Checkpoint Therapeutics(CKPT) - 2024 Q1 - Quarterly Results

Recent Corporate Updates Checkpoint Therapeutics received a CRL for cosibelimab BLA due to manufacturing issues, plans mid-2024 resubmission, and secured $14.0 million in financing - The FDA issued a CRL for the cosibelimab BLA in December 2023, citing only issues at a third-party contract manufacturing organization (CMO), with clinical data, safety, and labeling not being concerns, and Checkpoint plans to resubmit the BLA around mid-year 2024[1][6] - In January 2024, Checkpoint secured approximately $14.0 million in gross proceeds through a registered direct offering and a concurrent private placement of warrants[1] - Dr. Amit Sharma, a life sciences executive from Alexion, AstraZeneca Rare Disease, was appointed as a non-executive director to the Board in March 2024[1] Financial Results Checkpoint's Q1 2024 financial results show increased cash to $11.2 million, a 46% R&D expense reduction, and a net loss of $10.9 million Q1 2024 vs Q1 2023 Financial Highlights (in thousands) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $11,241 | N/A | +$6,313 (vs Q4 2023) | | Research & Development Expenses | $8,497 | $15,826 | -$7,329 | | General & Administrative Expenses | $2,451 | $2,292 | +$159 | | Net Loss | $10,945 | $10,474 | +$471 | Q1 2024 vs Q1 2023 Per Share Data | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss Per Share (Basic & Diluted) | $(0.33) | $(0.89) | | Weighted Average Shares Outstanding | 33,930,977 | 11,749,139 | Financial Statements Unaudited condensed financial statements for Q1 2024 detail the company's financial position, showing increased cash and assets, and reduced R&D spending Condensed Balance Sheets As of March 31, 2024, Checkpoint's balance sheet shows total assets of $12.0 million, total liabilities of $22.2 million, and a stockholders' deficit of $10.3 million Condensed Balance Sheet Data (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $11,241 | $4,928 | | Total current assets | $11,975 | $5,378 | | Total Assets | $11,975 | $5,378 | | Liabilities & Equity | | | | Total current liabilities | $22,225 | $18,425 | | Total Liabilities | $22,225 | $18,425 | | Total Stockholders' Deficit | ($10,250) | ($13,047) | Condensed Statements of Operations Q1 2024 statements of operations show no related-party revenue, a total operating loss of $10.9 million, and a net loss of ($0.33) per share Q1 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue - related party | $- | $35 | | Research and development | $8,497 | $15,826 | | General and administrative | $2,451 | $2,292 | | Total operating expenses | $10,948 | $18,118 | | Loss from operations | ($10,948) | ($18,083) | | Net Loss | ($10,945) | ($10,474) | | Net loss per common share | ($0.33) | ($0.89) | About Checkpoint Therapeutics Checkpoint Therapeutics is a clinical-stage biopharmaceutical company developing novel treatments for solid tumor cancers, including cosibelimab and olafertinib - The company's lead antibody product is cosibelimab, a potential best-in-class anti-PD-L1 antibody being evaluated for recurrent or metastatic cancers[2] - The lead small-molecule agent is olafertinib, an EGFR inhibitor for patients with EGFR mutation-positive non-small cell lung cancer[2] Forward-Looking Statements This section outlines forward-looking statements regarding cosibelimab's approval and business projections, subject to regulatory, manufacturing, and financial risks - Statements regarding the ability to address CRL issues, the timeline for BLA resubmission, and the potential approval of cosibelimab are forward-looking[8] - Key risks include potential for final data to differ from interim results, regulatory rejection, manufacturing and supply chain issues, and the need for additional funding[8]