Bio-Path(BPTH) - 2025 Q1 - Quarterly Report

PART I - FINANCIAL INFORMATION Financial Statements Unaudited Q1 2025 financials indicate a net loss, reduced cash, and a shareholders' deficit, raising going concern doubts Condensed Consolidated Balance Sheets (Unaudited) The March 31, 2025 balance sheet reflects decreased assets and cash, increased liabilities, and a shift to a shareholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $122 | $1,173 | | Total Current Assets | $2,120 | $3,776 | | Total Assets | $2,195 | $3,883 | | Liabilities & Equity | | | | Accounts Payable | $2,438 | $1,274 | | Notes Payable | $261 | $0 | | Total Current Liabilities | $4,744 | $3,295 | | Total Liabilities | $4,784 | $3,729 | | Total Shareholders' (Deficit) Equity | ($2,589) | $154 | | Total Liabilities & Shareholders' (Deficit) Equity | $2,195 | $3,883 | Condensed Consolidated Statements of Operations (Unaudited) Q1 2025 operations show a reduced net loss of $2.9 million, driven by lower research and development and general and administrative expenses Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,977 | $2,288 | | General and administrative | $1,264 | $1,407 | | Total operating expenses | $3,241 | $3,695 | | Net operating loss | ($3,241) | ($3,695) | | Change in fair value of warrant liability | $394 | $538 | | Net loss | ($2,852) | ($3,157) | | Net loss per share, basic and diluted | ($0.40) | ($4.88) | Condensed Consolidated Statements of Cash Flows (Unaudited) Q1 2025 cash flows reflect $1.3 million used in operations and a $1.1 million net decrease in cash, ending with $0.1 million Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,313) | ($1,038) | | Net cash provided by financing activities | $262 | $174 | | Net decrease in cash | ($1,051) | ($864) | | Cash, beginning of period | $1,173 | $1,052 | | Cash, end of period | $122 | $188 | Notes to the Unaudited Condensed Consolidated Financial Statements Notes detail the company's business, accounting policies, and significant going concern doubt due to insufficient cash, alongside new debt financing - The company is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing its proprietary DNAbilize® technology platform[20] - There is substantial doubt about the Company's ability to continue as a going concern, as cash of $0.1 million at March 31, 2025, plus April 2025 note proceeds, will not fund operations for the next 12 months[25] - In March 2025, the Company issued two promissory notes totaling $261.55 thousand principal, receiving $227 thousand net proceeds, with a 12% one-time interest charge[33][34] - The fair value of the warrant liability decreased from $0.4 million at year-end 2024 to $40 thousand at March 31, 2025, resulting in a non-cash gain of $0.4 million[40][42] - Subsequent to quarter-end, in April 2025, the company issued another promissory note for a principal of $161 thousand at a purchase price of $140 thousand[60] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage pipeline, reduced Q1 2025 net loss, and critical liquidity issues raising going concern doubts Overview The company is a clinical-stage RNAi drug developer with a pipeline including oncology and obesity candidates, highlighting progress in AML trials - The lead drug candidate, prexigebersen, is in a Phase 2 clinical trial for AML, with interim data showing a 75% remission rate in 20 evaluable newly diagnosed patients[63][69] - The Phase 1 clinical trial for BP1002 in refractory/relapsed lymphoma and CLL was discontinued to focus on the obesity program due to enrollment challenges[70] - The company is exploring BP1001-A for obesity treatment, with preclinical data confirming increased insulin sensitivity and plans for an IND filing in 2025[76][77] - On February 19, 2025, the company's stock was delisted from Nasdaq and began trading on the OTCQB Venture Market under the symbol 'BPTH'[85] Results of Operations Q1 2025 results show no revenue, with reduced R&D and G&A expenses leading to an improved net loss compared to Q1 2024 Comparison of Operating Results (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expense | $1,977 | $2,288 | | General and administrative expense | $1,264 | $1,407 | | Net Loss | $2,852 | $3,157 | - The decrease in R&D expense was primarily due to decreased clinical trial expenses for BP1001 and BP1002 related to patient enrollment timing[95] Liquidity and Capital Resources The company faces critical liquidity issues with only $0.1 million cash, insufficient for 12 months, relying on equity and debt financing - The company had a cash balance of $0.1 million as of March 31, 2025, insufficient to meet obligations and fund liquidity for the next 12 months[100] - Net cash used in operating activities was $1.3 million for the three months ended March 31, 2025[101] - Net cash provided by financing activities was $0.3 million for Q1 2025, sourced from warrant exercises and March 2025 Promissory Notes[103] - The company has engaged in multiple financing activities, including registered direct offerings, private placements, ATM offerings, and promissory notes in March and April 2025 to raise capital[105][108][111][112][116][119] Quantitative and Qualitative Disclosures About Market Risk This item is not applicable to the company for the reporting period - Not applicable[125] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal controls - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[127] - There were no material changes in internal control over financial reporting during the quarter[130] PART II - OTHER INFORMATION Legal Proceedings The company reports no legal proceedings - None[132] Risk Factors No material changes to risk factors were reported from the prior Annual Report on Form 10-K - There were no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[133] Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities or use of proceeds for the period - None[134] Other Information No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter[137] Exhibits This section lists exhibits filed with the Form 10-Q, including agreements, notes, lease amendments, and officer certifications