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Post-IPO, Talis Biomedical Looks Toward Expanding Infectious Disease Test Portfolio

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NEW YORK – Talis Biomedical started with the desire to help distribute diagnostic tests more widely and quickly at the point of care. After raising $253.9 million in an initial public offering in February, the Menlo Park, California-based firm is another step closer to its goal.

The company intends to submit its Talis One instrument and SARS-CoV-2 test to the US Food and Drug Administration for Emergency Use Authorization in the second quarter and is developing further infectious disease tests for launch later this year.

Talis CEO Brian Coe said the firm decided to go public now because its "vision is to be a company that provides care at scale." That scale requires capital, he said, and the firm decided to find that capital in the market.

"As a general idea, the cost of capital goes down for a public company versus a private company," he added, which contributed to the decision to go public. Through the money raised in its IPO, the company plans to expand its test menu, launch its platform and tests commercially, increase its scope, and ramp up its commercial scale and production, Coe said.

He said that the company has a "profound opportunity to impact how care is provided" globally with its sample-to-answer instrument, which is the size of a toaster and provides results in less than 30 minutes.

Running a test on the platform is easy, as a user simply has to pipette a sample into the consumables cartridge and insert it into the instrument. In the company's S-1 form filed with the US Securities and Exchange Commission for its IPO, it wrote that the modular design of the instrument, which is divided into subsystems for cartridge handling, sample preparation, amplification, and detection, "will facilitate automated assembly and low-cost manufacturing."

Coe noted that the sample preparation process is included in the cartridge, which makes Talis' platform special. The firm isn't alone in providing sample prep with near-patient and point-of-care instruments — Cepheid's GeneXpert also includes the sample preparation process — but "most point-of-care platforms do not have sample prep," he said. The instrument also comes with a central cloud database to help gather and track test results.

Right now, the cartridge is configured for five targets but it is designed to go up to 14 targets if necessary, although Coe said there are no plans for a test using all of those targets right now. The cartridge can also take a variety of sample types, including nasal swabs, vaginal swabs, saliva, urine, whole blood, plasma, serum, and sputum.

It requires a large sample volume input of about 1 ml, which "is designed to enable detection of pathogens at low concentrations," the company said in its S-1. According to Talis, its instrument has detected bacterial pathogens at concentrations as low as one infectious unit per milliliter in unpurified sample types.

When the COVID-19 pandemic began, Talis didn't have its platform cleared for regulatory submission and was "still in the later stages of developing" it but decided to reprioritize its planned menu to start with a SARS-CoV-2 test, Coe said. The firm performed clinical trials for its test and submitted it to the US FDA for authorization for use in moderate complexity labs, but there were concerns about the comparator assay Talis used in its trials. As a result, Talis decided to redo its submission for authorization at the point of care, bypassing the need for CLIA-moderate authorization altogether.

Once it receives EUA for its test, Talis will be able to manufacture up to 1 million tests per month, Coe said, owing to its investment in production lines that it has been developing since early on in the pandemic. "We got ahead of the curve very substantially on automated production capability," Coe said, and the firm is scheduled to reach its full production capacity in the second half of 2021 after its second and third production lines going active in the third quarter.

In addition to its isothermal nucleic acid amplification test for SARS-CoV-2, Talis will be launching a joint SARS-CoV-2 and influenza A/B test in time for the next flu season. The firm estimated in its S-1 that the potential annualized market opportunity in the US for its respiratory panel is greater than $7 billion.

Beyond SARS-CoV-2, Talis has developed a test for chlamydia and gonorrhea that will start clinical trials in the second half of 2021, which it will then expand into a panel for sexually transmitted infections that will include trichomonas and Mycoplasma genitalium. Talis plans to submit a 510(k) premarket notification for the chlamydia and gonorrhea test, along with the Talis One instrument, in early 2022. Later on, the company plans to move further into women's health with tests for vaginosis and urinary tract infections, Coe said. For women's health and STI diagnostics, Talis estimated the annualized market opportunity is approximately $5.5 billion.

The firm's assay development is "going to be pretty aggressive," as it continues to expand its test menu and has built its infrastructure to develop assays quickly, Coe said.

The company's future tests will run on the same card and instrument and will utilize the same production lines as its SARS-CoV-2 test, Coe said. It's only a matter of switching reagents for specific pathogens for different tests, which allows the company to transition between disease states easily, he added.

The ultimate goal is to build a global company, as infectious disease is a "global health crisis," Coe said. Its consumables are stable at ambient temperatures, making them easier to store, to ensure they can be used in places without refrigeration. "We've really spent a lot of time designing a system that would be conducive to cost compression as we get into increasing scale," Coe said. Although there is "a lot of demand here locally right now," the firm is "carefully looking" at regulatory options in other countries to expand its reach.

The point-of-care diagnostic business is a crowded field and Coe is aware that Talis is "not going to be alone in those markets." However, he believes that the company is "very well-positioned to have the quality, all the features, and the capabilities that we'll be one of the people [who are] relevant and making a real contribution," he said. In an analyst note, Piper Sandler's Steven Mah said the Talis One platform "fills an unexploited niche in the diagnostics landscape by providing central lab quality accuracy and sensitivity in a rapid POC device using high-margin consumables."

In its S-1, the company wrote that few point-of-care technologies "sufficiently meet the needs of healthcare providers in order to drive broad adoption of, and transition to, point-of-care testing for infectious diseases." Antigen tests have higher limits of detection despite their speed and low cost, while many currently available point-of-care molecular technologies "have sacrificed accuracy to increase speed," the company said.

Expectations for the company are high, with JP Morgan analyst Tycho Peterson writing in a note that "with robust COVID-19 demand driving initial instrument uptake, complemented by an expanding menu that should support post-COVID-19 utilization, we see an outsized near-term growth potential vs peers."

Peterson noted that COVID-19 will "significantly accelerate instrument installed base ramp at product launch" and create a channel for expanded menu options. In the first year of launch, Peterson estimated Talis will place more than 2,000 instruments.

Talis will first target large hospital systems and urgent care centers for its instrument, but as it scales up, it will move to doctors' offices and other point-of-care settings, Coe said. Part of the appeal of the instrument is that healthcare providers can move some of their testing in house instead of using a central laboratory and save money, the firm said in its S-1.

Peterson echoed this sentiment, saying the larger market shift toward point-of-care settings "will incentivize placements and utilization through improved economics for healthcare providers, creating new revenue streams for physician practices."

The firm hopes that those cost savings, along with the other features of the platform and its accuracy, will drive demand and allow the company to expand.

"We believe we have a high quality platform. It'll give us a great time to result, it's very easy to use, we can deliver it with attractive economics, and we can deliver it at scale," Coe said.

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