Zentalis Pharmaceuticals Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 2, 2023

There are 13 speakers on the call.

Operator

Good day, and welcome to the Corcept Therapeutics Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adibak Mukherjee, CFO. Please go ahead.

Speaker 1

Hello, everyone.

Speaker 2

Good afternoon and thank you for joining us. I'm Adabak Mukari, Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the Q2 and providing a corporate update. A copy is available at corecept.com. Our complete financial results will be available when we file our Form 10 Q with the SEC.

Speaker 2

Today's call is being recorded. A replay will be available at the Investors and Events tab of our website. Statements during this call other than statements of historical fact which might cause actual results to differ materially from those such statements expressed or implied. These forward looking statements are described in today's press release, And the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10 ks and our quarterly reports on Form 10 Q. Please refer to those documents for additional information.

Speaker 2

We disclaim any intention or duty to update forward looking statements. Our revenue in the Q2 of 2023 was $117,700,000 An increase of 14% compared to the Q2 of last year. To reflect that growth, We are raising our 2023 revenue guidance again to a range of $455,000,000 to $470,000,000 Up from $435,000,000 to $455,000,000 Net income was $27,500,000 or $0.25 per share in the 2nd quarter compared to $27,400,000 or $0.24 per share

Speaker 3

in the same period last year.

Speaker 2

Our cash and investments of $363,300,000 June 30 reflects the purchase of 6,600,000 Corecept shares for $145,400,000 during the quarter. I will now turn the call over to Charlie Rupp, our Chief Business Officer to provide a legal update. Charlie?

Speaker 4

Thanks, Adamak. In March 2018, we sued Teva Pharmaceuticals in federal district court to prevent it from marketing a generic version of Korlym in violation of our patents. Trial is set to begin next month on the 27th September. As a reminder, Teva cannot dispute the validity of 2 patents We are asserting against it. 214 patent and the 800 patent, which concern the safe co administration of Korlym, The commonly prescribed class of drugs known as strong CYP3A inhibitors.

Speaker 4

Issues determinative of these patents' validity were decided in our favor Teva lost the post grant review challenge it initiated at Patent Office. Teva's only defense with respect to these two patents That is proposed, products would not infringe them. A position we believe has no legal or factual support. 214 and Anheuser patents As I said last quarter

Speaker 5

and in all of

Speaker 4

the calls we've held since this litigation began, We are supremely confident in the strength of our case. We are happy that our trial date is approaching. We look forward to our day in court. Why? It's the law and the facts are on our side.

Speaker 4

I'll now turn the call over to Doctor. Joseph Belanoff, our Chief Executive Officer. Joe?

Speaker 3

Thank you, Charlie. The strong results of our commercial business in the Q2 reflect the early return on our substantial investment Stimulate physicians to both better recognize and treat hypercortisolism. In the Q2, we saw a continued increase in the number of patients receiving Korlym And the number of physicians prescribing the medication. The business translation of more patients benefiting from corollary treatment Is a new record high in our quarterly revenue. We expect our growth to continue.

Speaker 3

Korlym is an excellent treatment for patients with Cushing syndrome and there are many eligible patients who have yet to receive it. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing syndrome Results of our ongoing catalyst study will likely provide further evidence to bolster this belief And equally likely, we'll leave physicians to begin to identify and provide effective treatment for a large group of patients with hypercortisolism

Speaker 6

We

Speaker 3

are confident in the growth potential of our Cushing's syndrome business And are raising our 2023 revenue guidance range again, this time to $455,000,000 to $470,000,000 We're also very excited by the potential of our clinical development programs. Since inception, our research and development efforts have built on the hypothesis The cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol's effects By binding to the glucocorticoid receptor or GR, the receptor which is activated when cortisol levels are high. They do not bind to the progesterone receptor and don't cause some of Korlym's, our approved products, most serious off target effects. Interestingly, while our compounds modulate cortisol activity without modulating progesterone's activity, They are not identical.

Speaker 3

Some cross the blood brain barrier, others do not. Some perform best in models of solid tumors, Others are more potent in models of metabolic disease. Some appear to be tissue specific, others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with 3 of our proprietary selective Cortisol modulators, relacorilant, dasucorilant and miricorilant in ovarian, adrenal and prostate cancer, ALS, NASH and of course Cushing's syndrome.

