Candel Therapeutics(CADL) - 2024 Q2 - Quarterly Results

Executive Summary & Recent Highlights Overall Corporate Highlights Candel Therapeutics reported positive survival data for CAN-2409 in pancreatic cancer and NSCLC, received orphan drug designations for CAN-2409 and CAN-3110, and is on track for key prostate cancer data readouts in Q4 2024, with cash expected to fund operations into Q1 2025 - Announced positive survival data from the phase 2 randomized controlled clinical trial of CAN-2409 in borderline resectable pancreatic cancer[1] - Presented positive topline overall survival data from the phase 2 clinical trial of CAN-2409 in non-small cell lung cancer (NSCLC) at 2024 ASCO Annual Meeting[1] - Received orphan drug designation from the U.S. FDA for both CAN-2409 (pancreatic cancer) and CAN-3110 (recurrent high-grade glioma)[1] - On track for topline disease-free survival data from the phase 3 randomized controlled clinical trial of CAN-2409 in localized intermediate/high risk prostate cancer, expected in Q4 2024[1] - The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into Q1 2025[1] CEO Statement CEO Paul Peter Tak highlighted Q2 2024 as a pivotal period with robust clinical advancements and regulatory successes, validating Candel's immunotherapy approach, emphasizing the potential of CAN-2409 in NSCLC and pancreatic cancer, the promise of CAN-3110 in rHGG, and the significance of the Russell 3000 Index inclusion - The second quarter of 2024 represented a pivotal period for Candel, characterized by robust clinical advancements and key regulatory successes[2] - Encouraging overall survival phase 2 data for CAN-2409 highlights its potential for NSCLC patients non-responsive to immune checkpoint inhibitor treatment and for patients with borderline resectable pancreatic cancer[2] - FDA granting orphan drug designation for CAN-3110 in recurrent high-grade glioma underscores the promise of this first-in-class asset[2] - Inclusion in the Russell 3000 Index marks a significant milestone in Candel's growth and offers an opportunity to increase recognition within the investment community[2] Clinical Program Updates CAN-2409 – Pancreatic Cancer Updated positive survival data from the phase 2 trial of CAN-2409 plus valacyclovir with standard of care chemoradiation in borderline resectable PDAC showed significant improvements in median overall survival and survival rates at 24 and 36 months, with a favorable safety profile and confirmed immune response activation, also receiving FDA orphan drug designation - Announced positive updated survival data from the phase 2 randomized controlled clinical trial of CAN-2409 plus valacyclovir with standard of care chemoradiation in borderline resectable pancreatic ductal adenocarcinoma (PDAC)[3] Estimated Median Overall Survival (mOS) and Survival Rates | Metric | CAN-2409 Group | Control Group | | :----- | :------------- | :------------ | | mOS | 28.8 months | 12.5 months | | 24-month survival rate | 71.4% | 16.7% | | 36-month survival rate | 47.6% | 16.7% | - No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well-tolerated to date[4] - Analysis of resected tumors showed the formation of dense aggregates of immune cells, confirming the activation of a robust antitumoral immune response[4] - Received orphan drug designation from the FDA for CAN-2409 for the treatment of pancreatic cancer[4] CAN-2409 – Non-Small Cell Lung Cancer (NSCLC) Topline overall survival data from the phase 2 trial of CAN-2409 in combination with ICI therapy for patients with inadequately responding stage III/IV NSCLC showed a median overall survival of 20.6 months, significantly outperforming published results for standard chemotherapy, while activating a systemic immune response and maintaining a favorable safety profile - Presented topline overall survival data from the phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) therapy in patients with stage III/IV NSCLC inadequately responding to ICI therapy[4] Median Overall Survival (mOS) in NSCLC | Treatment | mOS | | :-------- | :-- | | CAN-2409 + ICI | 20.6 months | | SoC docetaxel-based chemotherapy (published) | <12 months | - CAN-2409 treatment resulted in activation of the systemic immune response, including increased numbers of circulating cytotoxic and memory T cells associated with subsequent prolonged survival[5] - CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile as of the April 1, 2024 data cut-off date[5] CAN-3110 – Recurrent High-Grade Glioma (rHGG) CAN-3110 received orphan drug designation from the FDA for the treatment of rHGG, and a Trial-in-Progress poster was presented at ASCO 2024 for the ongoing phase 1b clinical trial - Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG[5] - Presented a Trial-in-Progress poster at the 2024 ASCO Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG[5] enLIGHTEN™ Discovery Platform Preclinical data was presented at AACR Annual Meeting, unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy designed to induce tertiary lymphoid structures (TLS) for solid tumors - Presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting unveiling the second candidate from the enLIGHTEN™ Discovery Platform[5] - The candidate is a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors[5] Corporate Developments & Future Milestones Corporate Updates Candel hosted a successful NSCLC Research and Development panel during ASCO 2024, discussing CAN-2409 data, and was included in the Russell 3000 Index, effective July 1, 2024 - Hosted successful NSCLC Research and Development panel during the 2024 ASCO Annual Meeting, featuring prominent scientific and medical thought leaders discussing the topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC[6] - Announced inclusion in the Russell 3000 Index, effective July 1, 2024, as part of FTSE Russell's annual reconstitution of its U.S. equity indexes[6] Anticipated Milestones Candel expects updated phase 1b data for CAN-3110 in rHGG in H2 2024, with topline data for two CAN-2409 prostate cancer trials (phase 2b for low-to-intermediate-risk and phase 3 for intermediate/high-risk) expected in Q4 2024 - Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024[6] - Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024[6] - Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024[6] Financial Results for Q2 2024 Research and Development Expenses R&D expenses decreased to $5.0 million in Q2 2024 from $5.9 million in Q2 2023, primarily due to lower clinical development, regulatory, manufacturing, and