FALSE000153496900015349692023-08-092023-08-09

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): August 9, 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 WaySuite 200
Salt Lake CityUtah
84109
(Address of principal executive offices)(zip code)
Registrant’s telephone number, including area code: (801990-0520
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 August 9, 2023, Sera Prognostics, Inc. issued a press release announcing its financial results for the second quarter ended June 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
Interim Chief Financial Officer
Date: August 9, 2023

Exhibit 99.1
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SERA PROGNOSTICS REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS
Salt Lake City – August 9, 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 second quarter of 2023 ended June 30, 2023.
Recent Highlights:
Announced leadership changes and commercial actions in May 2023 to optimize business for market success toward accelerating test adoption and revenue including aligning management team for new refined commercial focus on institutions.
Appointed board member Zhenya Lindgardt as interim President and CEO, and Austin Aerts as interim CFO.
Engaged leading strategy house to rigorously evaluate best pathways toward enhanced revenue at significant reduced cost to more broadly commercialize Sera’s PreTRM® Test and pipeline of technology.
Executed select headcount reductions in commercial organization to better map current commercial costs in line with refined focus.
Over the last few weeks Sera has submitted new compelling data for scientific review anticipating several publications in the coming months.
“While we still have work to do, we are putting together the necessary structure and strategy to succeed commercially,” said Zhenya Lindgardt, interim President and CEO of Sera Prognostics. “Consistent with our vision to be The Pregnancy Company®, we are pursuing a disciplined commercial approach to broaden adoption of our PreTRM® Test and at the same time evaluating ways to leverage our large and growing pregnancy datasets to boost shareholder value through new products and partnerships. We believe this long-term vision will solidify our role as a leader in health diagnostics to improve the lives of women and babies through prenatal care.”
Second Quarter 2023 Financial Results
Second quarter 2023 revenue of $123,000 compared to $78,000 for the same period of 2022.
Total operating expenses were $11.6 million, down from $11.8 million for the second quarter of 2022.


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Research and development expenses for the second quarter of 2023 were $3.7 million compared to $3.3 million for the second quarter of 2022 due primarily to increased clinical study costs.
Selling, general and administrative expenses for the second quarter of 2023 were $7.8 million, down significantly from $8.5 million for the second 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 second quarter of 2023 was $10.5 million compared to $11.5 million for the same quarter a year ago.
As of June 30, 2023, the Company had cash, cash equivalents, and available-for-sale securities of approximately $92.1 million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and live webcast today to discuss second 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/5ZK3j2xMqY7
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.


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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 optimizing business for market success toward accelerating test adoption and revenue; enhanced revenue at significant reduced cost; more broadly commercializing Sera’s PreTRM® Test and pipeline of technology; putting together the necessary structure and strategy to succeed commercially; broadening adoption of the PreTRM® Test; leveraging the Company’s large and growing pregnancy datasets; boosting shareholder value; new products and partnerships; solidifying the Company’s role as a leader in health diagnostics; 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


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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.

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



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SERA PROGNOSTICS, INC.
Condensed Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2023202220232022
Revenue
$    123$    78$    223$    116
Operating expenses:
Cost of revenue
805614276
Research and development
3,6883,2617,7916,583
Selling and marketing
2,8724,2195,6908,677
General and administrative
4,9434,2889,3898,826
Total operating expenses
11,58311,82423,01224,162
Loss from operations
(11,460)(11,746)(22,789)(24,046)
Interest expense
(14)(18)(30)(22)
Other income, net
9322441,712340
Net loss
$    (10,542)$    (11,520)$    (21,107)$    (23,728)
Net loss per share, basic and diluted
$    (0.34)$    (0.37)$    (0.68)$    (0.77)
Weighted-average shares outstanding, basic and diluted
31,077,42030,945,61631,048,52630,873,995




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SERA PROGNOSTICS, INC.
Condensed Balance Sheets
(unaudited)
(in thousands)
June 30,
2023
December 31,
2022
Assets
Current assets:
Cash and cash equivalents$    32,285$    29,878
Marketable securities31,53652,826
Accounts receivable163113
Other receivables6,000
Prepaid expenses and other current assets4441,308
Total current assets64,42890,125
Property and equipment, net2,4113,059
Long-term marketable securities28,30721,329
Other assets1,5341,816
Total assets$    96,680$    116,329
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable$    1,244$    1,548
Accrued and other current liabilities3,4444,444
Finance lease obligation, current portion446464
Deferred revenue9,0499,082
Total current liabilities14,18315,538
Finance lease obligation, net of current portion422626
Operating lease obligation, net of current portion9381,222
Total liabilities15,54317,386
Commitments and contingencies
Stockholders' equity:
Common stock, Class A and Class B
33
Additional paid-in capital313,567310,575
Accumulated other comprehensive loss(672)(981)
Accumulated deficit(231,761)(210,654)
Total stockholders' equity81,13798,943
Total liabilities and stockholders' equity$    96,680$    116,329


v3.23.2
Cover
Aug. 09, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Aug. 09, 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

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