OncoCyte Corp., an early-stage molecular diagnostics firm focused on lung cancer care that counts a $160 million market capitalization and has plans for commercialization of a recently acquired testing product this year, is Orange County’s newest publicly traded company.
The company, which went public in 2016, this month is moving into new headquarters in the Irvine Spectrum area: a 26,800-square-foot spot at 15 Cushing, according to regulatory filings.
OncoCyte (NYSE: OCX) had been based in the Bay Area city of Alameda, with no listed operations in OC.
It went public four years ago when it was spun off by another biotechnology company, BioTime Inc., which is now known as Lineage Cell Therapeutics (NYSE: LCTX) and based in Carlsbad.
The development-stage firm has yet to generate sales, and at the start of 2019 OncoCyte counted an accumulated deficit of $71.3 million.
As of early 2019, its most promising product was called DetermaVu, a noninvasive molecular lung cancer confirmatory diagnostic test that was in the R&D validation process.
The liquid biopsy test, recently renamed to DetermaDX, is expected to aid in ruling-out malignancy in lung nodules and helping patients avoid unnecessary invasive lung biopsies.
The company last week announced “the successful completion” of DetermaDX in a regulatory process called Clinical Laboratory Improvement Amendments. The company said if another clinical validation is successful, it will prepare for a commercial launch of its product.
“This is a significant step towards making DetermaDx available to physicians and patients,” OncoCyte Chief Scientific Officer Lyndal Hesterberg said in a statement.
“With lung cancer being the leading cause of cancer death, primarily due to late diagnosis, we believe DetermaDx has the potential to significantly change the paradigm for early-stage lung cancer patients,” Hesterberg said.
Following the Jan. 7 announcement, the company’s shares rose about 14% to $2.83 and a $160 million market cap.
Local CEO
In early July, the company got a new chief executive with ties to OC, Ronald “Ronnie” Andrews.
Andrews has over 30 years of experience in the clinical and molecular diagnostics field, with a focus on oncology. He joined the company’s board in mid-2018.
Most recently, he was the founder and principal of Bethesda Group, a Rancho Santa Margarita-based firm that advertises itself a “boutique consulting group focused on helping small and mid-stage diagnostic companies and investment groups move emerging diagnostic content and platforms into the marketplace.”
Prior to that, he served as the president of the Genetic Science Division for Waltham, Mass.-based Thermo Fisher Scientific.
Andrews said at the time of the executive change that DetermaDX “represents a true breakthrough in the molecular diagnostics field and I am very excited to lead and build the OncoCyte team as we position the business to bring this groundbreaking technology to physicians and patients, while creating long-term value for our shareholders.”
Razor’s Edge
In September, Andrews and OncoCyte acquired access to a product closer to commercialization: a test created by Razor Genomics.
It agreed to pay $10 million in cash for an initial 25% equity interest in Razor and the rights to commercialize its testing product. It has the option to acquire additional stakes in the San Mateo County-based company.
The Razor test “enables the identification of lung cancer patients at high risk for recurrence and allows them to be treated at a time when their cancer can still be responsive to adjuvant chemotherapy,” according to the company.
Game Changer
The “acquisition of the rights to the test is a game changer for OncoCyte. It rapidly propels us to a commercial stage company,” Andrews said in November.
Razor is “a downstream complement to our proprietary [DetermaDX] liquid biopsy test that we are developing to help manage CT-identified lung nodules and thereby facilitate the early diagnosis of lung cancer,” the company said.
As of early 2019, the firm employed about a dozen full-time people, but officials said 2020 stands to be a year of hiring gains, as it brings the Razor test to market, as well as makes additional progress with DetermaDx.
Funding Boost
OncoCyte has lined up a few funding deals to help with the efforts.
Near the start of the year, two investors agreed to purchase nearly $8 million of its common stock in a registered offering.
New York-based Pura Vida Investments LLC was one of the investors, according to the company. The deal closed Jan. 6.
Other large investors in the company include N.Y.-based Broadwood Partners, according to regulatory filings.
“While we still have work ahead of us, there is an incredible momentum at OncoCyte, and the coming months will be important for us as we transition to a commercial stage company while maintaining our velocity of product development and validation,” Andrews said late last year.
HQ, Labs
The company’s growth will be seen at the new Irvine headquarters, according to regulatory filings.
OncoCyte said it expects to complete the relocation of its executive offices this month.
It will also construct a clinical diagnostic laboratory and a research laboratory at the site, and then relocate its laboratories from the Bay Area to the property later this year.