clinical trial costs for CAN-2409 programs, and reduced payroll-related expenses following a Q4 2023 restructuring, partially offset by increased stock-based compensation Research and Development Expenses (in thousands) | Period | Q2 2024 | Q2 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | R&D Expenses | $4,979 | $5,934 | -$955 (-16.1%) | | Non-cash stock compensation | $1,300 | $300 | +$1,000 (+333.3%) | - The decrease was primarily due to lower clinical development costs driven by a reduction in regulatory, manufacturing and clinical trial costs for CAN-2409 programs[7] - Lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023 contributed to the decrease[7] General and Administrative Expenses G&A expenses remained stable at $3.6 million for both Q2 2024 and Q2 2023, with a slight decrease attributed to lower insurance and recruiting costs, offset by increased professional and consulting fees General and Administrative Expenses (in thousands) | Period | Q2 2024 | Q2 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | G&A Expenses | $3,592 | $3,645 | -$53 (-1.5%) | | Non-cash stock compensation | $600 | $400 | +$200 (+50.0%) | - A small decrease was primarily due to lower insurance costs and recruiting costs, partially offset by increased professional and consulting fees[8] Net Loss The net loss for Q2 2024 significantly increased to $22.2 million from $9.6 million in Q2 2023, primarily driven by a substantial change in the fair value of the Company's warrant liability Net Loss (in thousands) | Period | Q2 2024 | Q2 2023 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss | $(22,237) | $(9,614) | $(12,623) (+131.3%) | | Other expense, net | $(13,666) | $(35) | $(13,631) (+38945.7%) | - The increase in net loss was primarily due to other expense, net of $13.7 million, mainly from the change in the fair value of the Company's warrant liability[8] Cash Position Cash and cash equivalents decreased to $21.5 million as of June 30, 2024, from $35.4 million at December 31, 2023, with the company anticipating this cash position will fund its operating plan into Q1 2025 Cash and Cash Equivalents (in thousands) | Date | Amount | | :--- | :----- | | June 30, 2024 | $21,454 | | December 31, 2023 | $35,413 | - Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2025[9] Company Overview About Candel Therapeutics Candel Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf multimodal biological immunotherapies for cancer, utilizing two clinical-stage platforms based on genetically modified adenovirus (lead candidate CAN-2409) and herpes simplex virus (lead candidate CAN-3110), and also has the enLIGHTEN™ Discovery Platform for new viral immunotherapies - Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies to help patients fight cancer[10] - Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus (CAN-2409 lead candidate) and herpes simplex virus (HSV) gene constructs (CAN-3110 lead candidate)[10] - CAN-2409 is in ongoing clinical trials in non-small cell lung cancer (NSCLC), borderline resectable pancreatic ductal adenocarcinoma (PDAC), and localized, non-metastatic prostate cancer[10] - Candel's enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors[10] Legal & Contact Information Forward-Looking Statements This section contains standard disclosures regarding forward-looking statements, cautioning readers about inherent risks, uncertainties, and important factors that could cause actual results to differ materially from expectations, emphasizing that these statements are based on current expectations and beliefs and are not guarantees of future performance - This press release includes certain disclosures that contain "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995[11] - Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially[11] - The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made[11] Investor and Media Contacts Provides contact information for investor relations (Theodore Jenkins) and media inquiries (Ben Shannon) - Investor Contact: Theodore Jenkins, Vice President, Investor Relations, and Business Development, Candel Therapeutics, Inc[12] - Media Contact: Ben Shannon, Vice President, ICR Westwicke[12] Consolidated Financial Statements Consolidated Statements of Operations Presents the unaudited consolidated statements of operations for the three and six months ended June 30, 2024, and 2023, detailing operating expenses (R&D, G&A), loss from operations, other income/expense, net loss, and net loss per share Consolidated Statements of Operations (Three Months Ended June 30, in thousands, except per share amounts) | Metric | Q2 2024 | Q2 2023 | | :-------------------------------------------- | :------ | :------ | | Research and development | $4,979 | $5,934 | | General and administrative | $3,592 | $3,645 | | Total operating expenses | $8,571 | $9,579 | | Loss from operations | $(8,571) | $(9,579) | | Total other income (expense), net | $(13,666) | $(35) | | Net loss and comprehensive loss | $(22,237) | $(9,614) | | Net loss per share, basic and diluted | $(0.74) | $(0.33) | | Weighted-average common shares outstanding | 29,878,210 | 28,919,810 | Consolidated Statements of Operations (Six Months Ended June 30, in thousands, except per share amounts) | Metric | H1 2024 | H1 2023 | | :-------------------------------------------- | :------ | :------ | | Research and development | $9,081 | $11,403 | | General and administrative | $7,392 | $7,809 | | Total operating expenses | $16,473 | $19,212 | | Loss from operations | $(16,473) | $(19,212) | | Total other income (expense), net | $(13,985) | $803 | | Net loss and comprehensive loss | $(30,458) | $(18,409) | | Net loss per share, basic and diluted | $(1.03) | $(0.64) | | Weighted-average common shares outstanding | 29,537,874 | 28,919,810 | Condensed Consolidated Balance Sheet Data Provides unaudited condensed consolidated balance sheet data as of June 30, 2024, and December 31, 2023, including cash and cash equivalents, working capital, total assets, warrant liability, total other liabilities, accumulated deficit, and total stockholders equity (deficit) Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 | | :-------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $21,454 | $35,413 | | Working capital | $8,739 | $22,613 | | Total assets | $26,485 | $41,201 | | Warrant liability | $14,248 | $916 | | Total other liabilities | $22,209 | $27,540 | | Accumulated deficit | $(167,486) | $(137,028) | | Total stockholders equity (deficit) | $(9,972) | $12,745 |