SERA PROGNOSTICS, INC. Q4 FY2024 earnings call

• Successfully executed on plans to grow business and shareholder value, including building evidence portfolio, awareness, and seeking publication of clinical trial results.
• PRIME study results showed 25% reduction in neonatal mortality and morbidity index, 18% reduction in neonatal length of hospital stay, 20% overall reduction in NICU admissions, and a number needed to screen of 41 to prevent a NICU admission.
• Recently completed a fund raise to fund evidence growth opportunities and has a debt-free balance sheet for flexibility.
• Starting a real-world evidence study, and planning more such trials. Launched an investigator-initiated research program at the Society for Maternal Fetal Medicine Meeting.
• Appointed Jeff Elliott to the Board; Ryan Trimble and Marcus Wilson stepping down in June.
• Targeting commercial expansion in 2025 with cash operating expenses targeted at $30M-$35M, driven by commercial investments.

Fourth quarter of 2024 net revenue was $24,000 compared to $41,000 in the same period of 2023. Total operating expenses in Q4 2024 were $9.4 million, up 6% from $8.9 million in Q4 2023. Research and development expenses were $3.1 million, down from $3.9 million in Q4 2023 due to reduced PRIME study expenses. Selling, general and administrative expenses were $6.3 million, up from $5.0 million in Q4 2023 due to focused commercial spending. As of December 31, 2024, the company had cash, cash equivalents, and available-for-sale securities of approximately $68.2 million. In February 2025, the company raised $57.5 million through a public follow-on offering.

• 2025 cash operating expenses targeted in the range of $30 million to $35 million, driven by planned new and significant investments in commercialization.
• Cash runway expected through 2028 based on current operating plans. The amount of investment in 2025 will be dictated by the timing of PRIME publication and commercial opportunities.
• Aim to expand commercial operations in the US and explore international expansion, including Europe.

Q: Dan Brennan asked about the three tenants to get into guidelines, elaborating on publications, real-world evidence, and clinical community adoption, and what investors should look for in 2025.

A: Evguenia Lindgardt said on publications, there are many potential topics from the PRIME data set; on real-world evidence, they're kicking off a study and launching an investigator-initiated research program; on clinical community adoption, more adoption will push professional societies to review usage.

Q: Dan Brennan followed up on Medicaid opportunity, how soon Medicaid might cover the test.

A: Evguenia Lindgardt said Medicaid is a big payer, and the test can save money, so could make inroads this year as savings are realized quickly.

Q: Dan Brennan asked about guidelines from SMFM and ACOG, and timeline.

A: Evguenia Lindgardt said both societies work together, feedback from opinion leaders is positive, and it's hard to predict timeline but ACOG Bulletin 234 was last updated in 2021.

Q: Austin Aerts was asked about cash runway and costs.

A: Austin Aerts said cash runway into 2028 based on current plans, with most increased spend going to commercial investment.

Q: Margarate Boeye asked about commercial investments in 2025 and beyond.

A: Evguenia Lindgardt said building sales organization with regional account managers, medical liaison, revenue cycle, and payer group; expanding commercial presence in waves.

Q: Margarate Boeye asked about pipeline initiatives, time to birth assay launch, and pricing.

A: Evguenia Lindgardt said Time to Birth product targeted for second half of 2025, priced around $150, consumer-directed.