8-K
SERA PROGNOSTICS, INC. (SERA)
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): March 20, 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, Suite 200<br>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 class | Trading<br>Symbol(s) | Name of each exchange<br>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 (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 March 20, 2024, Sera Prognostics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 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.
Item 7.01. Regulation FD Disclosure.
On March 20, 2024, the Company posted a new investor presentation to its corporate website. A copy of the investor presentation is furnished as Exhibit 99.2 hereto and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release dated March 20, 2024. |
| 99.2 | Investor presentation posted on March 20, 2024. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
The information contained in Item 2.02 and Item 7.01, including Exhibit 99.1 and Exhibit 99.2 furnished herewith, 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 under 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.
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: March 20, 2024
Document
Exhibit 99.1
SERA PROGNOSTICS REPORTS FOURTH QUARTER 2023 FINANCIAL RESULTS
Salt Lake City – March 20, 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 fourth quarter and full year ended December 31, 2023.
Recent Highlights:
•Announced that the Data Safety Monitoring Board (DSMB) overseeing Sera’s pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. In final stages of preparing manuscript submission to premier medical publications.
•Working diligently with guideline groups to develop appropriate implementation plans while working toward publication of the PRIME study results.
•Made continued progress in development of product pipeline and PreTRM® sample collection and assay enhancements, which will provide simpler, cheaper collection methods and more efficient lab processing, with validations nearly complete and plans to launch in the coming months across certain initial geographies.
•Engaged in focused commercial activities ahead of PRIME data to build toward greater PreTRM® test adoption expectations in 2024-2025.
•Started new initiatives to build awareness with expectant mothers and develop patient-facing products and a predictive analytics tool that can establish direct relationships with women and expand and diversify revenue opportunities.
“We are looking forward to an exciting year of developments for Sera, including publication of our PRIME study results while executing on commercial expansion and our plans to establish direct relationships with expectant mothers,” said Zhenya Lindgardt, President and CEO of Sera Prognostics. “We expect these activities and advancements in our product pipeline to complement what we believe is our leading position in the area of maternal and neonatal health and pave the way for a future inflection in revenue growth.”
Fourth Quarter 2023 Financial Results
Fourth quarter 2023 revenue of $41,000 compared to $65,000 for the same period of 2022.
Total operating expenses were $8.9 million, down significantly from $10.5 million for the fourth quarter of 2022.
Research and development expenses for the fourth quarter of 2023 were $3.9 million compared to $3.5 million for the fourth quarter of 2022 due primarily to higher clinical study costs.
Selling, general and administrative expenses for the fourth quarter of 2023 were $5.0 million, down significantly from $6.9 million for the fourth quarter of 2022 due primarily to steps to streamline commercial operations, better focus our commercial strategy and reduce overall operating expenses.
Net loss for the fourth quarter of 2023 was $7.9 million compared to $9.7 million for the same quarter a year ago.
Full Year 2023 Financial Results
Total full year 2023 revenue of $306,000 compared to $268,000 for the same period of 2022.
Total operating expenses were $40.1 million, down from $45.9 million for 2022.
Research and development expenses for 2023 were $15.2 million compared to $14.2 million for the prior year due primarily to higher clinical study costs.
Selling, general and administrative expenses for 2023 were $24.7 million, down significantly from $31.5 million for 2022 due primarily to steps to streamline commercial operations, better focus our commercial strategy and reduce overall operating expenses.
Net loss for 2023 was $36.2 million compared to $44.2 million for 2022.
As of December 31, 2023, the Company had cash, cash equivalents, and available-for-sale securities of approximately $79.9 million.
