-3246 will be evaluated in multiple lines of therapy in monotherapy and/or in combination with an ARSI, and in an all-comers population or patients with high expression of CD46. Slide 15 shows the recent and upcoming catalysts for the FG-3246 and FG-3180 program. We are very pleased to have received IND clearance for FG-3180, as this marks an important milestone as we explore its potential to be used as a diagnostic tool and potential biomarker for patient selection in the treatment of mCRPC. We plan to initiate the Phase 2 monotherapy trial in the third quarter, which will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. To summarize on slide 16, FG-3246 targets a novel epitope on prostate cancer cells with first-in-class potential. It is important to note that there are no other CD46-targeted projects in clinical development. Targeting CD46 with FG-3246 has already demonstrated promising early efficacy signals with an acceptable safety profile both in monotherapy and combination settings. We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress. Turning to roxadustat, slide 18 highlights the unmet need and the potential for roxadustat in patients with anemia associated with lower-risk MDS. There is a lack of effective second-line and beyond treatments, given that the currently available therapies are only effective in approximately 50% of patients. In addition, there are no oral options available or in late-stage development, which could be a meaningful differentiator for roxadustat and potentially translate into a significant commercial opportunity. Moving on to slide 19, we highlight data from the Phase 3 MATTERHORN study of roxadustat in a subgroup of patients with anemia of lower-risk MDS who entered the trial with a higher transfusion burden. In this post hoc analysis, roxadustat demonstrated a meaningful difference in transfusion independence versus placebo, results that are highly similar to the pivotal trials for two recently approved therapies for anemia associated with lower-risk MDS. On slide 20, we highlight the significant opportunity for roxadustat in lower-risk MDS. Based on other lower-risk MDS development programs, we believe the indication would support an orphan drug designation, which would provide seven years of data exclusivity in the US. This potential exclusivity, combined with an attractive market opportunity and efficient commercial model, provides a significant economic opportunity for further development of roxadustat. We look forward to near-term discussions with the FDA, which could pave the way for developing roxadustat for anemia associated with lower-risk MDS on our own or through a potential partnership. With that, I will now turn the call over to Dave to discuss the company's financials. Dave? David DeLucia Thank you, Thane. I will first review the updated FibroGen China transaction details and then provide the company's financial performance for the first quarter of 2025. As a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations in continued operations moving forward. On slide 22, we highlight the summary of key financial terms of the transaction. Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, estimated to now be approximately $100 million, totaling approximately $185 million. This is a $25 million increase from our initial net cash guidance in February. Given the company's current market capitalization of approximately $30 million, we believe this increase in expected net cash received upon the close of the transaction represents a meaningful outcome for shareholders. As a reminder, the value of FibroGen net cash in China includes FibroGen's portion of Falikang net cash, which is the joint distribution entity owned by FibroGen and AstraZeneca. Importantly, FibroGen will continue to accrue cash generated in China until the closing of the transaction, which is expected in the third quarter of 2025, pending customary closing conditions including regulatory review in China. This transaction is truly transformative for FibroGen and allows the company to pay down its senior term loan facility with MSTV, fully access our cash in China, and extend the company's runway into the second half of 2027 to support US development initiatives. Now, on to the company's financials for the first quarter. For the first quarter of 2025, total revenue was $2.7 million compared to $25.4 million for the same period in 2024. For the full year 2025, we reiterate total revenue to be between $4 million and $8 million. Now, moving down the income statement, total operating costs and expenses for the first quarter of 2025 were $17.7 million compared to $74.5 million for the first quarter of 2024, a decrease of $56.8 million or 76% year-over-year. R&D expenses for the first quarter of 2025 were $9.2 million compared to $36.5 million in the first quarter of 2024, a decrease of $27.3 million or 75% year-over-year. SG&A expenses for the first quarter of 2025 were $8.1 million compared to $16.7 million in the first quarter of 2024, a decrease of $8.6 million or 51% year-over-year. During the first quarter of 2025, we recorded a net loss from continuing operations of $16.8 million or $0.16 net loss per basic and diluted share, as compared to a net loss of $49 million or $0.49 per basic and diluted share for the first quarter of 2024. For the full year 2025, we reiterate our guidance for our total operating costs and expenses, including stock-based compensation, to be between $70 million and $80 million, which at the midpoint represents a 58% reduction from the full year 2024. Now, shifting towards cash, as of December 31, we reported $33.8 million in cash, cash equivalents, and accounts receivable in the US, and $128.4 million in total consolidated cash, cash equivalents, and accounts receivable when including balances in China. The company was cash flow positive in the first quarter of 2025, generating a total of $7.3 million in cash flow on a total consolidated basis when including balances in China. Given that the company will continue to accrue cash from its China operations until the close of the sale transaction, we expect the company to again be cash flow positive on a consolidated basis in the second quarter of 2025. Upon close of the China transaction, we plan to pay off our senior secured term loan with Morgan Stanley Tactical Value, resulting in a cash outflow of approximately $80 million. This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. Post the payoff of our MSTV term loan, we expect the company to have runway into the second half of 2027. Thank you, and we'll now turn the call back over to Thane. Thane Wettig Thank you, Dave. To conclude, we are extremely excited about the future prospects for FibroGen with a number of important catalysts in the coming months. We plan to advance our exciting pipeline, initiating the Phase 2 monotherapy study next quarter for FG-3246 and FG3-180 in mCRPC. We will gain important feedback from the FDA regarding the potential development of roxadustat in lower-risk MDS, and we anticipate the close of the FibroGen China sale, payoff of the MSTV term loan, and extension of our cash runway into the second half of 2027. In summary, we are committed to