8-K
SERA PROGNOSTICS, INC. (SERA)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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 06, 2024 |
|---|
Sera Prognostics, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-40606 | 26-1911522 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 2749 East Parleys Way<br><br>Suite 200 | ||
| Salt Lake City, Utah | 84109 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: (801) 990-0520 | ||
| --- |
(Former Name or Former Address, if Changed Since Last Report)
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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐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 class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Class A Common Stock, $0.0001 par value per share | SERA | 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 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 6, 2024, Sera Prognostics, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2024 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 registration statement or other document pursuant to the Securities Act of 1933, as amended, or into any filing or other document pursuant to the Exchange Act, except to the extent required by applicable law or regulation or as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release dated November 6, 2024. |
| 104 | Cover 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 hereunto duly authorized.
| SERA PROGNOSTICS, INC. | |||
|---|---|---|---|
| Date: | November 6, 2024 | By: | /s/ Austin Aerts |
| Austin Aerts<br>Chief Financial Officer |
EX-99.1
Exhibit 99.1
SERA PROGNOSTICS REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
Salt Lake City – November 6, 2024 – 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 2024 ended September 30, 2024.
Recent Highlights:
- Data analysis for full Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study underway after database was locked in September and now seeking publication of results in connection with key pregnancy and maternal health conferences in early 2025 and manuscript submission to a quality peer-reviewed journal.
- Awareness campaign activated with TV programs by Viewpoint with Dennis Quaid and Empowered with Meg Ryan. These programs are expected to be distributed to public television stations in all 50 states, and in over 84 million homes via MSNBC, CNBC, CNN or similar networks broadly supporting Sera’s goal of informing the public about our test-and-treat offering and how it can support improved pregnancy outcomes.
- Beginning October 1, 2024, and as featured in a Time Magazine article, began enabling access to PreTRM® testing through the Company’s website, with home sample collection. The expectant mother then will receive the results for discussion with her physician. This new capability is expected to drive consumer-initiated sales supported by the awareness campaign.
- To provide education, build relationships with pregnant women and support Sera’s product offerings, predictive analytics offering is now in beta testing, engaging women with informative reports based on the data from millions of pregnancy experiences, and personalized insights into pregnancies like theirs.
- Strengthened commercial team with select key hires in sales and marketing to drive test adoption and sales.
- Transition to ambient whole blood collection continues to yield improved physician and patient access to PreTRM, significantly lower cost of goods, and significantly increased lab capacity, to enhance scalability of the test and improve unit economics in anticipation of a commercial inflection point in Sera’s business.
“We are successfully putting in place the key prerequisites for commercial success in anticipation of our full PRIME study results achieving publication and further illustrating the benefits of our PreTRM capabilities and test-and-treat strategy,” said Zhenya Lindgardt, President and CEO of
Sera Prognostics. “Once expanded awareness and care guidelines have occurred, our multi-pronged approach to the maternal care market we serve is expected to create a sales inflection in our business coupled with more profitable margin and revenue growth as we showcase our unique platform as The Pregnancy Company.”
Third Quarter 2024 Financial Results
Third quarter 2024 revenue was $29,000 compared to $42,000 for the same period of 2023. Total operating expenses were $8.9 million, up 8% from $8.2 million for the third quarter of 2023 as Sera maintained tight controls on expenses other than those necessary for product development and anticipated future sales generation.
Research and development expenses for the third quarter of 2024 were $3.5 million, and approximately flat with the third quarter of 2023.
Selling, general and administrative expenses for the third quarter of 2024 were $5.4 million, up from $4.6 million for the third quarter of 2023 due primarily to the Company selectively investing in anticipated growth drivers.
Net loss for the quarter was $7.9 million compared to $7.2 million for the prior-year period.
