Company Overview - Candel Therapeutics is a pre-clinical stage company focused on researching two drugs: CAN-2409 and CAN-3110, with CAN-2409 being the most advanced candidate [1]. Drug Development - CAN-2409 is currently the most developed drug in Candel Therapeutics' pipeline, while CAN-3110 is in an earlier stage and may have long-term potential but is not yet significant compared to CAN-2409 [1].

Core Insights - The article emphasizes the importance of strong brand recognition, solid financials, and growth potential in identifying profitable investment opportunities within the consumer products sector [1]. Group 1: Investment Focus - The company specializes in the consumer products sector, aiming to identify firms that combine strong brand recognition with solid financial performance and growth potential [1]. - A keen understanding of consumer trends is highlighted as a critical factor in recognizing investment opportunities [1].

Summary of Candel Therapeutics (CADL) FY Conference Call Company Overview - Candel Therapeutics is focused on developing viral immunotherapies for difficult-to-treat solid tumors [2][3] - The company has two investigational medicines in the clinic: CAN-2409 and CAN-3110 [2][26] Core Points and Arguments CAN-2409 Development - CAN-2409 is an off-the-shelf therapy targeting pan-solid tumors, showing positive data in various solid tumors [2] - A Phase III pivotal clinical trial for CAN-2409 in intermediate or high-risk prostate cancer achieved the primary endpoint of disease-free survival [2][3] - The FDA has provided a Special Protocol Assessment and RMAT designation for CAN-2409, indicating regulatory support for its development [3] - Fast Track designation has also been granted for CAN-2409 in prostate cancer, allowing for a rolling submission before the final Biologics License Application (BLA) [3] Clinical Trial Insights - The trial enrolled 745 patients, comparing CAN-2409 with placebo, and demonstrated a 30% improvement in disease-free survival with a p-value of 0.155 [15] - The prostate cancer-specific disease-free survival showed a 38% improvement with a p-value of 0.0046, indicating strong efficacy [15] - A pathological complete response was achieved in 80.4% of patients receiving CAN-2409 compared to 63.6% in the placebo group [17] Other Indications - CAN-2409 is also being tested in borderline resectable pancreatic cancer, showing a median overall survival of 31.4 months compared to 12.5 months in the control group [19] - In therapy-resistant non-small cell lung cancer, CAN-2409 led to a median overall survival of 24.5 months, doubling the expected survival [21] Financial and Operational Highlights - Candel Therapeutics has over $100 million in cash, providing a runway into Q1 2027 [7] - The company is scaling up manufacturing for CAN-2409 in preparation for the BLA submission planned for Q4 next year [8][27] - Strong intellectual property protection and data exclusivity are in place to support the advancement of both investigational medicines [7] Future Directions - The company is preparing for a Phase IIB/Phase III adaptive design clinical trial for CAN-2409 in pancreatic cancer and is engaging with the FDA for protocol development [24][25] - CAN-3110 is being explored in high-grade glioma, with promising early results from a patient case report [25][26] Additional Important Content - The company emphasizes the importance of addressing the unmet needs of patients, particularly in prostate cancer where recurrence rates are significant [9][10] - The clinical trial design allows for flexibility in treatment approaches, ensuring alignment with standard care practices [11] - The involvement of a high-profile research advisory board, including a Nobel Prize laureate, enhances the credibility and strategic direction of the company [7] This summary encapsulates the key points from the Candel Therapeutics FY Conference Call, highlighting the company's focus on innovative cancer therapies, clinical trial successes, financial stability, and future growth strategies.