Speaker 3

We have additional compounds in clinical and preclinical development. In the next 12 months, we expect data from our GRACE, Gradient and Catalyst studies, submission of an NDA for relacorilant in Cushing's syndrome, completion of enrollment of our Roselda and DASL studies and initiation of Phase 2b trial of miricorilant in patients with NASH.

Speaker 6

This is

Speaker 3

a very exciting time for Corcept. We are evaluating relacorilant for the treatment of hypercortisolism in 2 Phase 3 trials, Grace and Gradient. Relacorilant is a selective cortisol modulator. Like Korla, It achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor, PR for short, As it does not cause PR related side effects, including termination of pregnancy, endometrial thickening and vaginal bleeding.

Speaker 3

By a different mechanism, relacorilant also does not cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's Relacorilant Phase 2 efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no relacorilant induced instances of endometrial thickening or vaginal bleeding The trial results were published in Frontiers in Endocrinology in July 2021. With enrollment in GRACE complete, we are focused on finishing the trial and preparing our NDA, which we plan to submit in the Q2 of 2024. Relacorilant has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing's syndrome and we are eager to make it available.

Speaker 3

Our second Phase 3 trial in hypercortisolism, GRADIENT, is studying relacorilant effects to patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, But their health outcomes are poor, including a higher risk of premature death. While we do not expect our NDA in Cushing's syndrome to depend on data from Gradient, We do expect the study to produce valuable data about an etiology of Cushing's syndrome that affects many patients whose hypercortisolism frequently goes undiagnosed I'm pleased to announce that our CATALYST study is progressing ahead of schedule. CATALYST is a 1,000 Patient Phase 4 trial examining the prevalence of hypercortisolism to patients with difficult to control type 2 diabetes. Patients diagnosed with hypercortisolism in the catalyst study may choose to enter a randomized double blind placebo controlled study of Korlym.

Speaker 3

Many independent studies conducted over the last 15 years have found that the prevalence of hypercortisolism in patients with Type 2 diabetes substantially higher than in general population. The most prominent diabetologists in the United States help us design and are participating in Catalyst, Which will be the largest study of its kind. We have received very positive feedback from leading endocrinologists regarding this study and expect to complete enrollment in the 4th quarter, Our oncology program is testing 3 anti cancer mechanisms first postulated by investigators at University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis, The program cell death, the chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy In our successful controlled Phase 2 trial in women with platinum resistant ovarian cancer, The addition of our selective cortisol modulator relacorilant enhanced the effect of chemotherapy, likely by glunting cortisol's anti apoptotic effect.

Speaker 3

Relacorilant provided meaningful benefit to many of the women in our study. While these women's disease have progressed on 2 or more previous lines of treatment, including previous Relacorilant appear to resensitize the disease to chemotherapy's beneficial effects in some women. Those who received relacorilant intermittently, the day before, the day of and the day after they received nab paclitaxel Exhibit a statistically significant improvement, progression free survival and duration of response compared to the group who received nab paclitaxel monotherapy. Women in the intermittent relacorilant group also live longer than those in the comparator arm with a p value that approach statistical significance. Our analysis to date indicates that 29% of the patients who took intermittent rilacorilant were alive 2 years after study start Versus only 14% who took nab paclitaxel alone.

Speaker 3

Just as important, the women who received relacorilant plus nab paclitaxel Experience no additional side effect burden compared to those who received not paclitaxel alone. The results from this study were recently published in the 2, European Society For Medical Oncology, ESMO Meeting and at the 2022 American Society of Clinical Oncology, ASCO Annual Meeting. Rosella, our confirmatory pivotal Phase 3 trial in platinum resistant ovarian cancer is enrolling patients. Rosella's design closely tracks our Phase 2 study and its goal is simply to replicate our positive Phase 2 results in a larger group. Planned enrollment is 360 women randomized 1 to 1 to receive the urelacorilant plus napaclitaxel or napaclitaxel alone.

