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OncoCyte Corporation (OCX)

NYSE American - NYSE American Delayed Price. Currency in USD
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1.4400+0.0400 (+2.86%)
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Momentum

Previous Close1.4000
Open1.4000
Bid1.2900 x 1800
Ask0.0000 x 800
Day's Range1.3600 - 1.4700
52 Week Range1.1500 - 3.5100
Volume404,725
Avg. Volume1,158,935
Market Cap96.841M
Beta (5Y Monthly)2.41
PE Ratio (TTM)N/A
EPS (TTM)-0.5140
Earnings DateNov 12, 2020 - Nov 16, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est3.10
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  • GlobeNewswire

    Rockwell Medical Announces Appointment of Russell L. Skibsted as Executive Vice President, Chief Financial Officer and Chief Business Officer

    WIXOM, Mich., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the appointment of Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer (“CFO”) and Chief Business Officer (“CBO”), effective today, September 15, 2020. In this new role, Mr. Skibsted will be responsible for business development, financial operations and investor relations for the Company and will oversee the Finance and Accounting, Legal and Compliance, and Human Resources and Administration functions, reporting to the Chief Executive Officer and Board of Directors."We are pleased to announce Russell’s appointment as CFO and CBO of Rockwell Medical. His more than two decades of life sciences industry executive experience, including roles as CFO and CBO of publicly-traded biotechnology companies, are an excellent match for our Company as we focus on transforming our business through executing our commercial and worldwide business development strategy for Triferic and Triferic AVNU in kidney dialysis, and prioritize the development potential of our FPC platform to address iron deficiency and iron deficiency anemia in other medical indications,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “Russell will be a dynamic contributor to our leadership team, and we warmly welcome him to the Company."“I am honored to join Rockwell Medical at this pivotal time for the Company and look forward to working with the executive team and other stakeholders to strategically advance the business and bring value to patients and stockholders,” said Mr. Skibsted.Mr. Skibsted is a seasoned executive with more than 25 years of experience in finance, global business development, capital raising, investor relations, and operations. He has worked with a variety of both public and private life sciences companies, from commercial stage, development stage and start up. Prior to joining Rockwell, he served as CFO of AgeX Therapeutics (NYSE American: AGE), a biotechnology company focused on cell therapy targeting the diseases of aging that was spun out of BioTime, Inc. (currently Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX)). Previously, Mr. Skibsted served as CFO of BioTime, Inc., a publicly-traded biotechnology company which he joined in 2015, where he simultaneously, from time to time, performed the role of Chief Financial Officer for several of BioTime’s public and private subsidiaries, including Agex Therapeutics, OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer (November 2015 through November 2017) and Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine with clinical programs in spinal cord injury and oncology immunotherapy (March 2016 through November 2016). Prior to BioTime, Mr. Skibsted served as CFO or Chief Business Officer for several public and private life science companies, including Proove Biosciences, Aeolus Pharmaceuticals, Spectrum Pharmaceuticals and Hana Biosciences. From time to time, he also acted as a consulting CFO to various life science companies as Managing Director of RSL Ventures. Earlier in his career, Mr. Skibsted held roles as Portfolio Management Partner and CFO at Asset Management Company, one of the oldest and most respected venture capital firms in Silicon Valley, and Vice President for GE Capital Services Structured Finance Group. Mr. Skibsted holds a B.A. in Economics from Claremont McKenna College and an M.B.A. from the Stanford Graduate School of Business.About Rockwell Medical Rockwell Medical is a biopharmaceutical company dedicated to transforming anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company’s initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.About Triferic Dialysate and Triferic AVNUTriferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintain hemoglobin without increasing iron stores (ferritin). Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood which is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no reports of anaphylaxis in over 1,000,000 patient administrations, addressing a significant medical need in overcoming Functional Iron Deficiency (FID) in ESKD patients.Important Safety Information Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials.Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).Triferic® is a registered trademark of Rockwell Medical, Inc.Notice of Issuance of Inducement GrantsPursuant to his employment agreement, Mr. Skibsted will be awarded stock-based compensation representing the right to acquire shares of common stock (the “Inducement Grants”). The Inducement Grants will consist of options to purchase up to 750,000 shares of common stock, subject to 600,000 of which are subject to time-based vesting conditions and 150,000 of which are subject to performance-based vesting conditions. The Inducement Grants will be issued upon Mr. Skibsted’s commencement of employment (the “Grant Date”), and all stock options included within the Inducement Grants will have an exercise price equal to the fair value of the common stock on the Grant Date. The Inducement Grants have been approved by the Company’s Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s stockholder-approved equity incentive plans as an inducement grant, in accordance with Nasdaq Listing Rule 5635(c)(4).CONTACTS Investors: Argot Partners 212.600.1902 Rockwell@argotpartners.comMedia: David Rosen Argot Partners 212.600.1902 david.rosen@argotpartners.com

  • GlobeNewswire

    Oncocyte to Participate at the Lake Street Capital Markets 4th Annual Best Ideas Growth Conference

