Sera Prognostics, Inc. (SERA) Bundle
A Brief History of Sera Prognostics, Inc.
Company Overview
Sera Prognostics, Inc. is a biotechnology company focused on developing innovative blood tests for pregnancy-related conditions. The company aims to improve maternal and neonatal health outcomes through its proprietary PreTRM test and other pipeline products.
Founding and Development
Founded in 2012, Sera Prognostics has evolved significantly since its inception, emphasizing research and development in the field of obstetrics and gynecology. The company went public with an IPO in July 2021, raising capital to support its commercialization efforts.
Financial Performance
As of September 30, 2024, Sera Prognostics reported the following key financial metrics:
| Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Revenue | $29,000 | $42,000 | $(13,000) |
| Net Loss | $(7,919,000) | $(7,210,000) | $(709,000) |
| Total Assets | $79,001,000 | $95,441,000 | $(16,440,000) |
| Total Stockholders' Equity | $54,651,000 | $70,158,000 | $(15,507,000) |
Research and Development
R&D expenses for the nine months ended September 30, 2024, amounted to $11,591,000, reflecting a slight increase from $11,330,000 in the previous year. The focus has been on advancing the PreTRM test and other pipeline products, which are critical to the company’s future revenue potential.
Market Position and Future Prospects
Sera Prognostics is positioned within a growing market for prenatal diagnostics. The company has taken steps to streamline operations and focus on institutional sales, which may enhance its market penetration as it continues to gather clinical data from studies such as the PREVENT-PTB and PRIME trials.
Liquidity and Capital Resources
As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling approximately $79.9 million. This liquidity is essential for sustaining operations and funding ongoing clinical studies and commercialization efforts.
Recent Developments
In August 2024, Sera Prognostics filed a universal shelf registration statement with the SEC for the potential sale of up to $100 million in various securities. This move is intended to bolster financial flexibility as the company navigates its growth trajectory.
Key Financial Highlights
The following table summarizes the financial highlights for Sera Prognostics for the nine months ended September 30, 2024, compared to the same period in 2023:
| Metric | 9M 2024 | 9M 2023 | Change |
|---|---|---|---|
| Revenue | $53,000 | $265,000 | $(212,000) |
| Operating Expenses | $27,265,000 | $31,238,000 | $(3,973,000) |
| Net Loss | $(24,319,000) | $(28,317,000) | $(3,998,000) |
The company continues to monitor its operational efficiencies and market opportunities to enhance its financial health and product offerings.
A Who Owns Sera Prognostics, Inc. (SERA)
Ownership Structure
Sera Prognostics, Inc. (SERA) has a dual-class common stock structure, consisting of Class A and Class B shares. As of September 30, 2024, the total shares outstanding were as follows:
| Class of Stock | Shares Authorized | Shares Issued | Shares Outstanding |
|---|---|---|---|
| Class A | 150,000,000 | 32,774,950 | 32,774,950 |
| Class B | 1,500,000 | 1,405,259 | 967,759 |
Major Shareholders
As of the most recent filings, the following entities are among the major shareholders of Sera Prognostics:
- Venture Capital Firms: Various venture capital firms hold significant stakes in SERA, primarily from previous funding rounds.
- Insider Ownership: Key executives and board members collectively own a notable percentage of shares, reflecting their commitment to the company.
- Public Investors: Following the IPO in July 2021, public investors have acquired shares, contributing to the shareholder base.
Financial Performance
As of September 30, 2024, SERA reported the following financial metrics:
| Financial Metric | 2024 | 2023 |
|---|---|---|
| Revenue | $53,000 | $265,000 |
| Net Loss | $(24,319,000) | $(28,317,000) |
| Accumulated Deficit | $(271,215,000) | $(246,896,000) |
| Cash and Cash Equivalents | $2,684,000 | $3,880,000 |
Recent Developments
In August 2024, Sera Prognostics filed a universal shelf registration on Form S-3 with the SEC, allowing it to register for sale up to $100 million in various securities, including Class A common stock. This move is aimed at enhancing liquidity and providing flexibility for future financing needs.
The company has not sold any shares under the 2024 Sales Agreement as of September 30, 2024, but this agreement allows for potential future capital raises.
