FALSE000153496900015349692023-11-082023-11-08

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 8, 2023
SERA PROGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware001-4060626-1911522
(State or other jurisdiction
of incorporation)		(Commission File Number)(IRS Employer
Identification No.)
2749 East Parleys Way, Suite 200
Salt Lake City, Utah
84109
(Address of principal executive offices)(zip code)
Registrant’s telephone number, including area code: (801) 990-0520
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading
Symbol(s)		Name of each exchange
on which registered
Class A Common Stock, $0.0001 par value per shareSERA
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging Growth Company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o


Item 2.02    Results of Operations and Financial Condition.
On November 8, 2023, Sera Prognostics, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2023 and providing business highlights.  The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01    Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
99.1
104Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SERA PROGNOSTICS, INC.
By:/s/ Austin Aerts
Austin Aerts
Chief Financial Officer
Date: November 8, 2023

Exhibit 99.1
image_0.jpg

SERA PROGNOSTICS REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS
Salt Lake City – November 8, 2023 – 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.

image_0.jpg        

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.

image_0.jpg        

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

image_0.jpg        

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.

Contacts
Investor Contact
Peter DeNardo, CapComm Partners
peter@capcommpartners.com
+1 (415) 389-6400
Media Contact
Glenn Silver, Lazar FINN
Glenn.silver@finnpartners.com
+1 (646) 871-8485


image_0.jpg        

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,
2023202220232022
Revenue$42 $87 $265 $203 
Operating expenses:
Cost of revenue44 58 186 134 
Research and development3,539 4,176 11,330 10,759 
Selling and marketing1,355 2,967 7,045 11,644 
General and administrative3,288 4,074 12,677 12,900 
Total operating expenses8,226 11,275 31,238 35,437 
Loss from operations(8,184)(11,188)(30,973)(35,234)
Interest expense(14)(21)(44)(43)
Other income, net988 497 2,700 837 
Net loss$(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 diluted31,286,148 31,005,978 31,128,604 30,918,473 



image_0.jpg        

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 securities36,461 52,826 
Accounts receivable155 113 
Other receivables— 6,000 
Prepaid expenses and other current assets1,275 1,308 
Total current assets47,546 90,125 
Property and equipment, net2,197 3,059 
Long-term marketable securities38,922 21,329 
Other assets1,392 1,816 
Total assets$90,057 $116,329 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable$1,177 $1,548 
Accrued and other current liabilities2,891 4,444 
Finance lease obligation, current portion438 464 
Deferred revenue9,039 9,082 
Total current liabilities13,545 15,538 
Finance lease obligation, net of current portion309 626 
Operating lease obligation, net of current portion792 1,222 
Total liabilities14,646 17,386 
Commitments and contingencies
Stockholders' equity:
Common stock, Class A and Class B3 3 
Additional paid-in capital314,993 310,575 
Accumulated other comprehensive loss(614)(981)
Accumulated deficit(238,971)(210,654)
Total stockholders' equity75,411 98,943 
Total liabilities and stockholders' equity$90,057 $116,329 

v3.23.3
Cover
Nov. 08, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 08, 2023
Entity Registrant Name SERA PROGNOSTICS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-40606
Entity Tax Identification Number 26-1911522
Entity Address, Address Line One 2749 East Parleys Way
Entity Address, Address Line Two Suite 200
Entity Address, City or Town Salt Lake City
Entity Address, State or Province UT
Entity Address, Postal Zip Code 84109
City Area Code 801
Local Phone Number 990-0520
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Entity Ex Transition Period false
Title of 12(b) Security Class A Common Stock, $0.0001 par value per share
Trading Symbol SERA
Security Exchange Name NASDAQ
Amendment Flag false
Entity Central Index Key 0001534969
Sera Prognostics (NASDAQ:SERA)
Historical Stock Chart
Von Apr 2024 bis Mai 2024 Click Here for more Sera Prognostics Charts.
Sera Prognostics (NASDAQ:SERA)
Historical Stock Chart
Von Mai 2023 bis Mai 2024 Click Here for more Sera Prognostics Charts.