Tempest Therapeutics(TPST) - 2022 Q1 - Quarterly Report

PART I — FINANCIAL INFORMATION This section presents the unaudited financial statements, management's analysis, and internal controls for the reporting period Item 1. Financial Statements (unaudited) The unaudited financial statements for Q1 2022 show a net loss of $8.5 million, a decrease in total assets, and an accumulated deficit of $108.6 million Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2022, shows total assets decreased to $67.0 million, primarily due to reduced cash, while stockholders' equity declined to $29.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $45,754 | $51,829 | | Total current assets | $62,710 | $68,963 | | Total assets | $66,953 | $73,238 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $20,815 | $20,026 | | Total liabilities | $37,596 | $37,121 | | Total stockholders' equity | $29,357 | $36,117 | | Total liabilities and stockholders' equity | $66,953 | $73,238 | Condensed Consolidated Statements of Operations The statements of operations for Q1 2022 show a net loss of $8.5 million, an increase from the prior year, driven by higher operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $5,109 | $3,592 | | General and administrative | $3,052 | $1,535 | | Loss from operations | ($8,161) | ($5,127) | | Net loss | ($8,491) | ($5,355) | | Net loss per share, basic and diluted | ($1.18) | ($10.55) | Condensed Consolidated Statements of Stockholders' Equity (Deficit) Stockholders' equity decreased to $29.4 million as of March 31, 2022, primarily due to the $8.5 million net loss for the quarter - The company's total stockholders' equity declined by $6.7 million during the first quarter of 2022, moving from $36.1 million to $29.4 million[19] - The primary driver of the decrease in equity was the net loss of $8.5 million incurred during the three-month period[19] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $7.1 million for Q1 2022, resulting in a $5.7 million net decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Cash used in operating activities | ($7,107) | ($6,310) | | Cash used in investing activities | ($3) | ($14) | | Cash provided by financing activities | $1,403 | $14,944 | | Net (decrease) increase in cash | ($5,707) | $8,620 | Notes to Condensed Consolidated Financial Statements The notes detail the company's oncology business, the Millendo merger accounting, cash sufficiency, and a $15 million legal settlement fully covered by insurance - Tempest is a clinical-stage oncology company with two main clinical programs: TPST-1120 (PPARα antagonist) and TPST-1495 (EP2/EP4 antagonist)[25] - The June 2021 merger with Millendo was accounted for as a reverse recapitalization, with Private Tempest as the accounting acquirer[28] - Management believes cash and cash equivalents as of March 31, 2022, are sufficient to fund operations for the next 12 months, further strengthened by a $15 million PIPE financing completed in April 2022[30][31] - A shareholder class action lawsuit (Dahhan v. OvaScience) was preliminarily settled for $15 million, which will be funded entirely by insurance and recorded as both an accrued legal settlement and an insurance recovery[53] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's oncology programs, continued operating losses, increased expenses, and sufficient cash position for the next 12 months, bolstered by recent financing - The company is advancing three novel, orally available therapies for solid tumors: TPST-1495 (dual EP2/EP4 antagonist), TPST-1120 (PPARα antagonist), and a preclinical TREX-1 inhibitor[91] Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2022 | Q1 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $5,109 | $3,592 | +$1,517 | | General and administrative | $3,052 | $1,535 | +$1,517 | - The increase in R&D expense was due to expanded research efforts, while the rise in G&A expense was primarily due to increased professional fees and insurance costs associated with being a public company post-merger[108][109] - As of March 31, 2022, the company had $45.8 million in cash and cash equivalents and believes this is sufficient to fund operations for at least the next 12 months, further strengthened by a $15 million PIPE financing completed in April 2022[95][96][112] Controls and Procedures Management concluded that disclosure controls and procedures were ineffective as of March 31, 2022, due to identified material weaknesses, for which a remediation plan is underway - Management concluded that disclosure controls and procedures were not effective as of March 31, 2022[125] - The ineffectiveness is due to previously identified material weaknesses, including insufficient resources with appropriate expertise in financial reporting and failure to design and implement controls to review clinical trial expenses[128][129] - A remediation plan is underway, involving recruiting additional accounting personnel and finalizing the design and implementation of management review controls for clinical trial expenses[130][132] PART II — OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other disclosures pertinent to the company's operations Legal Proceedings The company is involved in litigation inherited from the Millendo/OvaScience merger, including a $15 million shareholder class action settlement fully covered by insurance - The company is involved in litigation inherited from the Millendo/OvaScience merger[50][139] - A shareholder class action (Dahhan v. OvaScience) has been preliminarily settled for $15 million, which will be fully covered by insurance and has been recorded on the balance sheet[53] Risk Factors The company faces significant financial, operational, clinical, regulatory, and intellectual property risks, including a history of losses and material weaknesses in internal controls - Financial Risks: The company has a history of operating losses, expects them to continue, and will need to raise additional capital, which may not be available on acceptable terms[142][151][154] - Internal Control Risks: Material weaknesses have been identified in internal control over financial reporting, which could harm the business and stock value if not remediated effectively[144][160] - Clinical and Regulatory Risks: There is a high risk of failure in clinical development, with success in early trials not guaranteeing later success, and the regulatory approval process being lengthy, costly, and uncertain[144][177][187] - Operational and Commercialization Risks: The company faces significant competition, relies on third parties for manufacturing, and the commercial success of its products depends on market acceptance and adequate reimbursement from payors[218][221][206] - Intellectual Property Risks: The company's success depends on its ability to obtain, maintain, and protect its intellectual property, which is a difficult and costly process with an uncertain outcome[290] Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period covered by this report - None[373] Defaults Upon Senior Securities Not applicable - Not applicable[374] Mine Safety Disclosures Not applicable - Not applicable[375] Other Information Not applicable - Not applicable[376] Exhibits This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files - The report includes a list of exhibits filed, such as the Agreement and Plan of Merger, Restated Certificate of Incorporation, and various officer certifications[378][379]