
PART I - FINANCIAL INFORMATION Financial Statements The company presents unaudited Q1 2024 financials showing a $1.1 million net loss and a going concern warning Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash | $675,977 | $1,975,799 | | Total Current Assets | $1,854,948 | $3,639,906 | | Total Assets | $3,441,740 | $5,259,476 | | Total Current Liabilities | $4,080,307 | $5,062,616 | | Total Liabilities | $4,396,206 | $5,387,209 | | Total Stockholders' Deficit | ($954,466) | ($127,733) | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total Operating Expenses | $2,092,468 | $4,803,845 | | Loss From Operations | ($2,092,468) | ($4,803,845) | | Other Income, Net | $1,022,724 | $41,767 | | Net Loss | ($1,069,744) | ($4,762,078) | | Basic and Diluted Net Loss per Share | ($1.68) | ($24.15) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($1,033,417) | ($3,869,891) | | Net Cash Used In Financing Activities | ($264,394) | ($469,810) | | Net Decrease In Cash | ($1,299,822) | ($4,323,926) | | Cash - End of Period | $675,977 | $2,646,184 | - The company is a clinical-stage biotech firm with R&D activities significantly slowed or suspended due to resource constraints24 - The company is actively evaluating strategic alternatives, including potential mergers or asset sales, to maximize stockholder value25145 - Significant losses and a $128.4 million accumulated deficit raise substantial doubt about the company's ability to continue as a going concern2627 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses a reduced net loss in Q1 2024 but highlights a critical financial state and exploration of strategic alternatives Going Concern and Management Liquidity Plans The company faces a going concern issue with cash expected to last only through October 2024 despite recent funding - As of March 31, 2024, the company had an accumulated deficit of $128.4 million and a working capital deficit of $2.2 million135 - The company has a minimum monthly cash requirement of approximately $300,000 to support operations137 - Following insurance reimbursements, the company had approximately $1.5 million in cash as of May 13, 2024, expected to fund operations through October 2024170 Consolidated Results of Operations Net loss decreased 78% in Q1 2024, driven by lower operating expenses and a one-time income from forgiven liabilities Comparison of Operating Results (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $365,186 | $578,309 | -37% | | General & Administrative | $1,556,740 | $4,008,852 | -61% | | Other Income, Net | $1,022,724 | $41,767 | +2,349% | | Net Loss | ($1,069,744) | ($4,762,078) | -78% | - The decrease in G&A expenses was primarily due to reduced legal fees (~$1.3M), accounting/regulatory fees ($450k), salaries ($300k), and stock-based compensation (~$280k)161 - The significant increase in Other Income is attributable to the forgiveness of $1,039,364 in liabilities owed to contractors for certain R&D programs41162 Liquidity and Capital Resources The company has severely constrained liquidity with a working capital deficit and significant future cash requirements - Cash balance decreased from $2.0 million at year-end 2023 to $676k at March 31, 2024, while the working capital deficit increased to $2.2 million163 - Cash used in operating activities for Q1 2024 was $1.0 million, a significant reduction from $3.9 million in Q1 2023164 - The company estimates material cash requirements of approximately $4.1 million for 2024 and $23.5 million for 2025 through 2028167 - In November 2023, the company amended its August 2023 offering, raising an additional $0.8 million in net proceeds and modifying warrant terms176177 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the firm is exempt from providing market risk disclosures - As a "smaller reporting company," the Company is exempt from the requirement to provide disclosures about market risk under Item 305(e) of Regulation S-K183 Controls and Procedures Management concluded disclosure controls were ineffective due to a material weakness in financial reporting - The principal executive and financial officers concluded that disclosure controls and procedures were not effective as of March 31, 2024186 - A material weakness was identified from the misclassification of a forgiven liability as a reduction to R&D expense instead of an increase in Other Income186 - Management's remediation plan includes implementing an additional layer of technical review for significant, non-routine entries190 PART II - OTHER INFORMATION Legal Proceedings The company is involved in several legal proceedings but does not expect a material adverse financial impact - The company is party to various legal proceedings, which are described in detail in Note 8 of the financial statements195 - Management believes the ultimate resolution of current legal proceedings will not have a material adverse effect on the company's financial position, though the outcome is uncertain194195 Risk Factors The company faces a significant risk of delisting from Nasdaq due to non-compliance with listing standards - The company is not in compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million200 - On May 14, 2024, the company received a delist determination letter from Nasdaq for failing to regain compliance by the May 13, 2024 deadline205 - The company intends to request a hearing with the Nasdaq Hearings Panel to appeal the delisting, which is expected to stay the suspension of trading206 - The company is also non-compliant with Nasdaq's audit committee requirement of at least three independent directors208211 - Delisting from Nasdaq could make trading the company's securities difficult and impair the ability to raise capital212 Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or issuer repurchases occurred during the quarter - There were no unregistered sales of equity securities during the quarter ended March 31, 2024, that were not previously disclosed213 Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or other trading arrangement during the quarter ended March 31, 2024214 Exhibits This section lists required Sarbanes-Oxley certifications and other exhibits filed with the Form 10-Q - The report includes required certifications from the Principal Executive Officer and Principal Accounting Officer under Sections 302 and 906 of the Sarbanes-Oxley Act216217