Conference Call Information
Sera Prognostics will host a corresponding conference call and live webcast today to discuss fourth quarter and full year 2023 operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. The Company notes that, although this will not be referred to in the prepared remarks during the call, it has posted an updated slide presentation to the investor relations page of its website at www.seraprognostics.com. 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/Za419djMmLE
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 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 Company being in the final stages of preparing a PRIME manuscript submission to premier medical publications; the Company working with guideline groups to develop appropriate implementation plans; sample collection and assay enhancements providing simpler, cheaper collection methods and more efficient lab processing, with validations nearly complete and plans to launch in the coming months; building toward greater PreTRM® test adoption expectations in 2024-2025; building awareness with expectant mothers and developing patient-facing products and a predictive analytics tool that can establish direct relationships with women and expand and diversify revenue opportunities; publication of our PRIME study results in 2024; commercial expansion; a future inflection in 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<br>December 31, | Year Ended<br>December 31, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| Revenue | $ | 41 | $ | 65 | $ | 306 | $ | 268 |
| Operating expenses: | ||||||||
| Cost of revenue | 24 | 59 | 210 | 193 | ||||
| Research and development | 3,895 | 3,485 | 15,225 | 14,244 | ||||
| Selling and marketing | 1,304 | 3,055 | 8,349 | 14,699 | ||||
| General and administrative | 3,666 | 3,884 | 16,343 | 16,784 | ||||
| Total operating expenses | 8,889 | 10,483 | 40,127 | 45,920 | ||||
| Loss from operations | (8,848) | (10,418) | (39,821) | (45,652) | ||||
| Interest expense | (11) | (18) | (55) | (61) | ||||
| Other income, net | 934 | 690 | 3,634 | 1,527 | ||||
| Net loss | $ | (7,925) | $ | (9,746) | $ | (36,242) | $ | (44,186) |
| Net loss per share, basic and diluted | $ | (0.25) | $ | (0.31) | $ | (1.16) | $ | (1.43) |
| Weighted-average shares of common stock outstanding, basic and diluted | 31,414,446 | 31,017,472 | 31,200,652 | 30,943,426 |
SERA PROGNOSTICS, INC.
Condensed Balance Sheets
(unaudited)
(in thousands)
| December 31, | ||||
|---|---|---|---|---|
| 2023 | 2022 | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 3,880 | $ | 29,878 |
| Marketable securities | 45,199 | 52,826 | ||
| Accounts receivable | 160 | 113 | ||
| Other receivables | 11,310 | 6,000 | ||
| Prepaid expenses and other current assets | 795 | 1,308 | ||
| Total current assets | 61,344 | 90,125 | ||
| Property and equipment, net | 1,999 | 3,059 | ||
| Long-term marketable securities | 30,841 | 21,329 | ||
| Other assets | 1,257 | 1,816 | ||
| Total assets | $ | 95,441 | $ | 116,329 |
| Liabilities and Stockholders' Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 1,046 | $ | 1,548 |
| Accrued and other current liabilities | 2,722 | 4,444 | ||
| Finance lease obligation, current portion | 440 | 464 | ||
| Deferred revenue | 20,235 | 9,082 | ||
| Total current liabilities | 24,443 | 15,538 | ||
| Finance lease obligation, net of current portion | 196 | 626 | ||
| Operating lease obligation, net of current portion | 644 | 1,222 | ||
| Total liabilities | 25,283 | 17,386 | ||
| Commitments and contingencies | ||||
| Stockholders' equity: | ||||
| Common stock, Class A and Class B | 3 | 3 | ||
| Additional paid-in capital | 317,066 | 310,575 | ||
| Accumulated other comprehensive loss | (15) | (981) | ||
| Accumulated deficit | (246,896) | (210,654) | ||
| Total stockholders' equity | 70,158 | 98,943 | ||
| Total liabilities and stockholders' equity | $ | 95,441 | $ | 116,329 |
sera-20240320x8kxexhibit
WE AIM to change pregnancy care, to transform the experience into one with fewer uncertainties.
Safe Harbor Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The company has no obligation to provide any updates to these forward-looking statements, even if its expectations change, whether as a result of new information, future events or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company’s Registration Statement on Form S-1, most recent Annual Report on Form 10-K, and/or subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the company’s other filings with the SEC. The information in this presentation should be considered in conjunction with a review of the company’s filings with the SEC including the information in the company’s Registration Statement on Form S-1, most recent Annual Report on Form 10-K, and/or subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIALCONDITION AND RESULTS OF OPERATIONS.
