Precision oncology company ArcherDx has disclosed plans to raise $100 million through an initial public offering, according to a registration statement filed with the U.S. Securities and Exchange Commission.
ArcherDx has yet to spell out how much in net proceeds it expected to generate—which would depend on how much money the company agrees to raise in the IPO—or how much it would set aside toward the purposes outlined in its S-1 registration statement, filed Friday.
Headquartered in Boulder, CO, ArcherDx has developed more than 325 unique research-use only (RUO) products that have been sold to over 300 academic and reference laboratories, as well as more than 50 biopharmaceutical companies and contract research organizations (CROs) across 40 countries. Those products have facilitated the analysis of over 375,000 samples, the company said.
ArcherDx is also developing two new tests that have yet to be approved by the FDA.
One is STRATAFIDE, a pan-solid tumor companion diagnostic (CDx) which, according to the company, is the first multi-gene, pan-solid tumor companion diagnostic designed to accept both tissue and blood samples. STRATAFIDE has been developed to identify actionable genomic alterations in tissue or blood, including alterations targeted by emerging therapies undergoing clinical trials, therapies already recommended in clinical guidelines such as those of the National Comprehensive Cancer Network (NCCN), and therapies approved by the FDA.
Also under development by ArcherDx is the Personalized Cancer Monitoring (PCM) platform, designed to enable local labs to assess therapy success and identify disease recurrence much earlier than current standard of care such as imaging or antigen test modalities, making successful treatment more likely.
Both STRATAFIDE and PCM have received the FDA’s Breakthrough Device designation.
“We currently expect to use the net proceeds from this offering for research and development activities, including development of STRATAFIDE and PCM, and for working capital and general corporate purposes, including sales and marketing activities, operating expenses and capital expenditures,” ArcherDx stated in its preliminary prospectus.
Furthering the development of STRATAFIDE and PCM were among uses identified for the proceeds of a $55 million in Series C financing completed by ArcherDx in December 2019. That financing brought ArcherDx’s total capital raised to $150 million since it was founded in 2013.
This year, ArcherDx signed a non-exclusive, multi-year commercial partnership agreement with Illumina, through which the companies agreed to co-market STRATAFIDE and other future ArcherDX in vitro diagnostic (IVD) tests with Illumina’s NextSeq 550Dx and MiSeq Dx sequencing systems. The value of the partnership[ was undisclosed.
Last month, ArcherDx announced two collaborations with biopharma giants whose values were not disclosed. The company is partnering with Bayer to develop an NGS-based CDx for VITRAKVI® (larotrectinib), a TRK inhibitor approved in the U.S. and Europe for adult and pediatric patients with TRK fusion cancer across solid tumors.
Also in May, ArcherDx launched a strategic collaboration with AstraZeneca designed to develop assays to support multiple planned Phase III clinical trials for AstraZeneca’s targeted immuno-oncology therapeutics. Through that partnership, ArcherDX agreed to perform Whole Exome Sequencing (WES) of resected non-small cell lung cancer (NSCLC) patient samples and generate patient-specific circulating tumor DNA (ctDNA) assays. ArcherDX plans to leverage the PCM assays to develop CDx for AstraZeneca’s associated therapies, and together, the companies plan to seek global regulatory approval if the Phase III clinical trials are completed successfully.
PCM is one of ArcherDx’s five RUO product lines. The other four consist of DNA-based VariantPlex, RNA-based FusionPlex, ctDNA-based LiquidPlex and RNA-based Immunoverse, which the company collectively refers to as ArcherPlex. ArcherDx uses a product development platform based on its proprietary Anchored Multiplex PCR, or AMP, chemistry. In addition, the company offers Assay Designer and Designer Pro as services to clinical and biopharmaceutical customers, enabling them to customize biomarker targets and develop new applications.
ArcherDx finished the first quarter with a net loss of $19.317 million and total revenue of $14.790 million, compared with a $5.365 million net loss on revenue of $9.449 million a year ago. The company reported a net loss of $40.978 million on total revenue of $50.565 million for all of last year, and a net loss of $5.553 million and $28.454 million in total revenue for 2018.
ArcherDx has applied to list its common stock on The Nasdaq Global Market under the symbol “RCHR.” Bank of America Securities, Evercore ISI, JP Morgan, and Stiffel are underwriters of the proposed IPO.