Latest news with #OCX
Yahoo
13-05-2025
- Business
- Yahoo
OncoCyte Corp (OCX) Q1 2025 Earnings Call Highlights: Strategic Advances in Transplant Testing ...
Release Date: May 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OncoCyte Corp (NASDAQ:OCX) has finalized its clinical trial design and received central IRB approval, marking a significant milestone in its strategic pivot towards transplant rejection testing. The company is on track to submit a data package to the FDA by the end of the year, with FDA approval targeted for the first half of 2026. There is strong interest from top transplant centers in the US and Germany to participate in the clinical trial, representing nearly 10% of US transplant volumes. OncoCyte Corp (NASDAQ:OCX) has successfully expanded its RUO assay to 10 sites across the US, Germany, UK, Switzerland, Austria, and Southeast Asia, with researchers exploring new applications for the tests. The company reported Pharma Services revenue of $2.1 million, exceeding expectations and extending its cash runway, with gross margins of 62%. Pharma Services revenue is situation-driven and expected to vary, with Q2 revenue anticipated to be less than $500,000, highlighting potential revenue volatility. The company's oncology pipeline, while promising, is still in the early stages compared to its transplant focus, indicating a longer timeline for revenue generation in this area. OncoCyte Corp (NASDAQ:OCX) is undergoing a corporate rename, which, although budget-conscious, may cause temporary brand recognition challenges. The company anticipates a couple of quarters with increased cash burn due to clinical trial costs and FDA-compliant software development, impacting financial stability. There is uncertainty regarding the speed at which transplant centers will adopt the new test post-FDA approval, as these centers are generally risk-averse and may require time to integrate new technologies. Warning! GuruFocus has detected 6 Warning Signs with OCX. Q: Can you expand on the interest from a larger pharma customer regarding oncology kits? A: Josh Riggs, CEO: The interest is primarily around Determa IO and its potential as a standalone PCR assay or in conjunction with a larger NGS panel. The data is seen as differentiating, especially in challenging cancers like colon cancer. Q: What are the next milestones for Determa IO, and when might it represent a tangible revenue opportunity? A: Josh Riggs, CEO: We submitted for reimbursement in December 2022 and are awaiting results. The SWAG study, involving 800 patients, is a significant milestone, with results expected towards the end of the year, potentially at the San Antonio Breast Cancer Symposium. Q: What feedback have you received from large US transplant centers about participating in your study? A: Josh Riggs, CEO: The centers are enthusiastic and eager to access the technology. They are interested in answering complex questions that are difficult with only send-out options. The partnership approach is fostering strong relationships. Q: How do you anticipate the iota model impacting market growth? A: Josh Riggs, CEO: The model is expected to increase demand for testing as more marginal organs are used, leading to more adverse events. This will drive the need for tools to manage patients, and we are hopeful that new drugs will mitigate some negative effects. Q: What is the focus of the final Q-sub meeting with the FDA, and what has been de-risked? A: Ecky Schutz, Chief Science Officer: We are submitting the CSA to the FDA and have had productive pre-meetings. The FDA has provided clear guidance on what they want to see, which we have incorporated into our QA. We are on track to submit by the end of the year. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Washington Post
12-05-2025
- Business
- Washington Post
OncoCyte: Q1 Earnings Snapshot
IRVINE, Calif. — IRVINE, Calif. — OncoCyte Corp. (OCX) on Monday reported a loss of $6.7 million in its first quarter. The Irvine, California-based company said it had a loss of 26 cents per share. The cancer diagnostic test developer posted revenue of $2.1 million in the period. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on OCX at
Yahoo
25-03-2025
- Business
- Yahoo
OncoCyte Corp (OCX) Q4 2024 Earnings Call Highlights: Strategic Partnerships and Regulatory ...
Release Date: March 24, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OncoCyte Corp (NASDAQ:OCX) launched Graft Assure, a kidney transplant test, with leading transplant centers, enhancing their IVD product development. The company achieved a breakthrough designation for a drug from the FDA, signaling potential market expansion. OncoCyte Corp (NASDAQ:OCX) published data showing their assay can detect organ rejection 11 months ahead of standard protocols, leading to Medicare claims expansion. The company attracted a strategic partner, Bio-Rad Laboratories, which participated in all three equity funding rounds, strengthening their financial position. OncoCyte Corp (NASDAQ:OCX) successfully raised $29 million in February, ensuring a financial runway of over a year and supporting their clinical assay development. There are macro uncertainties around federal government actions that could affect OncoCyte Corp (NASDAQ:OCX)'s timeline for FDA submissions. The company is not projecting any material revenue from their RUO product this year, indicating potential delays in revenue generation. OncoCyte Corp (NASDAQ:OCX) faces competition from established lab-based competitors with a significant market presence. The FDA submission timeline has been pushed back by two quarters, partly due to uncertainties in the regulatory environment. The company anticipates higher cash burn in Q2 and Q3 due to bonuses and incremental sales and marketing expenses. Warning! GuruFocus has detected 5 Warning Signs with OCX. Q: Can you explain the regulatory pathway for your assay and the expected timeline for FDA approval? A: (Josh Riggs, CEO) We are using the de novo pathway, which is expected to take about seven months. This pathway was chosen because there is no predicate device for donor-derived cell-free DNA. We anticipate submitting our data package to the FDA by the end of this year, with an approved product on the market by mid-2026. Q: How many centers are required for the FDA package, and how many patients need to be enrolled? A: (Josh Riggs, CEO) We need a minimum of three sites for reproducibility work, but we expect to double that in the US and have additional centers in Europe. (Ecky Schutz, CSO) We need about 150 biopsy-matched samples to provide statistically significant results. Q: What are your expectations for revenue from the