In the U.S., maternal and neonatal mortality rates are increasing, signaling a need for improved healthcare and innovation. One-third of pregnant women experience complications, often without warning, posing significant health risks for both mother and child.
Vision Mission Sera Prognostics aims to be a global leader in high- value women’s health diagnostics, delivering pivotal information to physicians and mothers to improve the health of pregnant women and newborns, and to simultaneously improve the economics of pregnancy care. Pregnancy complications occur frequently, often without warning. In the U.S., this is the reality for one-third of pregnancies. Sera Prognostics is transforming the pregnancy journey with innovative products aimed at identifying complications early and accurately. We provide personalized insights into the risk of preterm birth and other pregnancy complications, empowering all pregnant women and their caregivers with innovative products aimed at delivering better outcomes for mothers and babies.
The Pregnancy Company® SPECIALTY LAB INNOVATIVE TESTS & PRODUCTS PREGNANCY OUTCOMES EMPOWERMENT RESEARCH- DRIVEN GLOBAL IMPACT Focuses on obstetric test offerings and analytics products Provides information to healthcare providers to guide personalized interventions Committed to driving advancements in maternal-fetal medicine through rigorous research and clinical trials Works towards shaping the future of pregnancy care worldwide Aims to empower expectant mothers with actionable insights Utilizes cutting-edge technologies such as proteomics and AI
SOCIETAL IMPACT Focusing on neonatal and maternal outcomes can yield numerous benefits for all members of society Families: Decrease the burden linked to pregnancy complications Payers: Improve outcomes and the economics of care delivery Communities: Address growing health disparities in maternal care Healthcare Providers: Provide tools to address unmet needs in pregnancy care Self-insured Employers: Enhance employer healthcare for employees and their families Policy: Support government programs targeting improvements in maternal healthcare
Improved pregnancy outcomes start with better information Utilize proteomic testing early in the pregnancy to identify high-risk pregnancies Target individuals identified as high-risk for tailored preventive treatments Achieve healthier outcomes by reducing morbidity, mortality, and hospitalization time for newborns 1st Trimester 2nd Trimester 3rd Trimester Postpartum E N H A N C E D S C R E E N I N G P E R S O N A L I Z E D M E D I C I N E I M P R O V E D O U T C O M E S
Given the limitations of current screening practices for pregnancy complications, scientists at Sera discovered a biomarker prediction that fills a critical diagnostic gap. Why Proteomics? Personalized insights for each pregnancy. Proteomics provide insights into the biology of each pregnancy and go beyond genetic inheritance. Early detection and intervention. Proteins reflect the functions of specific cells allowing for early detection and intervention before symptoms arise. Answers provided by proteomics.
Sera’s proprietary data assets and technology platform generate powerful insights Biobank of Blood Samples Clinical Outcomes Data Demographic & Geographic Diversity Advanced Mass Spectrometry Artificial Intelligence & Machine Learning Global Dataset 20,000 pregnant women Multiple clinical utility studies Broad sample collection across U.S. population North America, Europe, Asia and Africa 300+ proteins analyzed Discovering important predictors POWERFUL INSIGHTS: • Early risk prediction such as preterm birth or preeclampsia, before symptoms manifest. • Improving health outcomes by identifying high-risk individuals and implementing targeted interventions • Shared decision-making by empowering patients to make informed decisions regarding prenatal care • Reduced healthcare costs through improvements in the health of the baby and reducing the need for the NICU • Research advancements to help understanding the biology of pregnancy
Sera’s technology platform transforms national averages into personalized insights The national risk of a complicated pregnancy is 31%. The probability of pregnancy complications range from 10 - 90%. Utilizing proteomic markers and data analytics, Sera can identify a mother’s pregnancy journey inclusive of her complication risk within a 4% margin. 31% 10% 90%to +/-4%
NEAR TERM EXECUTION Accelerate PreTRM Adoption & Revenue
