Talis Biomedical Corporation (Nasdaq: TLIS), a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point-of-care, today reported financial results and business progress for the second quarter ended June 30, 2021.  

"During the second quarter, we made meaningful progress on the execution of our strategic business initiatives, including the successful completion of our point-of-care clinical validation study for the Talis One™ COVID-19 assay and subsequent EUA submission to the FDA in July,” said Brian Coe, Chief Executive Officer of Talis. “As we prepare for commercial launch of this first assay, continue to optimize our manufacturing capabilities and broaden our test menu, we are building our core foundation for the future to meet the needs of the large and growing respiratory, sexual health and women’s health testing markets.”

Business Updates

  • Completed a clinical validation study for Talis One COVID-19 assay in a point-of-care environment to support an Emergency Use Authorization (EUA) application submission to the FDA.
  • Conducted analysis of 10 distinct COVID-19 variants through the NIH RADx program demonstrating high sensitivity of detection. At the time of testing in June, the emerging Delta variant was not available to be included in this study. Subsequently, a small internal study showed correct identification of the delta variant in clinical specimens.
  • Submitted an EUA application for Talis One System and Talis One COVID-19 Assay to the FDA on July 23, 2021.
  • Completed installation and are in the final stages of validation for the first set of automated cartridge production lines.

Second Quarter 2021 Financial Results

Revenue was $0.1 million for the second quarter of 2021, as compared to $0.8 million in the same period in 2020. The revenue for the second quarter of 2021 was grant revenue related to an NIH grant.

Operating expenses were $64.5 million in the second quarter of 2021, compared to $10.8 million in the same period in 2020. The increase in operating expenses was primarily driven by investments in manufacturing scale-up and development of the first test using the Talis One system.

Net loss was $64.5 million for the second quarter of 2021, compared to $10.0 million for the same period in 2020.

Cash and cash equivalents on June 30, 2021, were $313.5 million, and restricted cash was $34.7 million.

Conference Call and Webcast DetailsThe company will host a live conference call and webcast to discuss these results and provide a corporate update on Tuesday, August 10, 2021, at 4:30 PM ET / 1:30 PM PT.

To participate in the call, please dial (833) 715-1329 (domestic) or (430) 755-1933 (international) and provide conference ID 5966606. The live webcast will be available on the News & Events page of the investors section of Talis Biomedical’s website at talisbio.com.

About Talis BiomedicalTalis is dedicated to transforming diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, low cost, and rapid molecular testing for infectious diseases at the point-of-care. The company is developing the Talis One, a compact, sample-to-answer, cloud-enabled, molecular diagnostic platform. For more information, visit talisbio.com.

Forward-Looking StatementsThis press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or other words that convey uncertainty of future events or outcomes can be used to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our plans to commercialize Talis One following regulatory authorization; our future ability to meet the needs of the large and growing respiratory, sexual health and women’s health testing markets; and our ability to grow and expand our business. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: the impact to our business of the ongoing COVID-19 pandemic, including any impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption in our supply chain, our ability to achieve or sustain profitability, our ability to gain market acceptance for our products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using our products, product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Talis assumes no obligation to updates forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Investor Contact Media & InvestorsEmily Faucetteefaucette@talisbio.com415-595-9407

Talis BiomedicalConsolidated Balance Sheet(In thousands)(Unaudited)
    June 30,     December 31,  
    2021     2020  
Current assets:                
Cash and cash equivalents   $ 313,458     $ 138,483  
Restricted cash     34,650       34,650  
Grants receivable           238  
Unbilled grants receivable     117       233  
Prepaid research and development expenses     2,431       12,014  
Prepaid expenses and other current assets     3,209       3,106  
Total current assets     353,865       188,724  
Property and equipment, net     10,178       9,114  
Operating lease right-of-use-assets     13,747       567  
Other long-term assets     1,748        
Total assets   $ 379,538     $ 198,405  
Liabilities and Stockholders’ Equity (Deficit)                
Current liabilities:                
Accounts payable   $ 11,695     $ 4,906  
Accrued compensation     5,291       2,738  
Accrued liabilities     54,761       7,694  
Operating lease liabilities, current portion     882       693  
Total current liabilities     72,629       16,031  
Operating lease liabilities, long-term portion     13,177        
Total liabilities   $ 85,806     $ 16,031  
Convertible preferred stock           290,945  
Stockholders’ equity (deficit):                
Series 1 convertible preferred stock     3        
Common stock     2        
Additional paid-in capital     591,597       64,335  
Accumulated deficit     (297,870 )     (172,906 )
Total stockholders’ equity (deficit)     293,732       (108,571 )
Total liabilities, convertible preferred stock and stockholders’ equity   $ 379,538     $ 198,405  

Talis BiomedicalConsolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(Unaudited)
    Three Months Ended June 30,     Six Months Ended June 30,  
    2021     2020     2021     2020  
Grant revenue   $ 117     $ 820     $ 7,117     $ 1,219  
Operating expenses:                                
Research and development     54,495       8,184       114,688       13,898  
Selling, general and administrative     9,983       2,660       17,310       4,740  
Total operating expenses     64,478       10,844       131,998       18,638  
Loss from operations     (64,361 )     (10,024 )     (124,881 )     (17,419 )
Other expense, net     (111 )     (22 )     (83 )     (1 )
Net loss and comprehensive loss   $ (64,472 )   $ (10,046 )   $ (124,964 )   $ (17,420 )
Net loss per share, basic and diluted   $ (2.51 )   $ (4.75 )   $ (6.44 )   $ (8.23 )
Weighted average shares used in the calculation of net loss per share, basic and diluted     25,648,151       2,116,623       19,414,066       2,116,437  
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