Sera Prognostics(SERA) - 2021 Q3 - Quarterly Report

PART I — FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) The unaudited condensed financial statements for the period ended September 30, 2021, show a significant increase in cash and marketable securities following the company's IPO in July 2021, with total assets growing to $153.7 million from $14.8 million at year-end 2020, while net losses increased to $22.5 million for the first nine months of 2021, up from $14.5 million in the prior year, driven by increased operating expenses, and the IPO fundamentally changed the company's capital structure from a significant deficit to a positive stockholders' equity of $150.0 million Condensed Balance Sheets Condensed Balance Sheet Comparison (in thousands) | Account | September 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $82,479 | $13,533 | | Marketable securities | $67,495 | $0 | | Total current assets | $122,339 | $13,733 | | Total assets | $153,689 | $14,796 | | Liabilities & Equity | | | | Total liabilities | $3,651 | $12,330 | | Convertible preferred stock | $0 | $128,036 | | Total stockholders' equity (deficit) | $150,038 | ($125,570) | | Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | $153,689 | $14,796 | - Following its IPO and financing activities in 2021, the company's capital structure shifted dramatically, with all convertible preferred stock being converted to common stock and stockholders' equity moving from a deficit of $125.6 million to a positive equity of $150.0 million[14] Condensed Statements of Operations and Comprehensive Loss Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $23 | $5 | $56 | $19 | | Total operating expenses | $9,465 | $4,649 | $22,904 | $13,236 | | Loss from operations | ($9,442) | ($4,644) | ($22,848) | ($13,217) | | Net loss | ($9,859) | ($5,072) | ($22,525) | ($14,473) | | Net loss per share | ($0.39) | ($3.30) | ($2.32) | ($9.46) | - Operating expenses more than doubled in Q3 2021 compared to Q3 2020, driven by significant increases in R&D, selling & marketing, and general & administrative costs, leading to a substantially higher net loss[16] Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - In Q3 2021, the company completed its IPO, raising net proceeds of $66.6 million[19] - Concurrent with the IPO, all outstanding Junior and Senior Convertible Preferred Stock, with a carrying value of $226.9 million, was converted into 23,839,389 shares of common stock[19] Condensed Statements of Cash Flows Condensed Statement of Cash Flows (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($22,484) | ($12,683) | | Net cash used in investing activities | ($68,127) | ($105) | | Net cash provided by financing activities | $159,557 | $10,080 | | Net increase (decrease) in cash | $68,946 | ($2,708) | - Financing activities provided $159.6 million in cash for the first nine months of 2021, primarily from $99.0 million in proceeds from Series E preferred stock and $66.6 million in net proceeds from the IPO[24] - Investing activities used $68.1 million, mainly for the purchase of $67.6 million in marketable securities following the capital raises[24] Notes to Condensed Financial Statements - The company has incurred net losses since inception, with an accumulated deficit of $154.0 million as of September 30, 2021[29] - Management believes existing financial resources, including $82.5 million in cash and cash equivalents and $67.5 million in marketable securities, are sufficient to fund operations for at least the next 12 months[30][31] - In July 2021, the company completed its IPO, issuing 4,687,500 shares of Class A common stock for net proceeds of approximately $66.6 million, and all convertible preferred stock was converted into common stock[66] - The company's $1.1 million Paycheck Protection Program (PPP) loan was fully forgiven in June 2021, resulting in a gain on extinguishment[52] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's position as a women's health diagnostic company focused on its first commercial product, the PreTRM test, with a key element of the commercialization strategy being the multi-year contract with Anthem, and while the company has a history of significant operating losses expected to continue due to commercialization activities, clinical studies, and R&D, its liquidity was significantly strengthened by its July 2021 IPO and a Series E preferred stock financing, providing sufficient capital to fund operations for at least the next 12 months Results of Operations Comparison of Operating Results (in thousands) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $23 | $5 | $56 | $19 | | Research and development | $2,724 | $1,888 | $7,944 | $5,690 | | Selling and marketing | $2,690 | $1,054 | $5,780 | $2,634 | | General and administrative | $4,041 | $1,704 | $9,157 | $4,904 | | Net loss | ($9,859) | ($5,072) | ($22,525) | ($14,473) | - The increase in R&D expenses for the nine months ended