Talis Biomedical Announces Third Quarter 2021 Financial Results and Business Progress
Talis Biomedical Corporation (Nasdaq: TLIS) reported its third quarter 2021 results, highlighting significant progress with the FDA's Emergency Use Authorization for the Talis One COVID-19 Test System. The product demonstrated 100% concordance in clinical studies, including for the Delta variant. Q3 grant revenue was $0.2 million, a drop from $9.5 million in Q3 2020, while operating expenses were relatively stable at $38.6 million. The net loss increased to $38.4 million compared to $29.5 million in the previous year. Cash reserves stood at $273.6 million as of September 30, 2021.
- Secured FDA Emergency Use Authorization for the Talis One COVID-19 Test System.
- The Talis One COVID-19 Test System showed 100% concordance in clinical studies.
- Appointment of Brian Blaser as new CEO effective December 1, 2021.
- Grant revenue significantly declined to $0.2 million from $9.5 million year-over-year.
- Net loss increased to $38.4 million, compared to $29.5 million in Q3 2020.
Conference call and webcast today at 4:30pm Eastern/1:30pm Pacific
MENLO PARK, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Talis Biomedical Corporation (Nasdaq: TLIS), a company dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care, today reported financial results and business progress for the third quarter ended September 30, 2021.
"We are pleased to report meaningful progress against our previously outlined business initiatives, highlighted by the FDA’s recent Emergency Use Authorization for use of the Talis One COVID-19 Test System in a variety of healthcare settings,” said Kim Popovits, interim chief executive officer of Talis. “As we are launching both an assay and new instrument system for the first time under EUA, we will execute a controlled product rollout designed to ensure an exceptional customer experience. We believe this measured approach will drive long-term adoption and success as we continue to develop a broad menu of tests to address the significant and unmet needs of the respiratory, sexual health and women’s health testing markets we plan to serve.”
Business Updates
- Secured FDA Emergency Use Authorization (EUA) for the Talis One™ COVID-19 Test System.
- In a clinical study, the Talis One COVID-19 Test System demonstrated
100% concordance with the comparator test results, including both the positive and negative percent agreements. - Conducted a separate bioinformatic analysis for the Delta variant as well as testing in vitro transcript samples to support the EUA submission. In testing for all variants, including Delta, no loss in sensitivity or impact on the Talis One COVID-19 Test System’s performance was detected.
- In a clinical study, the Talis One COVID-19 Test System demonstrated
- Completed feasibility for COVID/Flu and Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) pipeline assays and progressed into development.
- Announced appointment of Brian Blaser to Director, President and Chief Executive Officer of Talis, and Kim Popovits’ return to Board of Directors, effective December 1, 2021.
Third Quarter 2021 Financial Results
Grant revenue was
Operating expenses were
Net loss was
Cash and cash equivalents on September 30, 2021, were
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 Monday, November 15, 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 3618139. 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 Biomedical
Talis is dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care. The company plans to develop and commercialize innovative products on its sample-to-answer Talis One system to enable accurate, low cost, and rapid molecular testing. The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for use of the Talis One COVID-19 Test System in a variety of healthcare settings. 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 scale our operational and commercial capabilities; 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, 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.
Contact
Media & Investors
Emily Faucette
efaucette@talisbio.com
415-595-9407
Talis Biomedical Corporation
Condensed Balance Sheets
(in thousands, except for shares and par value)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 273,603 | $ | 138,483 | ||||
| Restricted cash | — | 34,650 | ||||||
| Grants receivable | — | 238 | ||||||
| Unbilled grants receivable | 219 | 233 | ||||||
| Prepaid research and development expenses | 938 | 12,014 | ||||||
| Prepaid expenses and other current assets | 2,797 | 3,106 | ||||||
| Total current assets | 277,557 | 188,724 | ||||||
| Property and equipment, net | 10,391 | 9,114 | ||||||
| Operating lease right-of-use-assets | 13,400 | 567 | ||||||
| Other long-term assets | 1,748 | — | ||||||
| Total assets | $ | 303,096 | $ | 198,405 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,388 | $ | 4,906 | ||||
| Accrued compensation | 6,635 | 2,738 | ||||||
| Accrued liabilities | 18,194 | 7,694 | ||||||
| Operating lease liabilities, current portion | 1,125 | 693 | ||||||
| Total current liabilities | 31,342 | 16,031 | ||||||
| Operating lease liabilities, long-term portion | 12,962 | — | ||||||
| Total liabilities | $ | 44,304 | $ | 16,031 | ||||
| Commitments and contingencies (Note 6) | ||||||||
| Convertible preferred stock, | — | 290,945 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Series 1 convertible preferred stock, | 3 | — | ||||||
| Common stock, | 2 | — | ||||||
| Additional paid-in capital | 595,075 | 64,335 | ||||||
| Accumulated deficit | (336,288 | ) | (172,906 | ) | ||||
| Total stockholders’ equity (deficit) | 258,792 | (108,571 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 303,096 | $ | 198,405 | ||||
Talis Biomedical Corporation
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except for share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Grant revenue | $ | 218 | $ | 9,486 | $ | 7,335 | $ | 10,705 | |||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 25,841 | 36,011 | 140,529 | 49,909 | |||||||||||||
| Selling, general and administrative | 12,792 | 3,058 | 30,102 | 7,798 | |||||||||||||
| Total operating expenses | 38,633 | 39,069 | 170,631 | 57,707 | |||||||||||||
| Loss from operations | (38,415 | ) | (29,583 | ) | (163,296 | ) | (47,002 | ) | |||||||||
| Other income (expense), net | (3 | ) | 69 | (86 | ) | 68 | |||||||||||
| Net loss and comprehensive loss | $ | (38,418 | ) | $ | (29,514 | ) | $ | (163,382 | ) | $ | (46,934 | ) | |||||
| Net loss per share, basic and diluted | $ | (1.49 | ) | $ | (13.90 | ) | $ | (8.41 | ) | $ | (22.15 | ) | |||||
| Weighted average shares used in the calculation of net loss per share, basic and diluted | 25,787,101 | 2,122,931 | 19,427,730 | 2,118,607 | |||||||||||||
FAQ
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