
PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) The company reported a net loss of $7.4 million for Q1 2021, with cash and equivalents at $39.7 million and total assets at $48.2 million, reflecting a $158.8 million accumulated deficit Condensed Consolidated Balance Sheets As of March 31, 2021, total assets decreased to $48.2 million, liabilities increased to $14.7 million, and stockholders' equity decreased to $33.5 million Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $39,695 | $47,076 | | Total current assets | $41,647 | $50,202 | | Total assets | $48,198 | $51,911 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $10,850 | $10,099 | | Total liabilities | $14,727 | $11,966 | | Accumulated deficit | ($158,830) | ($151,408) | | Total stockholders' equity | $33,471 | $39,945 | | Total liabilities and stockholders' equity | $48,198 | $51,911 | Condensed Consolidated Statements of Operations Net loss for Q1 2021 increased to $7.4 million from $6.4 million in Q1 2020, primarily due to a $1.1 million rise in R&D costs Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $4,704 | $3,571 | | General and administrative | $2,635 | $2,260 | | Total operating expenses | $7,339 | $5,831 | | Loss from operations | ($7,339) | ($5,831) | | Net loss | ($7,422) | ($6,402) | | Net loss per share - basic and diluted | ($0.14) | ($0.90) | | Basic and diluted weighted average shares outstanding | 51,313 | 7,122 | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $5.6 million, resulting in a $7.5 million net decrease in cash, bringing the end-of-period balance to $39.8 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,605) | ($7,761) | | Net cash used in investing activities | ($13) | ($12) | | Net cash used in financing activities | ($1,875) | $0 | | Net change in cash, cash equivalents and restricted cash | ($7,493) | ($7,773) | | Cash, cash equivalents and restricted cash at end of period | $39,846 | $17,793 | Notes to Unaudited Condensed Consolidated Financial Statements Notes confirm the company's biopharmaceutical business, 12-month funding outlook, new lease standard adoption, term loan details, and COVID-19 impact on trials - The company is a clinical-stage biopharmaceutical company developing proprietary antibody therapeutics for cancer treatment23 - Based on current plans, the company expects its cash and cash equivalents of $39.7 million (as of March 31, 2021) to fund operating expenses and capital requirements for the next 12 months27 - The company adopted the new lease accounting standard ASU 2016-02 on January 1, 2021, resulting in the recognition of a right-of-use asset of $5.1 million and a corresponding lease liability3244 - As of March 31, 2021, the company had $7.5 million in debt outstanding from its Credit Facility with Pacific Western Bank, with principal payments of $625,000 due monthly through March 202239101 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage biopharmaceutical focus, Q1 2021 net loss of $7.4 million due to increased R&D, and cash expected to fund operations into Q2 2022, with substantial additional funding required Overview and Pipeline The company is a clinical-stage biopharmaceutical firm with lead product CTX-471 in Phase 1b and CTX-8371 in IND-enabling studies, having incurred significant operating losses - Lead product candidate CTX-471 is in the dose expansion stage (Phase 1b) of its trial, with a Phase 2/3 trial expected to start in H2 202265 - Second product candidate CTX-8371 is undergoing IND-enabling studies, with an IND submission targeted for H1 202265 - The company has incurred significant operating losses since inception, with an accumulated deficit of $158.8 million as of March 31, 202167 Results of Operations Total operating expenses increased by $1.5 million to $7.3 million in Q1 2021, driven by a $1.1 million rise in R&D and a $0.4 million increase in G&A Comparison of Operations (in thousands) | Line Item | Q1 2021 | Q1 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $4,704 | $3,571 | $1,133 | | General and administrative | $2,635 | $2,260 | $375 | | Total operating expenses | $7,339 | $5,831 | $1,508 | | Net loss | ($7,422) | ($6,402) | ($1,020) | R&D Expenses by Program (in thousands) | Program | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | CTX-471 | $998 | $865 | | CTX-8371 | $1,494 | $55 | | Unallocated R&D | $2,095 | $2,606 | | Total R&D | $4,704 | $3,571 | Liquidity and Capital Resources As of March 31, 2021, the company had $39.7 million in cash, expected to fund operations into Q2 2022, with substantial additional funding required for future development - The company had $39.7 million in cash and cash equivalents as of March 31, 20216990 - Existing cash is expected to fund operating expenses and capital expenditure requirements into the second quarter of 202269104 - Future operations will require substantial additional funding, which the company expects to raise through equity/debt financings or strategic collaborations6894105 Controls and Procedures Management concluded disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2021111 - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting112 PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings115 Item 1A. Risk Factors No material changes to risk factors from the 2020 Form 10-K, highlighting limited operating history, significant losses, funding needs, and clinical development uncertainties - The company has a limited operating history, no products approved for sale, and a history of significant losses which are expected to continue4 - Substantial additional financing is required to pursue business objectives, and failure to obtain it could force delays or termination of development efforts4 - Clinical development is lengthy, expensive, and uncertain. Positive results from early-stage trials may not be predictive of future results4 - The business could be materially and adversely affected by the COVID-19 pandemic5 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities during the period118