driving significant shareholder value by advancing our US development initiatives, supported by our strong balance sheet. We look forward to providing further updates to our stakeholders over the coming months. I would now like to turn the call over to the operator for Q&A. Operator (Operator Instructions) Andy Hsish, William Blair. Andy Hsieh Thanks for taking our questions. Congratulations on the higher-than-expected proceeds from the AstraZeneca deal and the JCO publication. So, we have three questions. One has to do with clinical development on FG-3246 and so this has to do with some of the market dynamic changes after the Pluvicto approval based on the PSMA 4 study in the pre-chemo setting. I'm curious if you have contemplated potentially running the monotherapy study or the pivot program in the Pluvicto experienced population just to mitigate some of the risk associated with a highly heterogeneous population and maybe targeting a higher unmet medical need. So, that's question number one. Question number two, has to do with some of the macro disruptions that we have read about in the news or reported by the media. I'm just curious if you can comment on some of the recent FDA correspondence or communication, especially with the Roxadustat study and the opportunity. And third, I think this is something you have mentioned a couple of times in previous calls. Given the cash infusion from AstraZeneca, is it worthwhile, maybe from a capital allocation perspective, to conduct some feasibility studies in colorectal cancer, especially in light of [CytomX's] success this morning? Thank you very much Thane Wettig Hey, thanks, Andy, for the comments and the questions. Appreciate that. So, let me touch on the first one and then I'll ask Dave to comment as well. As it relates to clinical development for FG-3246 and some market dynamic changes with Pluvicto's new indication, as part of our synopsis or protocol for the Phase 2 monotherapy trial, we are going to allow Pluvicto experienced patients who happen to progress while on Pluvicto in that pre-chemo or post-ARSI pre-chemo setting to be entered into our trial. We don't think it makes sense to only or exclusively study those patients who are post-Pluvicto because, as I'm sure you can appreciate, Andy, you never have rapid adoption of an agent with a new indication. It usually takes time for clinicians to begin to adopt it. So, if we would require all patients who would be entered into our Phase 2 monotherapy trial to have been Pluvicto experienced, we just think that would create too much of an enrollment challenge. But we will be allowing patients who have been treated with Pluvicto to be entered into our Phase 2 monotherapy trial. Dave, anything to add to that? David DeLucia Nothing to add there, thanks. Thane Wettig Okay, and then in terms of the macro news and a lot of what's going on with respect to (inaudible) and FDA and the like, the only thing that we can point to are recent interactions that we've had with the agency. Maybe I'll give you just a flavor of that. The first one was when we filed the IND for FG-3180, which is our PET imaging agent. Everything progressed exactly on schedule. The questions, there were just a few of them, they came in a timely way. We answered them, the IND got cleared right on time. The next example that we have for the agency was the reactivation of the roxadustat IND in the US. We had deactivated it once we got the license back from AZ a little over a year ago. We needed to reactivate it in order to file the Type C meeting request. We requested the reactivation, that was also achieved right on time. And then in terms of the Type C meeting request that we filed, typically the FDA has 21 days or so to get back to the sponsor once a Type C meeting request has been filed. If they accept the Type C meeting request, there is then a date that has been set. We filed that Type C meeting request a week ago and have already heard back from the agency on the date that the Type C meeting is set for. So, the experiences that we have, Andy, I think are very favorable in terms of the FDA continuing to keep to certain timelines. In fact, we haven't experienced anything that's different than that. And then finally, in terms of cash from AZ and potentially doing a feasibility study for FG-3246 in mCRPC, I think we're going to hold off on that for now. We continue to evaluate lifecycle opportunities. The most important thing that we need to do is get the Phase 2 monotherapy trial started and then we'll be evaluating other opportunities that we think make sense from a lifecycle perspective. Dave, anything to add to that? David DeLucia No, I think you hit the nail on the head there, Thane. I think for us, obviously, we have identified colorectal cancer as a potential opportunity for FG-3246 given the expression of CD46 in those patients. But at the same point, I think our goals for this calendar year are really to close the transaction for China, kick off our Phase 2 studies, and really get the ball rolling around the development pathway for roxadustat in MDS as well. So, great question, Andy. Andy Hsieh Great, thank you so much. Thane Wettig Any other follow-up questions, Andy? Andy Hsieh I think that's it from us. Thank you so much. Thane Wettig Okay. Yeah, thanks for the questions. Appreciate it. Operator (Operator Instructions) Matthew Keller, HCW. Matthew Keller Hey everyone, congrats on the quarter and thanks for taking our questions. Just two quick ones from us. The first one, I was wondering if you have any additional or any rate-limiting steps ahead of the upcoming Phase 2 monotherapy study? And then secondly, with the updates on today's call, I was wondering how we should start to view the evolving commercial opportunity for FG-3180? Thane Wettig Thanks, Matt, for the questions. I'll take them and then ask Dave to add some additional commentary as well. Originally, as it relates to the Phase 2 monotherapy trial, we weren't certain how quickly we were going to get the FG-3180 IND cleared. So, there was a point in time where we thought that the majority of the patients in the Phase 2 monotherapy trial, the 75 patients, would be able to be treated with the PET biomarker in addition to the ADC. Now, with the clearing of the IND, I wouldn't call it a rate limiter, but what that allows us to do is to get an amendment in front of the sites that includes FG-3180 as part of the Phase 2 monotherapy study. So that all of the patients in the Phase 2 trial will be able to be treated with the PET biomarker in advance of receiving the ADC. We're going through that process right now as we speak. The rate limiter is the close of the China transaction so that we can move forward rapidly to then start the Phase 2 monotherapy trial. In terms of the question around the evolving landscape, what was that one question again? Matthew Keller Kind of like how we should view the commercial opportunity for FG-3180 as it evolves, both as a stand-alone product or in combination with some of the other things you guys have going on as well. Thane Wettig Yeah, it's a really important question. The Phase 2 trial will tell us a lot. It will give us even more information relative to what we have