Sera Prognostics, Inc. (SERA) Mission Statement
Company Overview
Sera Prognostics, Inc. is a women’s health company focused on improving maternal and neonatal health through the development of blood-based biomarker tests and predictive analytic products. Their vision emphasizes delivering actionable information throughout the pregnancy journey to enhance health outcomes for mothers and babies while aiming to reduce healthcare costs.
Mission Statement
The mission of Sera Prognostics is to leverage proprietary proteomics and bioinformatics platforms to develop innovative solutions that provide clinically meaningful insights for pregnant women and their healthcare providers. This commitment is aimed at enhancing maternal and neonatal health through rigorous clinical testing and data analysis.
Financial Data
As of September 30, 2024, Sera Prognostics reported the following financial metrics:
| Financial Metric | Value (in thousands) |
|---|---|
| Cash and Cash Equivalents | $2,684 |
| Marketable Securities | $47,068 |
| Total Assets | $79,001 |
| Accumulated Deficit | $(271,215) |
| Total Stockholders' Equity | $54,651 |
| Net Loss (9 months ended September 30, 2024) | $(24,319) |
| Net Loss per Share (basic and diluted) | $(0.74) |
| Revenue (9 months ended September 30, 2024) | $53 |
Operational Highlights
For the nine months ended September 30, 2024, Sera Prognostics incurred significant operating expenses, detailed below:
| Expense Category | Amount (in thousands) |
|---|---|
| Research and Development | $11,591 |
| Selling and Marketing | $3,507 |
| General and Administrative | $12,117 |
| Total Operating Expenses | $27,265 |
Market Strategy and Future Outlook
Sera Prognostics continues to focus on the commercialization of its PreTRM test while also exploring additional pipeline products. The company is strategically streamlining its operations to enhance market adoption and improve revenue potential. The management anticipates maintaining adequate cash runway into 2027 based on current operating plans.
Key Challenges and Risks
The company acknowledges that it will continue to face challenges related to achieving significant revenue growth and securing funding for future operations. As of September 30, 2024, Sera Prognostics has not generated substantial commercial revenue from product sales and expects to incur additional operating losses moving forward.
How Sera Prognostics, Inc. (SERA) Works
Overview of Operations
Sera Prognostics, Inc. is a women's health company focused on utilizing its proprietary proteomics and bioinformatics platform to improve maternal and neonatal health. The company primarily develops blood-based biomarker tests and predictive analytic products.
As of September 30, 2024, Sera Prognostics reported an accumulated deficit of $271.2 million and had cash and cash equivalents of $2.7 million. The company is headquartered in Salt Lake City, Utah, where it operates a CLIA-certified laboratory.
Financial Performance
For the nine months ended September 30, 2024, Sera Prognostics generated revenue of $53,000, a significant decrease from $265,000 in the same period in 2023. The company's operating expenses for the same period totaled $27.3 million, compared to $31.2 million in 2023.
| Metric | 2024 (9 Months) | 2023 (9 Months) | Change |
|---|---|---|---|
| Revenue | $53,000 | $265,000 | ($212,000) |
| Operating Expenses | $27.3 million | $31.2 million | ($3.9 million) |
| Net Loss | ($24.3 million) | ($28.3 million) | $3.998 million |
Research and Development
Research and development (R&D) expenses for the nine months ended September 30, 2024, were $11.6 million, slightly higher than $11.3 million for the same period in 2023. The breakdown of R&D expenses is as follows:
| Category | 2024 | 2023 | Change |
|---|---|---|---|
| Clinical Studies | $3.6 million | $5.0 million | ($1.4 million) |
| Research and Bioinformatics | $5.6 million | $3.2 million | $2.4 million |
| Laboratory Operations | $2.5 million | $3.1 million | ($0.6 million) |
Market Strategy
Sera Prognostics is focusing on the commercialization of its PreTRM test, which predicts the risk of preterm birth. The company has initiated marketing efforts and is processing whole-blood specimens to enhance patient and provider accessibility.
In August 2024, Sera filed a universal shelf registration on Form S-3 with the SEC, allowing for the potential sale of up to $100 million in various securities. This includes a provision for $50 million in shares that can be issued under an at-the-market offering.
