SALT
LAKE CITY, May 8, 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 first quarter
of 2024 ended March 31, 2024.
Recent Highlights:
- Submitted manuscript of PRIME study interim analysis results
for peer-reviewed publication.
- Shipped first ambient whole blood collection kits, which we
believe is critical to facilitating new commercial opportunities
and is expected to yield significant reduction in cost of goods
sold via simpler, cheaper collection methods and more efficient lab
processing, which should also enable increased lab processing
capacity.
- Working with payers and providers, in collaboration with other
stakeholders, on targeted state implementation programs to promote
health equity to address spontaneous premature births and improve
pregnancy care.
- Exploring attractive international markets by beginning to
engage with regulators in countries with a significant number of
premature births where the addressable market for the Sera™
PreTRM® Test could be large.
"While revenue for the quarter was impacted by revenue
adjustments related to old accounts, we continue to be pleased with
our progress in setting the stage for a potential revenue
inflection by submitting data for publication to enhance our
evidence portfolio that we believe could ultimately lead to broad
adoption, and by exploring growth opportunities in the interim
where PreTRM can make a sizeable difference in improving maternity
and birth outcomes," said Zhenya Lindgardt, President and CEO of
Sera Prognostics. "Our new ambient whole blood collection method
allows us to access more patients and, as revenue ramps, we expect
should significantly improve gross margin and enable Sera to
process more tests efficiently to meet future demand."
First Quarter 2024 Financial Results
First quarter 2024 revenue before adjustments was $39,000 compared to $100,000 for the same period of 2023, but net
revenue was nil after our periodic review of accounting estimates
for older tests.
Total operating expenses were $9.1
million, down 20% from $11.4
million for the first quarter of 2023.
Research and development expenses for the first quarter of 2024
were $3.7 million, down 10% from
$4.1 million for the first quarter of
2023 due primarily to lower clinical study costs.
Selling, general and administrative expenses for the first
quarter of 2024 were $5.4 million,
down 26% from $7.3 million for the
first quarter of 2023 due primarily to steps to streamline
commercial operations, better focus our commercial strategy and
reduce overall operating expenses.
Lower costs resulted in a 24% narrower net loss for the first
quarter of 2024: $8.1 million
compared to $10.6 million for the
same quarter a year ago.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss first quarter 2024 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: (800) 836-8184
International callers: (646) 357-8785
Webcast Registration Link:
https://app.webinar.net/24aZA3pXRQp
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, 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 shipping of ambient
whole blood collection kits facilitating new commercial
opportunities, yielding significant reduction in cost of goods sold
via simpler, cheaper collection methods and more efficient lab
processing, and enabling increased lab processing capacity;
targeted state implementation programs; exploring attractive
international markets and engaging with regulators in countries
where the addressable market for the Sera™ PreTRM® Test
could be large; a potential revenue inflection; publication of data
to enhance our evidence portfolio; broad adoption and interim
growth opportunities for PreTRM testing; the company's new ambient
whole blood collection method allowing the company to access more
patients; a revenue ramp; significantly improved gross margin;
processing more tests efficiently; future demand; 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
March 31,
|
|
2024
|
|
2023
|
Revenue
|
$
—
|
|
$
100
|
Operating
expenses:
|
|
|
|
Cost of
revenue
|
17
|
|
62
|
Research and
development
|
3,683
|
|
4,103
|
Selling and
marketing
|
1,227
|
|
2,818
|
General and
administrative
|
4,170
|
|
4,446
|
Total operating
expenses
|
9,097
|
|
11,429
|
Loss from
operations
|
(9,097)
|
|
(11,329)
|
Interest
expense
|
(9)
|
|
(16)
|
Other income,
net
|
1,009
|
|
780
|
Net loss
|
$
(8,097)
|
|
$
(10,565)
|
Net loss per share,
basic and diluted
|
$
(0.25)
|
|
$
(0.34)
|
Weighted-average shares
outstanding, basic and diluted
|
32,220,038
|
|
31,019,311
|
SERA PROGNOSTICS,
INC.
Condensed Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
March 31,
2024
|
|
December 31,
2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
4,239
|
|
$
3,880
|
Marketable
securities
|
48,734
|
|
45,199
|
Accounts
receivable
|
117
|
|
160
|
Other
receivables
|
—
|
|
11,310
|
Prepaid expenses and
other current assets
|
756
|
|
795
|
Total current
assets
|
53,846
|
|
61,344
|
Property and equipment,
net
|
1,808
|
|
1,999
|
Long-term marketable
securities
|
32,386
|
|
30,841
|
Other assets
|
1,846
|
|
1,257
|
Total
assets
|
$
89,886
|
|
$
95,441
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,026
|
|
$
1,046
|
Accrued and other
current liabilities
|
2,863
|
|
2,722
|
Finance lease
obligation, current portion
|
448
|
|
440
|
Deferred
revenue
|
20,231
|
|
20,235
|
Total current
liabilities
|
24,568
|
|
24,443
|
Finance lease
obligation, net of current portion
|
81
|
|
196
|
Operating lease
obligation, net of current portion
|
487
|
|
644
|
Total
liabilities
|
25,136
|
|
25,283
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
319,921
|
|
317,066
|
Accumulated other
comprehensive loss
|
(181)
|
|
(15)
|
Accumulated
deficit
|
(254,993)
|
|
(246,896)
|
Total stockholders'
equity
|
64,750
|
|
70,158
|
Total liabilities and
stockholders' equity
|
$
89,886
|
|
$
95,441
|
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SOURCE Sera Prognostics, Inc.