Q2 2020 Corcept Therapeutics Inc Earnings Call

Good day, Hello, everyone and welcome to the course up there appear to be conference call.

Unknown Executive: Good day, hello everyone, and welcome to the Corcept Therapeutics conference call.

Today's conference is being recorded if you would like to ask your question. Please signal by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure that your mute function is turned off to allow your signals to reach our equipment.

Unknown Executive: Today's conference is being recorded. If you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment.

Again that is star one to ask your question.

Unknown Executive: Again, that is Star 1 to ask a question. At this time, I would like to turn the conference over to Charlie Rove. Please go ahead, sir.

At this time I would like to turn the conference over to Charlie Rose. Please go ahead Sir.

Thank you good afternoon, everyone. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update.

Charlie Rove: Thank you. Good afternoon, everyone.

Charlie Rove: Today we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available through August 18th at 888-203-1112 in the United States and 719-457-0820 internationally. The passcode will be 680-0706.

Pete Israel, but of course up dotcom complete results will be available when we file our form 10-Q with the FCC.

Today's call is being recorded.

A replay will be available through August 18 at 888, Choosy 3111, too in the United States, and 7194 or 570 weight to zero internationally.

Pass code will be six 800 706.

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 differ materially from those such statements expressed or implied.

Charlie Rove: 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 differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs. The availability of competing treatments, including generic versions of Coraline The Initiation or Outcome of Litigation Our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Coralim and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on physicians, patients, insurers, regulators, and the practice of medicine generally.

These risks and uncertainties include but are not limited to our ability to operate our business and achieve our goals during the cold 19, pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs the availability of competing treatments, including generic versions of Korlym.

She should or outcome of litigation.

Our ability to obtain acceptable prices are adequate intralinks coverage and reimbursement for korlym and risks related to the development of our product candidates, including their clinical attributes regulatory approvals mandates oversight and other requirements and the impact of the Kobin 19 pandemic on our employees consultants and been Oh and vendors as well as on physician.

Once patients insurers regulators and the practice of medicine generally.

These other risks are set forth in our SEC filings, which are available at our website and the Fccs website.

Charlie Rove: These and other risks are set forth in our SEC filings, which are available on our website and the SEC's website. On this call, forward-looking statements include those concerning our 2020 revenue guidance, cash flow, and expected growth, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients. Physician awareness of hypercortisolism in the selection of Corallum is the optimum medical treatment.

On this call forward looking statements include those concerning our 2020 revenue guidance cashflow unexpected gross.

Impact of the Tobin 19 pandemic on our commercial operations financial performance clinical development programs physicians payers and patients.

Physician awareness of hyper cortisol ism and the selection of Korlym is the optimum medical treatment.

The timing cost an outcome of litigation, including our lawsuits against Teva Pharmaceuticals, and Sun Pharmaceuticals, and Tevas challenge to our intellectual property before the patent trial and Appeals board the scope and protected Powervar electoral property the benefits of orphan drug designation the progress enrollment timing design and results of our clinical trials and the.

Charlie Rove: The timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceuticals and Sun Pharmaceuticals and Teva's challenge to our intellectual property before the Patent Trial and Appeals Board. The scope and protective power of our intellectual property, the benefits of orphan drug designation, the progress, enrollment, timing, design, and results of our clinical trials, and the clinical and commercial attributes of Relacorrelant, Exacorrelant, Miracorrelant We disclaim any intention or duty to update forward-looking statements.

Clinical and commercial attributes umbrella corlanor exit Korlyms mirror correlate <unk> other selective cortisol modulators.

We disclaim any intention or duty to update forward looking statements.

Our revenues for the second quarter was $88.6 million, a 23% increase from the second quarter of 2019.

Charlie Rove: Our revenue for the second quarter was $88.6 million, a 23% increase from the second quarter of 2019. However, it was $4.7 million lower than in the first quarter of this year, primarily because in March some patients refilled their prescriptions a few days earlier than usual so as to have a small amount of extra medicine on hand to safeguard against pandemic-related delivery delays. These early refills increased our first quarter tablet shipments and revenue. However, when patients consumed their small safety stocks in the second quarter, they postponed refilling their prescriptions by a few days, which decreased our second quarter tablet shipments and revenue by a similar amount. Let me illustrate with a hypothetical example. A patient who filled her Corlin prescription on March 2nd and who would normally have refilled it on April 2nd instead refilled it on March 29th.

It was $4.7 million lower than in the first quarter of this year, primarily because in March some patience rebuild their prescriptions a few days earlier than usual supposed to have a small amount of extra medicine on hand to safeguard against pandemic related delivery delays.

These early refills increased our first quarter tablet shipments and revenue.

The patients consumes they're small safety stocks in the second quarter, they postponed refilling that prescriptions by a few days, which decreased our second quarter tablet shipments and revenue by a similar amount.

Let me illustrate with a hypothetical example.

Patient who failed her korlym prescription on March 2nd and who would normally every field on April 2nd instead refills on March 29 that is to say in the first quarter rather than the second quarter in April when it becomes clear that no deliveries are being delayed she consumes those few extra tablets and rather than refilling prescriptions in April two.

Charlie Rove: That is to say, in the first quarter rather than the second quarter. In April, when it becomes clear that no deliveries are being delayed, she consumes those few extra tablets and, rather than refilling her prescription on April 29th, waits until May 2nd, skipping April. She then returned to her normal monthly refill cadence, receiving another shipment on June 2. This patient received six shipments in the first half of 2020, an average of one per month, as one would expect. But four of those shipments were in the first quarter, and only two were in the second.

Any night waits until may 2nd skipping April.

She didn't returns are normal monthly refocus since receiving another shipment on June 2nd.

This patient received six six shipments in the first half of 2020, an average of one per month as one would expect but for those shipments when the first quarter and only two were in the second.

Variations in refill timing such as I. Just described caused her shipments of Korlym tablets and our revenue to increase in March the decrease in the second quarter by comparable amount then resume their normal cadence in effect about 4 million revenue, we would've recognizing the second quarter got shifted to March.

Charlie Rove: Variations in refill timing, such as I just described, caused our shipments of Corlum tablets and our revenue to increase in March, then decrease in the second quarter by a comparable amount, then resume their normal cadence. In effect, about $4 million of revenue we would have recognized in the second quarter got shifted to March. We did not see this sort of early refill behavior in the second quarter. Our second quarter gap net income was $28.3 million compared to $20.2 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $39.7 million, compared to $31.0 million in the second quarter of 2019. Our cash and investments increased $60.6 million in the second quarter, to a balance of $409.6 million at June 30.

We did not see this sort of early refill behavior in the second quarter.

Our second quarter GAAP net income was $20.3 million compared to $20.2 million and the same period last year, excluding noncash expenses related to stock based compensation in the utilization of deferred tax assets together with related income tax effects non-GAAP net income in the second quarter was $39.7 million compared to.

$31.0 million in the second quarter of 2019, our cash and investments increased $60.6 million in the second quarter, two a balance of $409.6 million at June Thirtyth.

Now a brief legal update.

Charlie Rove: Now, a brief legal update. In March 2018, we sued Teva Pharmaceuticals and Federal District Court to stop it from marketing a generic version of Coraline in violation of our patent. Our lawsuit stayed final FDA approval of Teva's proposed product for 30 months, a period which ended at midnight on August 1st. Discovery is underway.

In March 2018, we soon Teva pharmaceuticals in Federal District Court to stop at some marketing a generic version of Korlym in violation of our patents are lawsuit stayed final FTC approval of Tevas propose product to 30 months period, which ended at midnight on August 1st Discovery is underway trials.

To begin February 2nd 2021.

Charlie Rove: The trial is set to begin February 2, 2021. In addition, TEVA has challenged the validity of one of our patents, the 214 patent, in a proceeding known as a post-grant review, or PGR, before the U.S. Patent Office's Patent Trial and Appeals Board, or PTAB. Briefing in the PGR is complete, and oral argument is set for September 2nd. We expect the PTAB's decision on November 19th. The losing party may appeal to the Federal Circuit Court of Appeals, during which time those portions of the PTAB decision that are under appeal will have no effect.

In addition, Tevas challenge the validity of one of our patents. The two one for patent in a proceeding known as a post grant review or P.G.R. before the U.S. patent offices patent trial Appeals Board work P. tab.

Briefing in the PDR is complete oral argument is set for September 2nd we expect the P. tabs decision on November 19th losing party you May appeal to the Federal Circuit Court of Appeals during which time those portions of the P. PTAB decision that are under appeal will have no effect Federal circuit Appeals, usually take about one year too.

Resolved as soon as we expect definitive resolution of the P.G.R. is the fourth quarter of 2021.

Sun Pharmaceuticals is also seeking to market generic korlym or lawsuit against Sun has stayed final FDA approval of SUNS proposed product into the earlier December Eightth 2021 that is next year and a decision by the district court that the patents, we have asserted against son or invalid unenforceable, we're not infringed.

