Agendia Inc., an Irvine-based provider of genomic breast cancer tests, is seeking to raise $75 million in an initial public offering, according to an Oct. 28 filing with the Securities and Exchange Commission.
Agendia, incorporated in 2003 in the Netherlands but with its base of operations in Irvine, says it’s the only molecular diagnostics company focused solely on developing tests for breast cancer, the leading cause of cancer death in women around the world.
The company promises test results within six days and a 95% success rate; its total addressable market is estimated to exceed $12 billion globally.
“We do this for the people who have to watch their mother or father go through a debilitating disease—for the women who don’t need treatment, but do it anyway,” Mark Straley, who became the company’s chief executive in 2015, said on the company’s website.
It’s the second Irvine cancer testing company with ties to Europe in recent weeks to seek an IPO.
MDxHealth, an Irvine and Belgium-based firm that makes prostate cancer tests, raised $45 million in an IPO that launched last week; see the Nov. 1 print edition of the Business Journal for more.
Straley, 60, has more than 25 years’ experience in the clinical diagnostics industry at companies like Thermo Fisher Scientific, Johnson & Johnson and Metamark Genetics.
As of Sept. 30, Agendia had a total of 248 employees, including 193 at its corporate headquarters in Irvine.
It reported 2020 revenue rose 18% to $57.9 million. Its loss narrowed to $20 million from $22.3 million in the prior year.
In the first nine months this year, its sales rose 8.4% to $43.9 million while its loss also grew, to $25.7 million.
The IPO filing lists five investment funds with more than 5% of the company’s shares, including Norgine Ventures B.V., which is backed by Norgine B.V., an Amsterdam-based health company with 115 years of experience in the pharma space.
Agendia is no stranger to funding rounds; as of last year it has reported raising over $190 million.
MammaPrint and BluePrint
The commercial-stage company offers two proprietary tests: MammaPrint and BluePrint.
MammaPrint is a 70-gene, FDA-cleared prognostic test that identifies the likelihood of breast cancer recurrence in a patient. It can also help physicians make the decision to pursue adjuvant chemotherapy or endocrine therapy, the company said in the filing.
According to the company, BluePrint is the only commercially available, 80-gene molecular subtyping test that classifies an individual breast tumor, identifies the cause of its growth, and how it might respond to therapy. It may also provide information on breast cancer subtypes, including Luminal, HER2 and Basal, the company said.
The BluePrint has been CE-marked for use in Europe while it hasn’t yet been approved by the FDA.
The filing said the combined MammaPrint and BluePrint platform helps guide surgeons, oncologists and pathologists objectively select the best course for pre and post-operative treatment for each patient.
The company’s 13,000-square-foot facility in the Irvine Spectrum can generate up to 140,000 tests per year, according to Agendia’s registration statement.
The company intends to use the proceeds from the IPO to expand sales, fund research, pay a long-term note and other general corporate purposes.
The company plans to list on the Nasdaq Global Market under the ticker symbol “AGDX.”
Goldman Sachs, Citigroup, Cowen, and Stifel are the joint bookrunners on the deal; no pricing terms have been disclosed yet.
