On May 5, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended March 31, 2022 (Press release, Corcept Therapeutics, MAY 5, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results [SID1234613658]).

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Financial Results

Revenue of $93.7 million, compared to $79.4 million in first quarter 2021
Reiterated 2022 revenue guidance of $400 – $430 million
Diluted net income per share of $0.20, compared to $0.18 in first quarter 2021
Cash and investments of $368.1 million, compared to $335.8 million at December 31, 2021
"As pandemic restrictions and fears recede, we expect our growth to continue and are reiterating our 2022 revenue guidance of $400 – $430 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it."

Corcept’s first quarter 2022 revenue was $93.7 million, compared to $79.4 million in the first quarter of 2021. First quarter operating expenses were $66.9 million, compared to $59.8 million in the first quarter of 2021, due to increased expenses to support the expansion of our clinical development and commercial teams and legal fees. Diluted net income per share was $0.20 in the first quarter of 2022, compared to $0.18 in the first quarter of 2021.

Cash and investments increased $32.3 million in the first quarter, to $368.1 million at March 31, 2022.

Clinical Development

"Corcept was founded on the premise that cortisol modulation has the potential to help treat many serious diseases," said Dr. Belanoff. "Our clinical development programs have produced increasing amounts of evidence validating this hypothesis and our programs in castration-resistant prostate cancer, antipsychotic-induced weight gain and non-alcoholic steatohepatitis will produce important data this year. We are especially excited about our advancing platinum-resistant ovarian cancer program. Based on the statistically significant and clinically meaningful results of our large, controlled Phase 2 study, we will soon initiate a pivotal trial."

Solid Tumors

Phase 3 trial in patients with recurrent platinum-resistant ovarian cancer planned
to start this quarter; Oral presentation of Phase 2 trial results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 6 in Chicago
Selection of the optimum dose of exicorilant or relacorilant plus enzalutamide in patients
with castration-resistant prostate cancer (CRPC) expected this quarter
Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus
PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"We are excited to start our Phase 3 trial of relacorilant in patients with recurrent platinum-resistant ovarian cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Our goal is to replicate the positive findings of our 178-patient Phase 2 trial, in which women who received relacorilant in addition to nab-paclitaxel exhibited meaningful improvements in progression-free survival, duration of response and overall survival, without increased side effects, when compared to women who received nab-paclitaxel alone. The 20,000 women in the United States and an equal number in Europe with platinum-resistant ovarian cancer have few good treatment options. If our Phase 3 trial is successful, relacorilant plus nab-paclitaxel could become the new standard of care for these patients. We plan to meet with the FDA in June regarding our proposed path forward."

Metabolic Diseases

Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG); data from both trials expected in fourth quarter 2022
Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients
with presumed NASH
"We look forward to the results of GRATITUDE and GRATITUDE II," said Dr. Guyer. "Weight gain and other metabolic adverse effects caused by antipsychotic medications pose serious risks to the health of millions of patients, who have few treatment options. We initiated these double-blind, placebo-controlled trials to build on the positive data from our studies of both miricorilant and mifepristone in healthy volunteers."

Cushing’s Syndrome

Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome; new drug application (NDA) submission now expected
in second half 2023
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients
with Cushing’s syndrome caused by adrenal adenomas
"We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial, which is accruing patients and generating data, to serve as the basis for relacorilant’s NDA in Cushing’s syndrome. The timing for the completion of this trial has been impacted by the pandemic, as clinical trial sites have experienced challenges in recruiting and managing patients. We are currently planning to submit this relacorilant NDA in the second half of 2023," said Dr. Guyer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that has not been subject to rigorous, controlled study, but affects many patients."

Conference Call

We will hold a conference call on May 5, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. A replay will be available through May 12, 2022 at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 6942208. A replay will also be available on the Investors / Past Events tab of our website.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On May 5, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended March 31, 2022 (Press release, Corvus Pharmaceuticals, MAY 5, 2022, View Source [SID1234613657]).