Charlie Rove: Federal Circuit Appeals usually take about one year to resolve, so as soon as we expect definitive resolution of the PGR in the fourth quarter of 2021. Sun Pharmaceuticals is also seeking to market Generic Coraline.

Charlie Rove: Our lawsuit against Sun has stayed final FDA approval of Sun's proposed product until the earlier of December 8, 2021, that is, next year, and a decision by the district court that the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Despite overlaps in subject matter and legal issues, our dispute with SUN is separate from our litigation against TEVA and is following its own timeline. A Markman hearing in the Sun Case is set for November of this year, but no trial date has been set. The impact of the COVID-19 pandemic on the timing of these disputes is impossible to know with certainty. However, we do not expect delays in the PGR because the Patent Office conducts much of its work, including PTAB hearings, remotely as a matter of course.

Despite overlaps and subject matter and legal issues or dispute with Sun is separate from our litigation against Teva is following its own timeline.

Markman hearing in the Sun case is set for November of this year No trial date has been set.

The impact of the coping 19 pandemic on the timing of these disputes is impossible in there with certainty we do not expect delays in the P.G.R. because the patent office conducts much of its work, including Pete had hearings remotely as a matter of course.

Predicting the ultimate timing of our district Court litigation is more difficult the judge hearing or Teva and Sun lawsuits is not delayed our February trial date with Teva or our November markman hearing in the Sun case that being said I would not be surprised if our district court timelines are extended.

Of course, we will be ready, whether there are delays or not we're confident in our intellectual property and look forward to putting our case before the judge.

Now I'll turn the call over to Dr., Joseph Feldman off our Chief Executive Officer Joe.

Charlie Rove: Predicting the ultimate timing of our district court litigation is more difficult, but the judge hearing our Teva and Sun lawsuits has not delayed our February trial date with Teva or our November Markman hearing in the Sun case. That being said, I would not be surprised if our district court timelines are extended. Of course, we will be ready whether there are delays or not. We're confident in our intellectual property and look forward to putting our case before the judge. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Thank you Charlie.

I want to start by combining our clinical specialist patient advocates and medical science liaisons, who have worked hard and successfully to shore patients continued access to korlym and during the cold at 19 pandemic.

Over the past quarter, we have seen physicians adopt their practices. So they can safely care for their patients managing the complex multi step process of diagnosing and treating patients with Cushing syndrome is hard even under normal conditions, adding stress and uncertainty of zoom office visits patients who are reluctant to lead the.

Joseph K. Belanoff: Thank you.

Joseph K. Belanoff: Thank you, Charlie. I want to start by commending our clinical specialists, patient advocates, and medical science liaisons who have worked hard and successfully to assure patients continued access to Quorulum during the COVID-19 pandemic. Over the past quarter, we have seen physicians adapt their practices so they can safely care for their patients. Managing the complex, multi-step process of diagnosing and treating patients with Cushing Syndrome is hard even under normal conditions. Adding the stress and uncertainty of Zoom office visits, patients who are reluctant to leave the safety of their homes, and limited access to laboratory and scanning centers increases the challenge. In-person meetings of our clinical specialists and medical science liaisons with physicians and their staff are quite limited at this time. Our commercial team has done an excellent job devising ways to support physicians by video and telecom, but these methods are just being developed.

Safety of their homes unlimited access to laboratory and scanning sensors increases the challenge in person meetings of our clinical specialists and medical science liaisons with physicians and their staff are quite limited at this point.

Commercial team has done an excellent job devising ways to support positions by video in teleconference. But these methods are just developing.

We are focused intently on helping physicians provide optimal care because cobot 19 is especially dangerous for patients with Cushing syndrome.

Around the virus interest cells I binding to the east to receptor.

Cortisol causes the ace two receptive to proliferate, putting patients with Cushing syndrome, a heightened risk.

In addition, excess cortisol activity suppress the immune system as a result patients with Cushings syndrome, or four to five times more likely to suffer from severe infections or any type of hyper cortisol or some also increases the risk of blood clots and thrombo embolism, a leading cause of death in patients with Covidien 19.

Joseph K. Belanoff: We are focused intently on helping physicians provide optimal care because COVID-19 is especially dangerous for patients with Cushing's. The coronavirus enters cells by binding to the ACE2 receptor. Cortisol causes the ACE2 receptor to proliferate, putting patients with Cushing syndrome at heightened risk. In addition, excess cortisol activity suppresses the immune system. As a result, patients with Cushing's Syndrome are four to five times more likely to suffer from severe infections of any type.

I want to underscore our full confidence in the commercial potential of Korlym and its plant successor relic correlate there remain many patients who could benefit from treatment with the cortisol modulator, who have not yet received it the challenges temporarily posed by the pandemic are likely to varying their impact and are subject to rapid change we believe any.

Further changes will be manageable and have reaffirmed our standing revenue guidance of $355 million to $375 million.

We're now testing our proprietary selective modulator relative to our land our plan successor to Korlym for patients with Cushing syndrome into phase three trials like Korlym railcar led to the Cheez its effect against Cushing syndrome, competing with cortisol to bind to the glucocorticoid receptor GR for short.

Joseph K. Belanoff: Hypercortisolism also increases the risk of blood clots and thromboembolism, a leading cause of death in patients with COVID-19. I want to underscore our full confidence in the commercial potential of Coralim and its plant successor, Relacoralant. There remain many patients who could benefit from treatment with a cortisol modulator who have not yet received treatment. However, the challenges temporarily posed by the pandemic are likely to vary in their impact and are subject to rapid change.

Unlike korlym Relamorelin does not finds its progesterone receptor PR for short, which means does not cause the off target effects, including termination of pregnancy, endometrial thickening and fashionable bleeding caused by korlyms affinity for PR.

By different mechanism Relamorelin also does not appear to cause hyperkalemia low potassium serious side effects experienced by 44% of patients and Korlyms pivotal trial that is a leading cause of korlym discontinuation today.

Well Korlyms clinical data have been positive patients in its phase two trial experienced meaningful improvements in hypertension and glucose control as well as in a variety of secondary endpoints. There were no relamorelin induced in some instances of endometrial thickening virginal bleeding or hyperkalemia.

Joseph K. Belanoff: We believe any further changes will be manageable and have reaffirmed our standing revenue guidance of $355 to $375 million. We are now testing our proprietary selective modulator, Reliquorolint, our planned successor to Coraline for patients with Cushing's Syndrome, in two Phase III trials. Like Coraline, Relacoraline achieves its effect against Cushing's syndrome by competing with cortisol to bind to the glucocorticoid receptor, GR for short. However, unlike Corallum, Relacoraline does not bind to the progesterone receptor, PR for short, which means it does not cause the off-target effects including termination of pregnancy, endometrial thickening, and vaginal bleeding By a different mechanism, Reliquorland also does not appear to cause hypokalemia, or low potassium.

Our patient present, a poster presentation of rail coral into phase two results can be found at the investors post events tab of our website.

Well the Korlyms phase three Grace trial, GRT see trial, which we believe will serve as the basis for our Andy a submission continues to enroll patients and open it continues to enroll patients and open additional clinical trend of clinical trial sites.

Recruitment is now underway at 60 sites in the United States, Canada, Europe, and Israel planned enrollment is 130 patients, we expect to submit or India in the second quarter Twentytwenty too.

We dosed the first patient and Reliv correlates other phase three trial as a treatment for patients with Cushing syndrome gradient last week gradient will study grella correlates effects in patients, whose Cushing syndrome is caused by an adrenal adenomas or adrenal hyperplasia.

Joseph K. Belanoff: Serious side effects experienced by 44% of patients in Corallim's pivotal trial that is a leading cause of Corallim discontinuation today. However, Relic Horlant's clinical data have been positive. Patients in its Phase II trial experienced meaningful improvements in hypertension and glucose control, as well as in a variety of secondary and, There were no relaquorreline-induced instances of endometrial thickening, vaginal bleeding, or hypokalemia. A poster presentation of Relic Oralyn's Phase 2 results can be found on the Investors Post Events tab of our website. Relic Oralyn's Phase 3 GRACE trial, G-R-A-C-E trial, which we believe will serve as the basis for our NDA submission, continues to enroll patients and open additional clinical trial sites. Recruitment is now underway at 60 sites in the United States, Canada, Europe, and Israel.

Although patients with this etiology of 'cause Cushing syndrome, usually have a rush less rapid decline in their condition. They ultimately have poor health outcomes.

Radian is the first controlled study in patients with this etiology of Cushing syndrome study participants will receive either relic core lunch or placebo for 22 weeks.

Trials primary endpoints will be statistical statistically significant improvements in either hypertension or glucose metabolism.

Planned enrollment is 130 patients at sites in the United States in Europe. Many of the investigators who are participating in Grace will also participate ingredient.

By the poster presentation of gradients design at the research and pipeline publications tab of our web site.

I'll now turn to our oncology program, which has its origin and series postulated by our academic collaborators at the University of Chicago, where the 12 years ago.

