Talis Biomedical Corporation (Nasdaq: TLIS), a diagnostic 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 for
the second quarter ended June 30, 2023, and provided a business
update.
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 Rob Kelley, chief executive
officer of Talis Biomedical. “With the data we are generating, our
focused execution and healthy cash position, it is our plan to
secure regulatory clearance for three test panels by the end of
2025. We are excited for the opportunity to capture this large and
growing market and to make a meaningful impact on the delivery of
timely and accurate patient care.”
Second Quarter 2023 Financial Results Revenue
was $0.6 million for the second quarter of 2023, which includes
$0.5 million of NIH grant revenue. Revenue was $0.6 million for the
same period in 2022.
Operating expenses were $17.0 million in the second quarter of
2023, compared to $27.8 million for the same period in 2022. The
decrease was primarily driven by lower investments in raw card
inventory and manufacturing as well as the realization of benefits
from the spending reduction measures implemented during 2022.
Net loss was $15.0 million for the second quarter of 2023,
compared to $27.0 million for the same period in 2022.
Cash and LiquidityUnrestricted cash and cash
equivalents as of June 30, 2023, were $98.2 million.
Net cash used in operating activities for the six months ended
June 30, 2023 was $30.7 million, as compared to $65.8 million in
the same period of 2022. This decrease was primarily driven by
lower headcount costs from the Company’s spending reduction program
as well as declines in payments for raw card inventory and
manufacturing investments.
To support long-term financial objectives, the Company recently
reduced its Redwood City, California office and lab space by
two-thirds. The Company expects approximately $9 million of cash
savings over the life of the lease.
About the Talis One SystemThe 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 Talis BiomedicalTalis Biomedical 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. 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,” “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
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. These statements are based upon information available
to us as of the date of this press release, and while we believe
such information forms a reasonable basis for such statements, such
information may be limited or incomplete, and our statements should
not be read to indicate that we have conducted an exhaustive
inquiry into, or review of, all potentially available relevant
information. These statements are inherently uncertain and
investors are cautioned not to unduly rely upon these statements.
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 & InvestorsEmily
Faucetteefaucette@talisbio.com 415-595-9407
Talis Biomedical
Corporation Condensed Balance
Sheets (in thousands)
|
|
June 30, |
|
December 31, |
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
Talis Biomedical
Corporation Condensed Statements of
Operations and Comprehensive Loss (Unaudited)(in
thousands)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
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 |
|
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