SALT
LAKE CITY, Aug. 9, 2023 /PRNewswire/ -- Sera
Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA),
focused on improving maternal and neonatal health by providing
innovative pregnancy biomarker information to doctors and patients,
today announced financial results for the second quarter of 2023
ended June 30, 2023.
Recent Highlights:
- Announced leadership changes and commercial actions in
May 2023 to optimize business for
market success toward accelerating test adoption and revenue
including aligning management team for new refined commercial focus
on institutions.
- Appointed board member Zhenya Lindgardt as interim President
and CEO, and Austin Aerts as interim
CFO.
- Engaged leading strategy house to rigorously evaluate best
pathways toward enhanced revenue at significant reduced cost to
more broadly commercialize Sera's PreTRM® Test and pipeline of
technology.
- Executed select headcount reductions in commercial organization
to better map current commercial costs in line with refined
focus.
- Over the last few weeks Sera has submitted new compelling data
for scientific review anticipating several publications in the
coming months.
"While we still have work to do, we are putting together the
necessary structure and strategy to succeed commercially," said
Zhenya Lindgardt, interim President and CEO of Sera Prognostics.
"Consistent with our vision to be The Pregnancy Company®, we are
pursuing a disciplined commercial approach to broaden adoption of
our PreTRM® Test and at the same time evaluating ways to leverage
our large and growing pregnancy datasets to boost shareholder value
through new products and partnerships. We believe this long-term
vision will solidify our role as a leader in health diagnostics to
improve the lives of women and babies through prenatal care."
Second Quarter 2023 Financial Results
Second quarter 2023 revenue of $123,000 compared to $78,000 for the same period of 2022.
Total operating expenses were $11.6
million, down from $11.8
million for the second quarter of 2022.
Research and development expenses for the second quarter of 2023
were $3.7 million compared to
$3.3 million for the second quarter
of 2022 due primarily to increased clinical study costs.
Selling, general and administrative expenses for the second
quarter of 2023 were $7.8 million,
down significantly from $8.5 million
for the second quarter of 2022 due primarily to steps we took prior
to year-end 2022 to streamline sales operations, and better focus
our commercial strategy in response to market dynamics.
Net loss for the second quarter of 2023 was $10.5 million compared to $11.5 million for the same quarter a year
ago.
As of June 30, 2023, the Company
had cash, cash equivalents, and available-for-sale securities of
approximately $92.1 million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss second quarter 2023 operational
highlights, financial results and key topics at 5:00 p.m. Eastern Time. Individuals interested in
listening to the conference call may do so by dialing the
following:
US domestic callers: (866) 218-2405
International callers: (412) 902-6607
Webcast Registration Link:
https://app.webinar.net/5ZK3j2xMqY7
Live audio of the webcast will be available online from the
Investors page of the Company's website at www.seraprognostics.com.
The webcast will be archived on the Investors page and will be
available for one year.
About Sera Prognostics, Inc.
Sera Prognostics is a leading health diagnostics company
dedicated to improving the lives of women and babies through
precision pregnancy care. Sera's mission is to provide early,
pivotal pregnancy information to improve the health of mothers and
newborns, resulting in reductions in the costs of healthcare
delivery. Sera has a robust pipeline of innovative diagnostic tests
focused on the early prediction of preterm birth risk and other
complications of pregnancy. Sera's precision medicine PreTRM® Test
reports to a physician the individualized risk of spontaneous
premature delivery in a pregnancy, enabling earlier proactive
interventions in women with higher risk. Sera Prognostics is
headquartered in Salt Lake City,
Utah.
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks' gestation
and is the leading cause of illness and death in newborns. The 2022
March of Dimes Report Card shows that, for the last four
consecutive years, more than one in ten infants is born
prematurely. Prematurity is associated with a significantly
increased risk of major long-term medical complications, including
learning disabilities, cerebral palsy, chronic respiratory illness,
intellectual disability, seizures, and vision and hearing loss, and
can generate significant costs throughout the lives of affected
children. The annual health care costs to manage short- and
long-term complications of prematurity in the United States were estimated to be
approximately $25 billion for
2016.
About the PreTRM® Test
The PreTRM® Test is the only broadly validated, commercially
available blood-based biomarker test that provides an early,
accurate and individualized risk prediction for spontaneous preterm
birth in asymptomatic singleton pregnancies. The PreTRM® Test
measures and analyzes proteins in the blood that are highly
predictive of preterm birth. The PreTRM® Test permits physicians to
identify, during the weeks 18 through 20 of pregnancy, which women
are at increased risk for preterm birth and its complications,
enabling more informed, personalized clinical decisions based on
each woman's individual risk. The PreTRM® Test is ordered by a
medical professional.
Sera Prognostics, the Sera Prognostics logo, The Pregnancy
Company, and PreTRM are trademarks or registered trademarks of Sera
Prognostics, Inc. in the United
States and/or other countries.
