Avenue Therapeutics(ATXI) - 2020 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements Unaudited Q3 2020 financials show significant asset and cash declines, continued losses, negative cash flow, and a 'Going Concern' warning Condensed Balance Sheets As of Sep 30, 2020, total assets significantly decreased to $4.4 million from $8.9 million, impacting equity Condensed Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2020 (unaudited) (in thousands) | Dec 31, 2019 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $4,325 | $8,745 | | Total Assets | $4,352 | $8,915 | | Total Liabilities | $1,118 | $2,115 | | Total Stockholders' Equity | $3,234 | $6,800 | Unaudited Condensed Statements of Operations Net losses for Q3 and nine months ended Sep 30, 2020, significantly reduced to $1.0 million and $4.2 million due to decreased R&D Statements of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2020 (in thousands) | Three Months Ended Sep 30, 2019 (in thousands) | Nine Months Ended Sep 30, 2020 (in thousands) | Nine Months Ended Sep 30, 2019 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $466 | $1,706 | $2,382 | $18,339 | | General and administrative | $571 | $617 | $1,832 | $2,452 | | Net Loss | ($1,028) | ($2,242) | ($4,158) | ($20,493) | | Net loss per share | ($0.06) | ($0.14) | ($0.25) | ($1.32) | Unaudited Condensed Statements of Stockholders' Equity (Deficit) Stockholders' equity decreased from $6.8 million to $3.2 million due to $4.2 million net loss, partially offset by share-based compensation - The accumulated deficit grew from $(68.1) million at the end of 2019 to $(72.3) million as of September 30, 2020[8] Unaudited Condensed Statements of Cash Flows For nine months ended Sep 30, 2020, net cash used in operations was $3.4 million, resulting in a $4.4 million net decrease and $4.3 million ending balance Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2020 (in thousands) | Nine Months Ended Sep 30, 2019 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,420) | ($21,263) | | Net cash used in investing activities | ($1,000) | ($5,000) | | Net cash provided by financing activities | $0 | $32,333 | | Net change in cash | ($4,420) | $6,070 | Notes to Unaudited Interim Condensed Financial Statements Key notes highlight FDA's IV Tramadol CRL, a 'Going Concern' warning due to losses and limited cash, and InvaGen's 'Material Adverse Effect' claim - The company received a Complete Response Letter (CRL) from the FDA for IV Tramadol, citing deficiencies in terminal sterilization and safety concerns for the intended patient population[20][41] - These factors raise substantial doubt about the company's ability to continue as a going concern, as current cash of $4.3 million is only expected to fund operations through Q1 2021[22] - InvaGen, which has an agreement to acquire the company, communicated that it believes a Material Adverse Effect has occurred due to the COVID-19 pandemic, which could allow it to avoid closing the merger[17] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses FDA's IV Tramadol CRL, InvaGen's merger claim, narrowed net loss, and substantial doubt about going concern - The FDA issued a Complete Response Letter (CRL) for the IV Tramadol NDA, and a meeting with the FDA is scheduled for Q4 2020 to address the issues[55] - InvaGen has asserted a 'Material Adverse Effect' due to the COVID-19 pandemic's potential impact on IV Tramadol sales, which could jeopardize the second stage of the merger, a claim Avenue disputes[56] - The company had an accumulated deficit of $72.3 million as of September 30, 2020, and expects to continue incurring operating losses[51][60] - The company's cash position raises substantial doubt about its ability to continue as a going concern, as it may need additional capital to address FDA deficiencies or if the merger with InvaGen is delayed or terminated[74][75] Results of Operations Operating loss significantly decreased in 2020, driven by a $15.9 million reduction in R&D expenses to $2.4 million for the nine months ended Sep 30 Comparison of Operating Results (in thousands) | Period | Research & Development (in thousands) | General & Administrative (in thousands) | Loss from Operations (in thousands) | | :--- | :--- | :--- | :--- | | 3 Months Ended Sep 30, 2020 | $466 | $571 | ($1,037) | | 3 Months Ended Sep 30, 2019 | $1,706 | $617 | ($2,323) | | 9 Months Ended Sep 30, 2020 | $2,382 | $1,832 | ($4,214) | | 9 Months Ended Sep 30, 2019 | $18,339 | $2,452 | ($20,791) | - The $15.9 million decrease in nine-month R&D expenses was primarily due to the completion of the abdominoplasty study ($13.3 million) and safety study ($1.3 million)[71] Liquidity and Capital Resources Critical liquidity with $4.3 million cash raises substantial doubt about going concern, necessitating additional capital due to losses and merger uncertainties Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Activity | 2020 (in thousands) | 2019 (in thousands) | | :--- | :--- | :--- | | Operating Activities | ($3,420) | ($21,263) | | Investing Activities | ($1,000) | ($5,000) | | Financing Activities | $0 | $32,333 | - Net cash used in operating activities was $3.4 million for the nine months ended September 30, 2020, primarily comprised of the $4.2 million net loss, offset by non-cash charges like share-based compensation[78] - Net cash from financing activities was $0 in the first nine months of 2020, compared to $32.3 million in the same period of 2019, which came from the issuance of shares to InvaGen[80] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section