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics focuses on developing viral immunotherapies for challenging solid tumors, including localized non-metastatic prostate cancer, pancreatic cancer, non-small cell lung cancer, and recurrent high-grade glioma [2][4] Core Points and Arguments Unique Mechanism of Action - Candel's lead product, CAN-2409, utilizes a novel viral immunotherapy approach that educates the patient's immune system to recognize and eliminate tumor cells, providing durable anti-tumor immunity with only two to three administrations required [3][4][5] Unmet Medical Need - The company emphasizes the significant unmet need in early localized prostate cancer, where no treatments have been approved historically. Prostate cancer is the second most common cancer in men and a leading cause of cancer-related mortality [9][10][11] Clinical Data and Efficacy - Candel has achieved a 30% improvement in disease-free survival (DFS) for patients receiving radiotherapy combined with CAN-2409 compared to standard treatments [14][15] - The company reports that 65,000 patients in the U.S. choose radiotherapy annually, indicating a substantial market opportunity [16] Patient Experience and Acceptance - Patients undergoing the injection of CAN-2409 report it is well-tolerated, comparable to routine biopsies, and performed by urologists or radiation oncologists in outpatient settings [26][40] Regulatory Engagement - Candel has engaged with the FDA, agreeing that DFS is an acceptable primary endpoint for their prostate cancer studies, given the long progression times associated with the disease [29][31] Market Research Insights - Recent market research indicates overwhelming support from urologists and radiation oncologists for the use of CAN-2409, with 100% of respondents expressing willingness to adopt this approach [37][38] Commercial Opportunity - The potential market for CAN-2409 is projected to be multi-billion dollars annually, with pricing expected to exceed initial conservative estimates [44][45] Development Timeline - Candel is on track for a Biologics License Application (BLA) submission in Q4 2026, with ongoing manufacturing scale-up and regulatory studies [53][49] Additional Important Content Non-Small Cell Lung Cancer Program - Candel is also developing CAN-2409 for non-small cell lung cancer, targeting patients who have failed standard treatments. Preliminary results show a median overall survival of over 25 months in a population with poor prognostic factors [54][56] Financial Position - The company has over $100 million in cash, providing a runway into Q1 2027, and is exploring non-dilutive funding options to support ongoing and future studies [61][62] Future Milestones - Candel plans to advance its glioblastoma program and continue its pivotal studies in both pancreatic and lung cancers, with a focus on securing funding before initiating new trials [62]

Summary of Candel Therapeutics (CADL) Conference Call - September 03, 2025 Company Overview - Candel Therapeutics focuses on developing viral immunotherapies for challenging solid tumors, with three main platforms: CAN-2409, CAN-3110, and the enLIGHTEN Discovery Platform [8][10][60]. Key Programs and Developments CAN-2409 - **Prostate Cancer**: - Late-stage development with positive data from a pivotal phase 3 clinical trial for newly diagnosed localized prostate cancer, achieving a 30% improvement in disease-free survival (DFS) and a 38% improvement in prostate cancer-specific DFS [8][19]. - The company aims for BLA submission in Q4 2026, with ongoing work in commercial manufacturing and FDA alignment [22][23]. - Current treatment options for patients include radical prostatectomy and radiotherapy, with a potential shift towards radiotherapy combined with CAN-2409 [20][21]. - **Pancreatic Cancer**: - Positive phase 2a data in borderline resectable pancreatic cancer, with plans for a phase 2B/phase 3 adaptive trial design [50][51][55]. - The company is working with experts to align on the best standard of care and trial design [51][52]. - **Non-Small Cell Lung Cancer**: - Plans for a pivotal phase 3 trial focusing on patients with metastatic disease who have shown inadequate response to pembrolizumab [39][40]. - A small phase 2 mechanistic study will run in parallel to assess the contribution of CAN-2409 in combination with pembrolizumab [42][48]. CAN-3110 - Targets recurrent glioblastoma with a unique replication-competent herpes simplex virus that selectively replicates in tumor cells [9][60]. - Encouraging data showing a doubling of expected median overall survival after a single injection, with ongoing studies to determine the benefits of multiple injections [60]. Financial Outlook - As of the end of Q2 2025, the company reported over $100 million in cash, funding operations into Q1 2027 and supporting BLA submission for prostate cancer [62]. - Plans to explore non-dilutive financing opportunities and potential partnerships to fund additional clinical trials [62][63]. Discovery Platform - The enLIGHTEN Discovery Platform has produced three preclinical assets, with potential for partnerships to advance these programs [64][66]. - The platform aims to create cost-effective assets that can be combined with existing therapies to enhance treatment efficacy [66]. Market Dynamics - The prostate cancer market is significant, with approximately 65,000 patients treated with radiotherapy annually [21]. - The company anticipates a shift in treatment preferences towards radiotherapy combined with CAN-2409 if approved, potentially increasing market share [20][21]. Strategic Partnerships - Candel Therapeutics is open to partnerships for its enLIGHTEN Discovery Platform and is in discussions with mid-size and large pharmaceutical companies regarding both CAN-2409 and CAN-3110 [63][66]. Conclusion - Candel Therapeutics is strategically positioned with promising clinical data across multiple solid tumor indications, a solid financial foundation, and a proactive approach to partnerships and market engagement. The upcoming BLA submission and ongoing trials are critical milestones for the company's growth and market presence.

