SALT
LAKE CITY, March 22, 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 fourth quarter and full
year 2022 ended December 31,
2022.
Recent Highlights:
- Announced positive top-line results from the AVERT PRETERM
TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to
Historical Controls), conducted at ChristianaCare in Wilmington, Delaware. The results demonstrated
the generalizability of the PreTRM® test-and-treat strategy in
achieving meaningful clinical results in widely diverse U.S.
populations toward significant improvement in neonatal health
outcomes and hospital length-of-stay.
- Announced the publication of results from a clinical utility
and cost-effectiveness modeling study, ACCORDANT (Analyses aCross
Congruent studies ReDucing Adverse pregNancy ouTcomes), which,
based on rigorous clinical utility health economic analysis,
illustrated the impact of Sera's test-and-treat strategy and its
specific benefits in underserved racial and ethnic populations. By
combining the PreTRM® Test with enhanced prenatal care management,
real progress may be possible in better serving these populations
to enable better medical outcomes.
- Validated preeclampsia risk predictor, with results made
available publicly and being prepared for submission to a
scientific journal.
- Surpassed the required 2,800 PRIME study subject enrollment,
which enables the interim look analysis by year end.
"We are pleased with the growing body of data showing the
clinical utility and cost effectiveness of the PreTRM® Test in
mitigating the negative health and economic consequences of preterm
delivery," said Gregory C.
Critchfield, MD, MS, Chairman and CEO of Sera Prognostics.
"The exciting AVERT PRETERM TRIAL results are being prepared for
submission to a scientific journal for publication. We believe this
provides meaningful evidence of the value of our test in improving
the health of moms and babies. We are excited to pursue our mission
to work with doctors, patients and health systems in creating a
better standard of care in pregnancies."
Fourth Quarter 2022 Financial Results
Fourth quarter 2022 revenue of $65,000 compared to $26,000 for the same period of 2021.
Total operating expenses were $10.5
million, down from $12.6
million for the fourth quarter of 2021.
Research and development expenses for the fourth quarter of 2022
were $3.5 million compared to
$3.1 million for the fourth quarter
of 2021 due primarily to increased headcount and research
activities.
Selling, general and administrative expenses for the fourth
quarter of 2022 were $6.9 million,
down significantly from $9.5 million
for the year-ago period due primarily to steps we took during the
prior quarter to streamline our sales operations and to better
focus our commercial strategy in response to market dynamics, as
well as decreased administrative costs resulting from operational
efficiencies.
Net loss for the fourth quarter of 2022 was $9.7 million compared to $12.5 million for the same quarter a year
ago.
Full Year 2022 Financial Results
Total full year 2022 revenue of $268,000 compared to $82,000 for full year 2021.
Total operating expenses were $45.9
million, up from $35.5 million
for 2021.
Research and development expenses for 2022 were $14.2 million compared to $11.0 million for the prior year due to increased
clinical study costs and research activities.
Selling, general and administrative expenses for 2022 were
$31.5 million, up from $24.4 million for the prior year due primarily to
a larger sales force for the majority of the year, as well as
corporate infrastructure costs related to a full year of operating
as a public company.
As of December 31, 2022, the
Company had cash, cash equivalents, and available-for-sale
securities of approximately $104.0
million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss fourth quarter 2022 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/7E3P1Ox6ANJ
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
located 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 the interim look analysis
being enabled by year end; the growing body of data showing the
clinical utility and cost effectiveness of the PreTRM® Test; the
AVERT PRETERM TRIAL results being prepared for submission to a
scientific journal for publication; the conference call and live
webcast being held today and audio of the webcast being available
on the Company's Investors page for one year; 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
December 31,
|
|
Year Ended
December 31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenue
|
$
65
|
|
$
26
|
|
$
268
|
|
$
82
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
59
|
|
14
|
|
193
|
|
37
|
Research and
development
|
3,485
|
|
3,075
|
|
14,244
|
|
11,019
|
Selling and
marketing
|
3,055
|
|
4,548
|
|
14,699
|
|
10,328
|
General and
administrative
|
3,884
|
|
4,936
|
|
16,784
|
|
14,093
|
Total operating
expenses
|
10,483
|
|
12,573
|
|
45,920
|
|
35,477
|
Loss from
operations
|
(10,418)
|
|
(12,547)
|
|
(45,652)
|
|
(35,395)
|
Interest
expense
|
(18)
|
|
(2)
|
|
(61)
|
|
(746)
|
Other income,
net
|
690
|
|
65
|
|
1,527
|
|
1,132
|
Net loss
|
$
(9,746)
|
|
$
(12,484)
|
|
$
(44,186)
|
|
$
(35,009)
|
Net loss per share,
basic and diluted
|
$
(0.31)
|
|
$
(0.41)
|
|
$
(1.43)
|
|
$
(2.33)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
31,017,472
|
|
30,718,121
|
|
30,943,426
|
|
15,003,144
|
SERA PROGNOSTICS,
INC.
Condensed Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
December 31,
|
|
2022
|
|
2021
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
29,878
|
|
$
58,932
|
Marketable
securities
|
52,826
|
|
46,183
|
Accounts
receivable
|
113
|
|
27
|
Other
receivables
|
6,000
|
|
3,116
|
Prepaid expenses and
other current assets
|
1,308
|
|
1,993
|
Total current
assets
|
90,125
|
|
110,251
|
Property and equipment,
net
|
3,059
|
|
1,773
|
Long-term marketable
securities
|
21,329
|
|
34,848
|
Other assets
|
1,816
|
|
157
|
Total
assets
|
$
116,329
|
|
$
147,029
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,548
|
|
$
1,197
|
Accrued and other
current liabilities
|
4,444
|
|
3,885
|
Deferred rent, current
portion
|
—
|
|
139
|
Finance lease
obligation, current portion
|
464
|
|
74
|
Deferred
revenue
|
9,082
|
|
3,116
|
Total current
liabilities
|
15,538
|
|
8,411
|
Finance lease
obligation, net of current portion
|
626
|
|
54
|
Operating lease
obligation, net of current portion
|
1,222
|
|
—
|
Total
liabilities
|
17,386
|
|
8,465
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
310,575
|
|
305,212
|
Accumulated other
comprehensive loss
|
(981)
|
|
(183)
|
Accumulated
deficit
|
(210,654)
|
|
(166,468)
|
Total stockholders'
equity
|
98,943
|
|
138,564
|
Total liabilities and
stockholders' equity
|
$
116,329
|
|
$
147,029
|
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SOURCE Sera Prognostics, Inc.