Speaker 3

The primary endpoint is progression free survival with overall survival acute secondary endpoint. We are conducting this study in collaboration with leading clinicians From the gynecological oncology group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. We are on track to complete enrollment by the end of the year. Leading gynecological oncologists have told us that in their view, Relacorilant's potential benefit improved progression free and overall survival without increased side effect burden We're constituting an important medical advance and that relacorilant plus nab paclitaxel has the potential to become a new standard of care in women with platinum The second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor Antagonist enzalutamide eventually experienced resurgent disease. Deprived of androgen stimulation, their tumor switched to cortisol activity to Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

Speaker 3

Our collaborators at the University of Chicago plan to begin a randomized placebo controlled Phase 2 trial of relacorilant plus enzalutamide Theravada therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune Our hypothesis Is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of these therapies. We are conducting a Phase 1b trial of relacorilant plus the PD-one checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer. These tumors produce excess cortisol. Pembrolizumab is rarely effective as monotherapy in treating this form of adrenal cancer.

Speaker 3

ALS commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment. DASLs Our 198 patient randomized double blind placebo controlled Phase 2 trial of dasacorilant in patients with ALS is briskly enrolling patients. Dasacorilant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving We are conducting this important study in collaboration with TRICALES, Leading ALS academic consortium in Europe. We recently added clinical trial sites in the United States and are on track to complete enrollment in DASLs by early

Speaker 1

next year. Finally, I'll turn

Speaker 3

to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Miricorilant, an oral medication continues to demonstrate great promise as a treatment for NASH. In our prior NASH studies, patients who received 600 milligrams or 900 milligrams of miricorilant daily Exhibited large rapid reductions in liver fat, but also substantial albeit transient elevations of the liver enzymes ALP and AST. The improvements in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Our ongoing Phase 1b dose finding study, which evaluated a range of doses and dosing schedules of miricorilant Found that patients who received just 100 milligrams of miricorilant orally twice a week for 12 weeks Experiencing approximately 30% reduction in liver fat and showed improvements in liver enzymes and markers of liver disease.

Speaker 3

These patients also experienced improvements in key metabolic and lipid measures such as HOMA IR, serum triglycerides and LDL. Importantly, miricorilant is very well tolerated. We plan to submit these results for presentation at a scientific conference And we'll initiate a Phase 2b trial in the Q4. In conclusion, we are extremely optimistic about the future of Corcept. Our Cushing's syndrome business has tremendous growth potential and generates substantial profits even as we invest in our advancing development programs.

Speaker 3

We are again raising our revenue guidance for this year and anticipate growth for years to come. Our catalyst study holds great promise as the data generated will help physicians to improve the screening and treatment of patients Difficult to control diabetes is caused by hypercortisolism, a population whose Cushing's syndrome frequently goes undiagnosed. For these patients, hypercortisolism is their disease and diabetes is a symptom of their hypercortisolism. Our development programs are generating increasing evidence that validates our long held belief that cortisol modulation has the potential to treat a wide range of diseases. Reducing cortisol activity is a straightforward and effective way to treat Cushing's syndrome and can offer substantial benefits to patients with other serious disorders.

Speaker 3

Ovarian cancer, ALS and NASH are current examples, but there will be others. In addition to relacorilant, dasicorilant and miricorilant, we have many other proprietary selective cortisol modulators in our portfolio In the next 12 months, we will see data from our GRACE, RADIENT and catalyst studies in Cushing's syndrome. We'll submit relacorilant's NDA in Cushing's syndrome and we'll complete enrollment in large controlled studies of platinum resistant ovarian cancer and ALS. We will also begin a Phase 2b study in patients with NASH. As I said, this is an exciting time for Corcept.

Speaker 3

Thank our dedicated creative employees and loyal investors for making that possible. I'll stop here for questions.

Operator

Thank you. At this time, we will conduct the question and answer session. Our first question comes from the line of Matt Kaplan with Ladenburg. Your line is open.

Speaker 7

Hi, good afternoon and thank you for taking the question and congrats on the strong quarter. Thanks. You're welcome. Can you give us some sense in terms of what drove the revenues In the second quarter and your confidence in increasing your guidance for this year as well.