is not applicable as the company is a smaller reporting company - The company has indicated that there are no quantitative and qualitative disclosures about market risk to report[82] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of September 30, 2020, the Chief Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures are effective[86] - No changes in internal control over financial reporting occurred during the fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[88] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports that it is not currently involved in any litigation that it believes could have a material adverse effect on its financial position or results of operations - The company is not involved in any litigation that is expected to have a material adverse effect on its financial condition or operations[89] Item 1A. Risk Factors The company faces extensive risks, including potential merger failure, IV Tramadol FDA CRL, severe financial instability, and IP challenges Risks Related to our Potential Merger with InvaGen Pharmaceuticals The InvaGen merger faces significant uncertainty due to FDA approval conditions and InvaGen's 'Material Adverse Effect' claim, potentially leading to termination - InvaGen has communicated that it believes a 'Material Adverse Effect' has occurred due to the COVID-19 pandemic's impact on IV Tramadol's commercial prospects, potentially allowing it to avoid closing the merger[93] - If the merger is not completed, the company's business could be materially and adversely affected, and its stock price could decline, partly due to unrecovered expenses related to the transaction[91][93] Risks Related to Our Business and Industry Success depends entirely on IV Tramadol, facing major risks from FDA CRL, going concern doubt, single manufacturer reliance, and competition - The company is entirely dependent on the success of its only product candidate, IV Tramadol[98] - The FDA issued a CRL for IV Tramadol citing that it is not safe for the intended patient population and has deficiencies related to terminal sterilization validation, which may prevent or delay approval[104] - There is substantial doubt about the company's ability to continue as a going concern, given its financial condition and the uncertainty surrounding IV Tramadol's approval[111] - Public, medical, and governmental concern regarding opioid safety could negatively impact the ability to commercialize IV Tramadol, even if approved[156][158] Risks Related to Intellectual Property Commercial success relies on IV Tramadol patent protection, but faces risks from its generic active ingredient, non-infringing competitor formulations, and litigation - The company's ability to successfully commercialize its products may be impaired if it is unable to obtain and maintain sufficient patent protection[214] - The active ingredient in IV Tramadol is generic, limiting patent protection to the specific formulation, and competitors could develop alternative formulations that do not infringe on the company's patents[224][225] - The company may become involved in expensive and time-consuming lawsuits to protect its patents or defend against infringement claims from third parties[227][231] Risks Related to Our Finances and Capital Requirements History of significant losses and expected continued losses raise substantial doubt about going concern, necessitating additional funding that may not be available or could lead to dilution - The company has incurred significant losses since inception in 2015 and expects to incur losses for the foreseeable future, with substantial doubt about its ability to continue as a going concern[246][248] - Substantial additional funding will be required to advance clinical development and commercialize product candidates, but such funding may not be available on acceptable terms[255][256] - As an 'emerging growth company' and 'smaller reporting company,' the company is subject to reduced disclosure requirements, which may make its stock less attractive to some investors[267][271] Risks Relating to Securities Markets and Investment in Our Stock Investment in the company's stock carries significant risk due to high volatility, Fortress Biotech's controlling stake as a 'controlled company' with governance exemptions, and potential conflicts of interest - The company's stock price is subject to substantial price and volume fluctuations, typical for biotechnology and pharmaceutical companies[274][275] - Fortress Biotech controls a voting majority of the company's stock, giving it control over director elections and other major corporate decisions[277] - The company is a 'controlled company' under NASDAQ rules and relies on exemptions from certain corporate governance requirements, such as having a majority of independent directors[280][281] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section is not applicable - No recent sales of unregistered securities were reported[290] Item 3. Defaults Upon Senior Securities This section is not applicable - No defaults upon senior securities were reported[290] Item 4. Mine Safety Disclosures This section is not applicable - No mine safety disclosures were reported[290] Item 5. Other Information This section is not applicable - No other information was reported[290] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL-formatted financial statements - Exhibits include CEO and CFO certifications under Sarbanes-Oxley Act Sections 302 and 906[291] - The financial statements are provided in XBRL format as an exhibit[291]