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to optimizing business for
market success toward accelerating test adoption and revenue;
enhanced revenue at significant reduced cost; more broadly
commercializing Sera's PreTRM® Test and pipeline of technology;
putting together the necessary structure and strategy to succeed
commercially; broadening adoption of the PreTRM® Test; leveraging
the Company's large and growing pregnancy datasets; boosting
shareholder value; new products and partnerships; solidifying the
Company's role as a leader in health diagnostics; and the company's
strategic directives under the caption "About Sera Prognostics,
Inc." These "forward-looking statements" are based on management's
current expectations of future events and are subject to a number
of risks and uncertainties that could cause actual results to
differ materially and adversely from those set forth in or implied
by forward-looking statements. These risks and uncertainties
include, but are not limited to: net losses, cash generation, and
the potential need to raise more capital; revenues from the PreTRM
Test representing substantially all Company revenues to date; the
need for broad scientific and market acceptance of the PreTRM Test;
a concentrated number of material customers; our ability to
introduce new products; potential competition; our proprietary
biobank; critical suppliers; the COVID-19 pandemic and its
potential lingering impact on our operations, as well as the
business or operations of third parties with whom we conduct
business; estimates of total addressable market opportunity and
forecasts of market growth; potential third-party payer coverage
and reimbursement; new reimbursement methodologies applicable to
the PreTRM Test, including new CPT codes and payment rates for
those codes; changes in FDA regulation of laboratory-developed
tests; the intellectual property rights protecting our tests and
market position; and other factors discussed under the heading
"Risk Factors" contained in our Final Prospectus on Form S-1, which
was filed with the Securities and Exchange Commission on
July 14, 2021, as well as any updates
to those risk factors filed from time to time in our Quarterly
Reports on Form 10-Q, Annual Reports on Form 10-K, or Current
Reports on Form 8-K. All information in this press release is as of
the date of the release, and the Company undertakes no duty to
update this information unless required by law.
SERA PROGNOSTICS,
INC.
Condensed Statements
of Operations
(unaudited)
(in thousands, except
share and per share data)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue
|
$
123
|
|
$
78
|
|
$
223
|
|
$
116
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
80
|
|
56
|
|
142
|
|
76
|
Research and
development
|
3,688
|
|
3,261
|
|
7,791
|
|
6,583
|
Selling and
marketing
|
2,872
|
|
4,219
|
|
5,690
|
|
8,677
|
General and
administrative
|
4,943
|
|
4,288
|
|
9,389
|
|
8,826
|
Total operating
expenses
|
11,583
|
|
11,824
|
|
23,012
|
|
24,162
|
Loss from
operations
|
(11,460)
|
|
(11,746)
|
|
(22,789)
|
|
(24,046)
|
Interest
expense
|
(14)
|
|
(18)
|
|
(30)
|
|
(22)
|
Other income,
net
|
932
|
|
244
|
|
1,712
|
|
340
|
Net loss
|
$
(10,542)
|
|
$
(11,520)
|
|
$
(21,107)
|
|
$
(23,728)
|
Net loss per share,
basic and diluted
|
$
(0.34)
|
|
$
(0.37)
|
|
$
(0.68)
|
|
$
(0.77)
|
Weighted-average shares
outstanding, basic and diluted
|
31,077,420
|
|
30,945,616
|
|
31,048,526
|
|
30,873,995
|
SERA PROGNOSTICS,
INC.
Condensed Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
June 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
32,285
|
|
$
29,878
|
Marketable
securities
|
31,536
|
|
52,826
|
Accounts
receivable
|
163
|
|
113
|
Other
receivables
|
—
|
|
6,000
|
Prepaid expenses and
other current assets
|
444
|
|
1,308
|
Total current
assets
|
64,428
|
|
90,125
|
Property and equipment,
net
|
2,411
|
|
3,059
|
Long-term marketable
securities
|
28,307
|
|
21,329
|
Other assets
|
1,534
|
|
1,816
|
Total
assets
|
$
96,680
|
|
$
116,329
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,244
|
|
$
1,548
|
Accrued and other
current liabilities
|
3,444
|
|
4,444
|
Finance lease
obligation, current portion
|
446
|
|
464
|
Deferred
revenue
|
9,049
|
|
9,082
|
Total current
liabilities
|
14,183
|
|
15,538
|
Finance lease
obligation, net of current portion
|
422
|
|
626
|
Operating lease
obligation, net of current portion
|
938
|
|
1,222
|
Total
liabilities
|
15,543
|
|
17,386
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
313,567
|
|
310,575
|
Accumulated other
comprehensive loss
|
(672)
|
|
(981)
|
Accumulated
deficit
|
(231,761)
|
|
(210,654)
|
Total stockholders'
equity
|
81,137
|
|
98,943
|
Total liabilities and
stockholders' equity
|
$
96,680
|
|
$
116,329
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/sera-prognostics-reports-second-quarter-2023-financial-results-301897211.html
SOURCE Sera Prognostics, Inc.