Addressing the Problem of Preterm Birth References: 1. Osterman MJK, Hamilton BE, Martin, J.A., Driscoll AKV, C.P. Births: Final Data for 2020. Division of Vital Statistics, National Center for Health Statistics, U.S. Centers for Disease Control and Prevention. 2022 Feb 7 (https://www.cdc.gov/nchs/nvss/births.html. 2. Callaghan WM, et al. The contribution of preterm birth to infant mortality rates in the United States. Pediatrics. 2006 Oct;118(4):1566-73. 3. Howson CP, et al. Born Too Soon: Preterm birth matters. Reprod Health 10, S1 (2013). 4. Crump C, et al. Prevalence of Survival Without Major Comorbidities Among Adults Born Prematurely. JAMA. 2019 Oct 22;322(16):1580-1588. 1 10in babies are born too soon1 Preterm birth contributes to 34.2% of newborn deaths2 Causes numerous medical issues requiring more hospital time and pediatric visits3,4
Reducing the health impacts of an early delivery with the PreTRM® Test Challenges facing risk assessment for preterm birth Knowing the Risk Enables Informed Action Reduce the impacts of preterm birth Up to half of all pregnant women who deliver prematurely have no known risk factors1,2 PreTRM’s sensitivity of 88% allows healthcare providers to detect higher-risk patients who would have been missed with current screening tools3 Recent studies demonstrated an 18% reduction in severe neonatal morbidity and mortality when higher-risk pregnancies identified by the PreTRM Test received risk- reduction interventions compared to standard care4 1. Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm Birth: Causes, Consequences, and Prevention. Behrman RE, Butler AS, eds. Washington (DC): National Academies Press (US) 2. Iams JD, et al. Prevention of Preterm Parturition N Engl J Med 2014;370:254-61. DOI: 10.1056/NEJMcp1103640 3. Burchard, J., et al. Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating. J. Clin. Med. 2022, 11, 2885. https:// doi.org/10.3390/jcm11102885 4. Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker-guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503
A strong foundation of evidence C L I N I C A L S T U D I E S A N A L Y T I C A L V A L I D A T I O N C L I N I C A L V A L I D A T I O N C L I N I C A L U T I L I T Y E C O N O M I C U T I L I T Y CLINICAL MASS SPECTROMETRY / Bradford et al., 2017 • Achieved robust analytical validation of protein biomarkers for risk of spontaneous preterm birth PAPR / Saade et al., 2016 • AJOG editor’s choice establishing PreTRM® analytical validation ACCORDANT THRESHOLD / Burchard et al., 2021 AJP REPORTS / Caughey et al., 2016 • Empirical data demonstrating the clinical and cost impact of prognostic test for early detection of preterm birth • Validated PreTRM threshold for clinical decision-making for risk of spontaneous preterm birth (sPTB) and adverse maternal and neonatal outcomes in cohorts with diverse racial and ethnic backgrounds
Building on the foundation with new clinical utility evidence C L I N I C A L S T U D I E S A N A L Y T I C A L V A L I D A T I O N C L I N I C A L V A L I D A T I O N C L I N I C A L U T I L I T Y E C O N O M I C U T I L I T Y AVERT / Hoffman et al., 2023 PRIME / Iriye et al., ongoing Further investigates the value of implementing the PreTRM® test-and-treat strategy to reduce both adverse singleton pregnancy outcomes and overall healthcare costs PreTRM® test-and-treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length-of-stay PREDICTION AND PREVENTION OF PTB / Combs et al., 2023 Study concludes that screening with the PreTRM® Test followed by care management intervention and LDA prolonged pregnancy and reduced adverse outcomes ACCORDANT CU (TREETOP) / Burchard et al., 2022 Combines real-world observational data with simulation to project significant potential improvements in neonatal outcomes among racially and ethnically diverse populations PREVENT / Branch et al., 2021 Study demonstrates positive impact of the company’s PreTRM® test-and-treat strategy on improving neonatal healthcare COST-EFFECTIVENESS OF A PROTEOMIC TEST FOR PRETERM BIRTH PREDICTION / Grabner et al., 2021 Showed both improved neonatal outcomes and reduced immediate and long-term treatment costs associated with premature birth, when compared to routine care
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker-guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 The AVERT PRETERM Trial studied the health impacts of the PreTRM® test-and-treat Strategy • The study took place from June 2018 - September 2020 at ChristianaCare Hospital (Newark, DE) • The proportion of Black women in both arms was 26.5%, reflecting the racial diversity in the study site’s patient population Neonatal outcomes after proteomic biomarker guided intervention: the AVERT PRETERM TRIAL Study Design Historically Controlled Care management Daily open label vaginal progesterone 200mg Daily aspirin 81mg Screened with the PreTRM® Test Historical Controls Low Risk High Risk Treated with Interventions N=286 Normal Care N=953 Historical Controls N=10,000