Our program now consists of multiple clinical trials, one of which are controlled phase two trial in patients with recurrent platinum resistant ovarian cancer just completed enrollment.

Joseph K. Belanoff: The planned enrollment is 130 pages. We expect to submit our NDA in the second quarter of 2022. We dosed the first patient in Rella Chloralense's other phase three trial as a treatment for patients with Cushing syndrome, Gradient, last week. Gradient will study Rella Chloralense's effects in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Although patients with this etiology of Cushing syndrome usually have a less rapid decline in their condition, they ultimately have poor health outcomes. Gradient is the first controlled study in patients with this etiology of Cushing's syndrome.

We are investigating three mechanisms by which cortisol modulation may be helpful. In the treatment of cancer.

Cortisol activity blunt the effects of chemotherapy I suppressing the genes that trigger a pop ptosis. The programmed cell death chemotherapy is meant to cause.

Hi, reversing cortisols anti apoptotic effect cortisol modulation may also allow chemotherapy to achieve its full cancer, killing potential.

We have tested this hypothesis in an open label phase one slash two trial in which patients with advanced solid tumors received relamorelin combined with Nab Paclitaxel Celgenes drug Abraxane.

Joseph K. Belanoff: Study participants will receive either roaquarelent or placebo for 22 weeks. The trial's primary endpoints will be statistically significant improvements in either hypertension or glucose metabolism. Planned enrollment is 130 patients at sites in the United States and Europe. Many of the investigators who are participating in GRACE will also participate in GRADIENT. You can find the poster presentation of Gradients Design on the Research and Pipeline Publications tab of our website

Results were striking tumors in seven of 25 patients with metastatic pancreatic cancer and in five of 11 patients with platinum resistant ovarian cancer, either shrank or see scrolling for 16 weeks or longer.

To patients with metastatic pancreatic cancer exhibit a tumor shrinkage for more than 50 weeks, one patients ovarian tumor exhibit shrinkage for 65 weeks the tumors in all of these patients had progressed despite multiple lines of prior therapy, including therapy would taxanes you can find their poster presentation of these results at the investor slow.

Joseph K. Belanoff: I will now turn to our oncology program, which has its origin in theories postulated by our academic collaborators at the University of Chicago more than 12 years ago. Our program now consists of multiple clinical trials, one of which, our controlled phase two trial in patients with recurrent platinum-resistant ovarian cancer, has just completed enrollment. We are investigating three mechanisms by which cortisol modulation may be helpful in the treatment of cancer. For example, cortisol activity blunts the effects of chemotherapy by suppressing the genes that trigger apoptosis. The program Cell Death Chemotherapy is meant to cause.

Cash past events tab of our website.

We're excited to report that in July we closed enrollment in our 178 patient controlled phase two study of relic Orlando, let snap paclitaxel in patients with recurrent platinum resistant ovarian cancer disease with a very poor prognosis all the patients in the trial received Nab paclitaxel.

One third of them also receive Relamorelin every day another third of them receive relic correlate the day before the day ER and the day after each infusion with Nab Paclitaxel.

Charles primary endpoint is progression free survival with secondary endpoints, including objective response rate duration of benefit and overall survival. We expect results in the first half of next year.

Joseph K. Belanoff: By reversing cortisol's anti-apoptotic effect, cortisol modulation may also allow chemotherapy to achieve its full cancer-killing potential. We have tested this hypothesis in an open-label Phase 1-2 trial in which patients with advanced solid tumors receive relacorrelant combined with nabpaclitaxel, that's cell genes drug abracadabra. Our results were striking. Tumors in 7 of 25 patients with metastatic pancreatic cancer and in 5 of 11 patients with platinum-resistant ovarian cancer either shrank or ceased growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for more than 50 weeks.

We were equally excited to report then in June we began dosing patients in a phase three trial umbrella Cortland, plus Nab paclitaxel in patients with metastatic pancreatic cancer, a disease for which there are no. Good treatment options. The trial is called reliant reliant is an open label trial in which 80.

Patients will receive relic core legend, plus snap hack attacks all with the primary endpoint being objective response rate assessed by resist criteria, but secondary endpoints, including progression free survival and overall survival reliant will be conducted at 30 sites in the United States.

Joseph K. Belanoff: One patient's ovarian tumor exhibited shrinkage for 65. The tumors in all of these patients had progressed despite multiple lines of prior therapy, including therapy with taxonomy. You can find our poster presentation of these results on the investors slash past events tab of our website. We're excited to report that in July, we closed enrollment in our 178 patient-controlled Phase 2 study of relacorlin plus nabpaclitaxel in patients with recurrent, platinum-resistant ovarian cancer, a disease with a very poor prognosis. All of the patients in the trial received napaqlitaxel. One-third of them also received Reliquorilent every day.

We will perform an interim analysis of data from the first 40 patients and expect to have results of that analysis in the first half of next year.

It is important to note that the expected response rate and patients with such advanced the disease to Nab Paclitaxel monotherapy is zero.

For this reason, we believe sufficiently positive results in reliant would support accelerated approval.

Cortisol activity suppresses the immune system and effect that is often beneficial as it controls the inflammatory response and helps protect against auto immune diseases.

Unfortunately, cortisol induced immune suppression limits, the body's ability to kill tumor cells and once the efficacy of medications, such as checkpoint inhibitors, which analysts the immune system to fight cancer.

Joseph K. Belanoff: Another third of them received Reliquorilent the day before, the day of, and the day after each infusion of napaqlitaxel. The trial's primary endpoint is progression-free survival, with secondary endpoints including objective response rate, duration of benefit, and overall survival. We expect results in the first half of next year. We are equally excited to report that in June, we began dosing patients in a Phase 3 trial of relacorland plus nabpaclitaxel in patients with metastatic pancreatic cancer, a disease for which there are no good treatment options. The trial is called Reliance. Reliance is an open-label trial in which 80 patients will receive relacorrelant plus napacotaxel with the primary endpoint being objective response rate assessed by resist criteria with secondary endpoints including progression-free survival and overall survival. Reliant will be conducted at 30 sites in the United States.

Modulating cortisol activity bolsters, the immune system and May help checkpoint inhibitors and other immunotherapies achieved their full potential.

This quarter, we are starting an open label phase one be trial umbrella correlate plus the PD one checkpoint inhibitor pembrolizumab work strike Keytruda in 20 patients with advanced Adrenocortical cancer.

Because adrenocortical tumors produce cortisol. These patients also suffer from Cushing syndrome.

Our trial will examine whether relamorelin can by reducing the effects of excess cortisol activity treat these patients Cushing syndrome, and by reversing cortisol induced immune suppression help pembrolizumab achieve its maximum effect, we presented posters at this year's virtual ESCO and HCR with Clinicals.

Joseph K. Belanoff: We will perform an interim analysis of data from the first 40 patients and expect to have results of that analysis in the first half of next year. It is important to note that the expected response rate of patients with such advanced disease to nabpaclitaxel monotherapy is zero. For this reason, we believe sufficiently positive results and reliance would support accelerated approval. Cortisol activity suppresses the immune system, an effect that is often beneficial as it controls the inflammatory response and helps protect against autoimmune diseases.

ICL and clinical biomarker data supporting this hypothesis they are available at the research and pipeline publications tab of our web site.

I will conclude with an update on our programming metabolic diseases. As many of you know we're developing a proprietary cortisol modulator mirror core led as a treatment for anti psychotic induced weight gain and non alcoholic steatohepatitis for Nash like relic correlate an exit carland Mira Korlym is a selective.

Cortisol modulator binding potently to GE are but not PR merrell correlate was safe and well tolerated in its phase one trial.

Millions of patients rely on antipsychotic medications to treat schizophrenia bipolar disorder major depression, and other serious illnesses. Unfortunately patients often pay a terrible price in the form of extreme weight gain impaired glucose and limited metabolism and other manifestations of metabolic syndrome.

Joseph K. Belanoff: Unfortunately, cortisol-induced immune suppression limits the body's ability to kill tumor cells and blunts the efficacy of medications such as checkpoint inhibitors, which enlist the immune system to fight cancer. Therefore, modulating cortisol activity bolsters the immune system and may help checkpoint inhibitors and other immunotherapies achieve their full potential. This quarter, we are starting an open-label Phase 1b trial of relacoralin plus the PD-1 checkpoint inhibitor pembrolizumab, Merck's drug Keytruda, in 20 patients with advanced adrenocortical cancer. Because adrenocortical tumors produce cortisol, these patients also suffer from Cushing syndrome.

These adverse effects reduced patient adherence and post major health risks of their own for example, just by heart attack or stroke is common in patients taking anti psychotic medication cardiovascular diseases, the leading cause of death in patients with schizophrenia.

Cortisol modulators, a potent in animal models and anti psychotic induced weight gain more importantly, we've conducted three double blind placebo controlled clinical trials, which cortisol modulator meaningfully reduced weight gain and other metabolic adverse events caused by anti psychotic medications in two of these trials healthy.

