Cullinan Oncology(CGEM) - 2024 Q1 - Quarterly Results

Portfolio Highlights Cullinan Therapeutics provided updates on its clinical portfolio, including a strategic shift for CLN-978 to autoimmune diseases and key milestones for CLN-619 and Zipalertinib CLN-619 (Anti-MICA/MICB monoclonal antibody) Initial combination and monotherapy dose escalation data for CLN-619 will be presented at ASCO 2024, with disease-specific expansion cohort data expected in H1 2025 - Initial combination and updated monotherapy dose escalation data will be presented in a poster session at the ASCO Annual Meeting on June 1, 2024[21] - The company remains on track to report initial data from disease-specific dose expansion cohorts in the first half of 2025[21] CLN-978 (CD19xCD3 T cell engager) CLN-978 development now focuses exclusively on autoimmune diseases, with SLE as the initial indication, following positive B-NHL study observations and planned Q3 2024 IND submission - Development focus has shifted exclusively to autoimmune diseases, with SLE as the initial indication[20][23][27] - An IND application for SLE is planned for submission in the third quarter of 2024[23] - Enrollment in the B-cell non-Hodgkin lymphoma (B-NHL) study has been discontinued to prioritize development in autoimmune diseases[23] - Recent clinical observations in the B-NHL study showed CLN-978 is clinically active with a favorable safety profile at its initial dose[22] Zipalertinib (EGFR ex20ins inhibitor) Cullinan expects to complete enrollment in the pivotal Phase 2b REZILIENT1 study for EGFR ex20ins NSCLC by year-end 2024 - Enrollment in the pivotal Phase 2b REZILIENT1 study is expected to be completed by year-end 2024[1] Other Pipeline Programs Clinical data updates for CLN-049 in AML/MDS and CLN-418 in solid tumors are expected in H2 2024, with ongoing enrollment for CLN-617 Phase 1 study - A clinical data update for CLN-049 (FLT3xCD3) in r/r AML and MDS patients is expected in the second half of 2024[2][16] - A clinical data update for CLN-418 (B7H4x4-1BB) from the Phase 1 dose escalation study in advanced solid tumors is expected in the second half of 2024[5][16] - Enrollment continues in the ongoing Phase 1 study of CLN-617 (IL-2 and IL-12 cytokine fusion protein) in patients with advanced solid tumors[6] Corporate Updates Cullinan announced key leadership appointments, a strategic expansion into autoimmune diseases with a name change, and strengthened its financial position via a $280 million private placement - David Meek was appointed to the Board of Directors, effective May 15[7] - In April, the company appointed Mary Kay Fenton as Chief Financial Officer[9] - The company announced its strategic expansion into autoimmune diseases and changed its name to Cullinan Therapeutics[7] - Completed an oversubscribed $280 million private placement sale of common stock in April[8] First Quarter 2024 Financial Results Cullinan reported a Q1 2024 net loss of $37.3 million, an improvement from Q1 2023, driven by lower R&D expenses, ending with $434.8 million cash and an extended runway into 2028 - Cash, cash equivalents, investments, and interest receivable were $434.8 million as of March 31, 2024[10] - The company expects its cash resources to provide runway into 2028, bolstered by the April 2024 private placement[10][25] Key Financial Metrics | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Key Driver of Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $30.6 | $52.1 | Decrease primarily due to a one-time upfront in-licensing fee in 2023 | | G&A Expenses | $12.3 | $10.7 | Increase driven by personnel costs and non-cash equity-based compensation | | Net Loss | $37.3 | $58.1 | Reduction driven by lower R&D expenses | Consolidated Statements of Operations The company reported a Q1 2024 net loss of $37.1 million or ($0.86) per share, an improvement from Q1 2023, primarily due to reduced research and development expenses | (in thousands, except per share amounts) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $30,646 | $52,096 | | General and administrative | $12,343 | $10,660 | | Total operating expenses | $42,989 | $62,756 | | Loss from operations | ($42,989) | ($62,756) | | Interest income | $5,693 | $4,508 | | Net loss | ($37,340) | ($58,141) | | Net loss per share (Basic and diluted) | ($0.86) | ($1.42) | Condensed Consolidated Balance Sheets As of March 31, 2024, Cullinan Therapeutics reported total assets of $449.4 million, total stockholders' equity of $425.7 million, and $434.8 million in cash, equivalents, investments, and interest receivable | (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, investments, and interest receivable | $434,827 | $468,264 | | Total assets | $449,430 | $484,182 | | Total liabilities | $23,765 | $30,287 | | Total stockholders' equity | $425,665 | $453,895 |