Q2 2021 Corcept Therapeutics Inc Earnings Call
Good day, Thank you for standing by and work on and that's of course job at Sharp Your next conference call.
Operator: Thank you for standing by, and welcome to the Corsep Therapeutics Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during that session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. Thank you. I would now like to hand the conference over to your speaker today. Mr. Adabag-McCari, the floor is yours.
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And the.
I would now like to hand, the conference over to your speaker today, Mr. You're out of Voc Mccarty the floor is yours.
Atabak Mokari: Thank you. Good afternoon, and thank you for joining us. I'm Adabak Makari, Korsetsch, Chief Financial Officer. Today we issued a press release announcing our financial results for the
Thank you good afternoon, and thank you for joining us I'm out of Ireland of course, as Chief Financial Officer Today, We issued a press release announcing our financial results for the second quarter and providing a corporate update.
Atabak Mokari: Our financial results for the second quarter and providing a corporate update. A copy is available at courseup.com.
And copy is available of course on cycle, our complete financial results will be available when we file our form 10-Q with the SEC.
Atabak Mokari: Our complete financial results will be available when we file our Form 10Q with us. Today's call is being recorded. A replay will be available in the Investors Pass under the events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risk and uncertainties which might cause actual results to defer materially from those such statements express or impact.
This call is being recorded a replay will be available on the investors' past events tab of our website.
Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations.
And are subject to risks and uncertainties, which may cause actual results to differ materially from those such statements expressed or implied.
Atabak Mokari: 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 Corlum, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Corlum and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversights, and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on our physicians, patients, insurers, regulators, and the practice of medicine general. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's, On this call, forward-looking statements include those concerning the safety, efficacy, and other clinical and commercial attributes of Ellicorlin, Echicorlin, Miracorlin, Corp, 113-176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hyper-chortisolome, anti-psychotic-induced weight gain, amythropic lateral sclerosis, or ALS, and other disorders.
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 and our commercial operations.
And development programs, the availability of competing treatments, including generic versions of Korlym and the initiation or outcome on litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for korlym and risks related to the development of our product candidates, including their clinical attributes and regulatory approvals mandates oversights and other requirements.
And the impact of the COVID-19, pandemic, our employees consultants and vendors as well as on our physicians patients and chairs regulators and the practice of medicine generally.
These and other risks are set forth on our SEC filings, which are available at our website and the SEC's website.
And on this call forward looking statements include those concerning the safety.
Efficacy and other clinical and commercial attributes of Ela Korlym extra Cortland mirror Korlym Cort 113 hundred 76, and our other selective cortisol modulators for the treatment of patients with solid tumors liver disease hyper cortisol and.
Psychotic induced weight gain amyotrophic lateral sclerosis, or ALS and.
And other disorders, the progress enrollment timing design and results of our clinical trials, our revenue guidance cash flow and expected growth.
Atabak Mokari: The progress, enrollment, timing, design, and results of our clinical trials, our revenue guidance, cash flow, and expected growth, our stock repurchase program and its intended funding sources, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, positions, payers, and patients, and expectations regarding our financial performance and clinical development programs after the COVID-19 pandemic, Timing, cost, and outcome of the litigation, including our lawsuits against Teva and Hickma Pharmaceuticals, Tevah's appeal of its defeat in the post-crant review have brought before the Patent Trial and Appeals Board, known as PTAB, and our settlement of litigation with some pharmaceuticals, as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation. We disclaim any intention or duty to update forward looking.
<unk> repurchase program and its intended funding sources the impact of the COVID-19 pandemic on our commercial operations and actual performance clinical development programs, and physicians payers and patients and expectations regarding.
Our financial performance and clinical development programs after the COVID-19 pandemic its control.
And the timing cost and outcome of litigation, including our lawsuits against Teva and Hikma Pharmaceuticals and have its appeal of its defeat and the post Grant review and brought before the patent trial and appeals for it and known as <unk> and our settlement of litigation with Sun Pharmaceuticals.
And of course, as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation, we disclaim any intention or duty to update forward looking statements.
Our revenue and the second quarter with $91.6 million compared to $88.6 million and the second quarter of 2020 and 79.
Atabak Mokari: Our revenue in the second quarter was 91.6 million.
Atabak Mokari: With $91.6 million compared to $88.6 million in the second quarter of 2020 and $79.4 million in the first quarter of 2021. Second quarter 2021 gap net income was $26.5 million compared to $28.3 million in the same period. Excluding non-cash expenses related to stock-based compensation and utilization of deferred tax assets, together with related income tax effects, non-gap net income in the second quarter was $38.2 million compared to $39.7 million in the second quarter of the previous year.
$1 million and first quarter of 2021.
And second quarter of 2021, GAAP net income was $26.8 million compared to $28.3 million and the same period last year.
<unk> 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 and the second quarter was $38.2 million compared to $39.7 million and second quarter of 2020.
Atabak Mokari: We have reiterated our revenue guidance of $355 to $385 million, which assumes that pandemic-related restrictions will continue to ease in the second half. Our cash and investments totaled $471.6 million at June 30th, an increase of $16.8 million from March 35th. In the second quarter of this year, we repurchased 1.5 million shares of our common stock, 1.4 million shares pursuant to our stock repurchase program, and about 150,000 shares in connection with the net exercise of employee stock. The total cost of these repurchases was $30.8 million.
We have reiterated our revenue guidance of $355 million to $385 million, which assumes the pandemic related restrictions will continue to ease and the second half of this year.
Our cash and investments totaled 471.
$1.6 million at June 30, and increase of $16.8 million from March 31.
And the second quarter of this year, we repurchased 1.5 million shares of our common stock 1 formula and shares pursuant to our stock repurchase program and about 150000 shares in connection with the net exercise of employee stock options. The total.
These repurchases was $338 million.
Gary Charles Robb: Under the current terms of our stock refurbish program, $127.6 million remains available for the repurchase. We will determine the timing and size of future repurchases, if any, based on market conditions, our stock price, and other factors. And now Charlie Rob, our chief business officer, will provide a legal update.
Under the current terms of our stock repurchase program $127.6 million remains available for the repurchase of shares we will determine the timing and size of future repurchases, if any based on market conditions, our stock price and other factors and now Charlie Robb our.
Chief business Officer, who will provide a legal update Charlie thanks out of whack.
Briefly review, our litigation against generic manufacturers, Teva, Hikma and Sun Pharmaceuticals and <unk>.
Gary Charles Robb: Thanks, Out of Act. I'll briefly review our litigation against generic manufacturers, Teva, Hickma, and Sun Pharmaceuticals. In March 2018, we sued Teva in federal district court to prevent it from marketing a generic version of Corlum in violation of our patent. Originally, the trial was set to start in February of this year. Last quarter, the court vacated this date in order for the parties to be ready for trial in March.
