Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update

On July 29, 2024 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2024 (Press release, Corcept Therapeutics, JUL 29, 2024, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-2 [SID1234645129]).

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Financial Results

Revenue of $163.8 million, a 39 percent increase over the same period in 2023
Increase in 2024 revenue guidance to $640 – $670 million, from $620 – $650 million
Net income per common share of $0.32 (diluted), compared to $0.25 in second quarter 2023
Cash and investments of $492.5 million as of June 30, 2024
"Once again, we had a record number of new Korlym prescribers and a record number of patients receiving Korlym this quarter. Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "From the launch of Korlym, we implemented a unique system of patient and physician support and have invested in multiple refinements over the past 12 years. Hypercortisolism is a complicated disease and the expertise we have developed is critical to the life-changing impact for patients who receive Korlym treatment."

Corcept’s second quarter 2024 revenue was $163.8 million, compared to $117.7 million in the second quarter of 2023. Second quarter operating expenses were $128.2 million, compared to $88.1 million in the second quarter of 2023, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our commercial and clinical development teams. Net income was $35.5 million in the second quarter of 2024 compared to $27.5 million in the same period last year. Cash and investments were $492.5 million at June 30, 2024 compared to $451.0 million at March 31, 2024.

The company increased its 2024 revenue guidance to $640 – $670 million.

Clinical Development

"During the second quarter we presented the results from our GRACE and CATALYST trials. GRACE’s positive results are a welcome development for patients with hypercortisolism and constitute a significant step toward our new drug application for relacorilant, which we expect to submit in the fourth quarter. In addition, the results from the prevalence phase of our CATALYST study establish that hypercortisolism is a driving biological force in patients with diabetes refractory to treatment. We expect data from the treatment phase of the CATALYST study, as well as our other late-stage studies, GRADIENT, ROSELLA and DAZALS, by the end of this year," added Dr. Belanoff.

Cushing’s Syndrome

GRACE – Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognitive impairment and quality of life
Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the fourth quarter
GRADIENT – Phase 3 trial of relacorilant in 137 patients with Cushing’s syndrome caused by adrenal adenomas – enrollment completed; results expected in the fourth quarter
CATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – in the first 1,055 patients enrolled, 24% were found to have hypercortisolism; 136 patients with hypercortisolism entered a randomized, double-blind, placebo-controlled study of Korlym – treatment phase results expected in the fourth quarter
"Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase experienced significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. In the randomized withdrawal phase, GRACE met its primary endpoint and demonstrated that patients who remained on relacorilant maintained these improvements while those who received placebo saw a significant worsening in their signs and symptoms of hypercortisolism," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our Phase 4 CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. The prevalence results from CATALYST confirm there are considerably more patients with Cushing’s syndrome than was previously assumed. CATALYST is poised to become the landmark study that guides physicians toward expanded screening for hypercortisolism and will result in better health outcomes for many patients who are struggling today," said Dr. Guyer.

Oncology

ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – enrollment completed; results expected in the fourth quarter
Open-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess – improvement in Cushing’s syndrome signs and symptoms observed; no change in tumor progression
Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
"Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS – enrollment completed; results expected in the fourth quarter
"Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data by the end of this year and are hopeful that the trial results will create a much-needed advance for patients with ALS," said Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant with a cohort of patients with biopsy-confirmed MASH and a second cohort of patients with presumed MASH based on non-invasive diagnostic tests – enrollment continues
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures, and was well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer. "Miricorilant has the potential to greatly benefit the millions of patients with MASH."

Conference Call

We will hold a conference call on July 29, 2024, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors

On July 29, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a Phase 1 trial for COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody licensed to Gilead Sciences, Inc. (Gilead) (Press release, Compugen, JUL 29, 2024, View Source [SID1234645128]). The IND clearance triggered a $30 million milestone payment from Gilead and Compugen is on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024.