Speaker 3

Sure, Matt. I'm just going to reintroduce to the group Sean Nadeauk, who is the President of our Endocrinology division and runs our Cushing's syndrome business.

Speaker 5

Matt, thanks for the question. And I'll just start by saying we're very pleased with the results. Your question was what drove it. It was driven by improved access and improved field And we're starting to see some early returns from our investments. Many of our investments have been on sort of expanding the field and working to get our field More productive and efficient.

Speaker 5

So through that process this quarter, we've added both new patients and new prescribers and we have more patients Taking corona whenever before. Disease awareness continues to increase and really we're more confident than ever about the potential size of the Cushing's center market. For the remainder of the year, I mean, at this point, our belief is just a fraction of hypercortisolone patients have been identified and treated. And over the coming months quarters, there's going to be many more.

Speaker 7

Okay. That's helpful. And just looking at your pipeline with Grace and Gradient, Grace completing enrollment and grading to complete in the near term. Can you help us Set expectations in terms of what to expect from Grace and Gradient as they read out perhaps next year?

Speaker 3

Yes. Let me introduce you again to Bill Guyer, who runs all of our development here as Chief Development Officer. Bill comment? Great.

Speaker 1

Thank you, Matt for that question. So as we have now completed enrollment for the GRACE trial, the investigators and we are very excited Because of that, and now we're in the plans of submitting that NDA and we've actually been working on that NDA since last year. And as we will collectively work with the FDA, we're going to be working on developing and submitting all of our studies. So the The NDA will include many different studies. It will include the full Phase 2 data from a safety and efficacy perspective, the GRACE study from a safety and efficacy perspective, The GRADIENT trial from an integrated safety perspective as well as our long term extension study, which has been ongoing for over 5 years and we have patients on relacorilant And then we're also going to include many other new recently presented and published data that I think we're going to be excited To include in the NDA, one of those being we just completed a thorough QT study where we evaluated the heart's QT interval and looked at relacorilant and it saw No effects on the QT interval and that would make this the only drug in Cushing's syndrome that does not affect the QT interval.

Speaker 1

So that's exciting news as we have completed that study. We've also seen published preclinical research citing how relacorilant can uniquely shrink to the tumor tumors in tissue cultures. And with those tumors, we've also seen 2 published case reports highlighting similar clinical benefit of relacorilant in patients. This is a differentiating factor because nifepristone was also used in those preclinical studies and saw no change in pituitary tumors. And then finally, we just presented new data from our Phase 2 trial looking at coagulopathy parameters, which was important because Cushing's syndrome patients are high risk For developing hypercoagulopathy events and relacorilant showed no effects on those coagulopathy patterns.

Speaker 1

And that would be again the only drug in the Cushing's syndrome space to have no effect All of this data makes me confident in the benefit relacorilant can bring to patients and confident as we proceed towards our NDA in the next coming year.

Speaker 7

Great. And just a quick follow-up on that. Where are you with the

Speaker 3

Manufacturing is not a rate limiting step, Matt. And We'll certainly be ready to have commercial supply when and if our NDA is approved.

Speaker 7

And one last question for me and then I'll jump back in the queue. The catalyst study moving Ahead of plans,

Speaker 8

do you have a sense

Speaker 7

in terms of based on the design of the study, What percentage of patients that you're screening have hypercholesterolemia in this difficult to treat Type 2 diabetes patients?

Speaker 3

Yes, Matt. I understand the question. I'm going to hand you back to Bill.

Speaker 1

So, Catalyst is building on a tremendous amount of research Already generated with multiple different studies and I can cite all the studies and send you all the references. Many of those studies are in 100 of patients. And in those independent studies over the past 15 to 20 years, we found that hypercortisolism is higher than the Normal general population and I would guesstimate it to be around when you look at the average for those studies, it's about 10% to 20% for those patients who have dystrophin controlled diabetes. And with Catalyst, this would be then that landmark study because it is the largest study of its kind evaluating 1,000 patients to evaluate those with Type 2 diabetes who are difficult to control and we're doing a simple test of just one DST. All of our investigators are part of this, are highly motivated by this and that's why screening is ahead of schedule.

