Thank you for standing by and welcome to CourseUp Therapeutics first quarter 2026 earnings conference call. Currently, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again. I would now like to hand the call over to Adabak Makari, CFO. Please go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at coursehub.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. Today we'll be available at the Investor's Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which might cause actual results to be materially different from those such statements expressed or implied. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available at the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the first quarter of 2026 was $164.9 million compared to $157.2 million in the prior year period. We have increased our 2026 revenue guidance to $950 million to $1.05 billion. Net loss was $31.8 million in the first quarter of 2026 compared to net income of $20.5 million in the first quarter of last year. Our cash and investments at March 31st were $515 million. I will now turn the call over to Sean Madouk, President of our Endocrinology Division. Thanks, Ottobock.

Demand for our medications continues to increase. We ended the first quarter with a record number of new prescriptions written from a record number of prescribers, which translated to an all-time high for the number of patients receiving our medications. Importantly, we set a record for new patients starts in March and again in April. These figures are outstanding. It gives me great confidence in the current and future health of our hypercortisolism business. The full impact is not reflected in our revenue for three reasons. First, revenue often dips in the first quarter, as it does for many rare disease medications, because insurance companies impose onerous reauthorization procedures at the start of each year that interrupt patient coverage for a month or two. We provide patients with free drug to bridge the gap, but our revenue suffers. Second, new patients, whom we are adding at a rapid clip, provide much less revenue when they start treatment than they will later, after payer coverage has been secured and they have titrated to their optimum dose. The full revenue impact of patients added this quarter will grow substantially over the next few quarters. Finally, our specialty pharmacy vendor has done an excellent job onboarding the thousands of patients transferred from our former vendor and getting them the medicine they've been prescribed. They have also excelled at servicing new prescriptions written for our medications, the new patient starts I just described. The task that remains is grinding through the insurance prior authorization backlog that accumulated as patients transition to the new pharmacy. This is painstaking work, but it yields steady dividends that will be reflected in our revenue over the coming months. Our new pharmacy vendor's ability to handle large numbers of new patients skillfully is important, because I expect demand to increase substantially as physicians adapt their practices to the landmark findings of our Catalyst and Momentum trials. Catalyst showed that 24% of patients with resistant diabetes had hypercortisolism and that treatment with Coralum led to substantial reductions in hemoglobin A1c, weight, and waist circumference compared to placebo. Catalyst results were published in the field's prominent journal, Diabetes Care, in December of 2025 and were referenced in the March 2026 American Association of Clinical Endocrinology, or ACE, guidance document for the management of diabetes. This is an important step towards increasing the awareness of hypercortisolism by the broader physician community. The recently reported results of a Momentum study showed that 27% of patients with resistant hypertension had hypercortisolism. Momentum's results were featured in an oral presentation at the annual conference of the American College of Cardiology, or ACC, last month. Catalyst and Momentum will transform the practice of medicine. They provide consistent, complementary evidence that hypercortisolism is the underlying cause of many patients difficult to treat diabetes and hypertension. Physicians have begun responding to these findings, but a change of this magnitude takes some time to be fully absorbed and implemented in clinical practice. As medical practices adapt, screening for and treatment of Cushing's syndrome will increase, and so will the number of patients receiving our medications. We expect our current Cushing's syndrome business to grow to at least $2 billion in annual revenue by the end of this decade. When relicorlin is available, growth will accelerate further. I will now turn the call over to Roberto Vieira, President of our Oncology Division.

