New York, October 03, 2024 - PRISM MarketView - Oncocyte Corporation (Nasdaq: OCX), a diagnostics technology company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the care journey, is making headlines with two significant company announcements. In the same day, Oncocyte announced the signing of new leading transplant university hospital customers in the United States and Germany as well as a $10.2 million private placement of securities with both new and existing investors.
Oncocyte is featured in the PRISM Emerging MedDevices Index, which tracks small and micro-cap stocks developing or marketing medical devices. The dual announcement underscores the company’s momentum as Oncocyte leaders believe it is at a pivotal stage in commercializing its intellectual property in organ transplant.
Land-and-Expand Strategy Driving Growth and Adoption
Both new hospital customers are top-five-in-country in organ transplant volume and have entered into agreements for GraftAssure™, the company’s research-use-only assay to detect early evidence of graft organ damage in patients’ blood. This access represents a key part of Oncocyte’s “land-and-expand” strategy to capture market share in an estimated $1 billion transplant addressable market. The number of institutions expressing interest in GraftAssure continues to exceed corporate expectations.
After clearing the first stage gate in clinical product development, Oncocyte has submitted its plan for an in-vitro diagnostic (IVD) version of its kitted test to the U.S. Food and Drug Administration (FDA) to initiate the Q-submission process. A feedback meeting with the FDA is scheduled for December, a central component in the validation process expected to begin early next year.
“The two institutions located in the U.S. and Germany that we have entered into agreements with are well-regarded major research hospitals that are top-five centers in their respective countries. We believe these institutions share our vision of democratizing access to this molecular diagnostic technology.”
Oncocyte CEO Joshua Riggs
Securities Purchase Agreement Includes Strategic Partner Bio-Rad
The private securities purchase agreement includes strategic partner Bio-Rad Laboratories as well as new investors, with gross proceeds—to be used for working capital and general corporate purposes—expected to be about $10.2 million before placement agent fees and offering expenses.
The purchase agreement represents the purchase and sale of an aggregate of 3,461,138 shares of common stock at a purchase price of $2.948 per share of common stock. Certain insiders subscribed for 37,037 of the shares of common stock sold in the private placement at a purchase price of $2.970 per share. The private placement was priced at-the-market under Nasdaq rules and is expected to close on or about Oct. 4, subject to the satisfaction of customary closing conditions. Needham & Company is acting as the exclusive placement agent for the private placement.
“This funding helps us to continue delivering on the promise that we made to expand access to organ transplant rejection testing globally. We are grateful for the support of our current and new shareholders who share our vision of democratizing access for transplant patients, transplant centers and transplant researchers around the world. Our team remains committed to executing on our strategy and creating shareholder value.”
Oncocyte CEO Joshua Riggs
About Oncocyte
.Oncocyte Corporation is a molecular diagnostics technology company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test, GraftAssure™ is a research use only blood-based solid organ transplantation monitoring test, DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and the pipeline test DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information, visit https://oncocyte.com/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
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