now. There have been about 25 or 27 patients who have been treated with the PET imaging agent in the Phase 1/2 investigator-sponsored trial at UCSF in combination with enzalutamide. We've seen those scans. It's clear that the target lights up with the PSMA imaging agent, and as you know, it uses the same YS5 antibody that is part of the ADC. The scans look really clear. The Phase 2 trial will then tell us if we continue to see the scans appropriately light up the lesions and what we can learn in terms of the assessment of the expression level of CD46 in response to the ADCs. That will be a correlation analysis that we will do during the course of the trial and at the end of the trial so that we can understand the diagnostic performance of the agent itself. We have looked at the radioligand space, we've looked at the PSMA PET space. Clearly, with the PSMA PET imaging agents from Lantheus and from Telix that generate well over $1.5 billion in annual revenue, there is a clear commercial opportunity. But we're going to have to assess the performance of our PET imaging agent to determine what that potential commercial opportunity could be. Dave, please add to that. David DeLucia Yeah, I think the one thing that I want to add around the Phase 2 and the importance of being able to dose all 75 patients is that we're really trying to get to a point where we can have a large swath of patients being able to be tested with FG-3180. The fact that we could have 75 patients in the Phase 2, we have the Phase 2 portion of the combination therapy and the IST with UCSF. The more and more patients that we can get treated with FG-3180 allows us to get really smart around what the levels of expression would be that could correlate with efficacy and allows us to better understand how it can be used in future studies. Matthew Keller Yep, no, totally makes sense. Thanks again for taking our questions. Appreciate you guys. Thane Wettig Thank you, Matt. Operator I'm not showing any further questions at this time. I turn the call back over to Thane for closing remarks. Thane Wettig We appreciate everybody's participation today and continued interest in FibroGen. We look forward to updating you over the coming weeks and months on the important catalysts that are ahead of us. Thank you for your time today. Operator Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day. 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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13-05-2025
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Q1 2025 Mineralys Therapeutics Inc Earnings Call
Daniel Ferry; Investor Relations; LifeSci Advisors Jon Congleton; Chief Executive Officer, Director; Mineralys Therapeutics Inc David Rodman; Chief Medical Officer; Mineralys Therapeutics Inc Adam Levy; Chief Financial Officer, Company Secretary; Mineralys Therapeutics Inc Michael DiFiore; Analyst; Evercore Jin Law; Analyst; Goldman Sachs Seamus Fernandez; Analyst; Guggenheim Securities Rami Katkhuda; Analyst; LifeSci Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Mineralys' first-quarter 2025 earnings conference call. (Operator Instructions) This call is being recorded on Monday, May 12, 2025. I would now like to turn the conference over to Dan Ferry. Please go ahead. Daniel Ferry Thank you, operator. We'd like to welcome everyone joining us today for our first quarter 2025 conference call. Earlier this afternoon, we issued a press release providing our first quarter 2025 financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately 1 hour after its completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings. Please note that these statements reflect our opinions only as of today, May 12, 2025, and as except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. Jon Congleton Thank you, Dan. Good afternoon, everyone, and welcome to our first quarter 2025 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer; and Dr. David Rodman, our Chief Medical Officer. I'll begin with an overview of the business, then Dave will discuss our clinical programs and recent milestones, followed by Adam to review our first quarter financial results before we open up the call for your questions. This has been an exciting past few months for Mineralys as our team delivered on several clinical milestones to make significant progress across our entitlement pipeline. The most highly anticipated of these accomplishments was the simultaneous announcement of positive top line data from the pivotal trials Launch-HTN in Advance-HTN, which is understand in uncontrolled and resistant hypertension subjects. We were pleased to announce in March that both trials successfully achieved statistical significance and were clinically meaningful in Emery efficacy end points and demonstrated a favorable safety and tolerability profile. Detailed results from the Advance-HTN trial were also published in the New England Journal of Medicine, and presented in a late-breaking presentation at the American Cardiology's ACC '25 meeting. The Launch-HTN data has been accepted for a late-breaking presentation at the European Society of Hypertension on May 24 with a planned future publication. Each of these exciting outcomes helps to underscore the strength of these clinical data and the potentially transformative nature of a to help people achieve their blood pressure goal and potentially reduce their cardiovascular risk. The positive efficacy, safety and tolerability data from these 2 pivotal trials, along with the data from our Target-HTN Phase II trial of lorundrostat are key elements of our planned new drug application to the FDA. We continue to believe that this regulated aldosterone is not adequately addressed with currently available RAS directed therapeutics, including mineral corticoid receptor antagonist. These results we have seen with lorundrostat reinforce the need for a new Aldostero-directed therapeutic approach. The Transform-HTN open-label extension trial is evaluating the safety and efficacy of lorundrostat long-term use will be an important aspect of lorundrostat's profile and a critical component of our new drug application. We anticipate discussing the results from the Advance, Launch, Target and Transform HTN trials as well as the Explore-CKD trial with the FDA at a pre-NDA meeting in the fourth quarter of 2025, during which forward for an NDA submission and potential approval of lorundrostat. We look forward to providing updates on this program throughout the remainder of 2025. We're very optimistic about the interest physicians have on lorundrostat overall clinical profile based on the pivotal data, especially given the double-digit absolute reduction in systolic blood pressure. Supporting our excitement around the market opportunity from lorundrostat are the data we collected in a survey fielded in March, which evaluated the data from the Launch-HTN and Advance-HTN trials with cardiologists and primary care physicians. The results from that survey showed if lorundrostat is approved, 95% of the physicians are likely to prescribe lorundrostat broadly for hypertension and specifically in the third and fourth line position. This intent to prescribe is based on the health care professionals