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"We are thrilled to receive FDA IND clearance for COM503 which triggers a $30 million milestone payment from our partner Gilead, and the initiation of a Phase 1 trial will keep us on track to expedite COM503 development," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We are excited about the potential of COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics which we discovered through our computational discovery work at Compugen."

Dr. Cohen-Dayag added, "This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical program discovered through our predictive computational discovery engine. In addition, it further strengthens our balance sheet with an expected cash runway sufficient to take us into 2027. We look forward to the initiation of the Phase 1 trial in the fourth quarter of this year, for which our preparation is well-advanced."

About COM503 Phase 1 trial
The Phase 1 trial is a first-in-human, dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as a monotherapy and in combination with Gilead’s anti-PD-1, zimberelimab in participants with advanced or metastatic solid tumors globally.

About the Compugen-Gilead license agreement
In 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including the COM503 drug candidate. Compugen is responsible for preclinical development and the anticipated first- in-human Phase 1 trial evaluating the safety and tolerability of COM503. Gilead will have the sole right to develop and commercialize COM503 thereafter. Gilead provided Compugen with a $60 million upfront payment and will make a $30 million payment for achievement of the milestone of IND clearance of COM503, the subject of this press release. Compugen will be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of up to $848 million. Compugen will also be eligible to receive single- digit to low double-digit tiered royalties on worldwide net sales.

Can-Fite Provides Namodenoson Patent Update

On July 29, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported an update related to the intellectual property (IP) status of its lead drug candidate Namodenoson, currently being developed for advanced liver cancer, pancreatic cancer and MASH (Press release, Can-Fite BioPharma, JUL 29, 2024, View Source [SID1234645127]).

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The patents and patent applications cover methods of treating the two solid tumors, liver and pancreatic carcinoma by administering Namodenoson in an oral formulation as well as treating MASH to improve liver steatosis, inflammation and fibrosis. A patent application protecting the manufacturing of the drug has recently been filed. Patent terms of granted patents and patent application will have expiration dates of 2044 and beyond. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, including Europe and the US.

"We are delighted that the product protection of Namodenoson in the area of oncology and MASH is broad and covers the use and manufacturing of the drug for 20 years, and we look forward to expanding this to other geographies", said Pnina Fishman, Ph.D., Can-Fite CSO and Chairperson.

Can-Fite is currently conducting a pivotal Phase III study in advanced liver cancer and a Phase IIb study in MASH, both in agreement with the FDA and EMA.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

BIO-TECHNE ANNOUNCES STRATEGIC INVESTMENT IN SPEAR BIO

On July 29, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported its participation in Spear Bio’s $45 million Series A funding round (Press release, Bio-Techne, JUL 29, 2024, View Source [SID1234645125]). Spear Bio will use the proceeds from this funding round to further accelerate product development and scale its in-house manufacturing capacity. Bio-Techne joined Foresite Capital, and other investors, in this funding round.

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Founded in 2021 and headquartered in Woburn, Massachusetts, Spear Bio is an innovative leader in the development, and manufacture of ultra-sensitive immunoassays capable of measuring protein biomarkers at attomolar level from sub-microliter sample volume. Spear Bio’s proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology is exclusively licensed from the Wyss Institute for Biologically Inspired Engineering at Harvard University. SPEAR leverages target-binding probes that bind to proximal sites in a protein’s structure. This double-tagging event enables the two specially-designed probes to "shake hands" multiple times under a time-controlled manner to ensure true target-induced proximity and synthesize a unique DNA sequence which can then be amplified and quantified using standard qPCR instruments. In the absence of target protein, the transient interaction between free-floating probes does not allow multiple "shake hands" to initiate the synthesis of the amplifiable DNA sequence, reducing background over three orders of magnitude compared to conventional proximity-based assays. The ultra-sensitivity offered by Spear Bio’s technology makes it ideal for measuring historically challenging low abundant biomarkers in neurology, inflammation and oncology. The initial offering will focus on key biomarkers supporting translational research in Alzheimer’s disease.

