Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of $153 million. Friday’s Wall Street debut was a show of confidence, upsized from an original plan to offer 7.8 million shares at $15 to $17.
The Emeryville, Calif.-based company has granted the underwriters a 30-day option to acquire up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.
Lucira intends to use about $62 million to $69 million of IPO proceeds to fund manufacturing activities, according to a Form S-1/A filed with the U.S. Securities and Exchange Commission. Approximately $48 million to $53 million will go toward establishing commercial activities, including hiring and training sales and marketing personnel and funding marketing initiatives.
The remainder is earmarked for working capital and general capital purposes, including test kit development and research and development activities, the form says, noting that “a portion of the net proceeds may be used for acquisitions or strategic investments in complementary businesses, services, products or technologies.”
Shares began trading on the Nasdaq Global Market on Friday, Feb. 5, 2021, under the symbol LHDX. Trading opened at $22.10, hitting a high of $29.96 before closing up 46.94% at $24.98.
COVID-19 test
Founded in 2013, Lucira had already developed a single-use kit to diagnose influenza when it shifted gears to focus on SARS-CoV-2 detection in the COVID-19 pandemic. In November, the company won emergency use authorization (EUA) from the U.S. FDA for its COVID-19 All-in-One Test Kit, making it the first prescription molecular diagnostic test for the SARS-Cov-2 virus that can be performed from start to finish in the comfort of one’s home.
The single-use test employs a simple ‘swab, stir and detect’ design that delivers results within 30 minutes, enabling symptomatic individuals who suspect they have COVID-19 to get results while isolating at home. To ensure follow-up and support public health efforts, users are instructed to report their results to the provider who prescribed the test.
The test is authorized for at-home use by individuals 14 and older, and for all ages in point-of-care (POC) settings and other care venues. Tests for patients younger than 14 must be administered by a clinician.
Currently, the COVID-19 test kit is only available to patients served by Sutter Health in Northern California and Cleveland Clinic Florida. The company has begun manufacturing activities to support a commercial launch this spring, with a goal of increased scale by the second half of this year.
Expanding pipeline
Lucira’s growth strategy includes a range of tests for infectious diseases, starting with respiratory ailments.
After commercializing its COVID-19 test for POC and prescription at-home use, the company intends to submit an EUA application for over-the-counter (OTC) use of the test later this year. The company also intends to file an amended EUA for use of its test by asymptomatic individuals, facilitated by online prescription. A clinical trial is currently underway.
A combination test kit for COVID-19 and influenza A/B is in the works, with anticipated EUA or 510(k) submission sometime in 2022. And finally, there is the influenza kit, with plans for a 510(k) or de novo submission for OTC use in 2024.
Competitive space
Demand for greater access to COVID-19 testing has spurred a number of companies to offer at-home options.
In December 2020, the FDA granted Laboratory Corporation of America, of Burlington, N.C., an EUA for its Pixel home collection kit for direct-to-consumer sale – enabling anyone 18 years or older to purchase the nasal swab test without a prescription.
The same month, Australia-based Ellume Ltd. got an FDA for emergency use of a rapid lateral-flow test for antigen detection that yields results at home in 20 minutes. The company recently signed a $213 million supply agreement with the U.S. government for its COVID-19 tests.
Also in the space is Abbott Laboratories, which snagged an EUA for at-home use of its Binanxnow COVID-19 Ag Card Home Test, also in December. The company has partnered with Miami-based telehealth provider Emed to distribute and administer the tests, with an anticipated 30 million in the first quarter of 2021.