Sera Prognostics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total PreTRM test revenue for the quarter was $42,000, representing a 163% year-over-year increase from $16,000 in Q3 2025.
• PreTRM test volumes increased 54% sequentially and approximately five-fold from Q1 2026.
• Revenue was negatively impacted by lower average selling prices (ASPs) due to a higher mix of low or non-reimbursed tests.
• Operating expenses declined 11% sequentially from Q2 2026 to $8,929,000, driven by cost reduction initiatives implemented in June 2026, though partially offset by increased commercial spending for Illinois and Florida launches and $400,000 in severance expenses.
• Net loss for the quarter was $8,053,000, compared to a net loss of $7,814,000 in Q3 2025.
• Cash, cash equivalents, and marketable investment securities totaled $72.8 million at quarter-end.
• Cash burn from operations for the fiscal third quarter was $7.3 million.
• Deferred revenue was $20,268,000 at September 30, 2026, down slightly from $20,315,000 at December 31, 2025.
• Total assets were $79,980,000 at September 30, 2026, compared to $101,933,000 at December 31, 2025.

Guidance and Future Outlook:

• The company is scaling its commercial organization to support anticipated test volume ramp in fiscal year 2027.
• Discussions are underway with one of the largest commercial insurers regarding a large multi-state, multi-thousand-patient pilot planned for initiation in fiscal year 2027.
• The company is working with its notified body to submit a CE Mark for the PreTRM® Global test in Europe.
• Management indicated the company is transitioning from evidence generation to commercial execution.

Business Segments and Product Lines:

• The PreTRM® test is the primary product line, with revenue derived entirely from this test to date.
• Ordering healthcare providers increased 34% sequentially and approximately three-fold from Q1 2026.
• The sales team expanded by 25% in Q3 2026 to support Illinois commercialization and further expanded in early October 2026 for Florida commercialization.
• A fourth payer partnership program was launched, a state-based initiative with a national payer to expand PreTRM test-guided care.
• The company published a PRIME randomized controlled trial subgroup analysis showing a 22% reduction in NICU admissions among first-time mothers.
• Two analyses from the PRIME trial were presented at the 2026 Society for Maternal-Fetal Medicine Global Congress.

Market and Competitive Landscape:

• Florida became the second state to provide Medicaid coverage for the PreTRM® test, adding the PLA code 0247U to its fee schedule with established pricing.
• Florida Medicaid covers approximately 4 million beneficiaries and 90,000 births annually.
• Illinois Medicaid added the PLA code 0247U to its fee schedule at $525 with no prior authorization required; Medicaid credentialing is complete, and contracting with managed care plans is active.
• Total covered Medicaid lives now approximate 7 million patients.
• The European Association for Perinatal Medicine referenced the PreTRM® test in its guidelines as a potential tool for preterm birth risk prediction.
• The U.S. received a D+ grade for preterm birth for the fourth consecutive year, highlighting the market need.

Risks and Challenges:

• Revenue is currently negatively impacted by a higher mix of low or non-reimbursed tests affecting average selling prices.
• The company faces risks related to net losses, cash generation, and the potential need to raise additional capital.
• Future performance depends on broad scientific and market acceptance of the PreTRM® test and the ability to secure third-party payer coverage and reimbursement.
• Risks include potential competition, reliance on a concentrated number of material customers, and changes in FDA regulation of laboratory-developed tests.
• Intellectual property rights and critical supplier relationships are identified as potential risk factors.

Management Commentary and Tone:

• Zhenya Lindgardt, President and CEO, stated the quarter marked an important step forward in the transition from evidence generation to commercial execution.
• Management expressed confidence that recent accomplishments validate their strategy and position the company well to establish PreTRM as a foundational component of prenatal care.
• The tone highlighted strong growth in physician adoption, expanded reimbursement, and strengthened clinical evidence.

Other Key Points:

• The company hosted a conference call and live webcast on November 4, 2026, to discuss results.
• The PreTRM® test measures proteins in blood to predict spontaneous preterm birth risk in asymptomatic singleton pregnancies between weeks 18 and 21 of gestation.
• The company has a robust pipeline of innovative diagnostic tests focused on early prediction of preterm birth risk and other pregnancy complications.
• The press release includes a Safe Harbor Statement regarding forward-looking statements and potential risks that could cause actual results to differ materially.