Thank you, Sean. The FDA's approval of LeFioli for the treatment of patients with platinum-resistant ovarian cancer, three and a half months ahead of its PDUFA date, is wonderful news for patients. On behalf of Core Step, I want to thank the FDA's Division of Oncology for its rigorous and extremely rapid review of our new drug application. which reflected determination to make available a safe and effective new medication to women with a very difficult to treat disease. Our MDA was supported by compelling clinical data. Lifioli's pivotal trial, Rosella, met both of its primary endpoints, delaying disease progression, and even more important, significantly extending patient survival. Patients with Lifioli and Abipactaxel experienced a 35% reduction in risk of death, a hazard ratio of 0.65, comparing to patients with nabipacticexel monotherapy. The p-value was 0.0004. No biomarker testing was required to identify these patients. We presented Rosella's complete results earlier this month in our oral late-breaker session at the Society of Ginecology-Oncology, SGL, annual meeting with simultaneous publication in The Lancet. As one would expect, oncologists and patients' advocacy organizations have responded to this data with great enthusiasm. Lithioli's efficacy and safety profile make it a powerful treatment option. For those who want to learn more about Lithioli's clinical characteristics, there's a link to the Lancet article in today's press release. Even though Lithioli's approval came early, our commercial team was ready to translate our significant pre-launch investments in preparation into execution. Our sales and marketing, medical, and market access teams were on board and trained by the time of Lifioli's approval and its manufacturing and distribution infrastructure was in place. 36 days into our launch, things are going very well. We launched our patient support hub and ensured product availability within five days of approval. A wide group of physicians have requested information from our field teams, another indicator of strong interest in Lifioli. We began seeing enrollments within hours after approval. Prescriptions have already been written by over 200 physicians from all parts of the country, indicating adoption well beyond our study investigators and academic specialists. We are also beginning to see other signs of prescribing breath with patients coming from multiple physicians in large practices. With all this inclusion in the National Comprehensive Cancer Network, or NCCN, guidelines as a preferred regimen, just 15 days after approval, we support strong adoption and payer access. Lithioli's strong early results do not surprise us, given the drug's excellent efficacy and safety profile, the lack of biomarker test requirements, and convenient order of administration. We expect Lithioli to exceed a billion dollars in annual revenue in the United States by the end of the decade. But this is just the beginning of our journey in oncology. I will now turn the call over to Joe Belenoff, our Chief Executive Officer.

