Plus Therapeutics(PSTV) - 2022 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents Plus Therapeutics, Inc.'s unaudited condensed financial statements and detailed notes Condensed Balance Sheets Condensed Balance Sheet Highlights (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $21,239 | $18,400 | | Total current assets | $22,104 | $19,724 | | Total assets | $24,516 | $21,981 | | Total current liabilities | $4,921 | $5,870 | | Total liabilities | $9,874 | $11,145 | | Total stockholders' equity | $14,642 | $10,836 | - Total assets increased by $2.535 million, and total stockholders' equity increased by $3.806 million from December 31, 2021, to March 31, 2022[14] Condensed Statements of Operations Condensed Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,785 | $1,127 | | General and administrative | $2,141 | $1,352 | | Total operating expenses | $3,926 | $2,479 | | Operating loss | $(3,926) | $(2,479) | | Net loss | $(4,116) | $(2,720) | | Net loss per share, basic and diluted | $(0.19) | $(0.33) | | Weighted average shares | 21,507,061 | 8,267,901 | - Net loss increased by $1.396 million (51.3%) year-over-year, primarily driven by higher operating expenses[16] - Net loss per share decreased from $(0.33) to $(0.19) despite a higher net loss, due to a significant increase in the weighted average shares outstanding[16] Condensed Statements of Stockholders' Equity Changes in Stockholders' Equity (in thousands) | Item | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | | Balance at December 31, 2021 | $10,836 | | Stock-based compensation | $180 | | Sale of common stock, net | $7,742 | | Net loss | $(4,116) | | Balance at March 31, 2022 | $14,642 | - Total stockholders' equity increased by $3.806 million from December 31, 2021, to March 31, 2022, primarily due to net proceeds from common stock sales ($7.742 million) partially offset by the net loss ($4.116 million)[19] Condensed Statements of Cash Flows Condensed Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,876) | $(3,006) | | Net cash used in investing activities | $(577) | $(84) | | Net cash provided by financing activities | $7,292 | $9,191 | | Net increase in cash and cash equivalents | $2,839 | $6,101 | | Cash and cash equivalents at end of period | $21,239 | $14,447 | - Net cash used in operating activities increased by $0.870 million year-over-year, reflecting increased expenditures[21] - Net cash provided by financing activities decreased by $1.899 million year-over-year, primarily due to lower proceeds from common stock sales and no warrant exercises in 2022[21] Notes to Condensed Financial Statements - The Company plans to adopt ASU 2016-13 (Credit Losses) on January 1, 2023, and does not expect a material impact on its financial statements[24] - The Company incurred a net loss of $4.1 million for Q1 2022, with an accumulated deficit of $451.0 million, and used $3.9 million in cash for operating activities[27] - The Company believes its current cash and cash equivalents ($21.2 million) will be sufficient to fund operations for at least the next 12 months but continues to seek additional capital[28][14] - As of March 31, 2022, $3.6 million principal was outstanding under the Term Loan, excluding a $3.2 million final payment fee, and the Company was in compliance with all debt covenants[36] - The Company entered into a Statement of Work with Medidata Solutions, Inc. on March 31, 2022, to build a Synthetic Control Arm® (SCA) platform for its Phase 2 clinical trial of 186RNL in GBM, with managed services fees of $1.45 million and a contingent fee of $150,000[48][49] - The Company is a defendant in a lawsuit by Lorem Vascular, Pte. Ltd. claiming at least $6 million in damages for alleged false representations regarding a UK manufacturing facility, which the Company is vigorously defending[54] - The Company licensed BAM patents and technology from UT Health Science Center at San Antonio on December 31, 2021, and radiolabeled nanoliposome technology from NanoTx, Corp. on March 29, 2020[56][58] - During Q1 2022, the Company issued 5,665,000 shares of common stock under the Lincoln Park Purchase Agreement for $7.0 million net proceeds and 1,022,610 shares under the 2022 Distribution Agreement for $0.7 million net proceeds[70][71] - Total unrecognized stock-based compensation cost is approximately $1.3 million, expected to be recognized over a weighted average period of 2.79 years[77] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management's discussion and analysis of Q1 2022 financial condition and results of operations Overview - Plus Therapeutics is developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, utilizing novel drug formulations like Rhenium isotopes within nanoliposomes and microspheres[83][85] - The lead radiotherapeutic candidate, Rhenium-186 NanoLiposome (186RNL), targets CNS cancers (recurrent glioblastoma, leptomeningeal metastases, pediatric brain cancers)[86] - The recently acquired Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM) is designed to treat solid organ cancers, including primary and secondary liver cancers[86][109] - Interim results from the Phase 1/2a ReSPECT-GBM trial for recurrent glioblastoma show 186RNL