SALT
LAKE CITY, Nov. 8, 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 third quarter of 2023
ended September 30, 2023.
Recent Highlights:
- Sera Board of Directors approved
permanent President and CEO and CFO appointments for Zhenya
Lindgardt and Austin Aerts,
respectively.
- Management team completed planned cost reduction activities to
extend cash runway through most of 2027.
- Scaling our care coordination offering and providing it for
institutional customers for women identified as high-risk for
preterm birth using our PreTRM test. Sera believes this service
offering to patients can improve test adoption by physicians by
providing the availability of care coordination to their high-risk
patients.
- Moved new high-low risk predictor product into next phase of
market research in preparation for clinical validation.
- Shared findings from AVERT clinical trial highlighting PreTRM
test's impact of driving 2.5-week improvement in gestational age of
infants most at risk for early delivery, 18% reduction in severe
neonatal morbidity and mortality, and 28-day reduction in Neonatal
Intensive Care Unit length of stay for infants born before 32
weeks. We have begun actively sharing the data from AVERT with
potential institutional customers.
"We continue to lay the groundwork for a reinvigorated
commercial focus designed to cost-effectively target increased test
adoption through institutional customer focus, care coordination
program, and are exploring potential product and partnership
pathways to expand our commercial revenue," said Zhenya Lindgardt,
President and CEO of Sera Prognostics. "At the same time, we are
focused on continuing to share data that supports the value of
early, pivotal pregnancy information powered by Sera that, coupled
with interventions for high-risk patients, can lead to better
health for mothers and newborns at reduced healthcare costs."
Third Quarter 2023 Financial Results
Third quarter 2023 revenue of $42,000 compared to $87,000 for the same period of 2022.
Total operating expenses were $8.2
million, down significantly from $11.3 million for the third quarter of 2022.
Research and development expenses for the third quarter of 2023
were $3.5 million compared to
$4.2 million for the third quarter of
2022 due primarily to lower clinical study costs.
Selling, general and administrative expenses for the third
quarter of 2023 were $4.6 million,
down significantly from $7.0 million
for the third quarter of 2022 due primarily to steps we took prior
to year-end 2022 and more recently to streamline commercial
operations, better focus our commercial strategy in response to
market dynamics and align our administrative costs to match our
current level of operations.
Net loss for the third quarter of 2023 was $7.2 million compared to $10.7 million for the same quarter a year
ago.
As of September 30, 2023, the
Company had cash, cash equivalents, and available-for-sale
securities of approximately $85.0
million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss third 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/nDRAgqN8EqG
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 the date, time and content
of the Company's quarterly earnings release and conference call;
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
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue
|
$
42
|
|
$
87
|
|
$
265
|
|
$
203
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenue
|
44
|
|
58
|
|
186
|
|
134
|
Research and
development
|
3,539
|
|
4,176
|
|
11,330
|
|
10,759
|
Selling and
marketing
|
1,355
|
|
2,967
|
|
7,045
|
|
11,644
|
General and
administrative
|
3,288
|
|
4,074
|
|
12,677
|
|
12,900
|
Total operating
expenses
|
8,226
|
|
11,275
|
|
31,238
|
|
35,437
|
Loss from
operations
|
(8,184)
|
|
(11,188)
|
|
(30,973)
|
|
(35,234)
|
Interest
expense
|
(14)
|
|
(21)
|
|
(44)
|
|
(43)
|
Other income,
net
|
988
|
|
497
|
|
2,700
|
|
837
|
Net loss
|
$
(7,210)
|
|
$
(10,712)
|
|
$
(28,317)
|
|
$
(34,440)
|
Net loss per share,
basic and diluted
|
$
(0.23)
|
|
$
(0.35)
|
|
$
(0.91)
|
|
$
(1.11)
|
Weighted-average shares
outstanding, basic and
diluted
|
31,286,148
|
|
31,005,978
|
|
31,128,604
|
|
30,918,473
|
SERA PROGNOSTICS,
INC.
|
Condensed Balance
Sheets
|
(unaudited)
|
(in
thousands)
|
|
|
September
30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
9,655
|
|
$
29,878
|
Marketable
securities
|
36,461
|
|
52,826
|
Accounts
receivable
|
155
|
|
113
|
Other
receivables
|
—
|
|
6,000
|
Prepaid expenses and
other current assets
|
1,275
|
|
1,308
|
Total current
assets
|
47,546
|
|
90,125
|
Property and equipment,
net
|
2,197
|
|
3,059
|
Long-term marketable
securities
|
38,922
|
|
21,329
|
Other assets
|
1,392
|
|
1,816
|
Total
assets
|
$
90,057
|
|
$
116,329
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,177
|
|
$
1,548
|
Accrued and other
current liabilities
|
2,891
|
|
4,444
|
Finance lease
obligation, current portion
|
438
|
|
464
|
Deferred
revenue
|
9,039
|
|
9,082
|
Total current
liabilities
|
13,545
|
|
15,538
|
Finance lease
obligation, net of current portion
|
309
|
|
626
|
Operating lease
obligation, net of current portion
|
792
|
|
1,222
|
Total
liabilities
|
14,646
|
|
17,386
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
314,993
|
|
310,575
|
Accumulated other
comprehensive loss
|
(614)
|
|
(981)
|
Accumulated
deficit
|
(238,971)
|
|
(210,654)
|
Total stockholders'
equity
|
75,411
|
|
98,943
|
Total liabilities and
stockholders' equity
|
$
90,057
|
|
$
116,329
|
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SOURCE Sera Prognostics, Inc.