Core Insights - Candel Therapeutics, Inc. has appointed Dr. Carl H. June to its Research Advisory Board, enhancing its expertise in cancer immunotherapy [1][2][3] - Dr. June is recognized for his contributions to CAR-T cell therapy and will support Candel's development of its lead candidates, CAN-2409 and CAN-3110 [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal viral immunotherapies to combat cancer [4] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [4] Product Development - CAN-2409 is the lead candidate from the adenovirus platform, currently advancing through clinical trials for various solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5][6] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including stage III/IV NSCLC and localized prostate cancer [5] - CAN-3110, the lead candidate from the HSV platform, is in a phase 1b clinical trial for recurrent high-grade glioma and has also received Fast Track and Orphan Drug Designations from the FDA [6] Future Plans - Candel anticipates submitting a Biologics License Application (BLA) for CAN-2409 for prostate cancer in Q4 2026 [3]

Core Viewpoint - Candel Therapeutics, Inc. is actively engaging with investors through participation in multiple upcoming conferences, highlighting its focus on developing innovative immunotherapies for cancer treatment [1][2]. Group 1: Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company dedicated to creating off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [3]. - The company has developed two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [3]. Group 2: Product Development - Candel's lead product candidate, CAN-2409, has successfully completed phase 2a clinical trials for non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and is undergoing a pivotal phase 3 trial for localized prostate cancer [4]. - CAN-2409 has received several designations from the FDA, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer, and Fast Track Designation for both NSCLC and prostate cancer [4]. - The second lead product candidate, CAN-3110, is currently in a phase 1b clinical trial for recurrent high-grade glioma (rHGG) and has also received Fast Track and Orphan Drug Designations from the FDA [5]. Group 3: Upcoming Events - Candel Therapeutics will participate in the following investor conferences: - Citi's 2025 Biopharma Back to School Conference on September 3, 2025, at 9:00 AM ET [2]. - Cantor Global Healthcare Conference on September 4, 2025, at 8:00 AM ET [2]. - H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, at 7:00 AM ET [2]. - Live webcasts of these presentations will be available and archived for up to 90 days [2].