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 Reduce the time the baby spends in the hospital on average by one week 7 Day Reduction in neonatal hospital length of stay AVERT Study Results
Severe morbidity and mortality rates were significantly reduced • 1-4 score given (4 = infant mortality) • The score increases by 1 point for each additional diagnosis of: • Respiratory distress syndrome • Bronchopulmonary dysplasia • Intraventricular hemorrhage grade III or IV • All stages of necrotizing enterocolitis • Periventricular leukomalacia • Proven severe sepsis • The scale uses NICU stays to determine index scores if the length of stay gives a higher score than concomitant diagnoses: 1-4 days give a score of 1, 5-20 days a score of 2 and >20 days a score of 3.1 *Severe neonatal morbidity and mortality are defined as Neonatal Composite Morbidity & Mortality Index (NMI) ≥3 Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 NMI scores were significantly reduced in the prospective arm vs the historical arm (OR 0.81; 95% CI 0.67-0.98; P=0.03) 18% reduction in severe neonatal morbidity and mortality* (probability of NMI ≥ 3) 18% REDUCTION AVERT Study Results
Historical Arm (Standard of Care) N=155 Prospective (Test and Treat) N=15 Gestational Age at Birth <32 Weeks Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 Increase gestational age at birth to improve outcomes for those at risk of earliest delivery 2.48 Weeks Increased Gestational Age at Birth on Average by 27.46 (weeks) 29.93 (weeks) Mean Gestational Age at Birth (weeks) AVERT Study Results
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 Reduce the time the neonate spends in the hospital on average by one month for those at risk of earliest delivery 28 Day Reduction in neonatal length of hospital stay for patients born before 32 weeks’ gestation Neonatal length of hospital stay (days) for babies born <32 weeks’ gestation P ro p o rt io n o f N e o n a te s R e m a in in g i n t h e H o s p it a l Neonatal Hospital Length of Stay (days) Cox PH P = 0.046 AVERT Study Results
Advancing PreTRM®’s Evidence Development for Enhanced Pregnancy Outcomes PRIME Study & Real-World Evidence Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME) A pioneering clinical trial assessing the efficacy of the PreTRM Test and preventive interventions in lowering the occurrence of adverse pregnancy outcomes. Achievement of a primary endpoint resulted in the early termination of the study.
Published Elevance Cost-Effectiveness Model Elevance Claims Data Results Analysis of >40,000 mothers and babies within commercially insured Elevance membership • Evaluated screening with PreTRM along with proactive interventions given to PreTRM-higher risk patients vs. standard care • Demonstrated robust clinical and economic impacts of the PreTRM test-and-treat strategy • 20% reduction in preterm birth rates • $1,608 gross savings, excluding a $745 PreTRM list price per pregnant woman (amortized over all pregnancies including non-tested) • 10% reduction in neonatal intensive care admissions • 7% reduction in overall hospital length-of-stay • 33% reduction in births <32 weeks • The test-and-treat strategy is dominant with respect to cost savings across all conservative probabilistic sensitivity analyses and scenarios Economic Utility Study
Pregnancy Product Road Map
More than just the PreTRM® Test 2023 | 2024 | 2025 | 2026 | 2027 Commercially Available Estimated Product Launch P R E T R M T E S T P R E D I C T I V E A N A L Y T I C S P R O D U C T T I M E - T O - B I R T H T E S T P R E G N A N C Y R I S K P R E D I C T I O N P A N E L
Developing a portfolio to provide better answers to life changing questions To provide a woman and her physician a risk assessment for spontaneous preterm birth To show a woman the most common outcomes in pregnancies of other women with similar clinical and demographic characteristics To provide a more accurate estimate of when a mother’s baby will be delivered for the purposes of planning maternity leave, travel, visitors, etc. This is a lifestyle and wellness test rather than a clinical test. To provide a woman and her physician a risk assessment for multiple pregnancy complications assessing both High Risk (rule-in) and Low Risk (rule-out) results in a single test PreTRM® Test Predictive Analytics Product Time-to-Birth Test Pregnancy Risk Prediction Panel Test Am I at risk for a premature birth? What do pregnancies like mine look like? When will my baby be born? Am I at risk for the common pregnancy complications?
