PART I - FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents unaudited financial statements highlighting a 'going concern' issue, recent equity raises, and significant subsequent events Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $20,927,729 | $16,966,168 | | Total Current Assets | $22,164,523 | $17,556,279 | | Total Assets | $26,087,571 | $21,291,292 | | Liabilities & Equity | | | | Total Current Liabilities | $4,317,909 | $3,859,874 | | Total Liabilities | $7,126,160 | $7,092,726 | | Total Stockholders' Equity | $18,961,411 | $14,198,566 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Account | Nine Months ended Sep 30, 2020 | Nine Months ended Sep 30, 2019 | | :--- | :--- | :--- | | Total Revenues | $6,313 | $17,096 | | Research and development | $10,567,988 | $7,596,097 | | Total Operating Expenses | $15,595,009 | $12,335,037 | | Net Loss | ($15,238,380) | ($12,541,749) | | Net Loss Per Share | ($0.34) | ($0.33) | - The company has incurred losses of $105.0 million since inception and has negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern42 - In May 2020, the company completed a public offering, issuing approximately 5 million shares for aggregate gross proceeds of $13.8 million, resulting in net proceeds of $12.7 million61 - Subsequent to the quarter end, the company raised approximately $471,600 under its equity distribution agreement, borrowed $973,000, and entered a new $25 million "at the market" offering program122123129 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management analyzes financial results, noting increased R&D spending and a higher net loss, while highlighting liquidity from equity offerings and a going concern warning Company Overview, Developments, and Liquidity Details the company's epigenetics platform, cash position of $20.9 million, operating cash burn, and the auditors' going concern warning - The company applies its Nucleosomics platform to develop simple, cost-effective blood tests to help diagnose a range of cancers and other diseases136 - As of September 30, 2020, the company held cash and cash equivalents of approximately $20.9 million140 - Net cash used in operating activities increased to $13.7 million for the nine months ended September 30, 2020, from $10.1 million in the prior-year period, mainly due to higher R&D expenditures141 - Net cash provided by financing activities was $18.5 million for the nine months ended September 30, 2020, primarily from a public offering and an Equity Distribution Agreement145 - Auditors issued a going concern warning in their report for the year ended December 31, 2019, due to the company's history of not attaining profitable operations150 Results of Operations Compares quarterly and nine-month results, showing a widening net loss driven by a significant increase in R&D expenses Comparison of Operations - Three Months Ended September 30 | Metric | 2020 | 2019 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $575 | $17,096 | ($16,521) | (97%) | | R&D Expenses | $3,180,177 | $2,642,610 | $537,567 | 20% | | G&A Expenses | $1,080,308 | $1,354,992 | ($274,684) | (20%) | | Net Loss | ($4,335,948) | ($4,180,805) | $155,143 | 4% | Comparison of Operations - Nine Months Ended September 30 | Metric | 2020 | 2019 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $6,313 | $17,096 | ($10,783) | (63%) | | R&D Expenses | $10,567,988 | $7,596,097 | $2,971,891 | 39% | | G&A Expenses | $4,292,666 | $4,020,893 | $271,773 | 7% | | Net Loss | ($15,238,380) | ($12,541,749) | $2,696,631 | 22% | - The increase in R&D expenses for the nine-month period was primarily related to higher antibody costs, sample costs, laboratory expenses, and personnel expenses167 Item 3. Quantitative and Qualitative Disclosures About Market Risk The company is exempt from market risk disclosures as a smaller reporting company - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item181 Item 4. Controls and Procedures Management concludes disclosure controls were ineffective due to material weaknesses in financial reporting, with a remediation plan underway - Management concluded that the company's disclosure controls and procedures were not effective as of September 30, 2020183 - Material weaknesses were identified due to insufficient segregation of duties in Finance, inadequate oversight in Information Technology, and a lack of monitoring controls for complex transactions189 - The company is implementing a remediation plan that includes selecting a new financial reporting system to automate processes and strengthen controls185 PART II - OTHER INFORMATION Item 1. Legal Proceedings The company is not aware of any material existing or pending legal proceedings - The company knows of no material, existing or pending legal proceedings against it192 Item 1A. Risk Factors No material changes to risk factors have occurred since previous filings - There have been no material changes in the company's assessment of risk factors affecting its business since those presented in its Annual Report and the Q1 2020 Form 10-Q193 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported for the period - None194 Item 3. Defaults Upon Senior Securities No defaults upon senior securities were reported - None195 Item 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations - Not applicable196 Item 5. Other Information Discloses significant subsequent events, including a new CEO consulting agreement and a $25 million 'at the market' offering program - On November 10, 2020, the company entered into a new consulting services agreement for its Group Chief Executive Officer, Cameron Reynolds, with a monthly fee of $35,650197 - On November 12, 2020, the company entered into an Equity Distribution Agreement to sell up to $25,000,000 of its common stock through an "at the market" offering program199 Item 6. Exhibits Lists all exhibits filed with the report, including key agreements and officer certifications - The report includes several exhibits, notably the Equity Distribution Agreement (1.1), a legal opinion (5.1), a consulting services agreement (10.1), and certifications from the CEO and CFO (31.1, 31.2, 32.1)202
Volition(VNRX) - 2020 Q3 - Quarterly Report