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"We are advancing our three clinical product candidates according to a clear strategy focused on the interaction of tumors with the immune system," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our product candidates have demonstrated enhanced immune responses to a wide range of solid and hematologic cancers and are designed to act alone or in combinations. We are a leader in the modulation of CD73 and adenosine to affect tumor immunity, with mid-to-late stage clinical trials for mupadolimab and ciforadenant on track for initiation later this year. In addition, we have demonstrated encouraging potential of our ITK inhibitor on T cell differentiation, raising important new potential applications in cancer and autoimmune diseases."

2022 Key Areas of Focus
Corvus is advancing three clinical programs in 2022, including plans for a Phase 2 study for mupadolimab in front-line non-small cell lung cancer (NSCLC), a Phase 1b/2 study for ciforadenant in front-line renal cell cancer (RCC), and the ongoing Phase 1/1b study for CPI-818 in T-cell lymphoma.

The Company will host an R&D Symposium on Tuesday, May 10, 2022 to provide an update on these clinical programs. The event will take place in New York City from 9:00 – 11:30 am Eastern Time. A webcast of the event will be available on the Corvus website at www.corvuspharma.com.

Mupadolimab (anti-CD73)

The Company continues to enroll its two Phase 1b/2 clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in each expansion cohort and treated with the combination of mupadolimab and pembrolizumab.
The Company plans to initiate a randomized Phase 2 clinical trial evaluating mupadolimab as a front-line therapy for the treatment of patients with advanced NSCLC later this year. The randomized, blinded clinical trial will compare standard chemotherapy plus pembrolizumab (anti-PDL-1) with or without mupadolimab. The Company intends to enroll approximately 150 patients with any tumor PDL-1 expression in the clinical trial, potentially addressing a large patient population. The primary endpoint for the study will be progression free survival and secondary endpoints will evaluate objective response rate and overall survival.
Ciforadenant (adenosine 2a receptor antagonist)

The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial, which is anticipated to be initiated in the third quarter 2022, will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting. The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
CPI-818 (selective ITK inhibitor)

Corvus and its partner in China, Angel Pharmaceuticals, are enrolling patients with relapsed T cell lymphomas in Phase 1/1b trial evaluating single agent therapy with CPI-818. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China. Monitoring of immune modulation of normal T cells as well as safety and anti-tumor activity are being assessed in the clinical trial, with data expected later this year. Based on interim results observed in patients with peripheral T cell lymphoma (PTCL) in these Phase 1/1b clinical trials, the Company believes such results could provide the foundation for a potential global phase 2 clinical trial in advanced PTCL.
Financial Results
As of March 31, 2022, Corvus had cash, cash equivalents and marketable securities totaling $62.9 million. This compared to cash, cash equivalents and marketable securities of $69.5 million as of December 31, 2021.

Research and development expenses for the three months ended March 31, 2022 totaled $5.1 million compared to $8.2 million for the same period in 2021. The decrease of $3.1 million was primarily due to lower outside clinical trial and personnel costs.

The net loss for the three months ended March 31, 2022 was $8.3 million compared to a net loss of $11.6 million for the same period in 2021. Total stock compensation expense for the three months ended March 31, 2022 was $0.7 million compared to $1.2 million for the same period in 2021 and the non-cash loss from our equity method investment in Angel Pharmaceuticals was $1.0 million for the three months ended March 31, 2022 compared to $0.1 million in the same period in 2021.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. The Company’s second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

About Mupadolimab
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.

About CPI-818
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and leukemias and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.

On March 5, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported first quarter 2022 financial results and recent portfolio and business updates (Press release, Alector, MAY 5, 2022, View Source [SID1234613656]). As of March 31, 2022, Alector’s cash, cash equivalents, and marketable securities totaled $868.6 million.