interpretation of the efficacy data relative to what they currently have available for uncontrolled and resistant hypertension as well as lorundrostat safety and tolerability profile. The overall results speak to the desire for innovative solutions that physicians want in their treatment armamentarium to address uncontrolled and resistant hypertension. Our two ongoing proof of con trials address advanced chronic kidney disease, specifically those with uncontrolled hypertension as well as obstructive sleep apnea with nocturnal hypertension. These trials are designed to enhance and extend the lorundrostat profile in hypertension subjects with comorbid conditions, largely driven by inadequately controlled blood pressure in dysregulated aldosterone. We've made steady progress with both trials since the beginning of 2025, and anticipate announcing top line data from Explore-CKD trial later this quarter. We're also pleased to announce the appointment of Eric Warren as Chief Commercial Officer. Eric brings approximately [30] years of experience in the pharmaceutical industry, during which he has developed a breadth of commercial and partnering expertise, focusing primarily on cardiometabolic and acute care medicine. He started his career as a pharmacist and then joined Merck & Company where we went on to hold commercial positions of increasing responsibility for almost 2 decades. In addition, Eric has held commercial leadership roles at Sanofi and Nabriva and was most recently the Chief Commercial Officer of the Therapeutics. As the Chief Commercial Officer of Mineralys will lead our commercial strategy as we prepare for the potential FDA approval of lorundrostat and support our partnering ambitions in the U.S. and ex U.S. markets. In March, we completed a public equity financing that raised gross proceeds of approximately $201.2 million before deducting fees and expenses. This financing contributed meaningfully to the strength of our balance sheet. Now to provide more color on our clinical pipeline and recent milestones, I'll turn the call over to Dave. David Rodman Thank you, Jon, and good afternoon, everybody. As Jon mentioned, our team has been had an exciting few months with the advancement of our clinical programs. I'll start by summarizing the top line results of the pivotal Phase III Launch-HTN trial, which randomized 1,083 subjects in North America and Europe who had failed to achieve the U.S. guidelines specified blood pressure targets despite having been provided on multidrug antihypertensive regimen. The trial, which tested lorundrostat in a real-world clinical context met its primary and secondary endpoints with highly statistically significant, clinically meaningful placebo-adjusted reduction, installed blood pressure as well as in the observed change in blood pressure that is conventionally used by prescribing physicians to assess response to antihypertensive therapy. At week 6, the primary end point, the 50-milligram once daily lorundrostat arm demonstrated a 9.1-millimeter of mercury placebo-adjusted reduction in systolic blood pressure, and a 16.9 meter mercury reduction in observed systolic blood pressure. At week 12, the reduction in systolic BP was maintained with the point estimate being greater than that observed at week 6. 11.7 millimeters of mercury and 19 millimeters of mercury for placebo-adjusted and observed changes, respectively. Reductions in blood pressure and this magnitude is linked to significant reduction in overall cardiovascular risk and the incidence of major adverse cardiovascular events. The Launch-HTN trial confirmed expected modest on-target increase in serum potassium that accompanies the therapeutic benefit in individuals with inadequately controlled hypertension as well as an overall safe and well-tolerated profile. The incidence of any potential measurement over 6 millimole per liter in the Launch-HTN trial in (inaudible) milligram arm was 1.1% in placebo in active and 0.7% in placebo. The prespecified rate, excluding falsely elevated or factitious hyperkalemia was comparable to placebo with the demonstrated incidences being 0.6% and 0.4%, respectively. While quantitative comparisons between different clinical trials are difficult, the incidence of moderate or severe hyperkalemia of approximately one-half of 1% compares quite favorably with most prior reports of mineralocoid receptor antagonist tested in a similar clinical context. The Launch-HTN global pivotal trial is the largest aldosterone on synthase inhibitor trial reported to date and the benefit of risk profile compares quite favorably with previously reported smaller trials of the 3 other aldosterone synthase inhibitors that have been tested in hypertensive individuals. Now turning to the Advance-HTN trial. Here, we tested the effect of lorundrostat in the clinical context and hypertension intensive individuals who are the most refractory to current standard of care, and often referred to hypertension specialists. The trial used highly rigorous criteria for enrollment and randomized -- randomization designed to mirror best practice care provided in the most advanced hypertension referral centers, maximization of conventional best practice 2 and 3 drug treatment regimens along with active monitoring of compliance, we're used to document and confirm the existence of uncontrolled or resistant hypertension. The results from the trial in the 50-milligram once-daily lorundrostat arm were highly statistically significant. The 7.9 millimeter mercury reduction in placebo-adjusted systolic blood pressure and 15.4 millimeter mercury reduction in observed systolic blood pressure measured by 24-hour ambulatory blood pressure were observed at the prespecified 12-week visit. Lorundrostat demonstrated a favorable safety and tolerability profile with modest on-target changes in serum potassium, sodium and EGFR and a low discontinuation rate. This trial was designed and conducted in partnership with the comprehensive hypertension center at the Cleveland Clinic and their C5 research team. Results were presented by the Co-Director of the Cleveland Clinic Hypertension Clinic, Dr. Lu Lasan, in a late-breaking session at the American College of Cardiology's ACC '25 meeting and published in the New England Journal of Medicine on May 8. As was reported in the New England Journal of Medicine Paper, the Advance-HTN trial per protocol confirmed incidence of hyperkalemia over 6 millimole per liter in the 50-milligram arm was 2.1%. Given the high dose of olmesartan, a potent long-acting arm, which also elevates serum potassium, we feel that this incidence of serum potassium greater than 6 millimole per liter has an acceptable benefit risk profile appropriate for the use in these patients. Okay. Now turning to our other programs, Explore-CKD and Explore-OSA Phase II proof-of-concept trials. Both of these trials are designed to provide data that augments the anti-type pretensive protocol of lorundrostat by profiling the an efficacy of lorundrostat in these 2 special populations of hypertensive individuals. During the first quarter, we announced the completion of enrollment in the Explore-CKD Phase II trial. This trial evaluates the safety and efficacy of lorundrostat