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Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

[PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Candel Therapeutics' unaudited financial statements and management's analysis for the periods ended June 30, 2025 [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Candel Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, with notes for periods ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Candel Therapeutics' balance sheet shows a slight decrease in total assets, a significant decrease in total liabilities due to warrant liability, and an increase in stockholders' equity | Metric (in thousands) | June 30, 2025 (Unaudited) | Dec 31, 2024 | Change (in thousands) | | :-------------------- | :------------------------ | :----------- | :-------------------- | | Total Assets | $105,968 | $106,866 | $(898) | | Total Liabilities | $15,758 | $40,539 | $(24,781) | | Total Stockholders' Equity | $90,210 | $66,327 | $23,883 | | Cash and Cash Equivalents | $100,687 | $102,654 | $(1,967) | | Warrant Liability | $1,146 | $21,718 | $(20,572) | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)%20(Unaudited)) For the six months ended June 30, 2025, the company reported a net income of $2.58 million, a significant improvement from a net loss, primarily driven by warrant liability fair value changes | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $6,991 | $4,979 | $11,007 | $9,081 | | General and administrative | $4,186 | $3,592 | $8,300 | $7,392 | | Total operating expenses | $11,177 | $8,571 | $19,307 | $16,473 | | Loss from operations | $(11,177) | $(8,571) | $(19,307) | $(16,473) | | Interest income | $926 | $240 | $1,860 | $560 | | Interest expense | $(236) | $(567) | $(542) | $(1,213) | | Change in fair value of warrant liability | $5,691 | $(13,339) | $20,572 | $(13,332) | | Net income (loss) | $(4,796) | $(22,237) | $2,583 | $(30,458) | | Net income (loss) per share, basic | $(0.09) | $(0.74) | $0.05 | $(1.03) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)%20(Unaudited)) Stockholders' equity increased from $66.33 million to $90.21 million, primarily driven by registered direct and at-the-market offerings, and net income | Metric (in thousands) | Dec 31, 2024 | June 30, 2025 | | :-------------------- | :----------- | :------------ | | Common Stock | $469 | $549 | | Treasury Stock | $(448) | $(448) | | Additional Paid-in Capital | $258,511 | $279,731 | | Accumulated Deficit | $(192,205) | $(189,622) | | Total Stockholders' Equity | $66,327 | $90,210 | - Key drivers for the increase in stockholders' equity include **$14.33 million** from a registered direct offering, **$5.04 million** from at-the-market offerings, and **$2.58 million** in net income for the six months ended June 30, 2025[29](index=29&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Net cash used in operating activities increased to $17.51 million, while net cash provided by financing activities significantly increased due to stock offerings, resulting in a slight overall cash decrease | Cash Flow Activity (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(17,507) | $(14,636) | | Net cash used in investing activities | $(34) | $(13) | | Net cash provided by financing activities | $15,574 | $690 | | Net decrease in cash, cash equivalents and restricted cash | $(1,967) | $(13,959) | | Cash, cash equivalents and restricted cash at end of period | $100,953 | $21,720 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Provides detailed explanations of Candel Therapeutics' financial statements, including accounting policies, fair value measurements, and updates on capital raises and warrant liability - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies for cancer, with product candidates CAN-2409 and CAN-3110 in clinical trials[33](index=33&type=chunk) - The company reported a net income of **$2.6 million** for the six months ended June 30, 2025, a significant improvement from a **$30.5 million** net loss in the prior year, but still has an accumulated deficit of **$189.6 million**[35](index=35&type=chunk) - The company believes existing resources will fund planned operations for at least 12 months from the issuance date of these financial statements, indicating a going concern basis[39](index=39&type=chunk) - The company completed a registered direct offering on June 25, 2025, issuing **3,221,395 shares** of common stock for approximately **$15.0 million** in gross proceeds[38](index=38&type=chunk) - The warrant liability decreased significantly from **$21.7 million** at December 31, 2024, to **$1.1 million** at June 30, 2025, primarily due to changes in fair value[52](index=52&type=chunk)[73](index=73&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | R&D | $424 | $1,269 | $298 | $1,822 | | G&A | $626 | $572 | $1,066 | $1,062 | | Total | $1,050 | $1,841 | $1,364 | $2,884 | - The company operates in a single business segment focused on