Joe? Thank you, Roberto. And thank you, everyone, for joining us. Since CORCEP's inception, we've explored the potential of cortisol modulation to treat patients with serious diseases. That potential is vast. We have made important advances. It is now established that hypercortisolism is much more prevalent than previously thought, and the treatment with a modulator can benefit many patients. LeFiorle's FDA approval in platinum-resistant ovarian cancer indicates that reducing cortisol activity at the glucocorticoid receptor, GR, may be beneficial in treating a wide variety of solid tumors. And you should know, our plans go well beyond hypercortisolism and oncology. In April, we met with the FDA regarding relicloralance new drug application, its NDA, in Cushing syndrome. Our NDA was based on the positive outcome of our pivotal Phase 3 GRACE trial, with confirmatory evidence from our double-blind, placebo-controlled Phase 3 Gradient trial, our long-term extension study, and our earlier stage development data. Collectively, these results showed that patients treated with relachloralant experienced meaningful, durable improvements in the signs and symptoms of Cushing syndrome, without some of the serious adverse events associated with the currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency, or QT prolongation. We will provide an update on relicololant's regulatory path in the near future. I also want to underscore Sean's remarks regarding the importance of the catalyst and momentum studies. Their findings are changing medicine. As physicians expand screening for hypercortisolism in patients with difficult-to-control type 2 diabetes and in those with resistant hypertension. Patients whose health has been damaged by previously undiagnosed hypercortisolism will receive more targeted and better care. Increased demand for medications that treat Cushing syndrome will propel our endocrinology business for years to come. The approval of lipiorly is an important first step towards realizing the full potential of glucocorticoid receptor antagonism in oncology. Likuroli works in ovarian cancer by suppressing cortisol's anti-apoptotic effect so that napaclitaxel can achieve its full effect. We believe this mechanism has the potential to work with any solid tumor that expresses the glucocorticoid receptor and with any companion anti-cancer agent. We are currently evaluating relicoralin combined with other anti-cancer therapies and in a wide variety of solid tumors. The first arm of the BELLA trial is studying the effect of relicloralant plus napaclitaxel and bevacizumab in women with platinum-resistant ovarian cancer. Other studies are enrolling patients with endometrial, cervical, pancreatic, and platinum-sensitive ovarian cancers. Data from these studies will be NCCN guideline-enabling and will inform our future development decisions. The first arm of BELLA will produce results by the end of this year. Our other ongoing oncology trials will produce results by the end of next year. Successful results in these studies would immediately increase the number of patients that relicorla might potentially help by five-fold. GR antagonism may also augment the effects of immunotherapy. Cortisol suppresses the immune system, blunting the effectiveness of therapies that stimulate an immune response. A treatment regimen combining an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response. We are conducting a Phase I-B study of a proprietary selective GR antagonist, nenochorland, in combination with nivolumab, a PD-1-directed immunotherapy to treat patients with a broad range of solid tumors. Finally, cortisol activity at the GR stimulates the growth of prostate cancer tumors, helping them escape the effects of androgen deprivation therapy. Our collaborators at the University of Chicago are enrolling a randomized, placebo-controlled phase 2 trial of relichloralant plus the androgen receptor blocker enzalutamide in patients with early-stage prostate cancer to see if adding a GR antagonist can block cortisol-mediated tumor escape routes. Cortisol activity plays a role in the initial development and progression of a serious liver disorder known as metabolic dysfunction-associated steatohepatitis, or MASH, which afflicts millions of patients worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality. Our proprietary selective cortisol modulator, Miracorlent, is very potent in the liver. In a Phase 1b study, it rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. The drug was quite well tolerated without the gastrointestinal side effects commonly seen in patients being treated for MASH. Our 175-patient double-blind placebo-controlled Phase 2b Monarch study is fully enrolled and will produce results by year-end. Positive results would support advancement to Phase 3. Patients with ALS have dysregulated cortisol levels, which is why we believe our proprietary selective cortisol modulator, DASA Coralant, may provide a treatment. Results from our 249-patient double-blind placebo-controlled DASALS trial of DASA Coralant in patients with ALS have been very encouraging. In DASALS, patients who received 300 milligrams of DASA Coralant exhibited an 84% reduction in the risk of death at the one-year mark compared to patients who received placebo. The p-value for this finding was 0.0009. This benefit persisted into the study's second year with an 87% reduction in risk of death at the two-year mark. The p-value for this finding was less than 0.0001. I want to take a minute to be clear about the benefit Dasechloralant appears to offer because it's different from the way most medications targeting ALS are intended to work. Dasechloraline does not appear to prevent functional decline. It prevents early death. There is a common misperception that death resulting from ALS is always coterminous with severe functional decline. That is not the case. Many patients die from complications such as pneumonia and cardiovascular events early in the course of the disease when they still retain significant function and good quality of life. Preventing death during this period, giving back to these patients good time, would be of great benefit. We are currently conducting a small study to see if dose titration can improve dazochoralin's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in dazzles, an outcome that we think can be avoided. We will incorporate what we learned from our dose titration study into the design of the PIVOTAL trial that we plan to start later this year. To sum up, our Cushing syndrome business remains on a strong growth trajectory driven by increasing understanding of hypercortisolism's true prevalence and the need for treatment. Our landmark catalyst and momentum studies are causing expanded screening for Cushing syndrome, more accurate diagnosis, and improved care. Trends that will drive substantial revenue growth for our existing medications and even faster growth for relicloralant once it is approved. We are proud to have secured our first oncology approval for Lipiorely in platinum-resistant ovarian cancer and have made great progress in a very short time bringing it to patients. We are confident relicloralant can help patients with earlier stages of ovarian cancer and with other types of solid tumors, and in combination with other anti-cancer therapies. We expect results from our Phase II trial of relicloraline combined with nabpaclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year, and from our recently initiated portfolio of oncology studies by the end of next year. Following up on our positive Phase II DASLs findings, we expect to begin a Phase III trial in patients with ALS later this year. By year end, we will know the outcome of our Phase II MONARCH trial in patients with MASH, and we'll proceed to Phase III if that outcome is positive. The potential of cortisol modulation to benefit patients is immense. We remain deeply committed to converting this potential into meaningful patient outcomes. We thank the patients who participate in our trials, our employees, our clinical investigators, and our academic collaborators for being part of this important work operator