Joseph K. Belanoff: Our trial will examine whether Relochlorone can, by reducing the effects of excess cortisol activity, treat these patients' Cushing syndrome and, by reversing cortisol-induced immune suppression, help Pembrolizumab achieve its maximum effect. We presented posters at this year's Virtual ASCO and AACR with preclinical and clinical biomarker data supporting this hypothesis. They are available under the Research and Pipeline Publications tab of our website.

Subjects received daily doses of either Elanzapine or risperidone, along with either mistress down the active ingredient in core 11 or placebo. So.

Subject to receipt korlym experienced significantly less weight gain and other metabolic adverse events and those who received placebo. These results were published in the journals advances in therapy and obesity in 2009 in 2010.

Unfortunately, we could not advanced Mr., Paris down because its qualities as an a board of fashion disqualified as a treatment for common disorders miracle oral and can be advance. However, because it is a selective cortisol modulator with no affinity for the PR. He just not the abortion pill and if approved could be widely distributed.

Joseph K. Belanoff: I will conclude with an update on our program in metabolic disease. As many of you know, we are developing a proprietary cortisol modulator, Miracorlant, as a treatment for antipsychotic-induced weight gain and nonalcoholic steatohepatitis, or NASH. Like Relocorrelant and Exocorrelant, Miracorrelant is a selective cortisol modulator, binding potently to GR, but not PR.

Last quarter, we completed a double blind placebo controlled phase one be trial in which healthy subjects receive elanzapine any the 600 milligrams of mirror coral at 900 milligrams of mirror correlate or placebo for 14 days study participants received mirror Cortland and significantly less way than those who received placebo. In addition, they exhibit.

Joseph K. Belanoff: Miracorrelant was safe and well tolerated in its Phase 1 trial. Millions of patients rely on antipsychotic medications to treat schizophrenia, bipolar disorder, major depression, and other serious illnesses. Unfortunately, patients often pay a terrible price in the form of extreme weight gain, impaired glucose and lipid metabolism, and other manifestations of metabolic syndrome. These adverse effects reduce patient adherence and pose major health risks of their own.

It significantly smaller increasing triglycerides and in the liver enzymes HST inhale T markers of liver damage that rise at the onset of Elanzapine therapy. The full results of this study will be published later this year.

Our double blind placebo controlled phase two trial, a mirror coral and Miro Cortland to reverse recent anti psychotic induced weight gain known as gratitude is in progress.

Joseph K. Belanoff: For example, death by heart attack or stroke is common in patients taking antipsychotic medication. Cardiovascular disease is the leading cause of death in patients with schizophrenia. Cortisol modulators are potent in animal models of antipsychotic-induced weight gain. Furthermore, we have conducted three double-blind placebo-controlled clinical trials in which a cortisol modulator meaningfully reduced weight gain and other metabolic adverse events caused by antipsychotic medication. In two of these trials, healthy subjects received daily doses of either olanzapine or risperidone, along with either mifepristone, the active ingredient in corallum, or placebo. Subjects who received Corallum experienced significantly less weight gain and other metabolic adverse events than those who received placebo. These results were published in the journals Advances in Therapy and Obesity in 2009 and 2010. Unfortunately, we could not advance Mifepristone because its qualities as an abortive method disqualify it as a treatment for common disorders.

One entre patients with schizophrenia will receive in addition to their established Joe's anti psychotic medication, you just 600 milligrams Americorp, Ireland or placebo for 12 weeks.

Attitude will be conducted at approximately 20 centers across the United States.

Pleased to announce that we've completed one quarter ahead of schedule development of a mirror correlate formulation available for use in phase three trials and beyond.

As a result, we have moved up the start of two additional mirror Chloroquins top trials. This quarter, we plan to start a placebo controlled double blind phase two trial in patients with long standing anti psychotic induced weight gain called gratitude to.

Our year end, we also plan to start a double blind placebo controlled phase two trial Miracle orland in patients with Nash serious liver disease that affects millions of patients.

In animal models Miracle, Arland fence and are versus both fatty liver and liver fibrosis, two precursors of Nash.

Core shift had a strong second quarter, we reaffirmed our revenue guidance, our cash and investments grew by $60 million to $410 million, our strong financial position allows us to advance our growing portfolio of drug candidates even in times of great uncertainty.

Joseph K. Belanoff: Miracloraline can be advanced, however, because it is a selective cortisol modulator with no affinity for the PR. It is not an abortion pill and, if approved, could be widely distributed. Last quarter, we completed a double-blind, placebo-controlled Phase 1b trial in which healthy subjects received lansipine and either 600 mg of miracloralant, 900 mg of miracloralant, or placebo for 14 days. Study participants who received Miracorlin gained significantly less weight than those who received placebo. In addition, they exhibited a significantly smaller increase in triglycerides and in the liver enzymes AST and ALT, markers of liver damage that rise at the onset of lansipine therapy.

Recently, our development programs to achieve significant milestones more are on the horizon.

Although the cobot 19 pandemic continues to slow enrollment and make site activation more difficult recruitment continues at 60 sites and Ralcorp Olin's pivotal Grace trial with an expected in D.A. submission in the second quarter 2022.

In addition, enrollment is now underway ingredient double blind phase three trial for a lot korlym in patients with Cushing syndrome from an adrenal origin and understand etiology of the disease.

Clinical trials and oncology, having less affected by the pandemic most likely because our study participants are so gravely hill, they must see treatment no matter. The conditions, we've completed enrollment in our controlled phase two trials relamorelin plus snap paclitaxel in patients with recurrent platinum resistant ovarian cancer.

Joseph K. Belanoff: The full results of this study will be published later this year. Our double-blind placebo-controlled Phase II trial of Miracloraline to reverse recent antipsychotic-induced weight gain, known as Gratitude, is in progress. 100 patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miracloraline or placebo for 12 weeks. Gratitude will be conducted at approximately 20 centers across the United States. I'm pleased to announce that we've completed one quarter ahead of schedule the development of a mirror-correlate formulation available for use in Phase III trials and beyond. As a result, we have moved up the start of two additional Miracle Rewinds trials.

We will have results in first half of next year.

Our phase three reliant trial umbrella Corlanor, plus Nab paclitaxel in patients with metastatic pancreatic cancer is underway, we expect to perform and interim analysis of data from alliance first 40 patients in the first half of next year. We believe sufficiently positive results from a lot for Lyons will qualify relamorelin for accelerator pre.

In this indication.

This quarter, we plan to start an open label phase one be trial umbrella korlym combined with the PD, one checkpoint inhibitor pembrolizumab to treat patients with advanced adrenal cancer. Finally by the end of this year, we expect to selected dose for advancement any controlled phase two trials Xplore, Ireland in combination with Enzalutamide to treat.

Joseph K. Belanoff: This quarter, we plan to start a placebo-controlled, double-blind, Phase II trial in patients with long-standing antipsychotic-induced weight gain called Gratitude II. By year-end, we also plan to start a double-blind, placebo-controlled Phase II trial of miracloraline in patients with NASH, a serious liver disease that affects millions of patients. In animal models, miracloraline prevents and reverses both fatty liver and liver fibrosis, two precursors of NASH.

Patients with castration resistant prostate cancer.

Program in metabolic diseases has also made significant gains enrollment in site activation of resumed.

Our double blind placebo controlled phase two trials mirror coral and to reduce recent anti psychotic induced weight gain although the cobot 19 pandemic continues to slow the pace of both activities completion formulation work in mirror correlate has allowed us to advance the start dates of our other planned trials gratitude to a double blind placebo.

Joseph K. Belanoff: Corcept had a strong second quarter. We have reaffirmed our revenue guidance. Our cash and investments grew by $60 million to $410 million.

Controlled phase two trial americorp in patients with longstanding anti psychotic induced weight gain is planned to start in the third quarter. We plan to start a double blind placebo controlled phase two trial americorps alone in patients with Nash on your end.

Joseph K. Belanoff: Our strong financial position allows us to advance our growing portfolio of drug candidates, even in times of great uncertainty. Recently, our development programs achieved significant milestones, and more are on the horizon.

I'll stop here for questions.

Okay.

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Joseph K. Belanoff: Although the COVID-19 pandemic continues to slow enrollment and make site activation more difficult, recruitment continues at 60 sites in Brella Chloralent's Pivotal Grace Trial with an expected NDA submission in the second quarter of 2022. In addition, enrollment is now underway in Gradient, a double-blind phase three trial of Brella Chloralent in patients with Cushing syndrome from an adrenal origin, an understudied eti Our clinical trials in oncology have been less affected by the pandemic, most likely because our study participants are so gravely ill. They must seek treatment no matter what the case. We have completed enrollment in our controlled Phase 2 trial of VrelochloroLent plus SNAP haplotaxil in patients with recurrent platinum-resistant ovarian cancer. We will have results in the first half.

Again, Please press star one to ask a question.