Speaker 1

And thus far in the catalyst study, even though it's early, I would say that The results so far are mirroring what we've seen in the past published studies.

Speaker 7

Great, great. Thanks for the added color guys.

Speaker 3

Thank you, Matt.

Operator

One moment for our next question. Our next question comes from the line of Edward Nash with Canaccord. Your line is open.

Speaker 9

Hi. Thanks for taking the call. And yes, Congrats guys on such a strong quarter, really great. Thank you, Adam. To ask you, And I guess this goes in the same vein of it being a really strong quarter and just the additional input in the sales effort truly kind of But I see that the European Society of Endocrinology has updated their practice guidelines on the treatment of adrenal And I just wanted to find out what the implications are there.

Speaker 9

I think it's been a while since these have been updated. So just Want to kind of better understand what the implications could be there for usage of Korlym?

Speaker 3

Good, Edward. Thank you for the question. I'm going to direct it to Sean again.

Speaker 5

Yes. Ed, thanks for the question. And just adding on Bill There's study after study after study, there's been mounting evidence over time that this illness is more prevalent. And These European guidelines that were just updated are just another example of the evolution of the mindset around hydrocortisols. Endocrinologists Recognize that hypercholangolism is more prevalent than one's thought.

Speaker 5

And what these guidelines do is that we encourage physicians to look harder for the disease, Which is great. The guidelines also highlight the use of the relatively simple dexamethasone suppression test or the DST as the testing standard, which It's going to support increased screening. So these guidelines will influence and increase both screening and diagnosis of hypercortisol of patients. Great. Thank you.

Speaker 10

Thank you, Edward.

Operator

One moment for our next question. Our next question comes from the line of David Amsellem with Piper Sandler. Your line is open.

Speaker 11

Thanks. So just have a few. First, I wanted to ask a couple on miricorilant in NASH, I know you're going to have data at an Medical meeting, but just thinking about the Phase 2b, can you just talk about the contours of the design of that trial? Is it I'm assuming we're going to have Liver biopsies in this trial. And is this something where you're thinking about is more of a Phase twothree?

Speaker 11

And Or is this something where we should think about it as you're still going to have to do a full Phase 3 program Beyond this Phase 2b, that's number 1. Number 2 is, as you think about americorilant strategically, Is this something that you're going to look to partner down the road? Is this something that you're going to look to keep and commercialize? And where does it fit in The broader business, particularly given the comments about other cortisol modulators that you're looking at that you haven't disclosed. Thanks.

Speaker 3

Yes. Thanks, David. And then two questions, I think I understand. Phil, would you first I described these to be, your equivalent study and then I'll describe I'll discuss the business possibilities.

Speaker 1

Absolutely. Hey, thank you for that question. So as we progress towards our Phase 2b program, let me back up a little bit. 1, we just completed a great advisory board at the EASL Conference, which is the European Conference for the Study of Liver Disease. And we met with the top Hepatologists in the world who have done research for every molecule in the NASH space for the past decades, and I've known them for many decades as well.

Speaker 1

And as we reviewed all the Phase 2a data from our original study and all the Phase 2b or Phase 1b data, they were really impressed with that and they helped guide us And designing our Phase 2b trial. And so that was really encouraging as we move forward. And so that Phase 2b trial right now as our Study is a biopsy confirmed NASH study in patients with NASH. This study will be a double blind placebo controlled trial evaluating 150 patients randomized Miricorilant 100 milligrams twice weekly or placebo for 48 weeks. This is intended to be a Phase 2b study and based upon those results, We will then progress and design a Phase 3 trial.

Speaker 3

And David, the second question is an interesting one. And I just For a variety of reasons, particularly for those who follow Corcept for a long time. I mean, as you know, most of the things starting with Pushing syndrome that we've worked on have been orphan diseases, niche markets, very obvious clinical need, but to a relatively small group of patients. NASH is of course a different story. The number of people in the United States with fatty liver disease is Very large and a sizable percentage of them have NASH, which progresses to worse things than that.

Speaker 3

So it's a big market. I don't know if sort of the older term primary care market is the right way to describe it, but there's certainly a market with many, many patients in it. Now, it's a good question and one that we've thought about a lot. Is this something that we can do on our own as we have with the other diseases we've looked at or Is this a disease space where we need to partner? I don't really know the answer to that at this point in time.

