Candel Therapeutics(CADL) - 2024 Q1 - Quarterly Results

Corporate Highlights and Outlook Candel Therapeutics achieved significant clinical and preclinical advancements in Q1 2024, highlighted by positive long-term survival data for CAN-2409 and upcoming ASCO presentations - The company reported a period of significant progress, with maturing clinical data showing highly differentiated results in long-term patient survival[14] - The FDA granted CAN-2409 both Fast Track Designation and Orphan Drug Designation for the treatment of pancreatic cancer, signaling regulatory momentum[14][1] - Topline overall survival data from the phase 2 trial of CAN-2409 in non-small cell lung cancer (NSCLC) is scheduled for presentation at the ASCO meeting on June 3, 2024[26][25] - Progress was also made with the enLIGHTEN™ Discovery Platform, with the presentation of a second drug candidate at the AACR Annual Meeting[11][15] Clinical Program Updates and Milestones Candel provided updates on CAN-2409's survival data in pancreatic cancer, CAN-3110's safety profile, and new enLIGHTEN™ platform candidates, with key 2024 milestones outlined CAN-2409 Program The CAN-2409 program showed significant survival benefits in pancreatic cancer, received Orphan Drug Designation, and will present NSCLC overall survival data at ASCO CAN-2409 Pancreatic Cancer Survival Data | Metric | CAN-2409 Group | Control Group | | :--- | :--- | :--- | | Median Overall Survival | 28.8 months | 12.5 months | | 24-Month Survival Rate | 71.4% | 16.7% | | 36-Month Estimated Survival | 47.6% | 16.7% | - Received Orphan Drug Designation from the U.S. FDA for CAN-2409 for the treatment of pancreatic cancer[1] - Multiple injections of CAN-2409 were generally well tolerated, with no new safety signals, dose-limiting toxicities, or cases of pancreatitis reported[28] - Overall survival data for CAN-2409 in patients with stage III/IV NSCLC will be presented at the ASCO Annual Meeting on June 3, 2024[35] CAN-3110 Program (rHGG) The CAN-3110 program for recurrent high-grade glioma received FDA Fast Track Designation and demonstrated a favorable safety profile in its ongoing Phase 1b trial - Received Fast Track Designation from the FDA for CAN-3110 for the treatment of patients with recurrent high-grade glioma (rHGG) to improve overall survival[2] - In the ongoing phase 1b trial, multiple injections (up to six) of CAN-3110 have shown a favorable safety and tolerability profile[18] - A Trial-in-Progress poster for the CAN-3110 study will be presented at the 2024 ASCO Annual Meeting[36] enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform unveiled its second candidate, a first-in-class multimodal immunotherapy designed to induce tertiary lymphoid structures for solid tumors - Unveiled the second candidate from the platform, a first-in-class multimodal immunotherapy designed to induce tertiary lymphoid structures (TLS) for treating solid tumors[3] - The enLIGHTEN™ platform is a systematic, HSV-based discovery platform that uses human biology and advanced analytics to create new viral immunotherapies[6] Anticipated Milestones Candel Therapeutics anticipates key 2024 data readouts, including CAN-2409 NSCLC overall survival at ASCO, updated CAN-3110 rHGG data, and CAN-2409 prostate cancer data - June 3, 2024: Phase 2 topline overall survival data for CAN-2409 in NSCLC to be presented at ASCO[37] - H2 2024: Updated Phase 1b data for CAN-3110 in rHGG expected[29] - Q4 2024: Phase 3 topline disease-free survival data for CAN-2409 in localized prostate cancer expected[19] - Q4 2024: Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized prostate cancer expected[4] Financial Results for First Quarter 2024 Candel Therapeutics reported reduced Q1 2024 R&D and G&A expenses, leading to a lower net loss, with $25.7 million in cash expected to fund operations into Q4 2024 Q1 2024 Key Financials (vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | R&D Expenses | $4.1 million | $5.5 million | | G&A Expenses | $3.8 million | $4.2 million | | Net Loss | $8.2 million | $8.8 million | - Cash and cash equivalents were $25.7 million as of March 31, 2024, down from $35.4 million at year-end 2023[39] - The current cash position is expected to be sufficient to fund the operating plan into the fourth quarter of 2024[39] - The decrease in operating expenses was primarily driven by lower employee-related costs following a corporate restructuring and reduced clinical development costs[30][5] Financial Statements This section presents Candel Therapeutics' unaudited condensed consolidated financial statements, including the Q1 2024 statement of operations and balance sheet data Consolidated Statements of Operations For Q1 2024, Candel Therapeutics reported total operating expenses of $7.9 million and a net loss of $8.2 million, or $0.28 per share Consolidated Statements of Operations (Unaudited, in thousands, except per share amounts) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Operating expenses: | | | | Research and development | $ 4,102 | $ 5,469 | | General and administrative | 3,800 | 4,164 | | Total operating expenses | 7,902 | 9,633 | | Loss from operations | (7,902) | (9,633) | | Total other income (expense), net | (319) | 838 | | Net loss and comprehensive loss | $ (8,221) | $ (8,795) | | Net loss per share, basic and diluted | $ (0.28) | $ (0.30) | Condensed Consolidated Balance Sheet Data As of March 31, 2024, Candel Therapeutics reported $25.7 million in cash and cash equivalents and $31.2 million in total assets, with total stockholders' equity at $6.0 million Condensed Consolidated Balance Sheet Data (in thousands) | | March 31, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 25,713 | $ 35,413 | | Working capital | 13,599 | 22,613 | | Total assets | 31,217 | 41,201 | | Total stockholders' equity | $ 5,979 | $ 12,745 | About Candel Therapeutics Candel Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf multimodal biological immunotherapies for cancer, utilizing adenovirus and HSV platforms, including lead candidates CAN-2409 and CAN-3110 - Candel is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to elicit a systemic anti-tumor immune response[31] - The company has two main clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV)[31] - Lead product candidates include CAN-2409 (adenovirus platform) for NSCLC, pancreatic, and prostate cancer, and CAN-3110 (HSV platform) for recurrent high-grade glioma[31]