March 2018, and we sued Teva and Federal District court to prevent it from marketing and generic version of Korlym and violation of our patents originally trial.
Trial is set to start in February of this year.
Last quarter, the court vacated the state and northern parties to be ready for trial and March that trial ready date was also vacated a new trial date has not been set.
In April we asked the courts permission to file for summary judgment based on tenders and leg infringement of our Q1 and for Pat.
Gary Charles Robb: That trial-ready date was also vacated, and a new trial date has not been set. In April, we asked the court's permission to file for summary judgment based on Ten as an alleged infringement of our 214 patent. The court granted permission, and Teva responded by filing its own summary judgment motion with respect to the same patent. Summary judgment is a procedure whereby courts can decide a case without holding a trial.
Court granted permission and Teva responded by filing and some summary judgment motions with respect to the same time.
Summary judgment is a procedure whereby courts can decide the case without holding a trial. We believe that believes the court has all it needs with respect to the 2.1 and 4 patent and decide the case and our fever.
Having lawsuits action before the <unk>.
And we can no longer challenged and 214 patents validity and the district Court case, and we can only argue that it's product. It's proposed product would not and fringe position. We believe has no legal or factual support.
Gary Charles Robb: We believe the court has all it needs with respect to the 214 patent to decide the case in our favor. Having lost its action before the PTAB, Tev can no longer challenge the 214 patent's validity in the district court case. Tevac can only argue that its proposed product would not infringe, a position that, we believe, has no legal or factual support.
Moving in this matter is complete we await the court's decision.
The court grants our motion.
We will have 1 the case Teva would be margin marketing generic korlym and till 2037, and the 2.1 and 4 patent expires and we can appeal and of course, although the district Court's bar would remain in place until the appeal is resolved process. It usually takes 12 to 18 months.
Gary Charles Robb: Briefing in this matter is complete. We await the court's decision. If the court grants our motion, we will have won the case. Teva would be barred from marketing generic Corlum until 2037 when the 214 patent expires. Teva could appeal, of course, although the district court's bar would remain in place until the appeal is resolved, a process that usually takes 12 to 18 months.
The court rules and turbine failure, we will proceed to trial.
This year or sometime next year, there is a president and no timetable for the court's summary judgment ruling no trial date and no scheduled for any trial related activities and <unk>.
Parallel with the district Court actions Teva has as expected petitioned the federal Circuit Court of appeals to reverse its P tap loss briefing and this matter.
There is also complete a federal circuit decision is likely in the first or second quarter of 2022.
Earlier this year, we received notice of another Anda Filer Hikma Pharmaceuticals on March 12, we sued Hikmet and same federal District Court that is adjudicating a case against Teva and court has entered the schedule for the case.
Gary Charles Robb: The court rules in Tevitz's favor. We will proceed to trial late this year or sometime next year. There is currently no timetable for the court's summary judgment ruling, no trial date, and no schedule for any trial-related act.
That's a fact discovery deadline of July 1.2022 next year.
Finally, some pharmaceuticals is also seeking to market generic Korlym and June 2019, we suits and prevented from doing so as we announced a few weeks ago. We have settled this case settlement agreement allows SUNS.
Gary Charles Robb: In parallel with the district court action, Teva has, as expected, petitioned the Federal Circuit Court of Appeals to reverse its PTAB law. Briefing in this matter is also complete. A Federal Circuit decision is likely in the first or second quarter of 2022. Earlier this year, we received notice of another antifiler, Hickma Pharmaceuticals. On March 12, we sued Hickman in the same federal district court that is adjudicating our case against Teva.
Begin selling and generic version of Korlym and beginning October 1.2034 more than 14 years from now or earlier under circumstances.
Our customary for settlements of this tight.
I will now turn the call over to Dr. Joseph Belanoff, Our Chief Executive Officer Joan.
Thank you Charlie.
We are pleased with our commercial results and the second quarter and.
Gary Charles Robb: The court has entered a schedule for the case that sets a fact discovery deadline of July 1st, 2022 next year. Finally, Sun Pharmaceuticals is also seeking to market generic quarrel. In June 2019, we sued Sun to prevent it from doing so. As we announced a few weeks ago, we have settled this.
Pandemic related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide and patients to receive optimal care.
Diagnosing and treating patients with complex disease, such as Cushings syndrome requires frequent <unk>.
<unk> and contact for much of the pandemic. This level of contact was for many patients and physicians and possible. We are encouraged that and the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country clear indications and the country is opening more broadly.
Joseph K. Belanoff: The settlement agreement allows Sun to begin selling a generic version of Corlum beginning October 1st, 2034, more than 14 years from now or earlier, under circumstances customary for settlements of this type. I will now turn the call over to Dr. Joseph Bellanoff, our chief executive officer. Joe?
And is also heartening to patients recently.
And we introduced Korlym titrated towards their ideal dose more quickly and occurred and the last year as many physicians are now seeing and testing their patients with pre pandemic frequency.
Joseph K. Belanoff: Thank you, Charlie. We are pleased with our commercial results in the second quarter. Pandemic-related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide and patients to receive optimal care. Diagnosing and treating patients with a complex disease, such as Cushing Syndrome, requires frequent in-person contact. For much of the pandemic, this level of contact was impossible for many patients and physicians. We are encouraged that in the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country, clear indications that the country is opening more broadly.
Looking beyond this year and we expect that our Cortland business will continue to grow leading endocrinologist increasingly believe that there are many more patients with hydro.
And personalism and was once believed korlym is an excellent treatment for many of these patients the foundation of our business and effective lifesaving medication promoted by a dedicated commercial team that puts the interest of patients first remains rock solid.
We are also excited by the potential of our clinical development programs, which.
<unk> made important advances.
And the beginning our research and development efforts and built on the hypothesis and cortisol modulation is a powerful therapeutic mechanism and many serious disorders.
<unk> commercial success has provided and will continue to provide the funds needed to enlarge our portfolio.
Joseph K. Belanoff: It is also heartening that patients recently introduced to chloralum have titrated toward their ideal dose more quickly than occurred in the last year, as many physicians are now seeing and testing their patients with pre-pandemic frequency. Looking beyond this year, we expect that our Coralum business will continue to grow. Leading endocrinologists increasingly believe that there are many more patients with hypercorrhazolism than was once believed. Corlum is an excellent treatment for many of these patients. The foundation of our business, an effective, life-saving medication promoted by a dedicated commercial team that puts the interest of patients first, remains rock-solid.
Which of Rytary selective cortisol modulators and to develop the most promising.
Many of these selective cortisol modulators are attractive candidates for development.
Like Korlym, they bind strongly to the glucocorticoid receptor GR on.
Unlike korlym they have no affinity for the progesterone receptor and so don't cause.