We'll pause momentarily to allow everyone in opportunity to signal for questions.

And we will take her first question this will come from Chris.

Howerton with Jefferies.

Great Good afternoon, and thanks for taking the questions. So I guess, maybe the first question might be on.

The quarterly numbers I think maybe Charlie just to confirm you know I think that you were saying that most of the discrepancy with respect to the refill rate can you just confirmed to us that you're seeing the same patient numbers there between the first and second quarter or some way for us to calibrate then underway.

Yeah sure.

We are well, where it's a it was a phenomenon that occurred in the first quarter, we didn't see it in the second quarter or are in July although our analysis of july's and complete yet.

Joseph K. Belanoff: Our Phase III Reliant trial of Relocorrelant plus napaclitaxel in patients with metastatic pancreatic cancer is underway, and we expect to perform an interim analysis of data from Reliant's first 40 patients in the first half of next year.

And so it isn't didnt reflect a drop off of patients or anything else. It is really patients worried about fedex delays, taking their refills a couple of days early so they'd have a little bit of extra medicine on hand, any or by shifting things up a few days what that ended up doing was shifting some stuff into Q1 and.

Joseph K. Belanoff: We believe sufficiently positive results from Reliant will qualify Relocorrelant for accelerated approval in this indication. Additionally, this quarter, we plan to start an open-label Phase 1b trial of Brella Chloralent combined with a PD-1 checkpoint inhibitor, Pembrolizumab, to treat patients with advanced adrenal cancer. Finally, by the end of this year, we expect to select a dose for advancement in a controlled phase 2 trial of exacorrelant in combination with enzalutamide to treat patients with castration-resistant prostate cancer. Our program in metabolic diseases has also made significant gains. Enrollment and site activation have resumed in our double-blind, placebo-controlled Phase 2 trial of Miraclorelant to reduce recent antipsychotic-induced weight gain, although the COVID-19 pandemic continues to slow the pace of both activities. Completion of formulation work for Miraclorelant has allowed us to advance the start dates of our other planned trials. Gratitude 2, a double-blind, placebo-controlled, phase 2 trial of miraclorelant in patients with long-standing antipsychotic-induced weight gain, is planned to start in the third quarter. We plan to start a double-blind, placebo-controlled, phase 2 trial of miraclorelant in patients with NASH by year end. I'll stop here for questions.

In other stuff you know that would've been in Q2, and that's all that was going on so so you know just giving our sort of average dose and and price per tablet and so forth. You can think of it is about about 80 to 100 patients something like that.

Okay and those patients remain on medicine, there's nothing no interruption in their care at all [laughter].

Excellent, Okay, and then with respect to the pancreatic cancer trial.

Just curious is a duration of response would be part of the analysis and if so you know what what in your view, Joe or Andre. This would you see is clinically meaningful in this patient population.

Yeah, Chris and thanks. Thanks for the question good to talk to you, yes, certain certainly duration of response is important annual we're looking at all of those variables now. The second question. You've asked is a harder one because it because in some sense. You know these there's about the sickest patients you get an oncology I think as I said before you know.

Sadly, we had patients who.

Passed away in the earlier study between each time they consented in their first dose so how long their responses last.

It is difficult to assess the expectations for longevity are quite low and I think actually one of the things that was impressive in this study that has already being completed its if there were several patients whose duration of response and sees control went out far longer than what's an expected you know a couple of them.

Unknown Executive: Thank you. If you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Again, please press star 1 to ask a question. We will pause momentarily to allow everyone an opportunity to signal for questions, and then we will take our first question. This will come from Chris Howerton with Jeffries.

Got to duration of a year. So I don't have a from number for you but that is a variable that is consequential and I'm certain that the same way we will look at at the FDA, we'll look at it as well.

Got it okay.

And then perhaps a this isn't naive question I apologize, but just curious how we should think about the safety database is for relic coil and you know utilization within in oncology setting relative to Cushing syndrome, and how that may or may not impact any kind of view from a regulatory.

Chris Howerton: Great. Good afternoon, and thanks for taking the questions. So, I guess maybe the first question might be on the quorum numbers. So, I think maybe, Charlie, just to confirm, you know, I think that you were saying that most of the discrepancy was with respect to the refill rate. Can you just confirm to us that you're seeing the same patient numbers there between the first and second quarters, or is there some way for us to calibrate that in another way?

Perspective.

Well.

No I know that you have noticed Chris but all of the data for Relet correlate becomes part of the safety package for everything that you do.

And and its and so.

Charlie Rove: Yeah, well, sure, yeah, we are. It's a phenomenon that happened in the first quarter. We didn't see it in the second quarter or in July, although our analysis of July isn't complete yet. And so it didn't reflect a drop-off of patients or anything else. It is really patients worried about FedEx delays, taking their refills a couple of days early so they'd have a little bit of extra medicine on hand. And, you know, by shifting things up a few days, what that ended up doing was shifting some stuff into Q1 and then other stuff, you know, that would have been in Q2. And that's all that was going on. So, you know, just giving our sort of average dose and, you know, price per tablet and so forth, you can think of it as about 80 to 100 patients, something like that.

It gets counted together in that way I think the difference.

But some diseases that you had two diseases, where for instance, the risk profile disease was very different you can understand that there would be certain you probably wouldn't you just smaller safety database and you probably would be able to tolerate.

Worse adverse event profile, if the disease was more severe now really from our perspective Cushing syndrome, and the oncology diseases that we're talking about really also severe diseases and we actually think safety profile would be looked at roughly in the same way.

Okay. Okay, very good and you know maybe one more question inside me.

Just curious what what has been your experience with respect to medication compliance in the anti psychotic induced weight gain and kind of how you view that in terms of you know combination strategies with multiple or oral therapies for patients that that may be taking.

Charlie Rove: And those patients remain on medicine. There's nothing, no interruption in their care at all.

Charlie Rove: Excellent

Joseph K. Belanoff: Okay, and then with respect to the pancreatic cancer trial, just curious if duration of response would be part of the analysis, and if so, you know, what, in your view, Joe or Andreas, would you see as clinically meaningful in this patient population?

Got it it's got excuse me that's actually a oppression question because you know as a psychiatrist myself I can tell you that.

Joseph K. Belanoff: Yeah, Chris. Thanks for the question. It's good to talk to you.

Patient adherence to regimens is not a 100% and so I can't give you actually any data that study that were actually running is still in progress right now, but we'll I think have a better sense of that as we go up because we look at PK measures, we know where people stand and so forth but.

Joseph K. Belanoff: Yes.

Joseph K. Belanoff: Certainly, duration of response is important. I mean, we're looking at all of those variables.

Joseph K. Belanoff: Now, the second question you've asked is a harder one, because in some sense, you know, these are about the sickest patients you get in oncology. I think, as I said before, sadly, we had patients who passed away in the earlier study between the time they consented to their first dose. So how long their responses last is difficult to assess. The expectations for longevity are quite low, and I think, actually, one of the things that were impressive in the study that has already been completed is that there were several patients whose duration of response and disease control went on far longer than was expected. You know, a couple of them went out for the duration of a year. So I don't have a firm number for you, but that is a variable that is consequential, and I'm certain in the same way we will look at it, the FDA will look at it as well.

Gives me an opportunity for some I want to just be a little bit tangential just so people understand it I know you do because you're much more steeped in the story, but what we've been able to show. So far is that first corollary, but now specialty mirror coral. It is clearly active in an anti psychotic induced weight gain model, we've given healthy people anti.

Psychotic medication really pretty potent ways in a short period of time, we can see that we reduced the effects adverse metabolic effects of anti psychotic medication. The studies that were now conducting a really our first studies in patients and so you've asked one of the questions, which is important but there are other questions you know that relate to the epic.

Joseph K. Belanoff: [inaudible]

Joseph K. Belanoff: Okay, and then, you know, perhaps this is a naive question, I apologize, but I was just curious how we should think about the safety databases for relacorelant, you know, utilization within an oncology setting relative to Cushing syndrome and how that may or may not impact any kind of view from a regulatory perspective.

C of the medication that we'll get our first pieces of information on next year, obviously, we're excited and optimistic about it but I just want to draw a difference between what we've seen so far which is good medicine activity in animals and healthy people and how excited we are to actually see what happens in patients and to return to your question ability to hear the regimen is.

Joseph K. Belanoff: Well, you know, I know that you know this, Chris, but all of the data for Rella Chloralent becomes part of the safety package for everything that you do. And so, you know, it gets counted together in that way. I think the difference, you know, with some diseases is that you have two diseases where, for instance, the risk profile of the disease is very different. You can understand that there would be certain, you probably would need a smaller safety database, and you probably would be able to tolerate a worse adverse event profile if the disease was more severe. Now, really, from our perspective, Cushing syndrome and the oncology diseases that we're talking about are really all severe diseases, and we actually think that the safety profile would be looked at roughly in the same way.

Also a meaningful thing that we will we will observe.

