Welcome to our dedicated page for Oncocyte news (Ticker: OCX), a resource for investors and traders seeking the latest updates and insights on Oncocyte stock.
Oncocyte Corporation develops molecular diagnostic technologies focused on solid organ transplant monitoring and oncology. Company news centers on its blood-based transplant rejection assays, including GraftAssure research-use-only kits, VitaGraft clinical monitoring tests, and the GraftAssureCore lab-developed test, along with reimbursement updates, clinical publications, and development of regulated kitted products for transplant centers.
Updates also cover quarterly results, pharma services activity from its laboratory operations, strategic relationships such as Bio-Rad, capital actions, investor conference participation, and oncology assays such as DetermaIO and DetermaCNI.
Oncocyte (Nasdaq: OCX) has announced new agreements with two leading transplant university hospitals in the U.S. and Germany to utilize GraftAssure™, the company's research-use-only assay for detecting early evidence of graft organ damage. This development is part of Oncocyte's strategy to drive commercial adoption of its molecular diagnostic tests in the estimated $1 billion transplant addressable market.
The company has also submitted its plan for an in-vitro diagnostic (IVD) version of its dd-cfDNA kitted test to the FDA, initiating the Q-submission process. A meeting with the FDA is scheduled for early December. Oncocyte aims to begin the validation process in early 2025.
Since August 2024, additional transplant centers have committed to adopting GraftAssure. Oncocyte partnered with Bio-Rad Laboratories in April 2024 for global launch support, with Bio-Rad having exclusive distribution rights outside the U.S. and Germany.
Oncocyte (Nasdaq: OCX) has announced a $10.2 million private placement of securities priced at-the-market under Nasdaq rules. The company has secured participation from new and existing investors, including strategic partner Bio-Rad Laboratories. The private placement involves the sale of 3,461,138 shares of common stock at $2.948 per share, with certain insiders subscribing for 37,037 shares at $2.970 per share.
The net proceeds will be used for working capital and general corporate purposes. The placement is expected to close on or about October 4, 2024, subject to customary closing conditions. Oncocyte's CEO, Josh Riggs, stated that this funding will help expand access to organ transplant rejection testing globally. The company has also entered into a registration rights agreement to file a registration statement with the SEC within 15 days.
Oncocyte Corp. (Nasdaq: OCX) announced the publication of a case series study using its VitaGraft™ Kidney diagnostic test to monitor antibody-mediated rejection (AMR) in kidney transplant patients treated with daratumumab. The study showcases the test's potential to monitor anti-CD38 therapy efficacy. VitaGraft Kidney, a noninvasive biomarker, measures donor kidney DNA in patient blood post-transplantation.
Key findings include:
- Two patients with biopsy-confirmed chronic active AMR showed stabilized kidney function and decreased dd-cfDNA levels after daratumumab treatment
- Biopsies revealed complete or partial resolution of AMR activity
- This is the second study demonstrating VitaGraft Kidney's ability to monitor therapeutic efficacy
Oncocyte aims to improve graft longevity by enabling AMR detection, management, and monitoring. The company is commercializing its transplant product line, including VitaGraft™ and GraftAssure™ tests.
Oncocyte (Nasdaq: OCX) has successfully launched GraftAssure™, a research-use-only assay detecting graft organ damage in blood. The assay debuted in July 2024 at major transplant centers in the U.S. and Asia. The company reported Q2 2024 revenue of $104,000, a $4.5 million loss from continuing operations, and an $11 million cash balance. The GraftAssure launch is part of a strategy to capture market share in a $1 billion market, aligning with Bio-Rad's global infrastructure. Positive momentum is reported from partnerships and industry relationships. Oncocyte aims to establish over 20 transplant centers running GraftAssure by the end of 2025, targeting significant future revenue. The company is also preparing for FDA IVD clearance in late 2025. Andrea James has been appointed CFO. Additional details are in the company's updated investor deck.
Oncocyte Corp. (Nasdaq: OCX), a molecular diagnostics technology company, has announced its participation in two investor conferences this August. CEO Josh Riggs and CFO Andrea James will represent the company at:
1. The 9th Annual Needham Virtual MedTech & Diagnostics 1×1 Conference on August 12-13, 2024, where they plan to host meetings with investors.
2. The Sidoti Micro-Cap Virtual Conference on August 14-15, 2024. Oncocyte is scheduled to present on Wednesday, August 14, from 1:00 PM to 1:30 PM ET in Track 3, and will also participate in one-on-one meetings.
Investors interested in scheduling meetings with Oncocyte's management team can contact their Needham or Sidoti representative or reach out to the company's IR contact directly.
Oncocyte Corp. (Nasdaq: OCX), a diagnostics technology company, has announced it will release its second quarter 2024 financial results on Thursday, August 8, 2024, after U.S. market close. The company will host a conference call and webcast on the same day at 5:00 p.m. Eastern Time to discuss its financial results and highlights.
Interested parties can access the live call via telephone by dialing toll-free 800-715-9871 for domestic callers. The live webcast can be accessed through the 'Events & Presentations' section of Oncocyte's website. A replay of the webcast will be available on the company's website shortly after the call concludes.
Oncocyte (Nasdaq: OCX), a precision diagnostics company, has appointed Andrea James as Chief Financial Officer effective June 17, 2024. Andrea James brings extensive experience in financial strategy, investor relations, and capital raising from her previous roles at Axon Enterprise and Tesla. Her appointment comes as Oncocyte approaches significant commercialization milestones and aims to expand its diagnostic tool usage in the transplant community and oncology space through partnerships. Ms. James holds a BS in Computer Information Systems and an MS in Journalism. She will be pivotal in guiding Oncocyte through transformative years ahead.
On May 30, 2024, Oncocyte announced that favorable results for its VitaGraft Kidney test were published in the New England Journal of Medicine. Data from a phase 2 study indicated that the test could monitor graft injury and identify responses to the investigational drug felzartamab. Results showed significant reductions in donor-derived cell-free DNA (dd-cfDNA) levels at weeks 12 and 24. This advancement suggests potential new uses for VitaGraft Kidney in monitoring therapeutic efficacy and recurrence of antibody-mediated rejection (AMR) in kidney transplant patients. Up to 20.2% of kidney transplant patients develop AMR within 10 years, often leading to graft failure. Oncocyte’s CEO, Josh Riggs, emphasized the potential for VitaGraft to improve care and outcomes for high-risk patients.
Oncocyte (Nasdaq: OCX) reported Q1 2024 financial results, highlighting key developments. The company formed a global commercialization partnership with Bio-Rad Labs, raised $15.8M from equity private placement, and reduced cash burn to $3.9M. However, net revenue fell by 41% YOY to $176K. Research and development expenses rose by 2% to $2.2M, while general and administrative expenses decreased by 22% to $2.7M. The loss from operations was $9.3M, compared to a $5.9M income in Q1 2023, mainly due to a $3.3M loss from the change in fair value of contingent consideration. Oncocyte is set to ship its GraftAssure transplant monitoring test kits globally in 2Q 2024 and is advancing other diagnostic tests.
Oncocyte (Nasdaq: OCX) will release its first quarter 2024 financial results on May 15, 2024, after the U.S. market closes. A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the results.