Aligning Management Team given New Refined Commercial Focus
on Institutions Starting with Recent Appointment of Board Member
Zhenya Lindgardt as Interim President and CEO
Engages Leading Strategy House to Evaluate Best Pathways
Toward Targeting Enhanced Revenue Generation at Significantly
Reduced Operating Costs
Nadia Altomare Expected to Move from Chief Commercial Officer
to Consulting Role to Support Driving Efficiency and Effectiveness
in Our Commercial Spend in Partnership with Our External and
Internal Team
SALT
LAKE CITY, May 25, 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 certain commercial changes and plans to optimize
its strategy and commercial structure to highly focus business
activities on accelerating test adoption and revenue at
significantly reduced operating costs.
These plans include changes to better align leadership with a
new refined commercial focus on institutions and cost-effectively
accelerating test adoption and revenue in advance of upcoming data
readouts. This process started with the recent appointment of Board
Member Zhenya Lindgardt, a seasoned business operator for
high-growth organizations, as interim President and CEO, announced
on May 15, 2023.
Sera Prognostics has also engaged a leading strategy house to
rigorously evaluate the best pathways toward enhanced revenue at
significantly reduced cost to more broadly commercialize the
company's PreTRM® Test and pipeline of technology. This
evaluation is expected to be inclusive of efficient market focus
and potential strategic partnerships. As part of this process,
Nadia Altomare is expected to move
from Chief Commercial Officer to a consulting role to support
driving efficiency and effectiveness in our commercial spend in
partnership with our external and internal team.
The Company has also made select headcount reductions at month
end in its commercial organization to better map current commercial
and marketing costs toward refined focus on those opportunities
being deemed as the most lucrative in the near-term from a test
adoption and revenue generation perspective. Sera Prognostics is
evaluating other ways to further optimize its business while
reducing operating costs and protecting its strong balance sheet,
which currently affords a strong foundation toward realization of
the Company's goals outlined today coupled with targeting improved
shareholder valuation.
"We are taking decisive and well-defined steps to optimize for
market success given the macro environment, while also taking into
consideration the emerging role we seek to play in establishing our
first-of-its-kind PreTRM test as a standard of care in protecting
mothers and babies," said Sera Prognostics interim CEO,
Zhenya Lindgardt. "While change is
at times challenging, we anticipate our actions will prove
successful in supporting our goal to be The Pregnancy Company while
fostering significant growth, and we are thankful for our team's
role in creating a paradigm shift in pregnancy care to create
better healthcare outcomes for expectant mothers and their
children."
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 accelerating test adoption
and revenue; targeting enhanced revenue generation at significantly
reduced operating costs; driving efficiency and effectiveness in
our commercial spend; upcoming data readouts; potential strategic
partnerships; further optimizing the Company's business; improved
shareholder valuation; establishing the Company's first-of-its-kind
PreTRM test as a standard of care; fostering significant 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.
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SOURCE Sera Prognostics, Inc.