Sure Okay, well. Thank you so much and I'll hop back in the queue and indicates that maybe phone questions are available. Thanks again for pick up at night Nice to talk you heard us. Thank you. Okay. Thanks again.

Yeah.

And we will take or next question. This will come from Matt Kaplan with Ladenburg Thalmann.

Hi, guys. Thanks for taking my questions I just wanted to follow up on Chris' question with respect to the reliance study with on the interim analysis of 40 patients. What do you. What are you looking to see there and what would what would kinda represent a go no go.

Decision that on that interim about half the patients you plan.

Joseph K. Belanoff: Okay, okay, very good. And, you know, maybe one more question, if I may. Just curious what your experience has been with respect to medication compliance for antipsychotic-induced weight gain and kind of how you view that in terms of, you know, combination strategies with multiple oral therapies for patients that might be taking psychotics or antipsychotics.

Yes, we we don't have affirmed no go go level. There you know again as it started out by saying the response rate was really presumed to be zero or very close to it for patients with pancreatic cancer I can tell you at extreme numbers, obviously it almost all the people.

Had a tumor shrinkage that would be a fantastic results and if none of them do we'll expect gives us something as well.

Joseph K. Belanoff: That's actually a prescientious question because, you know, as a psychiatrist myself, I can tell you that patients' adherence to regimens is not 100 percent. And so I can't give you actually any data. That study that we're actually running is still in progress right now, but we'll, I think, have a better sense of that as we go along because we look at PK measures, we know where people stand, and so forth. But, you know, it gives me an opportunity, Chris, to just be a little bit tangential just so people understand it. I know you do because you're much more immersed in the story.

I think that.

This is one disease, where even a modest response rate I think would be viewed positively back practitioners, but beyond that.

I don't really have any more information than that for you.

Okay, and then a similar in terms of the phase two study, where and cotton resistant ovarian cancer, Yes, you complete enrollment data coming in and the first half as well.

What what are some the benchmarks there that that that we should be looking for.

Joseph K. Belanoff: But what we've been able to show so far is that first chloraline, but now especially miracloraline, is clearly active in an antipsychotic-induced weight gain model. We've given healthy people antipsychotic medication in really pretty potent ways, and in a short period of time, we can see that we've reduced the adverse metabolic effects of antipsychotic medication. The studies that we're now conducting are really our first studies in patients, and so you've asked one of the questions, which is important, but there are other questions, you know, that relate to the efficacy of the medication that we'll get our first pieces of information on next year. Obviously, we're excited and optimistic about it, but I just want to draw a difference between what we've seen so far, which is good activity in animals and healthy people, and how excited we are to actually see what happens in patients. To return to your question, ability to adhere to the regimen is also a meaningful thing that we will observe.

Yes, you know again this this is.

A dire illness, not probably to the degree the pancreatic cancer is but I'll give you sort of rough numbers for sort of how the study is powered Hum, we expect that theres about for Nab Paclitaxel alone about a three and a half a month average period for progression free survival.

And we're powering our study to add about another three months to that.

Okay, that's very helpful.

Great. Thank you and then I'm just.

Shifting to too because the Grace study.

What's really now that the rate limiting step for filing the N D. A day or in the second quarter of 2022 is it the accretion of the Grey study or there is there another moving part there that you need to yep.

Joseph K. Belanoff: Sure. Okay. Well, thank you so much, and I'll hop back in the queue in the case that maybe follow-up questions are available. Thanks again for taking the time to help us. Nice to talk to you, Chris. Thank you. Okay. Thanks again, Joe.

That's it Matt that everything else should be ready to go before that.

Okay and.

And then.

Last question I guess, maybe more for Charlie on the litigation just to be clear in terms of that the next I'm kind of announcement.

We're expecting on on that have a lawsuit will be a decision a in November of this year.

Chris Howerton: And we will take our next question, which will come from Matt Kaplan with Lattenberg Thalmann.

Matthew Lee Kaplan: Hi guys, thanks for taking my questions and just wanted to follow up on Chris's question with respect to the Reliance study. On the internal analysis of 40 patients, what are you looking to see there, and what would kind of represent a go, no-go decision?

Oral arguments on the P.T. I'd is that correct.

As far as litigations concerned yeah, I mean, there's it's the November November 19th as the scheduled date and I would expected to be you know plus or minus a day or two from their trials in February and the one other date. That's significant has already passed which just to remind folks you know when we suits ever back in March of two.

Joseph K. Belanoff: Yeah, we don't have a firm notion yet.

Joseph K. Belanoff: Go, LeBorg. Go, LeBorg.

Joseph K. Belanoff: I'll start off by saying the response rate was really presumed to be zero or very close to it for patients with pancreatic cancer. You know, I could tell you the stream numbers, obviously, if almost all of the people had a tumor shrinkage, that would be a fantastic result. And if none of them do, well, that gives us something as well. I think that this is one disease where even a modest response rate would be viewed positively by practitioners. But beyond that, you know, I don't really have any more information than that for you.

Thousand 18, our lawsuit instituted a 30 months stay of FDA approval of Tevas product or final approval and that stay expired midnight August 1st this weekend, so as far as the F.D.A. is concerned tevas frieson watches product at risk with <unk>.

I have no evidenced they've done so I've not seen it.

And I, yes from a business perspective, I think it makes it doesn't make sense for tend to do that they'd be at risk of treble damages in them and they were going to go on to lose their case with us So it's not.

Joseph K. Belanoff: Okay, okay, very good. And then, similar in terms of the Phase 2 study in platen-resistant ovarian cancer. Yes. Now you have complete enrollment data coming in the first half as well. What are some of the benchmarks there that we should be looking for?

And eventuality I expect although of course I'm not the type of manager and I don't get to decide.

Joseph K. Belanoff: Yes, you know, again, this is a dire illness, not probably to the degree that pancreatic cancer is, but I'll give you some rough numbers for sort of how the study is powered. We expect that there is about, for NAPA-Aquitaxel alone, about a three-and-a-half-month average period for progression-free survival, and we're powering our study to add about another

So and and we are ready to we're ready to respond to them no matter, what they do but in terms of getting a full calendar in front of people. There's a date in the past that they should also just be aware of.

Fair enough and then similarly with the with the Sun Oh Litigation you mentioned the ended December 2021, and then I guess currently before that this year the markman hearing as Ah, yes, as as times like that that we should expect and <unk>.

Matthew Lee Kaplan: Okay, great. That's very helpful. Thank you. And then just, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. What's the rate-limiting step for filing the NDA in the second quarter of 2022? Is it the completion of the GRACE study, or is there another moving part there that you need to... Yeah, that's it, Matt.

And in in terms of other things that we should here out of some litigation are those the to.

Kind of dates that we should expect.

Yes.

Okay, well, thanks for taking my question.

Yeah, Matt good good to hear anybody if I could just added revised and extend my response to Chris briefly about the revenue blip, because I know its little bit of an abstract concept.

Joseph K. Belanoff: Everything else should be ready to go before then.

Charlie Rove: Okay, fair enough. And then last question, I guess maybe more for Charlie on the litigation. Just to be clear in terms of the next kind of announcements we're expecting on the Teva lawsuit will be a decision in November of this year from the oral arguments on the PTAV, is that correct?

I really was it pains to make sure people could follow what happened just want a another way to look at it and when everyone to understand we are right you know with six months of the you're down halfway through we're right, where we expected to be which is why we can reiterate our guidance. So a you know as explain kind of the movement of a refill from one quarter to the other by a few days in the impact of that.

Charlie Rove: As far as the litigation is concerned, yeah, I mean, it's the November 19th, the scheduled date, and I would expect it to be, you know, plus or minus a day or two from their trials in February. And, you know, the one other date that's significant has already passed, which just, you know, to remind folks, you know, when we sued Teva back in March of 2018, our lawsuit instituted a 30-month stay of FDA approval of Teva's product or final decision. And that stay expired midnight, August 1st, this weekend. So, as far as the FDA is concerned, Teva is free to launch its product at risk. I have no evidence they've done so; I've not seen it. And from a business perspective, I think it doesn't make sense for Teva to do that.

I understand that at the halfway mark of the year. The net result of as all is that we are where we expected to be.

I want to make that clear with folks.

And we can take our next question this will come from Swayampakula Ramakanth with H.C. Wainwright.

Thank you.

But starting with Korlym for one.

One question and then I have.

A couple of pipeline ones on the Korlym it smells.

Regarding the uptick on time, Sagicor, explaining a well that's what's been going on during the second quarter.

Charlie Rove: They'd be at risk of treble damages in the event that they were going to go on to lose their case with us, so it's not an eventuality I expect, although, of course, I'm not the Teva manager, and I don't get to decide. So, and we are ready to respond to them no matter what they do. But in terms of getting a full calendar in front of people, there's a date in the past that they should also just be aware of.

But my question is on the third quarter, how how do you see things are moving along just cut in corn on the Q3.

For the for the last a month or so.

Well, so I'm just.