for treatment of hypertension in subjects with an eGFR from 30 to 90 and at least 200 milligrams of UACR despite receiving stable treatment with an ACE inhibitor or an ARB as well as an SGLT2 inhibitor. Hypertension and associated hypertensive nephropathy is a leading cause of kidney damage alone and in combination with other obesity associated comorbidities. This is another area with great unmet medical aldosterone synthase inhibition with lorundrostat has the potential for transformative benefit to patients. In this trial, the primary outcome measure is change in systolic blood pressure during a 4-week treatment period relative to that seen in a 4-week placebo treatment period in the same individuals. The key mechanism of kidney damage in hypertensive nephropathy is elevated blood pressure glomerular hyper perfusion, scarring and reduction of the number of glomeruli available to filter the blood. Changing prutinuria is being assessed in this trial as well. In contrast to CKD due to diabetes and metabolic syndrome, where proteinuria is a useful surrogate endpoint. Individuals with predominant hypertensive nephropathy tend to have modest levels of proteinuria, change in blood pressure, along with acute physiological reduction in eGFR and rather than changing proteinuria may be a more useful outcome measure for a Phase II trial in this population. In the first quarter of 2025, we announced initiation of the Explorer-OSA Phase II trial to evaluate the effect of lorundrostat in treatment of moderate to severe obstructive sleep apnea, blood pressure increases significantly as arterial oxygenation falls during upper airway obstruction at night. By dosing lorundostated bedtime, we believe we will suppress the majority of aldosterone produced during sleep, while maintaining 24-hour blood pressure control. Episodes of nocturnal hypertension are underdiagnosed and lack a demonstrated highly effective treatment. The current treatment armamentarium is limited to weight loss and the use of positive airway pressure. We believe that neither is sufficiently effective at minimizing the impact of OSA on major adverse clinical outcomes. In summary, we have now demonstrated the clinically meaningful benefit risk profile of lorundrostat in individuals with aldosterone mediated hypertension. We are focused both on moving lorundrostat towards an NDA submission as well as exploring its use in prevalent comorbidities such as OSA hypertensive nephropathy, for which normalizing aldosterone production may result in meaningful clinical benefits. I'll now turn the call over to Adam to review our financial results for the first quarter of 2025. Adam Levy Thank you, Dave. Good afternoon, everyone. Today, I will discuss elect portions of our first quarter 2025 financial results. Additional details can be found in our Form 10-Q which will be filed with the SEC today, May 12. We ended the quarter with cash, cash equivalents and investments of $343 million as of March 31, 2025, compared to $198.2 million as of December 31, 2024. We believe that our current cash, cash equivalents and investments will be sufficient to fund our planned clinical trials and regulatory activities as well as support corporate operations into 2027. R&D expenses for the quarter ended March 31, 2025, were $37.9 million, compared to $30.8 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily due to increases of $4.8 million in preclinical and preclinical costs and $2.8 million in compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, partially offset by $0.5 million in lower clinical supply, manufacturing and regulatory costs. G&A expenses were $6.6 million for the quarter ended March 31, 2025, compared to $4.6 million for the quarter ended March 31, 2024. The increase in G&A expenses was primarily due to $1.2 million of compensation expense resulting from additions to headcount, increase in accrued bonuses and increased stock-based compensation and $0.7 million in higher professional fees. Total other income net was $2.2 million for the quarter ended March 31, 2025, compared to $3.9 million for the quarter ended March 31, 2024. The decrease was primarily attributable to decreased interest earned on our investments in money market funds and U.S. treasuries. Net loss was $42.2 million for the quarter ended March 31, 2025, compared to $31.5 million for the quarter ended March 31, 2024. The increase was primarily attributable to the factors impacting the company's expenses described above. With that, I'll ask the operator to open the call for questions. Operator? Operator (Operator Instructions) Michael DiFiore, Evercore. Michael DiFiore Congrats on all the progress. Just two for me. With regards to the CKD trial, in the past, you said that these patients are so sick that physicians will readily accept some level of hyperkalemia if it means that largesat will improve their blood pressure. So I guess the question is, will it be the max level of Grade 2 hyperkalemia that would be acceptable if lorundrostat were to yield a high single-digit placebo-adjusted SBP reduction? And then I have a follow-up. Jon Congleton Yes, Mike, just quick response. So I don't know that we categorized what would be an acceptable level. I think what's key and critical is we talk to specialists and our advisers who are treating these patients with hypertension and more advanced kidney disease. They're really looking at providing a benefit to the BP as well as relieving or improving the kidney function overall. I think these specialists tend to be predominantly nephrologists are more comfortable with higher level of capacity meetings within these patients. They have a means to manage that. They've got tools to use that -- they're also more likely to modulate other background treatments. In other words, if they're getting to be production with lorundrostat, they may reduce the dose of ACE or arm. So the take with us is within export, you get a clear sense of the safety, characterize the efficacy with this drug and knowing the full well, they're providing the benefit on both BP as well as kidney function in these subjects is what the specialists who are treating these patients predominantly are looking for. Michael DiFiore Got it. That's helpful. And my final question is like despite cadrostats, shorter half-life and lesser selectivity for aldosterone synthase inhibition relative to rent. It still showed a high single-digit percent SBP reduction over 14 weeks in their Phase II CKD trial. So I guess, should we expect similar efficacy and safety with lorundrostat? Jon Congleton Yes, Mike, I think it's too hard to hedge what we expect to see. I think we would anticipate seeing the clinically meaningful reduction in BP. I think the profile for lorundrostat has been well characterized now with 3 successful studies from Target-HTN, Advance and Launch. But it's too early to hedge what we'd anticipate seeing, but I would anticipate certainly a clinically meaningful reduction and then we'll see how the data evolves as far for those other hemodynamic characteristics. Operator Richard Law, Goldman Sachs. Jin Law Great. And congrats on the process from me as well. So a couple of questions from me. Can you discuss how