"We are excited to invest in Spear Bio," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "Spear Bio’s ultra-sensitive detection technology offers significant advantages over traditional immunoassay and next-gen proteomic technologies, enabling the quantification of mere dozens of protein molecules in a sample. This level of sensitivity unlocks several challenging applications and high growth markets, including early diagnosis of neurodegenerative diseases. Importantly, Spear Bio’s assays run on qPCR equipment, which is routinely found in research and clinical facilities, representing an existing installed base to run these groundbreaking assays."

"Having an industry leader like Bio-Techne invest in Spear Bio is a testament to the high potential of the SPEAR technology," said Feng Xuan, Ph.D., Cofounder and Chief Executive Officer of Spear Bio. "Following this funding round, Spear Bio is ideally positioned to rapidly deploy our next-generation assay technology and enable the detection of biomarkers in historically challenging conditions, including neurodegenerative diseases."

Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukaemia in AMPLIFY Phase III trial

On July 29, 2024 Astrazeneca reported positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL) (Press release, AstraZeneca, JUL 29, 2024, View Source [SID1234645124]).

For the secondary endpoint of overall survival (OS), a trend was observed in favour of Calquence in combination with venetoclax, with or without obinutuzumab, versus standard-of-care chemoimmunotherapy. The OS data were not mature at the time of this analysis and the trial will continue to assess OS as a key secondary endpoint.

CLL is caused by the abnormal production of white blood cells and is the most prevalent type of leukaemia in adults worldwide, with numbers anticipated to grow.1-3 In the first-line setting, approximately 40,000 patients are treated with the current standard of care.4 Although CLL is considered an incurable cancer, patients often live with the disease for many years, and may remain on continuous treatment.5

Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the trial, said: "The AMPLIFY results demonstrate the potential of acalabrutinib and venetoclax with or without obinutuzumab to be effective and well-tolerated fixed-duration treatment options for patients with chronic lymphocytic leukaemia. This is an important advance in this setting as fixed-duration regimens allow those living with this chronic disease to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance and improving quality of life."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The progression-free survival and overall survival results from the AMPLIFY Phase III trial demonstrate the potential of including a BTK inhibitor in a fixed-duration regimen and reinforce our leadership in advancing science for patients with chronic lymphocytic leukaemia. If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers."

The safety and tolerability were consistent with the known safety profile of each medicine. No new safety signals were identified, with low rates of cardiac toxicity observed.

The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Notes

CLL
In CLL, there is an accumulation of abnormal lymphocytes within the bone marrow and in blood and lymph nodes.1 Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.6 As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets. This could result in anaemia, infection and bleeding.1 B-cell receptor signalling through BTK is one of the essential survival pathways for CLL.

AMPLIFY
AMPLIFY is a randomised, global, multi-centre, open-label Phase III trial evaluating the efficacy and safety of Calquence in combination with venetoclax with and without obinutuzumab compared to investigator’s choice of chemoimmunotherapy in adult patients with previously untreated CLL without del(17p) or TP53 mutation.7 Patients were randomised 1:1:1 to receive either Calquence in combination with venetoclax, Calquence in combination with venetoclax plus obinutuzumab for a fixed duration or standard-of-care chemoimmunotherapy.7

The primary endpoint is PFS in the Calquence and venetoclax arm as assessed by an Independent Review Committee (IRC) and PFS in this arm assessed by investigators (INV) is a key secondary endpoint. IRC and INV assessed PFS in the Calquence, venetoclax and obinutuzumab arm as a key secondary endpoint. Other key secondary endpoints include OS, event-free survival, overall response rate, duration of response and time to next treatment.7 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.7

The AMPLIFY trial enrolled patients from 2019 to 2021, continuing through the COVID-19 pandemic.7 Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalisation and death compared to the general population.8

Calquence
Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.9 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence has been used to treat more than 80,000 patients worldwide10 and is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. Calquence is also approved in the US, China and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is not currently approved for the treatment of MCL in Japan or the EU.

As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

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