Recent Business Highlights
- Initiated clinical study to support COVID-19 510(k) submission for clearance of the Talis One® system
- Presented positive data at the
Infectious Disease Society for Obstetrics and Gynecology (IDSOG) annual meeting differentiating the planned Talis One test menu- Development-stage chlamydia, gonorrhea and trichomonas (CT/NG/TV) assay demonstrated clinical performance comparable to widely used on-market molecular tests in less than 30 minutes
- Established ability to effectively lyse multiple Candida species in under four minutes on the Talis One system, positioning the Company to develop a point-of-care vaginal infection panel
- Appointed diagnostic industry veterans, Dr.
Heiner Dreismann to the Talis Biomedical Board of Directors and Dr.Andrew Lukowiak as president and chief scientific officer - Delivered 53% improvement in year-to-date net cash used in operating activities year-over-year to support cash runway into 2025
“During the second quarter, we made important progress across our strategic priorities to develop and deliver a targeted menu of infectious disease tests that women’s and sexual health providers are seeking at the point of care,” said
Second Quarter 2023 Financial Results
Revenue was
Operating expenses were
Net loss was
Cash and Liquidity
Unrestricted cash and cash equivalents as of
Net cash used in operating activities for the six months ended
To support long-term financial objectives, the Company recently reduced its
About the Talis One System
The Talis One system is a compact, sample-to-answer molecular testing platform designed to enable rapid, highly accurate point-of care infectious disease testing in non-laboratory settings. The Talis One test cartridge is a fully self-contained, closed device that includes all the necessary reagents to perform a Talis One test. When loaded into the Talis One instrument, each cartridge fully automates sample lysis, nucleic acid extraction and purification, isothermal amplification, and target detection. The Talis One test system is not authorized, cleared, or approved by the FDA and is not available for sale.
About
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,” “would,” “should,” “believe,” “expect,” “anticipate,” “could,” “estimate,” “continue,” “predict,” “potential,” “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 advance our pipeline, including the plans to develop Talis One assays in the women’s and sexual health markets; the size and potential of our opportunity in the women’s and sexual health markets; our ability to capitalize on any competitive advantages; our ability to position the Company to provide durable value to our shareholders; the benefits of our regulatory strategy; our future revenue growth and profit margins; and our ability to lower our cash burn, extend operations and extend our cash runway. 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: risks and uncertainties associated with development and regulatory approval, the impact to our business from global and regional economic conditions, including as a result of government policies, war, terrorism, natural disasters, public health issues and inflationary pressures and any related impact on our ability to develop our pipeline products, our ability to achieve or sustain profitability, our ability to launch and gain market acceptance for our pipeline products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing, 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
Contact
Media & Investors
efaucette@talisbio.com
415-595-9407
Condensed Balance Sheets
(in thousands)
2023 | 2022 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 98,200 | $ | 130,191 | ||||
Restricted cash | 1,010 | — | ||||||
Accounts receivable, net | 532 | 308 | ||||||
Prepaid expenses and other current assets | 2,223 | 2,783 | ||||||
Total current assets | 101,965 | 133,282 | ||||||
Property and equipment, net | 3,539 | 3,312 | ||||||
Operating lease right-of-use-assets | 16,030 | 30,920 | ||||||
Other long-term assets | 1,542 | 1,776 | ||||||
Total assets | $ | 123,076 | $ | 169,290 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,491 | $ | 3,768 | ||||
Accrued compensation | 3,097 | 4,212 | ||||||
Accrued liabilities | 938 | 989 | ||||||
Operating lease liabilities, current portion | 2,736 | 3,703 | ||||||
Total current liabilities | 9,262 | 12,672 | ||||||
Operating lease liabilities, long-term portion | 17,648 | 29,879 | ||||||
Total liabilities | $ | 26,910 | $ | 42,551 | ||||
Stockholders’ equity: | ||||||||
Series 1 convertible preferred stock | 3 | 3 | ||||||
Common Stock | — | — | ||||||
Additional paid-in capital | 606,982 | 604,690 | ||||||
Accumulated deficit | (510,819 | ) | (477,954 | ) | ||||
Total stockholders’ equity | 96,166 | 126,739 | ||||||
Total liabilities and stockholders’ equity | $ | 123,076 | $ | 169,290 | ||||
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands)
Three Months Ended | Six Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenue | ||||||||||||||||
Grant revenue | $ | 533 | $ | 70 | $ | 1,614 | $ | 944 | ||||||||
Product revenue, net | 48 | 502 | 185 | 2,815 | ||||||||||||
Total revenue, net | 581 | 572 | 1,799 | 3,759 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of products sold | 7 | 1,302 | 27 | 4,823 | ||||||||||||
Research and development | 10,555 | 17,365 | 24,351 | 38,068 | ||||||||||||
Selling, general and administrative | 6,410 | 9,178 | 12,809 | 21,108 | ||||||||||||
Total operating expenses | 16,972 | 27,845 | 37,187 | 63,999 | ||||||||||||
Loss from operations | (16,391 | ) | (27,273 | ) | (35,388 | ) | (60,240 | ) | ||||||||
Other income, net | 1,357 | 262 | 2,523 | 178 | ||||||||||||
Net loss and comprehensive loss | $ | (15,034 | ) | $ | (27,011 | ) | $ | (32,865 | ) | $ | (60,062 | ) | ||||
Net loss per share, basic and diluted | $ | (8.27 | ) | $ | (15.01 | ) | $ | (18.11 | ) | $ | (33.47 | ) | ||||
Weighted average shares used in the calculation of net loss per share, basic and diluted | 1,817,288 | 1,799,559 | 1,814,994 | 1,794,463 |
Source:
2023 GlobeNewswire, Inc., source