Just a his background for folks and <unk>, we provide annual revenue guidance, you know not quarterly revenue guidance and at the the started the year. We our guidance range was 355 million to $375 million in that and that's still the case and so I can't really give you any particulars beyond saying that you know we're.

Charlie Rove: And then, similarly, with the Sun litigation, you mentioned the end of December 2021 and, I guess, before that, this year, the Markman hearing as times that we should expect. And in terms of other things that we should hear out of the Sun litigation, are those the two kinds of dates that we should expect?

Really within that that case in that range and that's that's what we're seeing seen now.

Okay. Thank you and then on on the.

So for gradient, just which is or adrenal hyperplasia.

Charlie Rove: Yes.

Matthew Lee Kaplan: Well, thanks for taking my questions, guys.

Charlie Rove: Yeah, Matt. It's good to hear from you.

Is there any expectation up an interim analysis.

Charlie Rove: And if I could just add, revise, and extend my response to Chris briefly about the revenue blip. Because I know it's a little bit of an abstract concept, and I really was at pains to make sure people could follow what happened. I just wanted another way to look at it and want everyone to understand. We are right. With six months of the year down, halfway through, we are right where we expected to be, which is why we could reiterate our guidance. So, as he explained, kind of the movement of a refill from one quarter to the other by a few days and the impact of that. And understand that at the halfway mark of the year, the net result of it all is that we are where we expected to be. I just want to make that clear with folks.

Yeah, and also you know.

Could you give us a little bit off a little bit of an idea.

Due to expectations.

From this study.

Ah, Yes, I can I think I can answer your questions RK.

The answer is no we're not expecting to do a great an interim analysis, but just for the whole group <unk>, let me explain a little bit more about the study.

I think as probably.

At this point anyone his father company knows Cushing syndrome is very severe illness, and it's difficult to do a standard double blind placebo controlled study because placebo is really not perceived and I would certainly share at this point of view really work at all it's very difficult for investigators to accept to study like that it's difficult.

Swayampakula Ramakanth: And we can take our next question, which will come from Swayampakula Ramakanth with H.C. Wainwright.

For their higher Beast of except to study like that.

And so you know that's that's background now.

Charlie Rove: Thank you. Let's start with the quorum for one question, and then I have a couple of pipeline ones. On the quorum itself, regarding the uptake, thanks, Charlie, for explaining what has been going on during the second quarter. But my question is about the third quarter. How do you see things moving along in this current quarter, Q3, for the last month or so?

It's been increasingly.

Discovered in the last 10 years that were once thought to be perhaps you know sort of derisively called incidental omas or officially adrenal adenomas really are a serious medical problem overtime, but many of these patients at this point are treated for their symptoms, they're treated for their blood for their blood Glu.

Charlie Rove: Well, just as a background for folks, we provide annual revenue guidance, not quarterly revenue guidance. And at the start of the year, our guidance range was $355 million to $375 million, and that's still the case. And so I can't really give you any particulars beyond saying that we're still comfortably within that range and that range, and that's what we're seeing now.

Close abnormalities for their hypertension for infections that they get but they're not necessarily treated for hyper cortisol or something but as the field has really gotten more and more of edits. If these patients are really patients who are deserving of hyper for us all this and treatment really came up with the idea since none it ever.

And done that it was possible to do the first and I think really definitive study on treating patients for hyper cortisol ASM with a cortisol modulating agent in this case with relic correlate and that investigators since they werent already treating these patients in many cases for hyper quarters all of them, but we're just treating symptoms of around.

Swayampakula Ramakanth: Okay, thank you. And then on the pipeline. So for gradient, which is for adrenal hyperplasia, is there any expectation of an interim analysis? And also, could you give us a little bit of an idea of the data expectations from the study?

Joseph K. Belanoff: Yes, I think I can answer your questions, R.K. The answer is no; we're not expecting to do an interim analysis. But just for the whole group, let me explain a little bit more about the study. I think, as probably anyone who's part of the company knows, Cushing syndrome is a very severe illness, and it's difficult to do the standard double-blind placebo-controlled study because placebo is really not perceived, and I would certainly share this point of view, to really work at all. It's very difficult for investigators to accept a study like that. It's difficult for their IRBs to approve a study like that. And so, you know, that's the background.

Around this would accept the idea that we could do a double blind study and that's exactly what we're dealing with doing sort of gold standard double blind placebo controlled study for 22 weeks at that point, we'll break the blind and we'll see how how we did this disorder. We think that obviously that we have a lot of confidence that is that the.

We will work well and we the main reason really we embarked on this is because so many people in the field said now that we know this is a problem really see if you can create a study that will give us confidence to treat it.

Joseph K. Belanoff: It's been increasingly discovered in the last 10 years that what were once thought to be perhaps derisively called incidentalomas, or officially adrenal adenomas, really are a serious medical problem over time. But many of these patients at this point are treated for their symptoms; they're treated for their blood glucose abnormalities, for their hypertension, for infections that they get, but they're not necessarily treated for hypercortisolism. But as the field has really gotten more and more evidence that these patients are really patients who are deserving of hypercortisolism treatment, we really came up with the idea, since none had ever been done, that it was possible to do the first and, I think, really definitive study on treating patients for hypercortisolism with a cortisol-modulating agent, in this case, Reliquorolant.

It's the second question. Please please repeat.

RK I think a lost it there.

I was just wondering if there's any.

Interim analysis or.

Oh interim analysis.

Yeah.

Yeah. Okay. So my next question is on.

Uh huh, what's the patient population.

For metastatic I'm just a couple of then they'll cancer.

That does caused due to excess cortisol production.

What does the population. So these are pediatric patients with adrenal cancer.

And a renal cancer is itself a rare disease, but a fair percentage of the people with adrenal cancer also have Cushing syndrome, because they're tumors produce cortisol and again. This is for those of US a followed us for very long time and the study that we used to get Korlym approved we called the seismic.

Joseph K. Belanoff: And that investigators, since they weren't already treating these patients, in many cases, for hypercortisolism but were just treating the symptoms around it, would accept the idea that we could do a double-blind study. And that's exactly what we're doing. We're doing sort of the gold standard, double-blind, placebo-controlled study for 22 weeks. At that point, we'll break the blind, and we'll see how we did with this disorder. We think that, obviously, we have a lot of confidence that it will work well. The main reason we embarked on this is that so many people in the field said, now that we know this is a problem, really see if you can create a study that will give us confidence to treat it. Second question, please repeat that, RK, I think I lost it there.

Study, we had patients with amongst other etiologies Cushing syndrome patients with adrenal cancer and Korlym was equally effective in reducing the symptoms of Cushing syndrome in those patients.

Which is very meaningful to them, although it did not treat their cancer.

One of the things, which happened after that study was the advent of immunotherapy, but unfortunately immunotherapy has had very poor responses in adrenal cancer, where cortisol production is part of the picture.

And so again, because we have.

Quite a few academic connections with people, who treat adrenal cancer. The idea came 'cause it could you improve the response to immunotherapy and treat these people's Cushing syndrome, the effects of hyper cortisol ism by adding cortisol modulating agent like relic correlate to a drug like Kate.

Swayampakula Ramakanth: I was just wondering if there is any interim analysis or any...

Joseph K. Belanoff: [inaudible]

Swayampakula Ramakanth: Yeah. Yeah. Yeah. Okay. So, the next question is on... What's the patient population for metastatic unreceptable adrenal cancer that is caused due to excess cortisol production?

Trued up and that's the study that we're doing so very excited to give that a try but if I was to order. It what I would say and I think what really made it passed on our bar is.

Joseph K. Belanoff: What is the population? So these are patients with adrenal cancer, and adrenal cancer is itself a rare disease, but a fair percentage of people with adrenal cancer also have Cushing's syndrome because their tumors produce cortisol. And again, this is for those of us who have followed us for a very long time. In the study that we used to get Corleum approved, which we called the seismic study, we had patients with, amongst other etiologies of Cushing's syndrome, patients with adrenal cancer, and Corleum was equally effective in reducing the symptoms of Cushing's syndrome in those patients, which was very meaningful to them, although it did not And so, again, because we have quite a few academic connections with people who treat adrenal cancer, the idea came to you: could you improve the response to immunotherapy and treat these people's Cushing syndrome, the effects of hypercortisolism, by adding a cortisol modulating agent like relacoralant to...

Great deal of confidence that we will treat these patients Cushing syndrome, and that has great benefit to them.

We also now hoping there certainly are testing to see we can actually improve their cancer by improving the efficacy of fee at this point not very well working immunotherapy.

Okay. Thank you. Thank you booked for taking my questions.

Yeah, good to talk to you are today.

And we will take our final question in queue. This will come from Alan Leone with Biowatch news.

Hey, Joe well internally.

Hello, good to hear the progress on all fronts.

The first question can you.

Can you provide some color on the competitive profile for June or out of Nomura.

I can't imagine, it's the same with traditional crushing some of them korlym competitors.

Our even in the ballpark computing.

Disease, I, maybe wrong on that but if you could provide some color.