Operating Expenses
The total operating expenses for the nine months ended September 30, 2024, were as follows:
| Expense Category | 2024 | 2023 | Change |
|---|---|---|---|
| Cost of Revenue | $50,000 | $186,000 | ($136,000) |
| Selling and Marketing | $3.5 million | $7.0 million | ($3.5 million) |
| General and Administrative | $12.1 million | $12.7 million | ($0.6 million) |
Liquidity and Funding
As of September 30, 2024, Sera Prognostics had $74.3 million in cash, cash equivalents, and marketable securities. The company anticipates continued operating losses and negative cash flows as it advances its commercialization activities.
Net cash used in operating activities for the nine months ended September 30, 2024, was ($7.9 million), compared to ($20.4 million) in 2023.
| Cash Flow Summary | 2024 (9 Months) | 2023 (9 Months) |
|---|---|---|
| Net Cash Used in Operating Activities | ($7.9 million) | ($20.4 million) |
| Net Cash Provided by Investing Activities | $4.4 million | $0.1 million |
| Net Cash Provided by Financing Activities | $2.4 million | $0.1 million |
Stockholder Equity
As of September 30, 2024, the total stockholders' equity was $54.7 million, down from $70.2 million at the end of 2023. The company's common stock was reported at 33,742,709 shares outstanding.
How Sera Prognostics, Inc. (SERA) Makes Money
Revenue Sources
Sera Prognostics primarily generates revenue from the sales of its PreTRM test, a blood-based biomarker test designed to assess the risk of preterm birth. For the nine months ended September 30, 2024, the company reported total revenue of $53,000, a decrease from $265,000 in the same period of 2023.
Sales Performance
The sales figures for the PreTRM test indicate a significant challenge in market adoption. For the three months ended September 30, 2024, revenue was only $29,000 compared to $42,000 in the previous year. This decline highlights potential issues with payer coverage and market penetration.
Operating Expenses
Sera Prognostics incurs substantial operating expenses, which for the nine months ended September 30, 2024, totaled $27.3 million. This was a decrease from $31.2 million in the same period in 2023. The breakdown of operating expenses is as follows:
| Expense Type | 2024 (in thousands) | 2023 (in thousands) |
|---|---|---|
| Cost of Revenue | $50 | $186 |
| Research and Development | $11,591 | $11,330 |
| Selling and Marketing | $3,507 | $7,045 |
| General and Administrative | $12,117 | $12,677 |
| Total Operating Expenses | $27,265 | $31,238 |
Net Loss
The company reported a net loss of $24.3 million for the nine months ended September 30, 2024, compared to a net loss of $28.3 million in the same period in 2023. The loss per share for the same period was $0.74, a slight improvement from $0.91 the previous year.
Liquidity Position
As of September 30, 2024, Sera Prognostics had cash and cash equivalents of $2.7 million and marketable securities totaling $47.1 million. The company also reported an accumulated deficit of $271.2 million.
Future Funding Requirements
To sustain operations, Sera Prognostics anticipates the need for additional financing. The company filed a universal shelf registration statement on August 7, 2024, allowing it to raise up to $100 million through various securities. As of the end of September 2024, Sera had not yet utilized this registration for capital raises.
Market Adoption and Challenges
The adoption of the PreTRM test is crucial for generating revenue. However, challenges persist due to limited reimbursement from third-party payers. Currently, many insurers either do not cover the test or require prior authorization, which complicates patient access. The company's strategy includes enhancing payer coverage and improving engagement with healthcare providers.
Research and Development Focus
Sera Prognostics invests heavily in research and development, with expenses amounting to $11.6 million for the nine months ended September 30, 2024. This investment is aimed at developing additional tests and enhancing existing products.
Conclusion
In summary, Sera Prognostics, Inc. primarily relies on the PreTRM test for revenue, faces challenges in market adoption and payer coverage, and continues to incur significant operating losses while striving to enhance its product offerings through ongoing research and development efforts.
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Resources:
- Sera Prognostics, Inc. (SERA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Sera Prognostics, Inc. (SERA)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Sera Prognostics, Inc. (SERA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.