RUO product before FDA clearance? A: (Josh Riggs, CEO) We do not project any material revenue from the RUO product this year. The significant revenue opportunity lies in the regulated product in the US and Europe. We are incorporating feedback from beta sites and expect potential revenue generation in the second half of this year. Q: What clinical evidence will be prioritized post-FDA approval to drive broader utilization? A: (Josh Riggs, CEO) We have strong data showing our assay's clinical utility, including publications in the New England Journal of Medicine. Post-approval, we will focus on kidney transplants initially, then expand to heart, liver, and lung transplants. We aim to demonstrate our assay's effectiveness compared to existing tests. Q: How do you plan to drive early utilization of your assay, considering reimbursement risks? A: (Josh Riggs, CEO) We plan to bridge reimbursement from our service lab to the kitted product within MLAs, which will aid adoption. Centers will likely start with cautious adoption, gradually increasing usage as they integrate the assay into their systems. We expect significant revenue growth starting in 2027. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
20-02-2025
- Business
- Yahoo
Veradigm Announces Board Expansion and Changes
Appoints Vinit Asar and Louis Silverman to its Board of Directors Agrees to Add Two Additional Directors CHICAGO, February 20, 2025--(BUSINESS WIRE)--Veradigm® (OTCMKTS: MDRX) ("Veradigm" or the "Company"), a leading provider of healthcare data and technology solutions, announced today it has entered into a Cooperation Agreement (the "Agreement") with Kent Lake PR LLC ("Kent Lake"). The Agreement aligns with the Board's request for input from shareholders regarding board composition on January 30, 2025, and a desire to conduct an orderly refreshment of the Board following the conclusion of the exploration of strategic alternatives. As part of the Agreement, the Board has appointed two new independent directors, Vinit Asar and Louis Silverman, effective February 20, 2025. The Company will also identify two additional independent directors to join the Board, subject to Kent Lake's approval; one will be appointed by March 22, 2025, and the other will be appointed promptly following the filing of the Company's annual report on Form 10-K for the fiscal year ended December 31, 2022 (the "2022 Form 10-K"). On February 14, 2025, Jonathan Judge stepped down from the Board, effective immediately, and Chairman Greg Garrison will retire from the Board shortly following the filing of the 2022 Form 10-K. Vinit Asar is the former Chief Executive Officer ("CEO") of Hanger, Inc. ("Hanger") and brings 30 years of diversified global healthcare leadership experience in medical services and non-acute healthcare services. While CEO of Hanger, he grew revenue from $700 million to $1.4 billion via organic and inorganic growth combined with strategic divestitures and business exits. He also significantly strengthened Hanger's infrastructure, leadership team and governance while navigating a financial restatement and NYSE delisting process. He currently serves as the Executive Chairman of Hanger, which was taken private in 2022, and on the board of directors of ZimVie Inc. (NASDAQ: ZIMV). Louis Silverman is a seasoned healthcare executive currently serving as Chairman and CEO of Hicuity Health, the nation's largest provider of 24x7 high acuity telemedicine services. He brings over 30 years of leadership experience in health information technology and technology-enabled healthcare services. Mr. Silverman previously served as the CEO of Quality Systems (NASDAQ: QSII), a leader in the ambulatory electronic healthcare record market. Silverman also served as CEO of Marina Medical, a specialty revenue cycle management company. He currently serves on the board of directors of Oncocyte Corporation (NASDAQ: OCX). "We appreciate our stockholders' efforts to put forth well-qualified individuals to serve on the Board," stated Greg Garrison, Chairman of the Board. "In parallel with ongoing refreshment planning, we are adding new independent directors with deep strategic planning, finance, healthcare and restatement experience to strengthen the Board as we focus on our priorities: executing our standalone strategy, becoming current in financial reporting and relisting our common stock." Mr. Garrison continued, "Jon has been an invaluable member of our Board for almost nine years, bringing exceptional leadership, insight, and dedication throughout his tenure. On behalf of the Board and the entire organization, I sincerely thank him for his perspective, partnership, and commitment to Veradigm. We wish him success in his future endeavors." "On behalf of the entire Veradigm team, I want to express our sincere gratitude to Greg, who has served as an important thought partner to management for nearly a decade. We are incredibly thankful for his guidance and leadership throughout his tenure, particularly in connection with the ongoing restatement," said Tom Langan, Interim Chief Executive Officer of Veradigm. Benjamin Natter, Managing Member of Kent Lake Capital, added, "We appreciate the constructive dialogue with the Board and management team and are pleased to have reached this agreement. As long-term investors, we believe that Veradigm is well positioned to deliver value to customers and the healthcare system while also generating attractive returns for shareholders. We believe these new directors will provide the right experience and perspective during this critical time." Kent Lake has agreed to abide by certain customary standstill commitments in connection with the Cooperation Agreement. The full Agreement will be filed by the Company with the U.S. Securities and Exchange Commission as an exhibit to a Current Report on Form 8-K. About Veradigm® Veradigm is a healthcare technology company that drives value through its unique combination of platforms, data, expertise, connectivity, and scale. The Veradigm Network features a dynamic community of solutions and partners providing advanced insights, technology, and data-driven solutions for the healthcare provider, payer, and biopharma markets. For more information about how Veradigm is fulfilling its mission of Transforming Health, Insightfully, visit or find Veradigm on LinkedIn, Facebook, Twitter, Instagram, and YouTube. © 2025 Veradigm LLC and/or its affiliates. All rights reserved. Cited marks are the property of Veradigm LLC and/or its affiliates. All other product or Company names are the property of their respective holders, all rights reserved. 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