SALT
LAKE CITY, May 10, 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 first quarter
of 2023 ended March 31, 2023.
Recent Highlights:
- Announced positive top-line results from the AVERT PRETERM
TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to
Historical Controls).
- Increases in physician orders Q1 2023 vs. Q1 2022, as more
physicians deploy the PreTRM® test-and-treat strategy.
- PRIME study subject enrollment continues, with the interim look
analysis anticipated to take place by year-end.
- Anticipate submission this summer of new compelling data for
scientific review for publication.
"The exciting AVERT PRETERM TRIAL topline results announced in
February are a part of Sera's growing strong foundation of
compelling data demonstrating the value of the PreTRM
test-and-treat strategy," said Gregory C.
Critchfield, MD, MS, Chairman and CEO of Sera Prognostics.
"We see the publication of these data as a driver to enable
physicians and healthcare institutions to substantively address the
serious challenges of preterm birth. While implementation will take
time, we anticipate that the availability of additional clinical
utility information during this year, should serve as an additional
catalyst to help us expand the use of our PreTRM Test and to
increase revenue."
First Quarter 2023 Financial Results
First quarter 2023 revenue of $100,000 compared to $38,000 for the same period of 2022.
Total operating expenses were $11.4
million, down from $12.3
million for the first quarter of 2022.
Research and development expenses for the first quarter of 2023
were $4.1 million compared to
$3.3 million for the first quarter of
2022 due primarily to increased clinical study costs.
Selling, general and administrative expenses for the first
quarter of 2023 were $7.3 million,
down significantly from $9.0 million
for the first 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 first quarter of 2023 was $10.6 million compared to $12.2 million for the same quarter a year
ago.
As of March 31, 2023, the Company
had cash, cash equivalents, and available-for-sale securities of
approximately $100 million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and
live webcast today to discuss first 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/YPlZL7A5y82
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 PRIME study interim look
analysis being anticipated to take place by year-end; submission
later this summer of new compelling data; the publication of AVERT
data being a driver to enable physicians and healthcare
institutions to substantively address the serious challenges of
preterm birth; the availability of additional clinical utility
information during this year serving as an additional catalyst to
help us expand the use of our PreTRM Test and to increase revenue;
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,
|
|
2023
|
|
2022
|
Revenue
|
$
100
|
|
$
38
|
Operating
expenses:
|
|
|
|
Cost of
revenue
|
62
|
|
20
|
Research and
development
|
4,103
|
|
3,322
|
Selling and
marketing
|
2,818
|
|
4,458
|
General and
administrative
|
4,446
|
|
4,538
|
Total operating
expenses
|
11,429
|
|
12,338
|
Loss from
operations
|
(11,329)
|
|
(12,300)
|
Interest
expense
|
(16)
|
|
(4)
|
Other income,
net
|
780
|
|
96
|
Net loss
|
$
(10,565)
|
|
$
(12,208)
|
Net loss per share,
basic and diluted
|
$
(0.34)
|
|
$
(0.40)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
31,019,311
|
|
30,801,579
|
SERA PROGNOSTICS,
INC.
Condensed Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
March 31,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
27,201
|
|
$
29,878
|
Marketable
securities
|
43,587
|
|
52,826
|
Accounts
receivable
|
120
|
|
113
|
Other
receivables
|
—
|
|
6,000
|
Prepaid expenses and
other current assets
|
1,202
|
|
1,308
|
Total current
assets
|
72,110
|
|
90,125
|
Property and equipment,
net
|
2,907
|
|
3,059
|
Long-term marketable
securities
|
28,917
|
|
21,329
|
Other assets
|
1,676
|
|
1,816
|
Total
assets
|
$
105,610
|
|
$
116,329
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,590
|
|
$
1,548
|
Accrued and other
current liabilities
|
2,692
|
|
4,444
|
Finance lease
obligation, current portion
|
451
|
|
464
|
Deferred
revenue
|
9,067
|
|
9,082
|
Total current
liabilities
|
13,800
|
|
15,538
|
Finance lease
obligation, net of current portion
|
519
|
|
626
|
Operating lease
obligation, net of current portion
|
1,081
|
|
1,222
|
Total
liabilities
|
15,400
|
|
17,386
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common stock, Class A
and Class B
|
3
|
|
3
|
Additional paid-in
capital
|
311,883
|
|
310,575
|
Accumulated other
comprehensive loss
|
(457)
|
|
(981)
|
Accumulated
deficit
|
(221,219)
|
|
(210,654)
|
Total stockholders'
equity
|
90,210
|
|
98,943
|
Total liabilities and
stockholders' equity
|
$
105,610
|
|
$
116,329
|
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SOURCE Sera Prognostics, Inc.