SALT
LAKE CITY, March 20, 2024 /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 ended December 31, 2023.
Recent Highlights:
- Announced that the Data Safety Monitoring Board (DSMB)
overseeing Sera's pivotal Prematurity Risk Assessment Combined
with Clinical Interventions for Improved Neonatal OutcoMEs
(PRIME) study recommended stopping enrollment due to efficacy,
reporting that either of the co-primary endpoints met the stopping
criteria for statistical significance at the pre-planned interim
analysis. In final stages of preparing manuscript submission to
premier medical publications.
- Working diligently with guideline groups to develop appropriate
implementation plans while working toward publication of the PRIME
study results.
- Made continued progress in development of product pipeline and
PreTRM® sample collection and assay enhancements, which
will provide simpler, cheaper collection methods and more efficient
lab processing, with validations nearly complete and plans to
launch in the coming months across certain initial
geographies.
- Engaged in focused commercial activities ahead of PRIME data to
build toward greater PreTRM® test adoption expectations
in 2024-2025.
- Started new initiatives to build awareness with expectant
mothers and develop patient-facing products and a predictive
analytics tool that can establish direct relationships with women
and expand and diversify revenue opportunities.
"We are looking forward to an exciting year of developments for
Sera, including publication of our PRIME study results while
executing on commercial expansion and our plans to establish direct
relationships with expectant mothers," said Zhenya Lindgardt,
President and CEO of Sera Prognostics. "We expect these activities
and advancements in our product pipeline to complement what we
believe is our leading position in the area of maternal and
neonatal health and pave the way for a future inflection in revenue
growth."
Fourth Quarter 2023 Financial Results
Fourth quarter 2023 revenue of $41,000 compared to $65,000 for the same period of 2022.
Total operating expenses were $8.9
million, down significantly from $10.5 million for the fourth quarter of 2022.
Research and development expenses for the fourth quarter of 2023
were $3.9 million compared to
$3.5 million for the fourth quarter
of 2022 due primarily to higher clinical study costs.
Selling, general and administrative expenses for the fourth
quarter of 2023 were $5.0 million,
down significantly from $6.9 million
for the fourth quarter of 2022 due primarily to steps to streamline
commercial operations, better focus our commercial strategy and
reduce overall operating expenses.
Net loss for the fourth quarter of 2023 was $7.9 million compared to $9.7 million for the same quarter a year ago.
Full Year 2023 Financial Results
Total full year 2023 revenue of $306,000 compared to $268,000 for the same period of 2022.
Total operating expenses were $40.1
million, down from $45.9
million for 2022.
Research and development expenses for 2023 were $15.2 million compared to $14.2 million for the prior year due primarily to
higher clinical study costs.
Selling, general and administrative expenses for 2023 were
$24.7 million, down significantly
from $31.5 million for 2022 due
primarily to steps to streamline commercial operations, better
focus our commercial strategy and reduce overall operating
expenses.
Net loss for 2023 was $36.2
million compared to $44.2
million for 2022.
As of December 31, 2023, the
Company had cash, cash equivalents, and available-for-sale
securities of approximately $79.9
million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss fourth quarter and full year 2023
operational highlights, financial results and key topics at
5:00 p.m. Eastern Time. The Company
notes that, although this will not be referred to in the prepared
remarks during the call, it has posted an updated slide
presentation to the investor relations page of its website at
www.seraprognostics.com. 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/Za419djMmLE
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 2023
March of Dimes Report Card shows that, for the last five
consecutive years, more than one in ten infants is born prematurely
in the United States.
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 Company being in the
final stages of preparing a PRIME manuscript submission to premier
medical publications; the Company working with guideline groups to
develop appropriate implementation plans; sample collection and
assay enhancements providing simpler, cheaper collection methods
and more efficient lab processing, with validations nearly complete
and plans to launch in the coming months; building toward greater
PreTRM® test adoption expectations in 2024-2025;
building awareness with expectant mothers and developing
patient-facing products and a predictive analytics tool that can
establish direct relationships with women and expand and diversify
revenue opportunities; publication of our PRIME study results in
2024; commercial expansion; a future inflection in revenue growth;
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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue
|
$
41
|
|
$
65
|
|
$
306
|
|
$
268
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
24
|
|
59
|
|
210
|
|
193
|
Research and
development
|
3,895
|
|
3,485
|
|
15,225
|
|
14,244
|
Selling and
marketing
|
1,304
|
|
3,055
|
|
8,349
|
|
14,699
|
General and
administrative
|
3,666
|
|
3,884
|
|
16,343
|
|
16,784
|
Total operating
expenses
|
8,889
|
|
10,483
|
|
40,127
|
|
45,920
|
Loss from
operations
|
(8,848)
|
|
(10,418)
|
|
(39,821)
|
|
(45,652)
|
Interest
expense
|
(11)
|
|
(18)
|
|
(55)
|
|
(61)
|
Other income,
net
|
934
|
|
690
|
|
3,634
|
|
1,527
|
Net loss
|
$
(7,925)
|
|
$
(9,746)
|
|
$
(36,242)
|
|
$
(44,186)
|
Net loss per share,
basic and diluted
|
$
(0.25)
|
|
$
(0.31)
|
|
$
(1.16)
|
|
$
(1.43)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
31,414,446
|
|
31,017,472
|
|
31,200,652
|
|
30,943,426
|
SERA PROGNOSTICS,
INC.
Condensed Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
December
31,
|
|
2023
|
|
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
3,880
|
|
$
29,878
|
Marketable
securities
|
45,199
|
|
52,826
|
Accounts
receivable
|
160
|
|
113
|
Other
receivables
|
11,310
|
|
6,000
|
Prepaid expenses and
other current assets
|
795
|
|
1,308
|
Total current
assets
|
61,344
|
|
90,125
|
Property and equipment,
net
|
1,999
|
|
3,059
|
Long-term marketable
securities
|
30,841
|
|
21,329
|
Other assets
|
1,257
|
|
1,816
|
Total
assets
|
$
95,441
|
|
$
116,329
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,046
|
|
$
1,548
|
Accrued and other
current liabilities
|
2,722
|
|
4,444
|
Finance lease
obligation, current portion
|
440
|
|
464
|
Deferred
revenue
|
20,235
|
|
9,082
|
Total current
liabilities
|
24,443
|
|
15,538
|
Finance lease
obligation, net of current portion
|
196
|
|
626
|
Operating lease
obligation, net of current portion
|
644
|
|
1,222
|
Total
liabilities
|
25,283
|
|
17,386
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
317,066
|
|
310,575
|
Accumulated other
comprehensive loss
|
(15)
|
|
(981)
|
Accumulated
deficit
|
(246,896)
|
|
(210,654)
|
Total
stockholders' equity
|
70,158
|
|
98,943
|
Total
liabilities and stockholders' equity
|
$
95,441
|
|
$
116,329
|
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SOURCE Sera Prognostics, Inc.