Conference Call Information
Sera Prognostics will host a corresponding conference call and live webcast today to discuss third 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/L6rDpZAVdM8
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 publication of results in connection with key pregnancy and maternal health conferences in early 2025 and manuscript submission to a quality peer-reviewed journal; distribution of Sera-sponsored TV programs to public television stations in all 50 states, and in over 84 million homes via MSNBC, CNBC, CNN or similar networks; the new consumer-initiated testing channel driving sales supported by the awareness campaign; a strengthened commercial team with select key hires in sales and marketing driving test adoption and sales; the transition to ambient whole blood collection yielding improved physician and patient access to PreTRM, significantly lower cost of goods, and significantly increased lab capacity, enhanced scalability of the test and improved unit economics; the full PRIME study results achieving publication and further illustrating the benefits
of our PreTRM capabilities and test-and-treat strategy; a sales inflection in the Company’s business coupled with more profitable margin and revenue 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.
Contact
Investor Contact
Peter DeNardo, CapComm Partners
peter@capcommpartners.com
+1 (415) 389-6400
SERA PROGNOSTICS, INC.
Condensed Statements of Operations
(unaudited)
(in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue | $ | 29 | $ | 42 | $ | 53 | $ | 265 | ||||
| Operating expenses: | ||||||||||||
| Cost of revenue | 13 | 44 | 50 | 186 | ||||||||
| Research and development | 3,502 | 3,539 | 11,591 | 11,330 | ||||||||
| Selling and marketing | 1,181 | 1,355 | 3,507 | 7,045 | ||||||||
| General and administrative | 4,195 | 3,288 | 12,117 | 12,677 | ||||||||
| Total operating expenses | 8,891 | 8,226 | 27,265 | 31,238 | ||||||||
| Loss from operations | (8,862 | ) | (8,184 | ) | (27,212 | ) | (30,973 | ) | ||||
| Interest expense | (5 | ) | (14 | ) | (22 | ) | (44 | ) | ||||
| Other income, net | 948 | 988 | 2,915 | 2,700 | ||||||||
| Net loss | $ | (7,919 | ) | $ | (7,210 | ) | $ | (24,319 | ) | $ | (28,317 | ) |
| Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.23 | ) | $ | (0.74 | ) | $ | (0.91 | ) |
| Weighted-average shares outstanding, basic and diluted | 33,522,726 | 31,286,148 | 32,894,191 | 31,128,604 |
SERA PROGNOSTICS, INC.
Condensed Balance Sheets
(unaudited)
(in thousands)
| September 30, | December 31, | |||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 2,684 | $ | 3,880 | ||
| Marketable securities | 47,068 | 45,199 | ||||
| Accounts receivable | 79 | 160 | ||||
| Other receivables | – | 11,310 | ||||
| Prepaid expenses and other current assets | 1,276 | 795 | ||||
| Total current assets | 51,107 | 61,344 | ||||
| Property and equipment, net | 1,428 | 1,999 | ||||
| Long-term marketable securities | 24,591 | 30,841 | ||||
| Other assets | 1,875 | 1,257 | ||||
| Total assets | $ | 79,001 | $ | 95,441 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,378 | $ | 1,046 | ||
| Accrued and other current liabilities | 2,273 | 2,722 | ||||
| Finance lease obligation, current portion | 305 | 440 | ||||
| Deferred revenue | 20,226 | 20,235 | ||||
| Total current liabilities | 24,182 | 24,443 | ||||
| Finance lease obligation, net of current portion | 3 | 196 | ||||
| Operating lease obligation, net of current portion | 165 | 644 | ||||
| Total liabilities | 24,350 | 25,283 | ||||
| Commitments and contingencies | ||||||
| Stockholders’ equity: | ||||||
| Common stock, Class A and Class B | 3 | 3 | ||||
| Additional paid-in capital | 325,571 | 317,066 | ||||
| Accumulated other comprehensive income (loss) | 292 | (15 | ) | |||
| Accumulated deficit | (271,215 | ) | (246,896 | ) | ||
| Total stockholders' equity | 54,651 | 70,158 | ||||
| Total liabilities and stockholders' equity | $ | 79,001 | $ | 95,441 |