delivered up to 740 Gy of absorbed radiation to tumor tissue without significant toxicities, with a statistically significant difference in overall survival for patients receiving a presumed therapeutic dose (>100 Gy)[95][99][100] - The FDA granted Orphan Drug and Fast Track designations to 186RNL for glioblastoma and Fast Track designation for leptomeningeal metastases, with the ReSPECT-LM Phase 1 clinical trial initiating in Q1 2022[96][103] - The Company plans to submit an IND application for 186RNL for pediatric brain cancer (high-grade glioma and ependymoma) in late 2022 or early 2023[108] - A Statement of Work was entered with Medidata Solutions, Inc. on March 31, 2022, to build a Synthetic Control Arm® (SCA) platform for the 186RNL Phase 2 GBM clinical trial[111] Results of Operations Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change (YoY) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Research and development | $1,785 | $1,127 | +$658 (58.4%) | | General and administrative | $2,141 | $1,352 | +$789 (58.4%) | | Total operating expenses | $3,926 | $2,479 | +$1,447 (58.4%) | - The increase in R&D expenses was primarily due to increased development costs for 186RNL ($0.5 million), professional expenses ($0.1 million), and personnel expenses ($0.1 million) as the company plans for a pivotal trial[116] - General and administrative expenses rose mainly due to a $0.6 million increase in legal, intellectual property, and other professional expenses, and a $0.2 million increase in personnel-related expenses[118] Financing Items (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Interest income | $7 | $4 | +$3 | | Interest expense | $(198) | $(247) | +$49 | | Change in fair value of liability instruments | $1 | $2 | -$1 | | Total other expense | $(190) | $(241) | +$51 | - Interest expense decreased due to scheduled debt principal repayments that commenced in November 2021[121][122] Liquidity and Capital Resources Key Liquidity Measures (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $21,239 | $18,400 | | Current assets | $22,104 | $19,724 | | Current liabilities | $4,921 | $5,870 | | Working capital | $17,183 | $13,854 | - The Company believes its cash and cash equivalents of $21.2 million at March 31, 2022, will be sufficient to fund operations for at least the next twelve months[123] - During Q1 2022, the Company raised approximately $7.0 million in net proceeds from common stock sales under the Lincoln Park Purchase Agreement and $0.7 million under the 2022 Distribution Agreement with Canaccord Genuity LLC[125][127] Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,876) | $(3,006) | | Net cash used in investing activities | $(577) | $(84) | | Net cash provided by financing activities | $7,292 | $9,191 | | Net increase in cash and cash equivalents | $2,839 | $6,101 | - Material cash obligations include $1.45 million in managed services fees to Medidata (plus a $150,000 contingent fee), ongoing principal and interest payments on the Term Loan, and operating lease payments[131][132] Critical Accounting Policies and Significant Estimates - The Company's critical accounting policies and estimates, including those for goodwill impairment and fair value measurement of liability classified warrants, remain consistent with its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, with no material changes in Q1 2022[137][139][140][141] Item 3. Quantitative and Qualitative Disclosures about Market Risk No material quantitative or qualitative disclosures regarding market risk for the reported period - This item is not applicable for the Company[142] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective, with no material changes in internal control - Disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2022[144] - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2022[145] PART II. OTHER INFORMATION Item 1. Legal Proceedings Details an ongoing lawsuit against Plus Therapeutics, Inc. by Lorem Vascular, Pte. Ltd. claiming at least $6 million - Plus Therapeutics, Inc. is a defendant in a lawsuit filed by Lorem Vascular, Pte. Ltd. on June 22, 2021[146] - The complaint alleges false representations regarding a UK manufacturing facility purchased by Lorem, claiming at least $6,000,000 in compensatory damages and operational costs[146] - The Company believes the Lorem Claim is without merit and is vigorously defending the case[146] Item 1A. Risk Factors Refers to the Annual Report on Form 10-K for risk factors, confirming no material changes this quarter - There have been no material changes to the risk factors included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021[147] Item 6. Exhibits Lists all exhibits filed as part of this Form 10-Q, including agreements, certifications, and XBRL data - Key exhibits include the Distribution Agreement with Canaccord Genuity LLC, Medidata Services Agreement and Statement of Work, and certifications from the Principal Executive Officer and Principal Financial and Accounting Officer[150] - The filing also includes Inline XBRL Instance, Schema, Calculation, Definition, Label, and Presentation Linkbase Documents, along with the Cover Page Interactive Data File[150][151]