And our performance most serious off target effects beyond sharing the qualities of strong cortisol modulation and non perturbing the progesterone receptor preclinical and clinical testing have shown that our molecules behave differently from 1 another in important ways. Some cross the blood brain barrier others do not some performed best in models of solid.
Some of tumors, others are more potent and models metabolic disease, some appear to be tissue specific while others have more systemic effects.
Joseph K. Belanoff: We are also excited by the potential of our clinical development programs, which have recently made important advances. From the beginning, our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious diseases. Corlum's commercial success has provided and will continue to provide the funds needed to enlarge our portfolio of proprietary selective cortisol modulators and to develop the most promising. Many of these selected cortisol modulators are attractive candidates for development. Like Coralum, they bind strongly to the glucagonoid receptor, or GR.
They are diverse qualities and allowed us to initiate clinical trials and a wide variety of disorders, including ovarian adrenal and prostate cancer anti psychotic induced weight gain and.
And non alcoholic Seattle, hepatitis or Nash and of course Cushing syndrome.
We are now planning a phase 2 trial and patients with ALS another devastating disease with no, particularly effective treatment options and we have additional compounds in phase 1 and the latter stages of preclinical development.
I'll have to oncology program is testing 3 mechanisms first postulated by investigators at the University of Chicago and confirmed by other prominent researchers.
And 1 mechanism is increasing E pop ptosis.
Joseph K. Belanoff: Unlike Coralum, they have no affinity for the progesterone receptor and so don't cause some of Coralum's most serious off-target effects. However, beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. For example, some cross the blood-brain barrier; others do not.
If apoptosis the programmed cell death chemotherapy is meant to induce cordis.
Cortisol.
<unk> is a pop doses and our successful trial in women with advanced ovarian cancer edition of the selective cortisol modulator rella correlate and enhance the effect of chemotherapy by blending cortisol anti apoptotic effect.
Based on statistically significant and clinically meaningful phase II results.
Joseph K. Belanoff: Some perform best in models of solid tumors, others are more potent in models of metabolic disease. Some appear to be tissue specific, while others have more systemic effects. Their diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian, adrenal, and prostate cancer, anti-psychotic-induced weight gain, and non-alcoholic steato hepatitis, or Nash, and of course, Cushing Syndrome. We are now planning a phase two trial in patients with ALS, another devastating disease with no particularly effective treatment options.
And we're excited to initiate a phase III pivotal trial and patients with platinum resistant ovarian cancer and the first quarter of 2022.
As a reminder, our phase 2 trial is a controlled multicenter study of 178 women with platinum resistant ovarian cancer, who are randomized to 1 of 3 treatment arms.
In addition to Nab Paclitaxel 60, women and received 150 milligrams of railcar on intermittently, meaning they received rella correlate on a day before the day of and the day after they receive Nab Paclitaxel and 58 women received lower daily rather Cortland dose of 100 milligrams per day.
Joseph K. Belanoff: And we have additional compounds in phase one, and the latter stage is a preclinical adult. Our oncology program is testing three mechanisms, first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis. Apoptosis is programmed cell death.
60 women receive Nab Paclitaxel alone the trial's primary endpoint was progression free survival or PFS.
Women and participated in our study, we're very ill all and experienced disease progression. Despite prior lines of therapy. The median number of prior treatments was great.
Joseph K. Belanoff: Chemotherapy is meant to induce apoptosis. However, cortisol suppresses apoptosis. In our successful trial in women with advanced ovarian cancer, addition of the selective cortisol modulator, Relicorolent, enhanced the effect of chemotherapy by blunting cortisol's anti-apoptotic effect. Based on statistically significant and clinically meaningful phase two results, we are excited to initiate a phase three pivotal trial in patients with platinum-resistant ovarian cancer in the first quarter of 2022. As a reminder, our phase two trial is a controlled multi-center study of 178 women with platinum-resistant ovarian cancer who are randomized to one of three treatment arms.
It.
<unk> that real coral and benefited many of these women and those who received rella Cortland intermittently exhibited statistically significant improvement in PFS compared to the group that received Nab Paclitaxel monotherapy.
They're hazard ratio was <unk> 6.6 with a P value of point or 3.8 their median PFS was 5.6 month.
It is clear 1.8 months longer than the Nab Paclitaxel monotherapy group, which was $3.8 months safety and Tolerability data for the 2 groups were comparable.
And the women, who received a lower dose umbrella coral and every day also saw their disease progressed more slowly there median PFS was 1.5 months longer than the Nab paclitaxel.
Mono therapy group, they're hazard ratio was <unk> 8.3 points 83. Although this result was not statistically significant and we believe and more importantly, our investigators believe that these results are 1.8 month increase and PFS without an increase and side effects clinically meaningful.
Joseph K. Belanoff: In addition to NAPAthagotax, 60 women received 150 milligrams of relicorolant intermittently, meaning they received relicorillant on the day before, the day of, and the day after they had a napak attack. And 58 women received a lower daily dose of 100 milligrams; 60 women did not receive Paco-Taxal alone. The trial's primary endpoint was progression-free survival, or The women who participated in our study were very ill. All had experienced disease progression despite prior lines of therapy. The median number of prior treatments was three.
We are honored that.
Our phase 2 trial results have been accepted for a profit paper oral presentation at the European Society for medical oncology ESMO meeting in September in Paris.
And finally, we anticipate that overall survival results from this study will be available later. This later this year.
A.
And second visit mechanisms by which cortisol modulation may prove useful it's by blocking and important tumor growth pathway.
Cortisol stimulation is a major reason patients treated with the widely prescribed androgen receptor antagonist and <unk> eventually experience George and disease deprivation of androgen stimulation.
Joseph K. Belanoff: It is clear that Relicorland benefited many of these patients. Those who received Relicorland intermittently exhibit a statistically significant improvement in PFS compared to the group that received napalaxal monocle. Their hazard ratio was 0.66, with a p-value of.038. Their median PFS was 5.6 months, 1.8 months longer than the NAPActal Monotherapy group, which was 3.8.
And the private androgen stimulation their tumor switched to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.
We are conducting a dose finding study of our selective cortisol modulator extra coral and.
Joseph K. Belanoff: The women who received a lower dose of Borrel every day also saw their disease progress more slowly. Their median PFS was 1.5 months longer than the napakotaxal monotherapy. Their hazard ratio was 0.83, although this result was not statistically significant.
And combined with <unk> and men with castration resistant prostate cancer and expect to produce clarifying data next quarter.
Third oncologic mechanism recognizes cortisol ability to reduce inflammation and suppress the immune system.
Joseph K. Belanoff: We believe, and more importantly, our investigators believe, that these results, a 1.8 month increase in PFS without an increase in side effects, are clinically meaningful. We are honored that our phase two trial results have been accepted for a proper paper oral presentation at the European Society for Medical Oncology, ESMA, in September in Paris. Finally, we anticipate that overall survival results from the study will be available later, at your decision.