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"We made significant progress in the first quarter, highlighted by the presentation of 12-month data from our INFRONT-2 Phase 2 clinical trial of latozinemab in patients with symptomatic FTD-C9orf72, in which treatment with latozinemab demonstrated target engagement and resulted in increases in progranulin levels above physiological levels in all patients," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "Data from the FTD-C9orf72 cohort builds upon the results observed in our studies to date in patients with symptomatic FTD-GRN. The totality of the data supports our approach of elevating progranulin levels to address a range of neurodegenerative diseases including FTD, ALS, Parkinson’s disease and Alzheimer’s disease. We look forward to evaluating latozinemab and AL101 in multiple indications as part of our progranulin franchise in partnership with GlaxoSmithKline."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "In parallel to advancing and expanding our progranulin franchise, we continue to make progress in our Alzheimer’s and oncology programs. Our INVOKE-2 Phase 2 clinical trial evaluating AL002 in slowing disease progression in individuals with early Alzheimer’s disease is ongoing, and we also expect to initiate a Phase 1 trial for AL044, which targets MS4A, a major risk locus for Alzheimer’s disease, in the second half of 2022. Additionally, we presented exciting preclinical data from our AL009 immuno-oncology program at the 2022 AACR (Free AACR Whitepaper) Annual Meeting, with a Phase 1 trial slated to begin within the next year. This clinical momentum, coupled with the addition of veteran neurodegeneration expert, Gary Romano, as Chief Medical Officer, puts Alector in a strong position to execute our goal of halting the destruction caused by neurodegenerative diseases."

Recent Clinical Updates

Progranulin Franchise Portfolio

Twelve-month data from the INFRONT-2 Phase 2 clinical trial of latozinemab in frontotemporal dementia patients (FTD) with a C9orf72 genetic mutation (FTD-C9orf72) were presented at the AD/PD 2022 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders. Latozinemab treatment was well tolerated and resulted in a two- to three-fold increase in progranulin above physiological levels in cerebrospinal fluid (CSF) and plasma respectively, and a decrease in the neurodegeneration biomarker GFAP. When compared to a matched control cohort from the ALLFTD consortium, treatment with latozinemab in FTD-C9orf72 patients resulted in a trend towards an annual delay of disease progression of approximately 54 percent as measured by the CDR plus NACC FTLD-SB scale. These data support the company’s efforts to expand the progranulin franchise into additional neurodegenerative disease indications.
Enrollment is ongoing in INFRONT-3, a randomized, placebo-controlled, pivotal Phase 3 trial evaluating the efficacy and safety of latozinemab in at-risk and symptomatic patients with FTD due to a progranulin gene mutation (FTD-GRN). Participants in the trial will be given the option to continue receiving treatment in an open-label extension study.
In partnership with GSK, the company made a strategic, non-safety related decision to close enrollment in the Phase 2a biomarker trial of latozinemab in people with amyotrophic lateral sclerosis (ALS) who carry a C9orf72 mutation. In light of the evolving ALS landscape, the company is currently evaluating plans for a potential Phase 2b study for patients with all forms of ALS, including the C9orf72 mutation.
Alector completed enrollment in the ongoing Phase 1 clinical trial to test multiple doses of AL101 administered intravenously and subcutaneously. AL101, the second drug candidate in the company’s progranulin franchise, is designed to elevate progranulin levels, similar to AL001, with the potential for easier administration and/or less frequent dosing for the treatment of more prevalent neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease. The company expects to report data from the Phase 1 trial in the second half of 2022.
Alzheimer’s Disease Portfolio