Speaker 3

But what I will tell you is that we are not in need of anyone else's So if we decide that commercialization is better with a partner, we'll go in that direction. I think we're really in a lucky space because of our profitable business and our long term profitable business that we can take this as far as we want and should we partner We'll be in a place where it's clearly advantageous for us to do so. And I'll end it with a simple answer that decision has not yet been made.

Speaker 11

That's helpful. If I might sneak in an additional question, just on Catalyst, as you get learnings From the study, and particularly the answers That you're looking for, which is the Cushing's syndrome and hypercortisolism is more prevalent and raising awareness among diabetologists. Do you Think about calling on a sizable group of diabetologists in your rollout and Broader commercialization of relacorilant. In other words, is this going to be a bigger splashier, more expensive,

Speaker 2

Sean? Yes. No, thank you

Speaker 5

for the question. And look, we're in the process of really working through that now to understand what the most effective way It will be for us to launch relacorilant. We do recognize that these patients are in more than just endocrinology practices. Diabetologists in general are endocrinologists, but Cardiologists showing up in some primary care offices sort of throughout the country. So we are right now are working on trying to figure out scalable ways that we can Get this message to physicians that they can be educated appropriately.

Speaker 3

Yes. But just I appreciate the question, David, particularly because we have been thinking about that. I think at some point, maybe a decade ago, We thought that the patients with Prissing syndrome were likely to be treated by really a very, very small number of endocrinologists. We do not think that is true anymore. We think it's they are distributed to a much larger group.

Speaker 3

And making sure that these patients get to optimum treatment That's our ethos. That's what we really want to get to. So how it translates to practical matter is absolutely on our mind.

Speaker 7

Thanks a lot.

Speaker 3

Thank you, David.

Operator

One moment for our next question. Our next question comes from the line of Brianna Ruiz with Leerink. Your line is open.

Speaker 12

Hi, afternoon, everyone. So a couple from me, maybe on tagging on a question about your revenue guidance for a second. I was curious, what are some of the pushes and pulls that could get Korlym revenues closer to the higher end or the lower end of this range in your view?

Speaker 3

Sean, please take that.

Speaker 5

Yes. Thank you for the question. Look, our guidance, it's pretty simple, is driven by the number of patients on medicine. We have more patients taking Korlym than ever before and we expect there will be more in the future. We have a number of initiatives underway and we're expecting them to impact the second half of the year.

Speaker 5

So the The more patients that are prescribed Korlym, the higher the end of the range it will be. If it's a little bit fewer, it will be on the

Speaker 3

It's really as simple as that. There aren't other factors besides the number of patients that are really very appreciable.

Speaker 12

Got it. Okay. And wanted to ask a bit about your field force. So I know You've reached the target of 60. Are you thinking of possibly expanding that later this year or maybe into And what type of launch metrics are you looking forward to help you make that kind of decision?

Speaker 5

Sean, please? Yes, it's a great question. I'll start by saying we're always evaluating the effectiveness of the team and looking to see what is the appropriate size. I'm stepping back in time a little bit. Through the pandemic, we felt that it was very important for us to maintain the stability of that team.

Speaker 5

But over the last year, we've taken a very hard look And that's where we've made changes. We've strengthened and streamlined our training program, the goal of making our current clinical specialists more productive And our neuro clinical specialists are more productive more quickly. And we've also, as you just alluded to, added top talent to the team. So In terms of the current size of the team, we're actually currently in the mid-50s and we are continuing to add clinical specialists throughout the country. Right now, our target is 60, but we're unlikely to stop there.

Speaker 5

If we can continue to find top talent, we will be adding it to the team. And as we continue to evaluate what the future looks like, we'll determine if we need to go beyond that.

Speaker 12

Got it. Thanks.

Speaker 3

Thank you, Roanna.

Operator

One moment for our next question. Our next question comes from the line of Joon Lee with Truist. Your line is open.