There are often beneficial and healthy people, but.
Since with solid tumors diminish the effectiveness of immunotherapy.
We are conducting an open label phase 1 b trial of Rolla, coral and plus the PD, 1 checkpoint inhibitor <unk> merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol.
And patients suffered the effects of adrenal cancer and Cushing syndrome.
I usually quickly lethal combination.
<unk> has rarely effective as monotherapy patients. We believe that these patients cortisol excess may be countering the intended effects of <unk> as a map, which is to stimulate the immune system.
Joseph K. Belanoff: A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth path. Cortisol stimulation is a major reason patients treated with the widely prescribed androgen receptor antagonist and zlutamide eventually experience resurgent disease. Deprived of androgen stimulation, sorry, deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth.
And our trial is evaluating with a relic cortland and treat these patients cushings syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression and allow Pembroke is a map to achieve its full cancer, killing effect.
We plan to enroll 20 patients at 5 sites and the United States.
Joseph K. Belanoff: Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape. We are conducting a dose-finding study of our selective cortisol modulator exocor, combined with Enzaludamide, and men with castration-resistant prostate cancer, and expect to produce clarifying data next. The third oncologic mechanism recognizes cortisol's ability to reduce inflammation and suppress the immune system, effects that are often beneficial in healthy people but in patients with solid tumors diminish the effectiveness of immunotherapy.
These primary endpoint is objective response rate with secondary endpoints, including progression free survival duration of response and overall survival.
I'll now turn to our programs and metabolic disease and the recent findings of our proprietary selective cortisol modulator mirror Cortland and patients with Nash serious liver disorder.
We observed that patients who receive mirror cortland and our phase Iia trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes Alt and AST.
Joseph K. Belanoff: We are conducting an open-label phase 1b trial of relicorolin plus the PD1 checkpoint inhibitor, pembrolysmab, Merckstrog, Ktruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing syndrome, a usually quickly lethal combination. Hemoralizumab is rarely effective as monotherapy in these patients.
The improvement and liver fat and these patients was greater and occurred much more rapidly than we had expected.
<unk> reductions and liver fat on the magnitude that we observed in our study are rarely seen over any period of treatment. As a reminder, we have powered the trial and detect a 30% reduction after 12 weeks of treatment the patients and our study exhibited reductions ranging from 39% to 74% after receiving mirror.
Joseph K. Belanoff: We believe that these patients' cortisol excess may be countering the intended effects of Pembrolysmab, which is to stimulate the immune system. Our trial is evaluating whether RELACorralin can treat these patients' Cushing Syndrome by reducing excess cortisol activity and by reversing cortisol-induced immune suppression, allowing Pembrolysmap to achieve its full cancer-killing effect. We plan to The primary endpoint is subjective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival.
And 1 for just a month.
It may be that the rapidity of mirror correlates fat, reducing effect caused ELT and asti to rise.
1 way the liver shed status by metabolized into fatty acid, which Nick excessive amounts irritate the liver.
Interestingly levels of serum.
Corals and these patients did not increase wood treatment, providing further support for the metabolism hypothesis.
Our upcoming phase <unk> dose finding trial and patients with presume Nash, we will evaluate if there was a dosing regimen of mirror coral and that can produce such significant reductions in liver fat without causing liver irritation.
Joseph K. Belanoff: I'll now turn to our programs in metabolic disease and the recent findings of a proprietary selective cortisol modulator, mirror-correlant, and patients with Nash, a serious liver disorder. We observed that patients who received Miracorillant in our Phase 2A trial exhibited large, rapid reductions in liver fat but also substantial transient elevations of the liver enzymes, ALT, and ASP. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected. However, reductions in liver fat of the magnitude that we observed in our study are rarely seen over any period of treatment.
We're also evaluating mirror korlym as a potential treatment for patients with another serious and widespread disorder anti psychotic induced weight gain.
And the United States 6 million people take antipsychotic medications, such as Olanzapine and risperidone to treat illnesses, such as schizophrenia bipolar disorder and depression.
While these drugs are very effective the exact steep price and that form of rapid and sustained weight gain and cardiovascular disease and other metabolic disturbances patients can gain a pound per week and the first 10 weeks that they take these medications and their life expectancy is decreased on average by 20 years 2 and.
Joseph K. Belanoff: As a reminder, we powered the trial to detect a 30% reduction after 12 weeks of treatment. However, the patients in our study exhibited reductions ranging from 39% to 74% after receiving Miracloraline for just a month. It may be that the rapidity of Miracorolin's fat-reducing effect caused ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acids, which in excessive amounts irritate the liver. Interestingly, levels of serum lipids in these patients did not increase with treatment, providing further support for the metabolism hypothesis.
Increased cardiovascular events, such as heart attacks and strokes.
We are conducting 2 double blind placebo controlled phase II trials, and mirror Korlym and patients with this disorder gratitude and gratitude to the.
And these trials seek to build on the positive data from our study of mirror Korlym and healthy subjects.
Part 2 year, we completed a phase 1 b trial, and which 96 healthy patient subjects received olanzapine and either 600 milligrams of mirror correlate 900 milligrams and mirror correlate or placebo for 14 days subject to receive mirror coral and gained significantly less weight and those who received placebo. They also exhibited a smaller increase.
Joseph K. Belanoff: Our upcoming phase 1B dose-binding trial and patients with presumed Nash will evaluate if there is a dosing region of meurorelant that can produce such significant reductions in liver fat without causing liver irritation. We're also evaluating Mira Correlant as a potential treatment for patients with another serious and widespread disorder, antipsychotic-induced weight gain. In the United States, 6 million people take antipsychotic medications such as Alanzapine and Risperidone to treat illnesses such as schizophrenia, bipolar disorder, and depression.
Lastly, triglycerides, and and <unk> and ESG and pay.
Describing these results will be published and the journal of clinical Psychopharmacology this quarter.
The gratitude trial is evaluating with the mirror Korlym can reverse recent anti anti.
Anti psychotic induced weight gain 100 patients with schizophrenia or bipolar.
Increasing order will receive and addition to their established dose of anti psychotic medication, either 600 milligrams and mirror correlate or placebo for 12 weeks gratitude is being conducted 30 centers and the United States.
Joseph K. Belanoff: Well, these drugs are very effective, but they exact a steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances. Patients can gain a pound per week in the first 10 weeks that they take these medications, and their life expectancy decreases on average by 20 years due to increased cardiovascular events, such as heart attacks and stroke.
Our gratitude to John.
And as testing mirror korlym as a treatment for long standing anti psychotic.
Got it can be squeaking.
150 patients with schizophrenia will receive in addition to their established Joseph anti psychotic medication, either 600 milligrams or 900 milligrams and mirror correlate or placebo for 26 weeks.