The INVOKE-2 Phase 2 clinical trial evaluating the efficacy and safety of AL002 in slowing disease progression in individuals with early Alzheimer’s disease is ongoing. AL002 targets Triggering Receptor Expressed on Myeloid cells 2 (TREM2) to increase TREM2 signaling and the functionality of the microglia brain specific immune cells. It is being developed in collaboration with AbbVie.
AL003 is being developed to treat patients with Alzheimer’s disease in collaboration with AbbVie. AL003 focuses on modulating checkpoint receptors on the brain’s immune cells, targeting sialic acid binding Ig-like lectin 3 (SIGLEC 3, also called CD33). In 2021, we presented data from the Phase 1 trial of AL003 in healthy volunteers and Alzheimer’s disease patients. Alector is currently reviewing potential next steps for the AL003 program together with AbbVie.
Alector expects to initiate a Phase 1 clinical trial for AL044 in the second half of 2022. AL044 targets MS4A, a major risk locus for Alzheimer’s disease. MS4A gene family members encode a transmembrane protein that is expressed selectively in myeloid cells in the brain and is associated with control of microglia functionality and potentially with microglia viability.
Immuno-oncology Portfolio

At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Alector presented preclinical data from its first-in-class AL009 innate immuno-oncology program. AL009 is a dual function biologic that inhibits multiple Siglec receptors on myeloid cells and simultaneously activates a stimulating receptor on the same cells. The findings demonstrated that AL009 led to repolarization of myeloid cells and activation of innate and adaptive immunity against tumors. Pharmacologically relevant doses of AL009 appeared well-tolerated in initial non-human primate studies. IND enabling studies are ongoing, and a Phase 1 clinical study of AL009 in patients with advanced solid tumors is expected to begin within the next year.
Recent Corporate News

Gary Romano, M.D., Ph.D., will join Alector’s executive leadership team as Chief Medical Officer (CMO) on May 23, 2022, and Marc Grasso, M.D., joined as Chief Financial Officer (CFO).
Dr. Romano is a board-certified neurologist, neurodegeneration expert and recognized clinical leader in the industry with a demonstrated track record in progressing the development of therapeutics for multiple neuroscience indications. As CMO, Dr. Romano will lead the company’s global clinical development strategy, including oversight of the clinical development, clinical operations, biometrics and digital science and medical affairs functions.
Dr. Grasso brings extensive biotechnology industry leadership experience, including a successful track record in finance and corporate development. As CFO, Dr. Grasso leads all aspects of the company’s financial operations and plays a critical role in supporting corporate strategy.
First Quarter 2022 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2022, was $24.5 million, compared to $4.1 million for the same period in 2021. This increase was primarily due to revenue recognized from the GSK Agreement.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2022, were $53.0 million, compared to $45.7 million for the quarter ended March 31, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses, as well as increased spending to support advancement of several clinical and preclinical programs.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2022, were $15.6 million, compared to $11.0 million for the same period in 2021 was primarily due to an increase in personnel-related expenses and increase in legal expenses from the arbitration award in 2021 that reduced expenses.

Net Loss. For the quarter ended March 31, 2022, Alector reported a net loss of $44.6 million, or $0.54 per share, compared to a net loss of $52.2 million, or $0.66 per share, for the same period in 2021.

Cash Position. Cash, cash equivalents, and marketable securities were $868.6 million as of March 31, 2022. Management expects that this will be sufficient to fund current operations into mid-2024.

On May 5, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report its first quarter 2022 financial results on Thursday, May 12, 2022, after the U.S. financial markets close (Press release, Regulus, MAY 5, 2022, View Source [SID1234613655]).

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In connection with the earnings release, Regulus’ management team will host a live conference call and webcast at 5:00 PM ET on Thursday, May 12, 2022, to discuss the Company’s financial results and provide a corporate update. To access the call, please dial (866) 652-5200 (domestic) or (412) 317-6060. To access the telephone replay of the call, dial (877) 344-7529 (domestic) or (412) 317-0088 and refer to conference ID 6812601. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

On May 5, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended March 31, 2022 after the close of the U.S. financial markets on Monday, May 9, 2022 (Press release, Opko Health, MAY 5, 2022, View Source [SID1234613654]). OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on May 9th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 16, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 6587528. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.