the overall, like the Explore-CKD study fit in the strategy for were submission with Launch and Advance. My understanding is that the study is important to provide clinical support for patients below EGFR 45. And it will be great to hear your latest thinking on this and if that has evolved. And I have a follow-up. Jon Congleton Yes, Rich, thanks for the question. We're certainly excited about the benefit risk profile that's emerged now with lorundrostat with the successful completion of the Advance study and the Launch study, seeing double-digit reduction in BP with a really acceptable safety tolerability profile. The submission of the renters NDA will be inclusive of all 3 of those studies, as I noted, as well as the transform open-label extension, and Explore-CKD will be a component of that. Really, the biggest driver of Explore-CKD was related to informed blood pressure response in subjects with an EGFR down to 30 as well as going with a lower dose of 25 milligrams QD. And so it will be a component. I think it's going to be part of the totality of evidence of lorundrostat that will go into the NDA. I don't know if I could opine at this point as far as the specific language that will be included in the label from Explorer, but it's certainly a part of the total package what we have in the dialogue with the agency on. Jin Law Great. Fantastic. And then -- so we saw in the New England Journal publication that the patients who have the potassium levels greater than 6 have a much lower average eGFR compared to the rest of the population. What is -- I mean, in your view, like what is the typical EGFR between like such study population in EXPLORE CKD study and dosed in a general hypertension study, like the 1 in your pivotal study program. like BI, the CKD study is that a good benchmark in terms of patient population? Or is this a different population from that? Jon Congleton Rich, I'm sorry to do this. Can you rephrase your question? I just want to make sure I'm answering what you're looking for? Jin Law Yes. So in your New England Journal publication, patients who have the higher potassium levels greater than 6, they all have like lower than average eGFR compared to the rest of the population. So the question here is that how do we think about sort of the differences between the EGFR in your Explore-CKD study, compared to the Advance and Launch? And like what would be a good benchmark terms of the type of patient that would -- that -- in terms of the eGFR level, for your CKD study? Jon Congleton All right. Thanks, Rich. I appreciate that. Yes, I think that's why we're doing the Explore-CKD study. We know the eGFR, eGFR launch was higher than that in advance. Advance was a more high-risk population truly uncontrolled, truly confirmed resistant hypertension. They had a lower eGFR. I think you're alluding to what Luke shared at the ACC about the subjects above 6 had a mean of about 58. As far as how tight is the correlation between eGFR and risk and hypercare, I think we need more data and more evidence, but it's part of why we're doing the Explore-CKD trial. Looking at subjects going down to an eGFR 30. We know they have the risk of potential more challenges in managing electrolyze that's why we're testing the 25-milligram QD that we believe is an effective dose of lorundrostat. But as far as the correlation, I think that's something that will continue to unfold Dave, if you've got some additional thoughts, please. David Rodman Rich, good question. And how are you doing -- the -- when you talk about studies like this, the outliers are, in some ways, more important than the means, right? So the mean was above 60, say, for the people who didn't have any good incidents. It was a little bit lower and they had it. In this trial, what we're really looking for those individuals who are in that 30 to 45 range, maybe on the lower side and saying, what happens to them. Not that this is an issue other than giving guidance to clinicians for who to keep an eye on and probably who to give a potassium binder, if needed? Or as Jon said, back off on the art and see if you can maintain the same blood pressure. So it's a guidance, it's what we call a special population profiling study, and we anticipate looking just as much an outer as we do about means in that trial. Jin Law Got it. Very helpful. And then just one last question. Similar to Explore-CKD, do you expect to include data from the Explore-OSA in your found package? Jon Congleton I think, Rich, it's fair question. I think it's too early to opine on that. We haven't guided on top line data. We're excited about that study to address a significant unmet need within that resistant hypertension OSA population, but it's too early to comment what or would that not be included in the discussions with the FDA. Operator Seamus Fernandez, Guggenheim. Seamus Fernandez Great. So Jon, I think on the last discussion call, you mentioned that as many as 47,000 physicians could actually be appropriate for promotion in the uncontrolled and resistant hypertension opportunity. And then you also at ACC emphasized that the opportunity may sit a little bit more initially in the sort of fourth line hypertension opportunity. Can you just help us understand how does the sort of intersection of that broad physician base intersect with your view of the needs of a partner in that context? And what are you really looking for in the context of either a partner or something perhaps more strategic or an opportunity to actually start advancing the opportunity to promote on your own? Jon Congleton Yes. The 47,000, Rich, those that maybe hadn't heard before. So we did a significant project about a year ago with IQVIA with about [1 million] prescription claims within that. And when you basically narrowed down, where does 50% of the prescribing come from for third line or later priming, there's about 47,000 doctors that account for about half of that prescribing and a significant portion of the influence on the other 50%. And from our standpoint, there's a very efficient commercial model, particularly with kind of clinical profile that runestat has now demonstrated to go out and target the 47,000 prescribers and generate significant value. But as we've talked about in the past, partnering for us is inclusive of U.S., but certainly global, looking for partners they can help optimize the opportunity of lorundrostat U.S. because we have no intentions of creating Mineralys commercial entities stand-alone outside of United States. So finding a partner can help maximize that opportunity ex U.S. but then really fully tap into the opportunity in the United States as well. And that would basically mean some level of overall with the targeted physicians that we've talked about, but certainly coverage of those outside of those 47,000 that we target. And in fact, that target may be a little bit smaller as we think about an initial launch of lorundrostat, fourth line is probably going to be the ideal place to go. That's where there's minimal benefit with existing treatments beyond aldosterone directed therapeutics. We know spironolactone is thought to be valuable there, but it's greatly underutilized. I think our clinical program to date where