Cardiff Oncology(CRDF) - 2020 Q3 - Quarterly Report

PART I FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) Unaudited financial statements for Q3 2020 show significant increases in cash and total assets, driven by financing, despite continued net losses from R&D Condensed Balance Sheets As of September 30, 2020, total assets more than doubled to $39.5 million, primarily due to a substantial increase in cash and cash equivalents Condensed Balance Sheet Highlights (Unaudited) | Account | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $36,405,432 | $10,195,292 | | Total current assets | $38,188,657 | $11,353,729 | | Total Assets | $39,450,449 | $13,086,546 | | Liabilities & Equity | | | | Total current liabilities | $5,442,070 | $4,781,744 | | Total Liabilities | $5,927,899 | $5,775,202 | | Total stockholders' equity | $33,522,550 | $7,311,344 | Condensed Statements of Operations For Q3 2020, the company reported higher net losses despite increased royalty revenues, with net loss per share decreasing due to more shares outstanding Condensed Statements of Operations Summary (Unaudited) | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $136,401 | $51,687 | $246,738 | $152,055 | | Total operating expenses | $4,499,023 | $4,259,163 | $12,835,682 | $12,541,253 | | Loss from operations | $(4,362,622) | $(4,207,476) | $(12,588,944) | $(12,389,198) | | Net loss attributable to common stockholders | $(4,502,591) | $(4,147,609) | $(15,994,289) | $(12,458,072) | | Net loss per common share | $(0.19) | $(0.69) | $(1.00) | $(2.40) | | Weighted-average shares outstanding | 23,341,218 | 6,024,679 | 15,941,665 | 5,180,221 | Condensed Statements of Stockholders' Equity Stockholders' equity significantly increased from $7.3 million to $33.5 million, primarily driven by capital raised from stock and warrant issuances - The significant increase in stockholders' equity was a result of multiple financing activities, including the sale of common stock and warrants, issuance of preferred stock, and the exercise of warrants, which collectively raised substantial capital[13] Condensed Statements of Cash Flows For the nine months ended September 30, 2020, operating activities used $11.2 million cash, offset by $37.6 million from financing, resulting in a $26.2 million net cash increase Cash Flow Summary (Nine Months Ended September 30) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,191,025) | $(9,990,636) | | Net cash used in investing activities | $(153,784) | $(67,622) | | Net cash provided by financing activities | $37,554,949 | $7,637,331 | | Net change in cash and cash equivalents | $26,210,140 | $(2,420,927) | | Cash and cash equivalents—End of period | $36,405,432 | $9,032,206 | Notes to Condensed Financial Statements Notes detail the company's liquidity, accounting policies, fair value measurements, derivative liabilities, equity transactions, and subsequent events including a major public offering - The company believes its cash of $36.4 million as of September 30, 2020, is sufficient to fund requirements for at least the next 12 months. This position was further strengthened by a subsequent public offering in October 2020 that raised gross proceeds of approximately $100.9 million[32][33] - The company recognized non-cash deemed dividends totaling approximately $3.3 million related to the beneficial conversion features of its Series D and Series E Convertible Preferred Stock issuances, which increased the net loss attributable to common stockholders[67][70] - Subsequent to the quarter's end, the company completed an underwritten public offering raising net proceeds of approximately $94.0 million, received an additional $3.4 million from warrant exercises, and repaid its $305,000 PPP loan in full[86][87][88] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical-stage biotech focus on onvansertib, positive trial updates, increased net loss from expenses, and strengthened liquidity via financing activities Overview Cardiff Oncology, a clinical-stage biotech, focuses on developing onvansertib, a PLK1 inhibitor, for various cancers, highlighting three ongoing clinical trials - The company's primary focus is the clinical development of onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, for use in combination with standard-of-care treatments[94] - In May 2020, the company changed its name from Trovagene, Inc. to Cardiff Oncology, Inc. and its ticker to 'CRDF'[117] Clinical Program Updates Encouraging updates on three clinical trials show high disease control rates in mCRC, mCRPC on track, and a 24% complete response rate in AML - KRAS-mutated mCRC (TROV-054): Of 11 evaluable patients, 10 (91%) achieved disease control, and 5 (45%) achieved a partial response, with durable responses ranging from 6 to over 12 months[105] - mCRPC (TROV-053): The trial is on track to meet its primary endpoint, with a 31% disease control rate in evaluable patients from cohorts A and B[110] - AML (TROV-052): The Phase 1b portion was completed, and a complete response rate of 24% was observed across all dose levels[115] Results of Operations For the nine months ended September 30, 2020, revenues increased, R&D decreased, SG&A rose, and net loss attributable to common shareholders increased to $16.0 million Comparison of Operations (Nine Months Ended September 30) | Metric | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Total revenues | $246,738 | $152,055 | +$94,683 | | Research and development | $8,036,225 | $8,297,763 | -$261,538 | | Selling, general and administrative | $4,799,457 | $4,243,490 | +$555,967 | | Net loss attributable to common shareholders | $(15,994,289) | $(12,458,072) | +$3,536,217 | Liquidity and Capital Resources The company ended Q3 2020 with $36.4 million cash, bolstered by $37.6 million from financing, with management asserting sufficient funds for 12 months - As of September 30, 2020, the company had working capital of $32.7 million, a significant increase from $6.6 million at year-end 2019[142] - In October 2020, a public offering was completed, generating gross proceeds of approximately $100.9 million and net proceeds of approximately $94.0 million, substantially enhancing the company's capital resources[145] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section is not applicable to the company - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[147] Item 4. Controls and Procedures Disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2020, to provide reasonable assurance that required information is properly recorded and reported[148] PART II OTHER INFORMATION Item 1. Legal Proceedings The company reported no legal proceedings during the period - The company has no legal proceedings to report[153] Item 1A. Risk Factors The COVID-19 pandemic is identified as a material risk, potentially impacting clinical trials, regulatory reviews, and supply chain operations - The COVID-19 pandemic could cause significant disruptions to clinical trials, including delays in patient enrollment and retention[156] - Operations of the FDA and other regulatory authorities may be interrupted, potentially impacting review and approval timelines[156] - The company may face interruptions or delays in receiving supplies of its product candidate from contract manufacturing organizations[156] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities - The company reports 'None' for this item[162] Item 6: Exhibits This section lists exhibits filed with Form 10-Q, including the Underwriting Agreement, officer certifications, and Inline XBRL data files