Sep 30, 2021 was primarily due to a $1.2 million increase in laboratory operations costs (supplies, personnel), a $0.6 million increase in clinical study costs (PRIME study), and a $0.4 million increase in research and bioinformatics expenses[124] - Selling and Marketing expenses increased by $3.1 million for the nine-month period, driven by a $1.9 million increase in personnel-related costs from increased headcount to support commercialization[125] - General and Administrative expenses rose by $4.3 million for the nine-month period, mainly due to higher personnel costs ($1.7 million), professional services for public company compliance ($0.7 million), stock-based compensation ($0.7 million), and D&O insurance ($0.5 million)[126] Liquidity and Capital Resources - As of September 30, 2021, the company had cash and cash equivalents of $82.5 million and available-for-sale securities of $67.5 million[129] - Primary sources of liquidity in 2021 were proceeds from the sale of Series E convertible preferred stock ($99.0 million net) and the IPO ($66.6 million net)[133] - Management believes that existing cash and cash equivalents are sufficient to fund operating expenses and capital requirements for at least the next 12 months[135] Item 3. Quantitative and Qualitative Disclosure About Market Risk The company's primary market risk exposure is to interest rate changes, which affect the interest earned and market value of its cash, cash equivalents, and marketable securities, with the investment policy focused on capital preservation and liquidity, and foreign currency and inflation risks not considered material at this time - The company's exposure to interest rate risk is primarily related to its portfolio of cash, cash equivalents, and marketable securities[143] - A hypothetical 100 basis point increase in interest rates would have resulted in a $0.7 million decrease in the market value of the company's available-for-sale debt securities as of September 30, 2021[144] Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of September 30, 2021, with no material changes to the company's internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[148] - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[149] PART II – OTHER INFORMATION Item 1. Legal Proceedings The company reports that it is not currently a party to any material litigation or other material legal proceedings, but acknowledges that it may be involved in various legal proceedings from the normal course of business in the future - As of the filing date, the company is not a party to any material legal proceedings[152] Item 1A. Risk Factors This section outlines numerous risks and uncertainties facing the company, including its history of net losses and the expectation of future losses, the need for significant cash and potential need for additional capital, and reliance on the PreTRM test and its commercial agreement with Anthem, alongside intense competition, operational risks related to its single CLIA-certified lab and proprietary biobank, significant reimbursement challenges with third-party payers, and complex and evolving government regulations, particularly regarding Laboratory Developed Tests (LDTs), data privacy (HIPAA, CCPA), and potential intellectual property disputes - Financial Risks: The company has a history of net losses, expects them to continue, and may need to raise additional capital to fund operations[156][159][162] - Commercial Risks: The business is substantially dependent on the commercial success of the PreTRM test and its relationship with a limited number of customers, primarily Anthem[156][170][177] - Operational Risks: The company relies on a single CLIA-certified laboratory, a proprietary biobank, and a limited number of suppliers, making it vulnerable to operational disruptions[156][188][198][206] - Regulatory & Reimbursement Risks: The business faces challenges in securing adequate reimbursement from third-party payers and is subject to complex healthcare regulations, including potential changes in FDA oversight of Laboratory Developed Tests (LDTs)[158][223][269] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds During the first nine months of 2021, the company issued 8,054,138 shares of Series E convertible preferred stock for net proceeds of $100.1 million and also issued shares upon the exercise of stock options, confirming no material change in the planned use of proceeds from its July 2021 IPO as described in the final prospectus - In the nine months ended September 30, 2021, the company issued 8,054,138 shares of Series E convertible preferred stock for $100.1 million, net of issuance costs[341] - The company confirms no material change in the planned use of proceeds from its IPO[346] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including the company's amended certificate of incorporation, bylaws, various warrant forms, an employment agreement, and officer certifications