we've targeted those subjects failing to get to goal on to more med shows the value of an atosteron-directed treatment that physicians are going to want to work, patients are going to want to take and persist with. So we think there's significant opportunity there. We think we could tap into a significant portion of those prescribers, but having a partner clearly is going to help us maximize the value of the asset in the United States. Seamus Fernandez Great. And maybe just one follow-up. Can you just remind us what gating factors are to sort of finalizing and filing the NDA specifically? Jon Congleton Yes, happy to do that. First and foremost, recently very pleased with the benefit risk profile that we continue to see with this molecule. Now with the 2 active portions of the pivotal program completed. As we've stated before, the unlabeled extension is a critical aspect of that. If you think about when the last subjects enrolled and launched in advance that was at the end of October last year, we would anticipate also just completing the 52-week open label by Q1 of next year. Now we don't need to have all of those subjects to enable the filing. But we need the -- certainly, a majority of those subjects through 52 weeks before we'd be comfortable with the NDA. But that's part of what we'll have a dialogue with the FDA in Q4, as we've discussed in the pre-IND meeting. And so it will be both the pit programs for Advance and Launch will be part of the target data, the Explore-CKD data. And then a portion of that open-label extension will be informative for that pre-NDA meeting that will then have better guidance for timing of an NDA submission. Operator Tim Anderson, Bank of America. This is Alice on for Tim. I just want to check, can you hear me okay? Jon Congleton Yes, we can. Okay. Perfect. Just following on from Seamus' questions on partnering. Could you talk about any early discussions you may have had so far? And what are the limiting factors that a partner may be looking for? So we're going to have the full data from Launch and the top line CKD study very soon. But do potential partners need to wait for the outcome of the pre-NDA meeting, for example, as well as the AstraZeneca Baxters at for data? And then I have a follow-up. Jon Congleton Sure. So to date, we haven't given updates on our partnering discussion, but we do continue to believe that a partner or multiple partners will be a part of our story, and we'll keep you updated as appropriate. Okay. And then as to the economy references a $5 billion peak sales for baxdrostat. I'm curious how are you thinking that you can best leverage a partner in order to realize this sort of potential with lorundrostat. For example, does it involve developing fixed dose combinations or other indications and things like that? Jon Congleton Yes. Thanks, Alex. There's clearly great deal of unmet need in this space. We're focused exquisitely right now in hypertension, but we know there's utility for an ideal aldosterone-directed treatment beyond that. That's why we're looking at the adjacencies because there's such an overlap in all of these card renal metabolic syndromes that have either hypertension or diabetes kind of at the central point. And so we think there is significant unmet need. There's significant value to provide to patients to help reduce their BP, which is the leading modifiable risk factor for cardiovascular risk. But moving from hypertension into adjacencies, such substructive sleep apnea, hypertensive nephropathy. As you heard Dave speak about, we think basically generate significant value for us. As we have partnering dialogues, as I've spoken about in the past, part of that is partnering from a commercial perspective. But -- for those that have a shared vision, it also could be development partnerships as well. Looking at some of these adjacent areas, such as heart figure or CKD. Again, we know that aldosterone plays a role across the spectrum, and having what we believe to be a leading ASI gives us significant opportunity to tap into that value. Operator Annabel Samimy, Stifel. This is Jed on for Annabel. I have two questions. First is -- at what point do you think that guideline -- hypertension guidelines would in start including Launch and added HTN data? Is there any possibility that it could be updated before you guys would theoretically launch? Jon Congleton Yes, I appreciate the question. I don't know that we can opine on when the timing will be specifically. I think we can only look at historical precedents. And I think the various guideline committees when faced with new valued innovations have been responsive to try to guide their constituents on how they should think about and integrate these new innovations into their treatment paradigm. So it's too early to opine. But it's -- it's a fair question. That's why we went to the what we did in Advance-HTN because I think it fundamentally addresses the kind of questions that these guideline committees wish to have. And that is not only in maybe an existing background treatment, but when you get to truly high-risk patients like we tested in advance, what does the profile physicians could expect? And how would guideline committees inform their communication and their constituents. Got it. And my other question is related to Explore-CKD. What do you think is the primary if you're looking for here? Are you looking for safety in the CKD population with concomitant drugs, inhibitors and ARBs? And then do you expect efficacy to generally be in the line of what you saw in -- or are there some nuances with that patient population that we should know? Jon Congleton Yes. I'll just reiterate what Dave had said with a profiling the study like the safety is a key element of the analysis and what we expect from a clinical benefit standpoint would be clinically meaningful reduction in blood pressure. I think that's been well characterized in the 3 studies to date. That's what we would anticipate to see in this population, and then providing additional information about the 25-milligram QD dose. Operator Mohit Bansal, Wells Fargo. This is Fatima on for Mohit. And congrats on all the recent progress. So on the hypertension readout, you've previously mentioned plans for subgroup Can you elaborate on those plans for which subgroups you're focused on and the time line for presentation of that data? And can you talk about how it could potentially help physicians select patients for lorundrostat? And if it could also influence placement of lorundrostat into treatment guidelines? Jon Congleton Yes, thank you for the question. As you know, we've to prespecify analysis of populations that may be unique responders to lorundrostat. You saw some of that data within the Advance-HTN, ACC as well as Nigam presentation and publications, respectively. I would anticipate seeing something similar with Launch-HTN. I think to date, what we've seen and it's frankly beneficial for prescribers, whether failing to achieve goal on 2 meds or 3 meds on controller resistant hypertension, you're seeing a pretty profound reduction in regardless of gender, age, race, number of background medications. And so it creates a predictable response that physicians