Joseph K. Belanoff: We're conducting two double-blind placebo-controlled phase two trials of myuroloric in patients with this disorder, gratitude and gratitude two. These trials seek to build on the positive data from our study of Murricorilin and Healthy Subject. Last year we completed a phase 1B trial in which 96 healthy patients subjects received olanzapine and either 600 milligrams of Miracorolant, 900 milligrams of Miracorolant, or placebo for 14 days. Those who received Miracorillin gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and in ALT and AST.
<unk> 2 is being conducted 35 centers in the United States the primary endpoint.
And both studies is reduction in body weight and other.
And are important measures of metabolic activity will also be examined.
We expect to complete enrollment and gratitude to by the end of this year and and gratitude and MIT and mid 2022.
As most of you know relative orland as our planned succession.
Access to Korlym for the treatment of hyper cortisol ism.
We are evaluating and it in 2 phase III trials race and gradient to repeat what I said earlier relative Berlin is a selective cortisol modulator.
Joseph K. Belanoff: A paper describing these results will be published in the Journal of Clinical Psychopharmacology this quarter. The Gratitude trial is evaluating whether Miracorolin can reverse recent antipsychotic-induced weight gain; 100 patients with schizophrenia or bipolar disorder will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of mericorolent or placebo for 12 weeks. Gratitude is being conducted at Turkey Centers in the United States
Like Korlym and achieves its effect by competing with cortisol and the glucocorticoid receptor.
<unk> like oral and it does not bind to the progesterone receptor PR and for sure. It is not the abortion pill and it does not cause other PR related side effects, including endometrial thickening and vaginal bleeding.
By a different mechanism rella coral and also does not appear to cause hypokalemia low potassium.
Serious.
Okay and experienced by 44 cents of patients and Korlym is pivotal trial.
Joseph K. Belanoff: Our gratitude study is testing Miracorillin as a treatment for long-standing antipsychotic medication. 150 patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of Miracoralin or placebo for 26 weeks. Gratitude 2 is being conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight, but other important measures of metabolic activity will also be evaluated. We expect to complete enrollment in Gratitude 2 by the end of this year and in gratitude in mid-2020.
Korlym induced hypokalemia is a leading cause of korlym discontinuation.
Our Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome at sites in the United States, Canada Europe.
Items real.
<unk> phase II efficacy and safety data were strong the trial results were recently published and frontier and endocrinology.
Patients experienced meaningful improvements and hypertension, and glucose control as well as and a variety of other signs and symptoms of Cushing syndrome.
Joseph K. Belanoff: As most of you know, RELA Corraland is our planned successor to Corallum for the treatment of hyperboea. We are evaluating it in two phase three trials, race and grading. To repeat what I said earlier, Relicorlin is a selective cortisol module, Lycorla; it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Coralum, it does not bind to the progesterome receptor, PR for short. It is not an abortion pill, and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding.
There were no relative.
And induced instances endometrial thickening or vaginal bleeding and no drug induced hypokalemia.
And our investigators are eager to take race to the finish line.
We expect rates to serve as the basis for our NDA submission and Cushing syndrome, which we remain on track to submit and the second quarter of 2023.
Coral and our second phase III trial gradient studying relative Orleans effects and patients, whose cushings syndrome is caused by an adrenal adenomas or adrenal hyperplasia.
Joseph K. Belanoff: By a different mechanism, Relicoralin also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Coralum's pivotal trial. Coralum-induced hypokalemia is a leading cause of coralum discontinuation.
Patients with this etiology of Cushing syndrome up and experienced a less rapid decline, but ultimately their health outcomes are poor.
Joseph K. Belanoff: Our Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome at sites in the United States, Canada, Europe, and Israel. Relicorone's base-to-proven efficacy and safety data were strong. The trial results were recently published in Frontiers and Endocrinology. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing Syndrome. There were no reliclorin-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia. We and our investigators are eager to take grace to the finish.
And Tessa planned.
Enrollment of 130 patients and is being conducted at many of the sites participating in Grace.
Great and is the first controlled study dedicated to patients with this type of Cushing syndrome.
While we do not expect our NDA and Cushing syndrome to depend upon data from radiant and we do expect that its findings will help improve the care of these increases.
Planned and we recognized patients.
West a brief update on our intellectual property position for <unk> and Cushing syndrome.
As you are likely aware, we hold a composition of matter patent for <unk> that is valid through 2033.
We were recently issued a method of use patent and we expect.
Increasingly included and the Orange book Perilla, Coral and should it receive FDA approval that is valid at 220 <unk>.
Joseph K. Belanoff: We expect grace to serve as the basis for our NDA submission in Cushing Syndrome, which we remain on track to submit in the second quarter of 2023. Our second phase three trial, gradient, is studying Relicorolin's effects in patients whose Cushing Syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately, their health outcomes are poor. Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in grace.
Yeah.
Finally, a brief word about court 113, 107, and 6 which has shown promise in animal models of Ngls.
We are in discussion with leading clinicians and.
Spec da regarding our development plans and plan to initiate the phase II trial by early next year.
Our belief has always been that cortisol modulation can help treat many serious disorders.
And for patients with Cushings syndrome is 1 very clear example.
And yet the <unk>.
Pharmacy data and our ovarian cancer and Nash programs provide increasing proof of cortisol modulations broad worth while.
Joseph K. Belanoff: Gradient is the first controlled study dedicated to patients with this type of Cushing syndrome. While we do not expect our NDA and treatment decisions to depend upon data from Gradient, we do expect that its findings will help improve the care of these increasingly recognized patients. Last, a brief update on our intellectual property position for Relicorillant in Cushing Syndrome. As you are likely aware, we hold a composition of Matter patent for Reliclorin that is valid to 2033. We were recently issued a method of use patent that we expect will be included in the Orange Book for Rale Coral and should have received FDA approval that is valid to 2040.
While the pandemic dampened our commercial results for more than a year. We are confident that our business will resume its growth and as conditions continue to improve.
It is all.
T growing.
Even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.
Currently our oncology program is evaluating 2 of our proprietary cortisol modulators and combination with 3 different anti cancer agents.
Already 3 tumor types in.
In addition, our metabolic program is conducting important initial trials and Nash and anti psychotic induced weight gain.
Joseph K. Belanoff: Finally, a brief word about court 113-176, which has shown promise in animal models of ALS, while we are in discussion with leading clinicians and the FDA regarding our development plans and plan to initiate a phase two trial by early next year. Our belief has always been that cortisol modulation can help treat many serious disorders. Coraline for patients with Cushing Syndrome is one very clear example. The promising data in our ovarian cancer and Nash programs provide increasing proof of cortisol, modulations, and broad work.
We also continue to enroll patients and our flagship phase III trials umbrella coral and and Cushing syndrome, and will and advanced CT 113.176 tree.
Patients with ALS by early next year means.
Meanwhile, additional proprietary early stage compounds advance towards the clinic.