Speaker 10

Hi, congrats on the strong quarter and thanks for taking our questions. I'm particularly intrigued by your Phase 4 catalyst study of Korlym in difficult to treat diabetics. How are you making the determination of hypocortisone and advancing them to the randomized portion of the trial? And how deployable is that screening for hypocortisone by generalists and endocrinologists who treat diabetics? And lastly, What is the endpoint in the randomized portion?

Speaker 10

And is the product result there sufficient to get a labeled indication for diabetics? And I have a follow-up.

Speaker 3

Yes. Well, for June 1, welcome or welcome back. Nice to hear from you. And I think that, Bill has So, Bess got his arms around I think all of that information. So, I'm going to turn it over to him.

Speaker 6

So, thanks for the question. So, when

Speaker 1

we look at Catalyst, we designed it Specifically, again, and collaboratively with top diabetologists and endocrinologists to make this as simple and easy as possible. And it's now aligned with the guidelines as we spoke about earlier. We've just deployed a simple test of 1 DST, a dexamone suppression test And looking for those patients with a DST greater than 1.8, those are the patients who are then positive, who then can qualify and be screened for or enrolled into the randomized, placebo controlled trial of Korlym. In that trial, the primary endpoint is just to look at a difference between Glucose control between Korlym and that of placebo. And that will be our primary endpoint.

Speaker 1

And related to will it change the label of Korlym? It's already consistent with the label of Korlym because when you look at the Korlym indication, Korlym is indicated to control hyperglycemia secondary to hypercorbicilism And adult patients with endogenous Cushing's syndrome who have Type 2 diabetes.

Speaker 10

Excellent. Thank you. And

Speaker 3

I think you asked just another small question, which was, is that is the dexmedetine suppression test something that doctors in mutual practice can undertake? The answer is yes.

Speaker 10

Great. Thank you. So if Catalyst is positive, then would you need to run a trial Using relacorilant in difficult to treat diabetics to get the similar use commercially and If not, either way actually, would dosing be different or some aspect of the drug be different between The Cushing's patients and diabetics to maybe get different pricing given the different

Speaker 3

I just want to make sure to clarify this. All of these patients, the disease is hypercortisolism And diabetes or glucose intolerance is secondary to their hypercortisolism. It is what is causing their So in some sense, there's no difference except for degree of illness between these patients and some of them actually can be quite ill. So I just want to make that distinction. This is not diabetes in general.

Speaker 3

These medicines, whether it's Korlym or relacorilant are not for diabetes in general. And for the treatment of hyperchlurosem where diabetes appears as a prominent manifestation of hyperchlurosem.

Speaker 1

And then to answer your question about would we use relacorilant, I see no reason to repeat this study. I see this catalyst as a landmark study That would easily apply to relacorilant. And I'll remind you relacorilant, we're looking for an indication, a full indication for hypertension and diabetes, not just diabetes.

Speaker 10

Great. Looking forward to the progress in data. Thank you.

Speaker 3

Thank you, Jim.

Operator

One moment for our next question. Our next question comes from the line of

Speaker 8

This is RK from H. C. Wainwright. Good afternoon, Joe Most of my questions have been answered, but I have a quick question on Clinical data expectations for the rest of this year.

Speaker 3

I'm sorry, I didn't quite understand your question, RK, I apologize.

Speaker 8

So I'm just trying to understand what sort of clinical data could we expect This year, from here to the end of the year.

Speaker 3

Yes. I'm going to turn you over. Now I understand Bill, would you please answer that? So as I look at all

Speaker 1

of the studies that are ongoing, the one study that I could see that we are planning to submit to a conference in the Q4 of this year would be the NASH Phase 1b data. And so that is our plan to present that data, hopefully at that conference. Catalyst will be close. We're ahead of schedule. I would say it's probably Q1 of next year, but it could we could see results from the screening and prevalence study later this year in December.

Speaker 3

Yes. I'm just going to underscore that. I think what you can count on is the Phase 1b results. NASH will have that, but everything else falls into the Next year, often the early part of next year, but in 2024. Thank you.

Speaker 3

You're welcome.

Operator

One moment for our next question. Our next question comes from the line of Alan Leung with BioWatch. Your line is open.

Speaker 6

Hey, everyone. Glad to be here and congratulations on the

Speaker 3

Well, how wonderful is what do I need to help you with today?