can anticipate when using lorundrostat. We're going to continue to investigate and dive into the data. I mean what we've shared to date has been very informative about the value from a clinical reduction and safety standpoint. But there's a great deal of data we're going to continue to dig into within launch and advance and eventually Explore-CKD to really continue to further inform -- All right, what is the ideal population to respond to this drug. But to date, we've seen great responses across a multitude of subsets. And then on the OSA trial, how are you thinking about this 4-week endpoint? How it aligns with expected time lines for improvements in the hypoxia index and nocturnal blood pressure? And what magnitude of action would you consider to be clinically meaningful and also competitive in the context of the data reported with GLPs, for example? David Rodman Really good questions. Let me try to take those one at a time. So the first question was 4 weeks. What might we see? So as far as APMEA popular index, the primary mechanism through which our drug will work is the diuretic effect and reducing the amount of salt and water overload. Because when you lay down at night, the excess salt water, the fluid shifts up. It's called roster cattle redistribution into your upper body and neck. That benefit is accrued within a few weeks. And so by 4 weeks, we would expect to see the benefit on Apnea Hypopnea Index. As you know, around a 50% reduction has been seen with the Lilly study similar with the APMEA study of a different mechanism we're powered down to about 30%, and these are small trials. So we would ultimately be observing where we are in that range. So let me just say something. Treating at the FDA hypopnea index is important, but the main risk for adverse outcomes is this extreme burst of hypertension, these spikes that you see at night when those things happen, and we're going to be doing the first trial using sub-1-second measurements -- blood pressure over the course of an entire night. So we'll be able to look at how well does this drug actually reduce the risk for adverse clinical outcomes. In many ways, that's a more important endpoint. However, Apnea Hyponea Index and patient reported performance metrics are the current guidance from the agency for approval. So we're going down both of those paths. This is on antihypertensive drug, and it's a sodium depleter. We expect to see benefits on both, but both are going to be meaningful. So I can't tell you for sure if apnea hypoxia index is 30, but we see a terrific impact on nighttime blood pressure, maybe restoration, nighttime dipping. We'll be the only ones with those data at that point will be reporting them. And I think that will be really an important milestone in studying this disease. Operator Rami Katkhuda, LifeSci Capital. Rami Katkhuda I guess I just wanted to confirm a statement that Dr. Robin made that patients with hypertensive nephropathy may have more modest levels of proteinuria. I guess, is the patient population in Explore-CKD similar to that of the Bohringer study? Or are there other key differences in enrollment criteria? And I guess is that 37% placebo-adjusted UACR reduction with monotherapy a fair bar here? David Rodman Okay. Those are good questions. And if we think about this, and this has happened in other diseases, Chronic kidney disease is a syndrome, right? It can be autoimmune and you want to use an anti IGA, which has been very effective. If you -- it's in the context of obesity and diabetes, it's from metabolic syndrome, and that is the one that's associated with a fair amount of proteinuria, even nephrotic syndrome, which is an extreme of that. What we're looking at -- some of these patients may have high levels of proteinuria, but we anticipate that will not be the majority in this trial. So a different subset and it's actually a different subset of CKD. These people have scarring of their external part of their -- the cortex of their kidney, loss of these glomeruli from this water hammer effect of the pounding of blood pressure. For these people, getting their blood pressure down to 125 or 130 is not all they need. They need lower blood pressures than those to truly protect the globe live at our left. And so we're going to be looking at that and continuing to explore the possibility of differentiating on that basis as we get into this clinic kidney disease space. It's not our primary objective per se because we are going after hypertension broadly. We're now since we've proven, that's a highly safe and effective drug for uncontrolled and resistant hypertension. Now we're starting to go to the very high unmet need subpopulations, which right now is we consider to be hypertensive for nephropathy and OSA. Jon Congleton And Rami, just to add to that, the distinctions between the studies. I think the baseline is like BP in that study was low that is our inclusion criteria. So to Dave's point, we really are retreating the with GFR hypertension -- think that does create a distinct population between the two studies. Operator There are no further questions at this time. I would hand over the call to Jon Congleton for closing remarks. Please go ahead. Jon Congleton Thank you, operator. Mineralys Therapeutics, we're committed to improving the lives of patients with cardiorenal metabolic diseases. Uncontrolled and resistant hypertension are significant unmet medical needs impacting more than 20 million patients in the U.S. alone. Our Launch in Advanced studies reinforce the differentiated clinical profile of lorundrostat versus agents that are typically used in the third and fourth-line treatment positions and the quantitative research that we've done supports the commercial potential. We're excited for key upcoming milestones and look forward to sharing updates with you in the coming quarters. Thank you all. Thank you for joining for joining us today. And with that, we'll close the call. Thank you, everyone. Operator Ladies and gentlemen, this concludes today's conference call. 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Associated Press
20-03-2025
- Business
- Associated Press
Nektar Therapeutics to Participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference
SAN FRANCISCO, March 20, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the company will be webcasting its participation in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference: H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on Thursday, March 27, 2025 at 2:00 p.m. Eastern Time / 11:00 a.m. Pacific Time – webcast link here The fireside chat will be accessible via the webcast link above as well as on the Investor Events section of the Nektar website: A replay of the presentation will be available for 30 days. If you would like to request a one-on-one meeting with company management during the conference, please reach out to your respective H.C. Wainwright representative. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow Nektar on LinkedIn. Contact: For Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC [email protected] 212-915-2577 Ahu Demir, Ph.D. LifeSci Advisors, LLC 212-915-3820 For Media: Madelin Hawtin LifeSci Communications 603-714-2638