The breadth of our program reflects the power of our fundamental scientific hypothesis cortisol modulation is a.
Houghton therapeutic modality.
And moving that and patients with Cushings syndrome, we are now adding to the body of evidence that proves its worth for patients with other serious disorders.
Joseph K. Belanoff: While the pandemic dampened our commercial results for more than a year, we are confident that our business will resume its growth as conditions continue to improve. It is already growing. Even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.
Stop here for questions.
As a reminder to ask a question on your Rooney to grasp Taiwan on your.
And your telephone keypad again that is tier 1 on your telephone keypad.
Joseph K. Belanoff: Currently, our oncology program is evaluating two of our proprietary cortisol modulators in combination with three different anti-cancer agents in three tumor types. In addition, our Metabala program is conducting important initial trials in Nash and antipsychotic-induced weight loss. We also continue to enroll patients in our flagship phase three trials of Borrel, Coral, and Cushing syndrome, and will advance court 113-176 to treat patients with ALS by early Meanwhile, additional proprietary early-stage compounds advanced towards. The breadth of our program reflects the power of our fundamental scientific hypothesis.
Your first question comes from the line.
A prom and long from buyer Watson.
Your line is now open.
My question.
Congratulations on the quarter by 1 affirm kudos and frustrated and Sean for executing on the sofa.
And the business environment that was under transition and I don't know if he's there but congratulations.
Thanks Alan.
And that was shot.
So.
And if that's the question I guess for anyone.
And you mentioned, Joe you mentioned about Pie chart.
Trade and Korlym and quickly are the physicians, who are willing to venture into a stronger growth than say even.
Joseph K. Belanoff: Cortisol modulation is a potent therapeutic modality. We have proven that in patients, and we are now adding to the body of evidence that proves its worth for patients with other serious disorders. I'll stop here for questions. As a reminder to ask a question.
Even a couple of years ago or a little more.
So should I take that question.
So just the question is are physicians now and were more readily open to titration to titrate them to a higher dose was that the question.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. Your first question comes from the line of Alan Long from BioWatch News.
Yes.
And then are you asking that and specifically to how it may be different.
And the pandemic.
Well could be but more really.
Uh huh.
Really is.
Physician community I would expect.
Having more experience of reading more literature on talking to there.
Alan Leong: Your line is now open. My question.
Alan Leong: My questions and congratulations on the quarter by one of them to send kudos, especially to Deshaun, for executing on the sales plan in a business environment that was under transition. So I don't know if he's there, but congratulations. Thanks, Alan. Yeah, that was Sean. So this is a question, I guess, for anyone. You mentioned, Joe, you mentioned about titrating corlum quickly. Are physicians more willing to venture into a stronger dose than, say, even a couple of years ago or a little more? Sean, would you like to take that question?
Sure.
<unk>.
Their experience with Korlym.
And they feel a little bit less reluctant.
Raise the dose to an optimal level.
Yes, I mean, I would say you view and then.
And they have about right. There I mean positions that have had more experience with a cop out are more comfortable using it are more comfortable with the cadence of.
Patient visits or that are required to follow up definitely.
And then to remove to titrate too.
A higher dose and the most efficacious dose for that patient now and important point is that it really does vary patient by patient patient about it.
So I think Joe you want to add.
And I think Alan and I think really what you're getting at is.
Sean Maduck: Yeah, so just the question is, are positions now more readily open to titrating to a higher dose? Was that the question? Yes. And then are you asking that specifically about how it may be different than during the pandemic?
The behavior different and it was.
Several years ago and the answer to that is right now it really isn't at all and I think that that's actually a real positive its a very interesting point, which is that we're now seeing patients.
Alan Leong: Well, it could be, but more really, um, uh, uh, really, as the physician community, I would expect, having more experience or reading more literature or talking to their mates about their experience with Coralum may feel a little bit less reluctant to raise the dose to an optimal level.
I'm sorry.
Physicians titrate their patients' doses at the same cadence that we saw pre pandemic not more than.
Because at that point and time, they really werent getting to patients and their ideal dose.
The interesting thing and again, there were strange things and the pandemic and many areas with debt because doctors could not see patients as frequently seemed as if they were not on the same cadence of titration and so it's just heartening to see that they've returned to pre.
Sean Maduck: Yeah, I mean, I would say you've hit the nail on the head with that right there. Physicians that have had more experience with a compound or are more comfortable using it are more comfortable with the cadence of patient visits that are required to follow up, and they have definitely moved to titrate to a higher dose and the most efficacious dose for that patient. Now, I think an important point is that it really does vary patient by patient. It's individual. Drening, Joe, do you want to add to that?
That and make behavior at this point, but overall our.
The average dose per patient is very similar for now many years.
Yeah.
I have 1 more question there could be.
Sure.
Yes.
And then regarding the.
Recent Nash.
And so you have a raft of liver fat reduction and a little bit and then.
And our mature markets growing up did you already did you see any notable.
Joseph K. Belanoff: Yeah, you know, Alan, I think really what you're getting at is behavior different than it was several years ago. And the answer to that is, right now, it really isn't at all. I think that's actually a real positive.
Similar phenomenon.
Or with other Nash other Nash drugs, either in preclinical or.
Sure and human trials.
Dan and the literature.
Well what.
Joseph K. Belanoff: It's a very interesting point, which is that we're now seeing patients, I'm sorry, physicians titrating their patients' doses at the same cadence that we saw pre-pandemic. Not more than that, because at that point in time, they really were getting patients their ideal dose. The interesting thing, you know, and again, there were strange things in the pandemic in many areas, was that because doctors could not see patients as frequently, it seemed as if they were not on the same cadence of titration. And so it's just heartening to see that they've returned to pre-pandemic behavior you are at that. But overall, our average dose per patient is very similar to, for now, many years.
If you're referring to like a transit increase of transaminase and patients with Nash debt are treated with drugs to reduce liver fat various reports and that there are reports and literature.
And then known phenomenon.
And it's just the scale was different when we look at those both the scale of the liver fat reduction and the scale of the transaminase elevation.
And you often.
It's been described by some of the other Nash compounds is an increase of AFC and able to like 20% and.
We.
And have looked at a much bigger increase.
But but that's why we're going forward and trying to find our sweet spot where we.
Unknown Attendee: I have one more question. It could be for Joe or for Andreas.
<unk> achieved a good reduction in liver fat.
Unknown Executive: Regarding the recent Nash results, you had a rapid liver fat reduction and a little bit of an inflammatory markers going up. Did you see any notable similar phenomenon? or with other NASS drugs, either in preclinical or in human trials, done in the literature? Well, if you're referring to like a transit increase of transaminators in
Without.
Affecting the liver liver negatively on the way to 2 debt.
I mean.
I think that's exactly right Andreas and I just wanted to add a little color to that Allen, which is to say the question is has this phenomenon.
