Sera Prognostics(SERA) - 2023 Q4 - Annual Report

Part I Business Sera Prognostics develops blood-based biomarker tests for maternal and neonatal health, with PreTRM® for preterm birth as its key product Overview and Strategy Sera Prognostics develops blood-based tests for maternal health, expanding PreTRM payment and developing new pregnancy tests - The company's core business is developing and commercializing blood-based biomarker tests to improve pregnancy outcomes, with the PreTRM test for preterm birth risk as its first commercial product[16] - A key strategy is to expand payment for the PreTRM test across various market segments, including integrated systems, self-insured employers, and major health insurance payers, leveraging its commercial collaboration with Elevance Health[31] - Sera is actively developing a pipeline of new products to address other major pregnancy conditions, such as time-to-birth, preeclampsia, and gestational diabetes, by leveraging its proprietary technology platform[31] - Technological evolution is central to the company's strategy, including migrating from mass-spectrometry to immunoassays and implementing whole-blood collection and ambient specimen shipping to lower costs and improve user experience[31] Proprietary Technology Platform and Development Approach The company's platform uses biobanks, mass spectrometry, and bioinformatics to discover pregnancy biomarkers, adhering to NAM guidelines - The platform integrates proprietary biobanks, advanced mass spectrometry, and bioinformatics to characterize pregnancy biology and predict outcomes[39] - The company is enhancing its analytical techniques by developing an automated affinity-capture mass-spectrometry (AC-MS) PreTRM assay, expected to launch in H1 2024, which will increase throughput and lower costs[46] - Sera's development process strictly adheres to National Academy of Medicine (NAM) guidelines, requiring disciplined validation of predictions in independent specimen cohorts before clinical or commercial use[48] - A key part of the commercialization strategy is conducting controlled intervention trials (PREVENT-PTB, AVERT, PRIME) to demonstrate that its 'test and treat' strategy improves health outcomes and saves healthcare costs[50] The PreTRM Test and Clinical Evidence The PreTRM test predicts spontaneous preterm birth risk, validated in studies, with clinical utility shown in intervention trials - The PreTRM test is the only broadly validated, commercially available blood test to predict the risk of spontaneous preterm birth in singleton pregnancies[62] - The PREVENT-PTB study showed that for preterm infants, the test-and-treat strategy reduced hospital/NICU length-of-stay by over 70% and severe neonatal morbidity or death by 66%[78] - The AVERT PRETERM TRIAL met both co-primary endpoints, demonstrating a statistically significant reduction in severe neonatal morbidity/death and decreased length of neonatal hospital stay[80] - In December 2023, the Data Safety Monitoring Board for the PRIME study recommended stopping enrollment due to efficacy, as co-primary endpoints (neonatal hospital length of stay and composite neonatal morbidity/mortality) met statistical significance at the interim analysis[81] Product Pipeline Sera Prognostics develops a pipeline of biomarker tests for pregnancy conditions, following NAM guidelines Product Pipeline Development Status | Product Candidate | Condition Addressed | Development Stage | | :--- | :--- | :--- | | Molecular Time-to-Birth | Inaccurate due date prediction | Discovery and verification complete; assessing commercialization. | | Predictive Analytics | Various pregnancy features/conditions | Discovery complete; market assessment of prototype underway. | | Pregnancy Risk Prediction Panel | Overall risk of significant complications | Discovery and verification complete; market assessment underway. | | Preeclampsia Test | Preterm preeclampsia risk | Discovery, verification, and validation complete; selecting final predictor. | | Growth Restriction Test | Fetal Growth Restriction (FGR) | Discovery of placental dysfunction biomarkers complete. | | Gestational Diabetes (GDM) Test | Gestational Diabetes Mellitus | Discovery and verification complete. | | Stillbirth Predictor | Stillbirth risk | Discovery phase. | | Postpartum Depression Predictor | Postpartum depression risk | Discovery phase. | - The company estimates that the timing for its next commercially available product is a matter of months or years, contingent on performance data meeting NAM guidelines and the need for additional capital to accelerate progress[121] Commercialization, Operations, and Agreements Sera's commercialization focuses on payer reimbursement, operating a CLIA-certified lab, and developing cost-efficient processes - The company has a multi-year commercial collaboration agreement with Elevance Health, which agreed to purchase a specified minimum number of PreTRM tests for the first three years and facilitate commercialization among its members[122][127][128] - The company operates a CLIA-certified and CAP-accredited laboratory in Salt Lake City, Utah[125] - Sera is developing an affinity-capture mass spectrometry (AC-MS) process to increase capacity, decrease turn-around time, and lower the cost of goods sold for its tests[126] Competition and Intellectual Property Sera believes PreTRM has a first-to-market advantage but anticipates competition, protecting its technology with patents and trade secrets - The company believes it has a first-to-market advantage, as it is not aware of any other broadly validated, commercially available blood-based biomarker test to predict a woman's risk of spontaneous preterm birth[133] - As of December 31, 2023, the company's intellectual property