Robust Biomarker Pregnancy Pipeline PREDICTOR Est. U.S. Prevalence in Pregnancy PreTRM® Test for Risk of Preterm Birth Time-to-Birth Pregnancy Risk Prediction Panel Preeclampsia Predictive Analytics Product Fetal Growth Restriction (FGR) 10% 31% 5-8% N/A 3-7% DISCOVERY VERIFICATION VALIDATION COMMERCIALIZED Upcoming Expected Milestones and Anticipated Timing • Publications of additional clinical and economic outcome studies in 2024-2025 • PRIME: interim analysis complete; final in late 2024 • Publication of data in 2024-2025 • Validation underway to assess which risk factors and other major pregnancy complications to be included; began market research • Public release of validationdata in 2024 • Product profile development underway • Early market testing in progress • Biomarker discovery completed • Product profile development underway N/A
Technology Road Map
Transitioning analyses for cost-effectiveness, faster turnaround times, and enhanced market accessibility • Diagnostic tests rely on biological samples, but there are current limitations on collection and transport • Sera is shifting to ambient conditions for sample transport to enhance the patient and provider experience and improve access to testing Transitioning from frozen shipments to ambient conditions for sample transport Adding whole-blood sample types to test menus, alongside serum Developing capillary blood draw capabilities without the need for venipuncture Completed Ongoing Ongoing Venipuncture and frozen or ambient serum shipment Venipuncture and ambient blood shipment Capillary blood draw and ambient shipment S E R A ’ S A P P R O A C H T O S I M P L I F Y I N G B L O O D C O L L E C T I O N
Transitioning analyses for cost-effectiveness, faster turnaround times, and enhanced market accessibility • Sera utilizes proteomic methods for discovering, verifying, and validating pregnancy tests. • The PreTRM® test, a prime example, is commercially launched using mass spectrometry, enabling swift market access and evidence accumulation. • Immunoassays may offer cost-effectiveness, rapid turnaround times, and enhanced market accessibility via point-of-care testing or kit distribution. • Antibodies are developed for PreTRM analytes to facilitate immunoassay creation. • Immunoassay methods at Sera include affinity-capture mass spectrometry (AC-MS) and enzyme-linked immunosorbent assays (e.g., ELISA, ECLIA), with the latter typically requiring two antibodies per analyte. • AC-MS serves as a transitional tool to ELISA/ECLIA platforms. • In some instances, Sera directly transitions from proteomics discovery to commercialization via an ELISA format.
Sera Leadership Team Zhenya Lindgardt President & CEO • Former CEO, The Commons Project Foundation • Former VP of Platform and Customer Engagement, Uber Technologies • Former Senior Partner and Managing Director, The Boston Consulting Group • MBA, Harvard University Austin Aerts Chief Financial Officer • Former VP, Finance and Corporate Controller, Sera • Former finance team member, Myriad • Former auditor, Ernst & Young LLP • Master of Accounting University of Utah; CPA Jay Boniface, Ph.D. Chief Scientific Officer Robert G. Harrison Chief Information Officer Benjamin Jackson General Counsel Paul Kearney, Ph.D, Chief Data Officer Michael Foley, M.D. Medical Advisor Doug Roach VP of Commercial
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