<unk> simultaneous.
Unknown Executive: in patients with MASH that are treated with drugs that reduce liver function.
Decrease and liver fat and increase and liver functions and that's the answer to that is yes, but but but Andreas point is also on the second point is also an important.
Unknown Executive: Of that, there are reports in the literature,
Unknown Executive: It is a known phenomenon. It's just the scale was different.
Unknown Executive: when we look at them, both the scale of the liver fat reduction and the scale of the transaminase elevation. Well, you often know what's being described.
Never on the scale and we saw no 1 has seen the kind of rapid fat decrease and their studies.
And and at the same time deliver elevation in liver function tests, which which normalizes.
Unknown Executive: By some of the other Nash compounds is an increase in the ASC and ALT of like 20%, and we had looked at a much bigger increase. But that's why we're going forward and trying to find our sweet spot where we achieve a good reduction in liver fat without affecting the liver negatively on the way to that. I mean, I think that's exactly right, Andreessen.
Normalized as soon as the drug was withdrawn.
No 1 has ever seen that either.
And so.
Really take Andreas this conclusion as it is what we're really looking to do is if we can really harness this.
Unknown Executive: I just want to add a little color to that, Alan, which is to say, you know, the question is, has this phenomenon been observed of a simultaneous decrease in liver fat and increase in liver function tests? The answer to that is yes, but Andreas's point is also, and the second point is also important: never on the scale that we saw, no one has seen the kind of rapid fat decrease in their studies that we did.
Extreme activity without irritating the liver that's really the goal and that's what the next study we were looking for on the ideal dosing regimen is going to address.
And 1 thank you for taking my question. So it looks like a pretty interesting next 12 months.
Yes.
Thank you Allen excellence.
Your next question comes from the line of Matt Conference on buried Sandman.
Unknown Executive: And at the same time, the liver elevation and liver function test, you know, which normalized as soon as the drug was withdrawn, no one's ever seen that either. And so really, take Andreas's conclusion as it is, what we're really looking at is that we can really harness this extreme activity without ear. The liver, that's really the goal. And that's what the next study, we were looking for the ideal dosing regimen, is going to look at.
Hi, good afternoon, guys and thanks for taking the questions.
Just wanted to.
First congrats on the strength of the quarter a nice.
Nice rebound and the revenues.
Korlym.
To dig into your pipeline and a little bit.
Can you I guess first give us.
And update in terms of the.
<unk>.
The pace of enrollment and how enrollment is going at with the well call on to phase III study and phase III, great and studying and Cushings syndrome.
Alan Leong: Thank you for taking my questions. It looks like it will be a pretty interesting next 12 months. Yeah.
Yes, I mean, as I said, Matt, Matt and my remarks.
Unknown Executive: Yeah, thank you, Alan. Thank you.
We have not changed the timeline at all just as it was before and the only caveat.
Matthew Lee Kaplan: Your next question comes from the line of Matt Kaplan from Bird Tianmen.
And I would add to that is.
Matthew Lee Kaplan: Hi, good afternoon, guys, and thanks for taking the question. I just wanted to, you know, first congratulate you on the strength of the quarter, a nice rebound in revenues for a quarter, and then dig into your pipeline a little bit. Can you, I guess, first give us an update in terms of the pace of enrollment and how enrollment is going with the Relicolant Phase 3 Great Study and the Phase 3 Gradient Study in Cushing's syndrome?
We're and uncertain time and the world.
And we see.
See no need at the moment to make any alterations.
And certainly are better than they were a year ago, but we'll just have to see what happens. So I just I just would refer you to that the timelines are unchanged.
Okay.
Okay. That's helpful and then I guess youre on track to start.
Joseph K. Belanoff: Yeah, I mean, as I said, Matt, Matt, in my remarks, we have not changed the timeline at all; it's just as it was before. You know, and the only caveat I would add to that is, you know, we're in an uncertain time in the world. We see no need at the moment to make any alterations. Things certainly are better than they were a year ago, but we'll just have to see what happens. So I just would refer you to that. The timelines are unchanged.
Your phase.
Phase III study and ovarian cancer and the first quarter of next year can you give us a little color in terms of what that study will look like in terms of decline and and.
And points and stuff like that.
Okay. So let me just turn that question over to Andreas.
So we are.
Finalizing some of those questions and obviously many of them are important and I think there are a few things that are clear 1 is to dose debt or the regimen that we're going to test its intimate and regimen for <unk>.
Matthew Lee Kaplan: Okay, that's helpful. And then I guess you're on track to start your phase three study in ovarian cancer in the first quarter of next year. Can you give us a little color in terms of what that study will look like in terms of design and endpoints and stuff like that?
Cortland with map packs of attack.
The comparator.
We're favoring currently a physician's choice comparator. So we would give firm like a dealer's choice, we would trigger would give the physician the choice of the single.
Joseph K. Belanoff: Yes, but let me just turn that question over to Andre.
A single agent chemotherapy, and these platinum resistant or refractory patients and.
Unknown Executive: So we are finalizing some of those questions, and obviously, many of them are important. I think there are a few things that are clear. One is the dose or the reservoir.
Do you.
Excellent standpoint, I think our ingoing is and is overall survival is going to be required as a primary endpoint for approval.
But we are having.
Unknown Executive: or on the resume.
Conversations with high level of opinion leaders and we'll obviously eventually a pretty soon and have conversations with the regulators to firm those assumptions.
Unknown Executive: is the intermittent regimen of Rilacolin with an apactylaxal. The comparator, we're favoring currently a physician's choice comparator. So we would give, like a dealer's choice, we would give a physician the choice of single-agent chemotherapy in these platinum resistance or refractory patients.
Yeah.
The primary thing that's helpful. And then and then I guess lastly in terms of day.
And what work you're doing.
With net.
Miracle, Arlington, and metabolic diseases, specifically and antipsychotic induced weight gain how do those studies progressing now and when could we win when COVID-19.
Unknown Executive: and the primary endpoint, I think our in-going position is overall survival is going to be required as a primary endpoint for approval. But we're having a lot of conversations with high-level opinion leaders and will obviously eventually have conversations with the regulators to affirm those assumptions.
Okay.
And laid out.
Yes, I mean, you have few from sure you read what we shared in the press release, but we.
We want to complete enrollment and the gratitude to study by year end and initial gratitude study by mid 2022, we're on track.
Matthew Lee Kaplan: That's helpful. And then, and then, I guess, lastly, in terms of the work you're doing with Miracorilent and metabolic diseases, specifically antipsychotics and loose weight gain, how are those studies progressing now and when could we expect some lead-out from them?
And we occurred and then obviously we'll have to see.
On the cards over and see what we see what we observed in these trials. So we're quite excited about it and hope that we can demonstrate a treatment benefit.