Yeah, I think that's very important then you're you're making it an important distinction I think that sometimes its overlook so just a backup a little bit Cushing syndrome comes from the activity of cortisol, so higher cortisol activity causes hyper cortisol Ism and Cushing syndrome really comes from two different sources.

Joseph K. Belanoff: a drug like K-TRUDA, and that's the study that we're doing. So we're very excited to give that a try. But if I were to order it, what I would say, and I think what really made it pass on our bar, is we have a great deal of confidence that we will treat these patients with Cushing syndrome, and that has great benefit to them. We also now hope, and are certainly testing, to see if we can actually improve their cancer by improving the efficacy of the, at this point, not very well working immunotherapy.

As one adrenal tumors that produce cortisol or too easy T.H. tumors, which stimulates the body to produce excess cortisol easy th tumors, which are found in the pituitary gland or call cushings disease and that is a subset of patients with Cushing syndrome.

Now the interesting thing as I said before about Cushing syndrome caused by adrenal tumors is that although it was always recognized as part of the a part of Cushing syndrome. The amount of people with Cushing syndrome caused by adrenal tumors and the pathology and morbidity of adrenal tumors.

Swayampakula Ramakanth: Okay, thank you. Thank you both for taking my questions.

Joseph K. Belanoff: Yeah, it's good to talk to you, R&D.

Alan Leong: And we will take our final question in queue. This will come from Alan Leong with BioWatch.

Alan Leong: Hey Joe, Charlie.

Joseph K. Belanoff: Hello. Hello. Hello.

Joseph K. Belanoff: Hello, It's good to hear the progress on all fronts.

Joseph K. Belanoff: You know, the first question, can you... Can you provide some color on the competitive profile for adrenal adenoma? I can't imagine it's the same as traditional Cushing. Some of those common competitors aren't even in the ballpark for treating adrenal-based diseases. I may be wrong on that, but if you could provide some color.

It really only recently come forward in the last decade prior to that these for tumors that were sometimes picked up on scans for other things and doctors didn't know what to do with them and so forth. The interesting thing about that is that wall measures like urinary free cortisol can pick up cases, a very severe cushing since.

Joseph K. Belanoff: Yeah, I think that that's very important, and you're making an important distinction I think that, you know, sometimes is overlooked. So, just to back up a little bit, Cushing's Syndrome comes from the activity of cortisol, so higher cortisol activity causes hypercortisolism, and Cushing's Syndrome really comes from two different sources, one, adrenal tumors that produce cortisol, or two, ECTH tumors, which are found in the pituitary gland, are called Cushing's Disease, and that is a subset of patients with Cushing's Syndrome. Now, the interesting thing, as I said before, about Cushing syndrome caused by adrenal tumors is that, although it was always recognized as part of Cushing syndrome, the number of people with Cushing syndrome caused by adrenal tumors and the pathology and morbidity of adrenal tumor Prior to that, these were tumors that were sometimes picked up on scans for other things, and doctors didn't know what to do with them, and so forth.

Pro forma.

From a topic easy th producing tumors are cushings disease, they often do not pick up Cushing syndrome that are caused by adrenal adenomas.

During the latter Noam is far more commonly picked up in its recommended by the book to European American guidelines to use a different tests DEXA methicillin suppression tests to begin your analysis of whether somebody has Cushing syndrome caused by a Trina latter noma and of course, you have to image and adrenal adenomas, but the bottom line is that korlym.

For instance is approved for the treatment of all etiologies of Cushing syndrome. Other drugs for instance, a drug I know you're familiar with Cigna for proof only for Cushings disease. The subset of patients that have to rytary tumors that produce a C.T.H. The in the end cost Cushing syndrome, adrenal Adenomas really are.

Joseph K. Belanoff: The interesting thing about that is that while measures like urinary-free cortisol can pick up cases of very severe Cushing syndrome from ectopic ACTH-producing tumors or Cushing's disease, they often do not pick up Cushing syndrome that is caused by adrenal adenomas. Adrenal adenomas are more commonly picked up, and it's recommended by the book European American Guidelines to use a different test, the dexamethasone suppression test, to begin your analysis of whether somebody has Cushing syndrome caused by an adrenal adenoma. And, of course, you have to image an adrenal adenoma. But the bottom line is that Corleum, for instance, is approved for the treatment of all etiologies of Cushing syndrome. Other drugs, for instance, a drug I know you're familiar with, Signifor, are approved only for Cushing's disease, the subset of patients that have pituitary tumors that produce ACTH that, in the end, cause Cushing syndrome.

Certainly the newest frontier not that there are new disease, but I think that they're they're morbidity and the seriousness of the morbidity is really a last decade event and as a consequence, you know it's really the leaders in cortisol treating diseases. We've had a lot of interest in this and this was really the first opportunity to again combined.

And kind of the gold standard.

Study design with a disease that really was badly in need of further study.

Yes.

Oh switch gears and given to the pancreatic <unk> trial, Oh, yeah, congratulations with launching that.

Yeah, there's lots in clinical trials out there.

Our pancreatic cancer are you getting you feel about the reception for reliant Tropic clinical sites and many of the reliance side, where they offer you will be ovarian cancer trial.

Joseph K. Belanoff: So adrenal adenomas really are sort of the newest frontier, not that they're a new disease, but I think that their morbidity and the seriousness of the morbidity are really events of the last decade. And as a consequence, you know, as really the leaders in cortisol-treating diseases, we've had a lot of interest in this. And this is really the first opportunity to, again, combine kind of the gold standard study design with a disease that really was badly in need of further study.

Let me again, let me just asked that question more broadly.

In this pandemic.

Clinical trial enrollment has really been broiled as you know not just for a course up for every company that does clinical trials. It was really very interesting to see how it divided up because at this time our portfolio really covers many different diseases and the interesting thing was the most severe diseases like.

Joseph K. Belanoff: I want to switch gears and get into the pancreatic Reliant trial and congratulations on launching that. There are lots of clinical trials out there for pancreatic cancer. Are you getting any feeling about the reception for the Reliant trial at the clinical sites? And are many of the Reliant sites, were they also used for the ovarian cancer trial?

As an example, metastatic platinum resistant ovarian cancer continue to enroll briskly right through all of this these patients really need care that life expectancy ashore, they're coming to the hospital anyway, they're getting enrolled in clinical trials. The other end of the spectrum something like anti psychotic induced weight gain.

Joseph K. Belanoff: Again, let me just answer that question more broadly.

Which is often a chronic illness doesn't kill people tomorrow.

Joseph K. Belanoff: In this pandemic,

Joseph K. Belanoff: Clinical trial enrollment has really been royal, you know, not just for Corcept but for every company that does clinical trials. It was really very interesting to see how it split up, because at this time, our portfolio really covers many different diseases.

Yes priority was put on a rolling in that sort of study and of course, all the companies you follow you can.

Figure out those things as she goes through them pancreatic cancer in I think everyone's estimation is really in the severe end of the spectrum and we think that these patients will enter clinical trials there.

Joseph K. Belanoff: And the interesting thing was that the most severe diseases, like, as an example, metastatic platinum-resistant ovarian cancer, continue to grow briskly right through all of this. These patients really need care. Their life expectancy is short. They're coming to the hospital anyway.

At the stage disease were talking about there arent a whole lot of other proven efficacy proven proven drugs with efficacy and we think those that fit that study will enroll at relative to others quite a brisk pace and we are confident that we will enroll the first half of the trial and it's in a quick enough period of time to be.

Joseph K. Belanoff: They're getting enrolled in clinical trials. You know, at the other end of the spectrum, something like antipsychotic-induced weight gain, which is often a chronic illness that doesn't kill people tomorrow, less priority is put on enrolling in that sort of study. And, of course, all the companies you follow figure out those things as you go through them.

Able to give out results in the first half next year.

No that's great. Thank you.

[noise] or I will thank you very much thanks for everybody and hoping that by the time, we see you again in November things will be a little bit more open will be a little bit more back to normal but in the meantime, really everybody stay healthy and and we'll we'll report progress as we make thank you very much.

Joseph K. Belanoff: Pancreatic cancer, in I think everyone's estimation, is really in the severe end of the spectrum, and we think that these patients will go into clinical trials. There's, at the stage of disease we're talking about, there aren't a whole lot of other proven drugs with efficacy. And we think that that study will enroll, relative to others, at quite a brisk pace. And we are confident that we will enroll the first half of the trial in a quick enough period of time to be able to give out results in the first half of next year.

This concludes today's call. Thank you for your participation you may now disconnect.

[noise].

Joseph K. Belanoff: That's great. Thank you.

Unknown Executive: All right, well, thank you very much. Thanks for everybody, and I hope that by the time we see you again in November things will be a little bit more open, we'll be a little bit more back to normal, but in the meantime, really, everybody stay healthy, and we'll report progress as we make it. Thank you very much.

Unknown Executive: This concludes today's call. Thank you for your participation. You may now disconnect.

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