Speaker 6

Well, I have a few questions and thank you for your generosity and

Speaker 3

I apologize. It's a poor connection. Could somebody Alan's question? I really apologize, Alan. I really just couldn't hear you.

Speaker 6

Sorry about that. Yes, I'm using earbuds. Yes. Okay. What can you tell us about what you've learned about the dynamics of North Carolina with safety and efficacy in liver fat?

Speaker 3

I was going to repeat the question. Yes. The question was what have we learned about the dynamics of miricorilant In terms of efficacy and safety, Bill, we keep this off to that. Key pieces

Speaker 1

there, we've reviewed the Phase 2a data again using 6 900 milligrams, we saw those dramatic fat liver fat reductions in a month corresponding with rises in liver enzymes. And that's what Allow us to then explore various lower doses and different dosing regimens in Phase 1b. And as we have studied various different dosing regimens, We really have determined it's the rapidity of the liver fat reductions. And we confirmed that when we reviewed all the data with our top advisors just about a month ago. We've determined that that liver fat rapid reduction in liver fat is tied to that rise in increasing free fatty acids, Which then causes mitochondrial dysfunction, which then in turn causes that liver enzyme irritation and elevation.

Speaker 1

And that's key because What we also saw is as it's the liver is trying to metabolize all those free fatty acids, it actually can metabolize those because we're not seeing any dumping of fat So because in our study, we're seeing lowering effects on triglycerides, LDL and VLDL. But importantly, we also saw that if we can slow that down and we saw that with the 100 milligram twice a week dose When we slow that down, we see a steady decline up to 12 weeks and we saw that 30% production in liver fat with no rises in ALT or AST. We actually saw decreases in those liver enzymes. And so that's really what we have learned. And we've done many analysis looking at the slope of decline, Percentage of decline, it all matches up that it really is tied to the rapidity of liver fat reduction.

Speaker 1

And we believe we've solved that problem, which is why we're going to Phase 2b.

Speaker 6

Next set of questions, of the following 3 programs, which do you think has the greatest gap in understanding from your audiences that you kind of go there and you go, Wow. We have a little chasm in education to do. Feel free to split the investor community versus the life science specialist. Ovarian cancer versus go ahead.

Speaker 3

Yes. No, I just want to repeat your question as I understand it, which is Of our programs, which do we think is sort of least recognized by the investor community? And if that's essentially a distillation of your question, Yes, I get it because I think one of the things that's surprising, I think to people until they really dig into the science and as you know, Sort of a recovering academic, so I'm really all about the science.

Speaker 1

It's

Speaker 3

how broad a platform cortisol modulation is. Cortisol goes into every tissue in the body. So it really has the potential to affect many disease states. And it's Some sense obvious why a drug like Korlym or relacorilant would be effective in Cushing's syndrome. I think it's initially a little less obvious why it might be effective in a neurologic disease like ALS or a disease like Cancer, variety of cancers.

Speaker 3

But I think that the interesting thing for us is that there are individual investors who seem to Appreciate kind of individually parts of the story. But I think that there are few and I think this is going to change over time, Really understand the global application of Cortisol modulation to the whole platform. So I don't think it's a question of any Individual program particularly being unrecognized, I think that it's just that some people recognize one paralumab, some people recognize another program. And I'm really hoping to see over time is that people can actually connect all of those things because they really are connected. And I'll give you just one sort of personal example from that is that Every 4 years, we conduct a conference with all of our collaborators.

Speaker 3

As you know, we have many academic collaborations 35 or 40 of them. So they're all over the world and they're preclinical and they're clinical and we bring those people together, I just said one time, And many times they're unaware of the other work that people are doing, even though they're all working in cortisol modulation. It's our mission to make sure that people really understand this entire platform. And I hope that as I said, even investors who I know are busy people

Speaker 6

Well, thank you very much. The speech is back for both of us. Thanks.

Speaker 3

Okay. Thank you very much, Alan. And With that, we're out of questions. So, look forward to talking to everybody 3 months from now and hope you enjoy the rest of your summer.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now

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Earnings Conference Call
Zentalis Pharmaceuticals Q2 2023
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