let's proceed to questions thank you as a reminder to ask a question you will need to press star 1 1 on your telephone to remove yourself from the queue you may press star 1 1 again please stand by while we compile the Q&A roster our first question comes from the line of David Anselm of Piper Sandler your line is

open, David. Hey, thanks. So just a few, with the updated guidance, should we assume that it's mostly relic-oralant contribution? Have any assumptions changed on Corlin? So you can help us just go through that. Then secondly, can you talk to positioning versus Keytruda in practice and how we should think about that? And then lastly, just give us a little bit of color on how nanocoralant differs from RELA and what you see in that molecule that is driving your

development decisions there. Thank you. Thank you, David. Thank you. I think I got all of your questions. Anabok, why don't you take the first question about range? Okay, great. So,

hi, David. So, at this point, our endocrine business represents the bulk of our guidance range is just given where we are with oncology. But in terms of where we, the updates that we have since last quarter in oncology is that obviously now we have approval. We've published the final Rosella results in the Lancet and inclusion in the NCCN guidelines. And as Roberto mentioned, we're really happy with what we're seeing thus far. And to layer on top of that, what Sean talked about, we're really happy with what we're seeing on the Cushing syndrome, side of our business, and the strong fundamentals that we're seeing there, we expect to translate to revenue soon. So ultimately, given the strength on both sides, we are confidently raising our guidance

Thank you, Anabak. And I think the second question is really Roberto's.

Yeah, and so thank you for the question there. I think the first thing for us to think about when thinking about Keytruda and Lift Your is just to take into account that we only compete in a subset of the market. Lifioli is approved for an outcomer, and Ketruda is approved for a PD-L1 population. When you factor in testing rates, we are talking about something 35% to 40% of patients there. Now, when you actually look at the data from our Rosella trial, you see the strength of our overall survival data, You see the safety, tolerability of that regimen, as well as the convenience. So what we are hearing from physicians is that there is a preference, even within that population, to actually look into the Rosella regimen as being a preferred regimen. Perhaps that is also reflected in the treatment guidelines today. As you see, we have a preferred status. So we feel very confident that our regimen brings benefits to patients.

Thank you, Roberto. And let me introduce, the person who hasn't spoken yet, Bill Geyer, who runs all of our our chief development officer, runs all of our development activities to make a comment or two

about nanocoralant. Great. Thank you, David. I mean, one thing we've seen, you know, related to nanocoralant is that, you know, every selective glucocorticoid receptor antagonist that we've studied has unique properties and have shown specific benefits. What we've seen those is they progress through our development program. So continuing our research in new molecules like nanocoralant is definitely worth investigating. You know, we believe nanocoralant has unique properties that will allow us to test even more hypotheses for solid tumors that express the glucocorticoid receptor. In particular, nenocorlin has shown strong activity in animal models in combination with immunotherapy. And so based upon that, we felt that nenocorlin could be a good partner with immunotherapy, like nivolumab. But we're going to learn a lot from this phase one study that will help guide us to rapidly move forward into a phase two study. And from that study will be able to even better elucidate what those specific attributes are.

Thank you. Thank you, Bill. Okay, next question, please.