portfolio includes 3 issued U.S. patents, 5 pending U.S. non-provisional applications, 23 granted foreign patents, and 26 pending foreign patent applications[139] - Patents and applications related to the PreTRM test are expected to expire between 2034 and 2043[140] Government Regulation Sera Prognostics is subject to extensive government regulation, including CLIA/CAP, state licensing, and potential FDA LDT oversight - The company's clinical laboratory in Salt Lake City holds a CLIA Certificate of Accreditation and is also accredited by the College of American Pathologists (CAP)[148][149] - The PreTRM test is a Laboratory Developed Test (LDT) The FDA has historically exercised enforcement discretion over LDTs but issued a proposed rule in October 2023 to regulate them under the medical device framework, which could increase regulatory burdens[162][165] - The company is subject to federal and state data privacy and security laws, including the Health Insurance Portability and Accountability Act (HIPAA) and the California Consumer Privacy Act (CCPA)[172][180] - Operations are subject to federal and state anti-fraud laws, including the Anti-Kickback Statute (AKS), the Stark Law, and the Eliminating Kickbacks in Recovery Act (EKRA), which govern relationships with healthcare providers and referral sources[183][187][189] Reimbursement and Billing Commercial success depends on securing payer reimbursement, influenced by PAMA, with PreTRM's PLA code priced at $750 - The company's ability to commercialize its products depends on obtaining adequate coverage and reimbursement from third-party payers, who assess whether a product is a covered benefit, medically necessary, and cost-effective[200][201] - The Protecting Access to Medicare Act of 2014 (PAMA) has changed how clinical laboratory services are paid under Medicare, basing reimbursement on weighted-median private insurer payment rates[207] - In November 2021, CMS priced the unique PLA code for the PreTRM test at $750 under the PAMA framework, which influences reimbursement rates from commercial insurers[213] Human Capital As of December 31, 2023, Sera Prognostics had 57 employees, focusing on talent acquisition and retention - As of December 31, 2023, the company had 57 employees, 55 of whom were full-time[223] - The company's human capital strategy focuses on talent acquisition and retention, competitive total rewards, employee health and wellness, diversity, and training[224][225][226] Risk Factors The company faces significant risks including net losses, PreTRM test reimbursement, competition, regulatory changes, and operational challenges - The company has a history of net losses ($36.2 million in 2023) and expects to incur future losses, with an accumulated deficit of $246.9 million as of December 31, 2023[237] - Substantially all revenue is derived from the PreTRM test, and the business is harmed if adoption and reimbursement do not increase[235][255] - The company faces regulatory risk from potential FDA changes to the oversight of Laboratory Developed Tests (LDTs), which could increase costs and require additional clinical trials[353] - Operations are dependent on a single CLIA-certified laboratory in Salt Lake City, which, if it became inoperable, would halt testing and harm the business[235][270] - The company relies on a limited number of customers, including Elevance Health, for a significant portion of its revenue, creating customer concentration risk[259] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None[431] Cybersecurity The company has established a comprehensive cybersecurity program based on NIST frameworks to manage and mitigate threats - The company's cybersecurity policies and practices are based on recognized frameworks from the National Institute of Standards and Technology (NIST)[432] - The Audit Committee of the Board of Directors is responsible for overseeing risks from cybersecurity threats and receives updates from management at least annually[438][439] - The cybersecurity risk management and strategy are led by the Chief Information Officer and the information technology team[440] Properties The company's headquarters, R&D, and CLIA-certified laboratory are in Salt Lake City, leasing 24,300 square feet until 2025 - The company leases approximately 24,300 square feet in Salt Lake City, Utah for its headquarters, R&D, and laboratory[441] - The current facility lease expires on December 31, 2025, with an option to terminate after July 1, 2024[441] Legal Proceedings As of the report date, the company is not a party to any material litigation or other material legal proceedings - The company is not currently a party to any material legal proceedings[442] Mine Safety Disclosures This item is not applicable to the company - None[443] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Sera Prognostics' Class A common stock trades on Nasdaq under "SERA"; the company has never paid cash dividends and does not plan to - The company's Class A common stock trades on the Nasdaq Global Market under the symbol "SERA"[445] - As of March 15, 2024, there were 120 stockholders of record for Class A common stock and 2 for Class B common stock[446] - The company has never declared or paid a cash dividend and does not plan to in the foreseeable future[447] Management's Discussion and Analysis of Financial Condition and Results of Operations In 2023, Sera Prognostics reported a reduced net loss of $36.2 million, driven by lower selling and marketing expenses Results of Operations For 2023, Sera Prognostics reported a net loss of $36.2 million, improved from 2022, due to lower selling and marketing expenses Results of Operations (2023 vs. 2022) | | Year Ended December 31, | | | | :--- | :--- | :--- | :--- | | (in thousands) | 