TALIS BIOMEDICAL CORPORATION "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
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
Operating expenses were
Net loss was
Cash and cash equivalents on
Conference Call and Webcast Details
The company will host a live conference call and webcast to discuss these results and provide a corporate update on
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 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 Statements
This 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
Investor Contact
Media & Investors
efaucette@talisbio.com
415-595-9407
Consolidated Balance Sheet (In thousands) (Unaudited) | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| 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 | ||||
Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 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 | ||||||||||||
2021 GlobeNewswire, Inc., source