Thank you. Our next question comes from the line of RK with H.C. Wainwright. Your line is open, RK. Thank you. Good

afternoon. RK. Thanks for taking my questions. Congratulations on the launch of LeFiorly. So the three questions that I have, two on outside of Cushing syndrome, on the LeFiori business, what proportion of platinum-resistant ovarian cancer prescribers do you expect to convert to LeFiori, especially now that you have the NCC and preferred designation and in general what does a steady-state you know share of script look like in that and the second question is on dazzles you know if you think about a phase 3 design you know what or should we think about like that 300 milligram dose and in terms of endpoints and you know timing of that of the initiation of that study is question two and the third question is on the Corlin business itself you know glad to note that you know the pharmacy the specialty farmers able to handle all the all the increased scripts are you also looking to add one more specialty farmer so that we don't face the same situation which we faced last year, especially with the momentum that you're getting from Momentum and Catalyst.

Okay. R.K., I think I got all of those questions. I think the first one is best answered by Roberto.

So, R.K., your question about conversion of prescribers. Let me just go up to the top. we are targeting 5,000 physicians in the U.S. that actually respond to almost 90% of all the volume here. So our expectation is that the very large majority of those will become prescribers. That's supported by our market research as we have tested, but also by the very strong update. We have been able to capture more than 200 of those within the first month. And we are seeing this coming from community oncology, from gynecology, from academic setting, So in a very broad and diverse group of physicians from every part of the country. So we have every expectation that these physicians will adopt the therapy. We think that the profile, as we discussed, is very favorable to that because it's very easy to adapt to the clinical practice to utilize this drug given the safety profile we have. You asked about the share at steady state. I think that the most important consideration here is that we do have an expectation of becoming market leader in a relatively short time frame. We expect that the drug will be utilized by the majority of patients in different lines of therapy, but really it's a very attractive proposition for pretty much every patient there given our indication.

Thank you, Roberto. I think the second question is Bill's. Yeah, thank you, RK.

So related to DASL's, you know, the two-year overall survival benefit is highly encouraging and shows consistency of the 300 milligrams. And I think that's the focus, whether it's the 24-week blinded data showed significant benefit of survival for 300 milligrams over placebo, the one-year data showed survival benefit of the 300 milligram, as did the two-year data show benefit for the 300 milligrams. So that's going to be our focus in phase three. And we've designed a phase three study that works off the success of the DASLES trial to replicate those results and confirm that DASA correlant can reduce early death and improve survival. So, again, the endpoint would be survival, and the focus would be 300 milligrams. It would likely be a placebo-controlled trial. And we're working with the top ALS researchers around the world to help guide that study, and they've already commented on our study design. And we've also collaborated with the FDA and EMA and are incorporating their comments into that study, and that'll allow us to start this trial this year and enroll patients by the of this year. Thank you, Bill. And the core of the questions go to Sean.

Hi, RK. Thanks for the question. So I'll start just by saying we're very happy with what we've seen with Curant. They've done a very nice job transitioning our active patient base from our previous vendor and then handling all the new prescriptions that have come in. And again, they've been at an all-time high. So they've been working sort of in two places at once as they've been supporting these patients and have done a very nice job. They've scaled as our business has grown, and we know that they can continue to scale with that. That being said, we know that eventually our business is going to get to a place from a volume standpoint that it's going to be far too much for one pharmacy to be able to handle. So our plan is down the road to expand our network. When we expand and by how many we expand, we'll be driven by what we're seeing from a volume growth standpoint. But as it stands today, our plan is to bring in some additional support in the fourth quarter this year into the network. Okay, thank you.

I'm sorry, R.K., did you have something, a question there? No, no, fantastic.

Actually, I appreciate all the...

All right, thank you very much. Well, this concludes our call. Thank you very much for listening, for the questions. I think it's a very, very exciting time for the company. We're really pleased with what we're seeing both in the endocrinology and on the oncology side. Please look at our press release for all of the things which are going on in development. It really is wonderful to be able to see us really bringing forward towards the potential of cortisol modulation as a treatment for very many serious diseases. So thank you. Good evening, and we'll talk to you next quarter.

This concludes today's conference call. Thank you for participating. You may now disconnect.