2023 | 2022 | $ Change | | Revenue | $306 | $268 | $38 | | Operating Expenses | | | | | Cost of revenue | $210 | $193 | $17 | | Research and development | $15,225 | $14,244 | $981 | | Selling and marketing | $8,349 | $14,699 | ($6,350) | | General and administrative | $16,343 | $16,784 | ($441) | | Total operating expenses | $40,127 | $45,920 | ($5,793) | | Loss from operations | ($39,821) | ($45,652) | $5,831 | | Net loss | ($36,242) | ($44,186) | $7,944 | - Research and development expenses increased by $1.0 million, primarily due to a $1.0 million rise in clinical study costs related to increased activity in the PRIME study[475] - Selling and marketing expenses decreased by $6.4 million, mainly from a $4.3 million reduction in personnel-related costs and a $0.7 million cut in marketing programs, reflecting a strategic shift to focus on institutional sales[476] Liquidity and Capital Resources As of December 31, 2023, the company had $79.9 million in cash, with net cash used in operations decreasing - As of December 31, 2023, the company had $79.9 million in cash, cash equivalents, and available-for-sale securities, with an accumulated deficit of $246.9 million[479] Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,188) | ($34,610) | | Net cash provided by investing activities | $438 | $5,551 | | Net cash provided by financing activities | $752 | $5 | | Net decrease in cash and cash equivalents | ($25,998) | ($29,054) | - The company believes its current cash runway is sufficient to fund operations into 2027 based on its existing operating plans[462] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate risk on its cash and marketable securities, with no significant foreign currency risk - The company's main market risk is interest rate risk on its cash and marketable securities A hypothetical 100 basis point interest rate increase would decrease the market value of its securities by $0.6 million as of year-end 2023[499] - The company does not have material exposure to foreign currency risk but acknowledges that inflation could increase operating costs[501][502] Financial Statements and Supplementary Data Audited financial statements for 2023 and 2022 are presented, detailing assets, liabilities, equity, and net loss Financial Position As of December 31, 2023, total assets were $95.4 million, liabilities $25.3 million, and stockholders' equity $70.2 million Balance Sheet Summary (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total Current Assets | $61,344 | $90,125 | | Total Assets | $95,441 | $116,329 | | Total Current Liabilities | $24,443 | $15,538 | | Total Liabilities | $25,283 | $17,386 | | Total Stockholders' Equity | $70,158 | $98,943 | Operating Results For 2023, the company reported revenue of $306,000 and a net loss of $36.2 million, improved from 2022 due to lower expenses Statement of Operations Summary (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $306 | $268 | | Total Operating Expenses | $40,127 | $45,920 | | Loss from Operations | ($39,821) | ($45,652) | | Net Loss | ($36,242) | ($44,186) | | Net Loss Per Share | ($1.16) | ($1.43) | Cash Flows For 2023, net cash used in operating activities was $27.2 million, an improvement, with cash and equivalents ending at $3.9 million Statement of Cash Flows Summary (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,188) | ($34,610) | | Net cash provided by investing activities | $438 | $5,551 | | Net cash provided by financing activities | $752 | $5 | | Net decrease in cash and cash equivalents | ($25,998) | ($29,054) | | Cash and cash equivalents at end of period | $3,880 | $29,878 | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[616] Controls and Procedures Management concluded the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[619] - Management assessed internal control over financial reporting based on the COSO framework and concluded it was effective as of December 31, 2023[622] Other Information CSO adopted a Rule 10b5-1 trading plan, and the Board approved accelerated RSU vesting for CEO and CFO - On December 15, 2023, the Chief Scientific Officer adopted a Rule 10b5-1 trading arrangement for the sale of 120,737 shares[623] - On March 15, 2024, the Board approved accelerating the vesting of 100,000 RSUs for CEO Zhenya Lindgardt and 26,250 RSUs for CFO Austin Aerts[626][628] Disclosure Regarding Foreign Jurisdiction that Prevent Inspections This item is not applicable to the company - Not applicable[630] Part III Directors, Executive Officers and Corporate Governance Information regarding the company's directors, executive officers, and corporate governance is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[633] Executive Compensation Information regarding executive compensation is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[634] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information regarding security ownership of certain beneficial owners and management is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[635] Certain Relationships and Related Transactions, and Director Independence Information regarding certain relationships, related transactions, and director independence is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[636] Principal Accounting Fees and Services Information regarding principal accounting fees and services is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[637] Part IV Exhibit and Financial Statement Schedules This section lists the documents filed as part of the Annual Report on Form 10-K, including financial statements and exhibits - This section contains the index to financial statements and a list of all exhibits filed with the Form 10-K[639][641] Form 10-K Summary The company has not provided a summary for this item - None[648]