Unknown Executive: Yeah, I mean, you've, I'm sure you've read what we shared in the press release, right, but we still want to complete enrollment in the
And Matt I'd, just add to that is.
And as you know the pandemic.
And it created different.
Unknown Executive: Gratitude Study by year end and the initial gratitude study
Pressures and different sorts of studies at the moment, we're actually seeing things.
Unknown Executive: By mid-2020, we're on track for that. And, you know, then obviously we'll.
From restaurant and a law I, just again I'll, just add and when I said before it's an uncertain world, but at this moment in time, we really are fine with what we're seeing and as I said we.
Unknown Executive: flip the cards over and see what we see and what we observe in these trials. So we're quite excited about it and hope that we can demonstrate the treatment benefit. And Matt, what I'd just add to that is, As you know, the pandemic created different pressures on different sorts of studies. At the moment, we're actually seeing things, you know, progress right along. I just, again, I'll just add what I said before. You know, it's an uncertain world. But at this moment in time, we really are fine with what we're seeing, and as I said, we've repeated our timelines.
We've repeated our timelines.
And and and just a follow up on that in terms of yeah.
Your your sense in terms of moving what you need to see Uh huh from and impact point of view on on the weight gain and the unmet need I guess and this patient population.
And where where korlym could play a role there.
Well, let me address this 1 because you know Matt as you know on these are my patients I mean.
Every psychiatrists prescribe these medications they are very effective for what theyre intended to treat which is psychosis where as.
Matthew Lee Kaplan: And just a follow-up on that in terms of your sense of what you need to see from an impact point of view on weight gain and the unmet need, I guess, in this patient population and where Murakorland could play a role there.
Adjuncts to antidepressants and.
Major depression or bipolar disorder, so from an efficacy point of view there they're very good. Unfortunately, they had this terrible metabolic achilles' heel, which is that they really procure that system.
Joseph K. Belanoff: Well, let me address this one because, you know, Matt, as you know, these are my patients. I mean, every psychiatrist prescribes these medications because they're very effective for what they're intended to treat, which is psychosis or as adjuncts to antidepressants in major depression or bipolar disorder. So from an advocacy point of view, they're very good.
Cause and weight gain and even though it had mentioned and in my remarks.
<unk> and Thats actually a problem for treatment adherence people don't like how they look like him deal and they are disciplined enough to stay on their medications ultimately develop a lot of the disease, you see with 10 or 15% weight gain or sometimes more than that so.
Joseph K. Belanoff: Unfortunately, they have this terrible metabolic Achilles heel, which is that they really perturb that system, causing weight gain, and even though I didn't mention it in my remarks, that's actually a problem for treatment adherence. People don't like how they look, they don't like how they feel, and if they are disappointed enough to stay on the medications, ultimately, they develop a lot of the diseases you see with 10 or 15% weight gain or sometimes more than that.
There is no doubt among physicians, who treat these patients.
There is.
A great need for something to do with this problem and so.
Again, I'd sort of look at where both hats here as a treat or are these patients and some and developing medications for them I really believe that if you could come up with something which would help those issues.
Joseph K. Belanoff: So there's no doubt among physicians who treat these patients that there's a great need for something to do with this problem. And so, um, we, you know, again, sort of wear both hats here.
It is.
Very very meaningful and that's a large market with a lot of suffering and what it is.
Have to see.
Studies are set up to demonstrate pool on a week change.
Joseph K. Belanoff: As a doctor treating these patients and some in developing medications for them, I really believe that if you could come up with something which would help those issues, it would be very, very meaningful. It's a large market with a lot of suffering. And we'll just have to see.
And I think importantly to metabolic perturbations that come with that would change is good but it will be much better if you could actually develop something which.
Some of the other problems like things like increase and triglycerides or.
Matthew Lee Kaplan: I mean, the studies are set up to demonstrate both weight change and, I think importantly, the metabolic perturbations that come with that. Weight change is good, but it would be much better if you could actually develop something which helped with some of the other problems, like things like increase in triglycerides or fasting insulin, things which make people less prone to diabetes. So thanks for giving me the opportunity to expand at some length.
Fasting insulin and things, which make people less prone to diabetes. So thanks for giving me the opportunity to expand at some length. This is a met mental illness.
As a whole has a lot of stigma and isn't talked about within it. This is a big big.
Helped with album and.
And we can do something about it.
Thanks, Joe that's helpful context.
Matthew Lee Kaplan: This is a mental illness as a, you know, mental illness as a diet. It has a lot of stigma and isn't talked about within it. This is a big, big problem, and I'm hoping we can do something about it.
And for taking the questions.
Sure.
And then.
Yeah.
Your last question comes from the line of our turnkey from H C. Wainwright. Your line is now open.
And.
Good afternoon, everyone on these.
Inc for RK.
Matthew Lee Kaplan: Thanks, that's helpful to put it into context. Thanks for taking questions. Sure.
For taking my question.
Most of my question on of being and sorry that so.
Arthur He: Your last question comes from the line of Arthur He from H.C. Wainwright. Your line is now open.
So I'm just curious beside the shell bike program has management discussed and other plan too.
Arthur He: Good afternoon, everyone. This is authoring for RK. Thank you for taking my question. Most of my questions are being answered. So I'm just curious, besides the Shell Bike program, has management discussed any other plan to further improve shareholder value? Oh, we discuss it continuously, but you know our plan.
To further improve the shareholder value.
Oh are we discuss it continuously.
But you know what.
Plant.
No I love the most important thing we can do to increase shareholder value is for our programs to succeed and our commercial program to continue on the path and it's at other.
Joseph K. Belanoff: No, look, the most important thing we can do to increase shareholder value is for our programs to succeed in our commercial program and to continue on the path then it's at. Other ancillary things, we really do review; our board is very conscious of things like that. We feel that our stock is at an inexpensive price right now. As you know, we're committing our own funds to it, and we will continue to do that. But, no, beyond that, when we have something more specific, Arthur, we'll talk about it.
Larry things, we really do review our board is very conscious and things like that.
Deal that our stock is.
And as inexpensive price right now as you know we are committing our own funds to it and we will continue to do that but beyond.
Beyond that when we have.
Something more specific Arthur will talk.
About it.
Thank you. Thank you for that and congratulations on the strong quarter.
Joseph K. Belanoff: Thank you for that, and congratulations on a strong quarter. Thank you very much. And I want to just thank everyone else for listening to you. I'm sure it's a hot summer afternoon wherever you are. So stay cool and healthy, and we'll talk to you next quarter.
Thank you very much and.
And I wanted to just thank everyone else for listening to and I'm sure. It's a hot summer afternoon wherever you are so stay cool and healthy and we'll talk to you next quarter.
This concludes today's conference call. Thank you all for participating you may now disconnect.
Operator: This concludes today's conference call. Thank you all for participating. You may now disconnect.
unknown: and so on the other, and so on the You know,
[music].