    IRVINE, Calif., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that Ronald Andrews, Chief Executive Officer, and Doug Ross, MD., Ph.D., Chief Medical Officer, will participate at the upcoming Lake Street Capital Markets 4th Annual Best Ideas Growth Conference, being held virtually on September 17, 2020. About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.comSource: Oncocyte Corporation

  • GlobeNewswire

    Oncocyte Receives Final Pricing Decision for DetermaRx™ Molecular Test for Lung Cancer from Centers for Medicare and Medicaid Services

    Pricing in line with comparable high-value molecular tests for oncology indications Consistent growth in testing volumes now provides immediate and consistent revenue for OncocyteDetermaRx is the only test available today for therapeutic decisions in early stage NSCLC, addressing an estimated global market of $450M - $500MIRVINE, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it has received a pricing decision from Centers for Medicare and Medicaid Services (CMS) for DetermaRx™, the Company’s treatment stratification test that identifies which early stage lung cancer patients are at high risk for lung cancer recurrence post-surgery. This is the first and only testing available for this indication.The pricing decision is in line with similar high-value molecular tests in oncology and is within the range of the Company’s previously communicated pricing expectations. This CMS pricing decision establishes an immediate path to consistent revenue growth for Oncocyte. In addition, Oncocyte already has begun to receive payment from commercial payers including Blue Shield of California, Cigna and Anthem. The Company believes that the receipt of the final Medicare local coverage determination (LCD) for DetermaRx™, announced on July 20, 2020, and the receipt of this pricing decision, will drive favorable payment decisions from additional commercial payors.“This CMS pricing decision provides important validation of DetermaRx’s ability to improve patient outcomes and healthcare economics,” said Ron Andrews, Chief Executive Officer and President of Oncocyte. “We are thrilled to have received a pricing decision in line with our expectations, and we continue to be encouraged by the solid market uptake of the DetermaRx test. Despite the current headwinds created by the COVID-19 pandemic, we are on track to test between 250 to 300 patient samples by year end, which is representative of 100% quarter over quarter growth. With this pricing decision and the continued growth in orders, DetermaRx represents a rapidly growing source of revenue and cash flow for Oncocyte.”Mr. Andrews continued, “Medicare patients account for approximately 70 percent of eligible patients for DetermaRx, and we are pleased to be able to provide this important, potentially life-saving test to Medicare patients at no out-of-pocket cost. We are also excited by the growing support of key opinion leaders, which in combination with the high value pricing, we believe will provide a catalyst to increase our sales efforts around the world to take advantage of our first-mover status in the test’s approximately $450M - $500M global market opportunity, subject to pricing and adoption rates. We look forward to building on this success as we continue to expand the adoption of DetermaRx while also advancing our commercially available for research use test, DetermaIO™, toward clinical use in 2021.”In published clinical studies, patients identified as high risk by DetermaRx who did not receive chemotherapy treatment had a 49% five year disease free survival rate versus a 92% five year disease free survival rate for those who were high risk and received a standard chemotherapy, a significant improvement. Conversely, in these studies, none of the low risk patients received chemotherapy. These low-risk patients reported a 94% five year disease-free survival rate, which suggests that DetermaRx may also help low risk patients avoid the toxic side effects associated with unnecessary chemotherapy.Physician adoption of DetermaRx has continued to grow throughout 2020 despite the continued challenges associated with the global COVID-19 pandemic. Through August, Oncocyte has onboarded 55 hospitals across the United States, increasing the number of onboarded accounts by 60 percent since the second quarter of 2020. In addition, the test is already included in the diagnostic ordering systems of several large community health center networks, including Florida Cancer Specialists & Research Institute. DetermaRx test volume has grown rapidly since it was commercialized early in 2020, and the Company projects third quarter volumes to grow approximately 100 percent compared to second quarter volumes. The physician reorder rate has remained consistently high, and was approximately 60 percent through August.The table below summarizes the hospital adoption, physician adoption and volume growth of DetermaRx since its commercialization early in 2020. It is provided for illustrative purposes only. Revenue recognition and cash payments to Oncocyte are determined by accounting principles and contractual agreements, and therefore do not necessarily correlate with volume statistics during individual quarters.  Q1 2020Q2 2020July and August Cumulative sites onboarded 143655 Physician reorder rate Not Tracked60%~60% Billable Patients tested 3364Tracking to 100% QoverQ growth About DetermaRxDetermaRx is the first and only predictive test for the identification of patients with Stage I-IIA non-squamous non-small cell lung cancer who are at high risk for recurrence following surgery and who may benefit from adjuvant chemotherapy.There are an estimated 40,000 Stage I and IIA non squamous NSCLC patients in the United States each year. With an estimated 350,000 patients potentially eligible for the test on an annual basis globally, the Company believes there may be a total addressable market opportunity of approximately $450M to $500 million for the test, subject to pricing and adoption rates. Oncocyte recently announced that it has agreements in place for the distribution of the test in India, the Middle East, Africa and Israel.About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Oncocyte Forward Looking StatementsOncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.com