Tempest Therapeutics(TPST) - 2019 Q3 - Quarterly Report

PART I Financial Statements (unaudited) Millendo Therapeutics reported a $31.9 million net loss for the nine months ended September 30, 2019, with $48.3 million in cash and the adoption of ASC 842 Consolidated Balance Sheets Total assets decreased to $58.5 million by September 30, 2019, driven by reduced cash, while liabilities increased and stockholders' equity declined due to net loss Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $47,151 | $73,286 | | Total current assets | $53,652 | $83,422 | | Total assets | $58,479 | $84,074 | | Liabilities & Equity | | | | Total current liabilities | $10,513 | $9,817 | | Total liabilities | $13,650 | $10,952 | | Total stockholders' equity | $44,829 | $73,122 | | Total liabilities and stockholders' equity | $58,479 | $84,074 | Consolidated Statements of Operations and Comprehensive Loss The company reported no revenue, with a net loss of $11.6 million for Q3 2019 and $31.9 million for the nine months, driven by increased R&D and G&A expenses Operating Results (in thousands, except per share data) | Metric | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,308 | $3,871 | $19,493 | $9,840 | | General and administrative | $4,443 | $3,935 | $13,075 | $7,340 | | Loss from operations | $11,751 | $7,806 | $32,568 | $17,180 | | Net loss | $(11,632) | $(7,891) | $(31,869) | $(17,319) | | Net loss per share, basic and diluted | $(0.87) | $(10.61) | $(2.38) | $(23.43) | Consolidated Statements of Stockholders' Equity Total stockholders' equity decreased to $44.8 million by September 30, 2019, primarily due to a $31.9 million net loss, partially offset by stock-based compensation Changes in Stockholders' Equity (Nine Months Ended Sep 30, 2019, in thousands) | Description | Amount | | :--- | :--- | | Balance at January 1, 2019 | $73,122 | | Net loss | $(31,869) | | Stock-based compensation expense | $3,130 | | Exercise of stock options & warrants | $471 | | Other adjustments | $(25) | | Balance at September 30, 2019 | $44,829 | Consolidated Statements of Cash Flows Net cash used in operating activities was $29.5 million for the nine months ended September 30, 2019, resulting in a $25.4 million net decrease in cash, bringing the period-end balance to $48.3 million Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(29,531) | $(14,421) | | Net cash provided by (used in) investing activities | $4,021 | $(544) | | Net cash provided by financing activities | $83 | $7,134 | | Net decrease in cash, cash equivalents and restricted cash | $(25,422) | $(7,855) | Notes to Unaudited Interim Consolidated Financial Statements The notes detail the company's focus on orphan endocrine diseases with key candidates livoletide and nevanimibe, the discontinuation of nevanimibe for Cushing's, $48.3 million in cash for liquidity, and the adoption of ASC 842 - The company is a late-stage biopharmaceutical firm focused on orphan endocrine diseases, with key product candidates being livoletide (PWS), nevanimibe (CAH), and MLE-301 (VMS)[21] - In August 2019, the company discontinued its Phase 2 clinical trial and suspended development of nevanimibe for endogenous Cushing's syndrome (CS) due to slow patient enrollment[22] - As of September 30, 2019, the company had $48.3 million in cash, cash equivalents, marketable securities, and restricted cash, expected to fund operations through Q4 2020[29][31] - The adoption of ASC 842 resulted in the recognition of a $3.6 million operating lease right-of-use asset and $4.5 million operating lease liabilities as of September 30, 2019[35][41] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical trial advancements for livoletide and nevanimibe, including program updates and the suspension of the Cushing's program, alongside a $31.9 million net loss driven by increased R&D, with $48.3 million in cash expected to fund operations through Q4 2020 - The pivotal Phase 2b/3 clinical trial of livoletide in PWS is fully recruited for the Phase 2b portion, with topline results expected in H1 2020[75][77] - Topline results for nevanimibe in CAH (Cohort 1) are now expected in H2 2020, a delay from prior estimates[76][79] - In August 2019, the company discontinued its Phase 2 trial and suspended development of nevanimibe for Cushing's syndrome (CS) due to slow enrollment, redirecting resources to other programs[80] R&D Expenses by Program (in thousands) | Program | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | | Nevanimibe expenses | $2,595 | $3,140 | | Livoletide expenses | $9,881 | $3,192 | | MLE-301 expenses | $1,282 | $— | | Personnel & Other | $5,735 | $3,508 | | Total | $19,493 | $9,840 | Comparison of Operating Results (Nine Months Ended Sep 30, in thousands) | Item | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | Research and development | $19,493 | $9,840 | $9,653 | | General and administrative | $13,075 | $7,340 | $5,735 | | Net loss | $(31,869) | $(17,319) | $(14,550) | - The company has an "at-the-market" (ATM) equity distribution agreement for up to $50.0 million, with no shares issued to date[108] - As of September 30, 2019, the company had $48.3 million in cash, cash equivalents, marketable securities, and restricted cash, expected to fund operations through Q4 2020 and the livoletide Phase 2b trial topline results[109] Quantitative and Qualitative Disclosures About Market Risk This section is not required for smaller reporting companies, thus no information is provided - Disclosure is not required for smaller reporting companies[120] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2019[121] - No material changes to internal control over financial reporting occurred during the quarter ended September 30, 2019[122] PART II — OTHER INFORMATION Legal Proceedings The company is defending against multiple shareholder lawsuits inherited from the OvaScience merger, including derivative and class actions, believing them to be without merit - The company is defending against a shareholder derivative action (Cima v. Dipp) and a shareholder class action (Dahhan v. OvaScience) related to former OvaScience operations[126][127] - A third lawsuit, a shareholder derivative complaint (Chiu v. Dipp), is stayed pending resolution of the Dahhan Action[128] - For all ongoing legal matters, the company believes the complaints are without merit but cannot currently estimate potential losses[126][127][128] Risk Factors The company faces significant risks including ongoing operating losses, the need for additional capital, clinical development and regulatory approval uncertainties for livoletide and nevanimibe, intense competition, intellectual property limitations, and reliance on third-party manufacturers and CROs - The company has a history of significant operating losses ($31.9 million for the nine months ended Sep 30, 2019) and expects substantial future losses, requiring additional capital[132][140] - Future success is highly dependent on the successful clinical development, regulatory approval, and commercialization of livoletide and nevanimibe[149] - The company faces substantial competition for its product candidates in PWS, CAH, and VMS from companies with greater resources[168][170][171][172] - The company relies on third-party CMOs and CROs for manufacturing and clinical trials, exposing it to risks of supply delays and performance issues[292][301] - A key intellectual property risk is the lack of broad composition of matter patent protection for nevanimibe, potentially limiting competitive barriers[278] - The company is subject to ongoing legal proceedings inherited from the OvaScience merger, potentially incurring substantial costs and diverting management attention[335] Unregistered Sales of Equity Securities and Use of Proceeds The company did not sell any unregistered equity securities or repurchase any of its equity securities during the three months ended September 30, 2019 - The company did not sell any unregistered securities during the third quarter of 2019[345] - The company did not repurchase any of its equity securities during the third quarter of 2019[346] Defaults Upon Senior Securities This item is not applicable to the company - Not applicable[347] Mine Safety Disclosures This item is not applicable to the company - Not applicable[348] Other Information This item is not applicable to the company - Not applicable[349] Exhibits This section lists exhibits filed with the Form 10-Q, including amended employment and consulting agreements, and required CEO and CFO certifications - The report includes several new or amended management compensatory plans and agreements as exhibits[351][352] - CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act are filed with the report[351]