viral immunotherapies for cancer, with disaggregated R&D and G&A expenses provided[99](index=99&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides an overview of Candel Therapeutics' business, clinical development, financial condition, and results of operations, highlighting its focus on viral immunotherapies and liquidity [Overview](index=24&type=section&id=Overview) Candel Therapeutics is a clinical-stage biopharmaceutical company developing viral immunotherapies (CAN-2409, CAN-3110) for cancer, with recent positive clinical trial data and capital raises - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies (CAN-2409 and CAN-3110) to elicit systemic anti-tumor immune responses for cancer treatment[103](index=103&type=chunk)[105](index=105&type=chunk) - CAN-2409 received Regenerative Medicine Advanced Therapy (RMAT) designation for newly diagnosed localized prostate cancer in intermediate-to-high-risk patients in May 2025[106](index=106&type=chunk) - The pivotal Phase 3 clinical trial for CAN-2409 in prostate cancer met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS) (**p=0.0155; HR 0.70**) and an increase in pathological complete response (**80.4% vs. 63.6% in control; p=0.0015**)[107](index=107&type=chunk) - Final survival data from the Phase 2a clinical trial of CAN-2409 in NSCLC showed a median overall survival (mOS) of **24.5 months** in patients with inadequate response to ICI treatment, significantly longer than historical controls (**9.8–11.8 months**)[110](index=110&type=chunk) - Final analysis of the Phase 2a clinical trial of CAN-2409 in borderline resectable PDAC showed an estimated mOS of **31.4 months** in the CAN-2409 group versus **12.5 months** in the control group[110](index=110&type=chunk) - CAN-3110 received Fast Track and Orphan Drug Designations for recurrent high-grade glioma (HGG), with initial clinical activity data from repeat dosing showing improved survival compared to historical controls[109](index=109&type=chunk)[112](index=112&type=chunk) - The company's enLIGHTEN™ Discovery Platform is generating new viral immunotherapy candidates, with preclinical data supporting multimodal therapeutics for solid tumors[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk) - The company's cash and cash equivalents were **$100.7 million** as of June 30, 2025, expected to fund operations into Q1 2027[123](index=123&type=chunk) [Collaborations](index=28&type=section&id=Collaborations) Details Candel Therapeutics' license and collaboration agreements, including those with Periphagen, Mass General Brigham for CAN-3110, and Ventagen for specific territories - Amended exclusive license agreement with Periphagen in June 2023, reverting rights to NT-3 and Gene Transfer Neuro-Assets, while retaining exclusive rights for oncologic diseases[126](index=126&type=chunk) - Entered into an exclusive worldwide patent license agreement with MGB for CAN-3110, involving an initial fee, patent cost reimbursements, annual license fees, and potential milestone payments up to **$39.0 million** plus increasing royalties on net sales[130](index=130&type=chunk) - Maintains an exclusive license agreement with Ventagen, a related party (**49.5%** owned by company stockholders), for technology utilizing herpes-derived TK protein in specific Latin American territories[131](index=131&type=chunk) [Components of Our Results of Operations](index=29&type=section&id=Components%20of%20Our%20Results%20of%20Operations) Outlines Candel Therapeutics' financial results components, primarily operating expenses, interest income/expense, and warrant liability changes, with no product sales revenue yet - The company has not generated any revenue from product sales to date and does not expect to in the foreseeable future[132](index=132&type=chunk) - Research and development expenses are expected to increase substantially due to ongoing clinical trials, new product candidate discovery, and scaling manufacturing capabilities[135](index=135&type=chunk) - General and administrative expenses are projected to increase due to higher personnel headcount, public company compliance costs (accounting, legal, regulatory), and commercial readiness[140](index=140&type=chunk) - Changes in the fair value of warrant liability, driven by remaining contractual term, volatility, and stock price changes, significantly impact other income (expense)[143](index=143&type=chunk) - The company has significant federal and state net operating loss (NOL) carryforwards (**$111.6 million** federal, **$101.9 million** state as of Dec 31, 2024) and research and development tax credits, but a full valuation allowance has been established due to uncertainty of realization[145](index=145&type=chunk)[146](index=146&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Candel Therapeutics reported a net income of $2.58 million for the six months ended June 30, 2025, a substantial improvement from a net loss, primarily driven by warrant liability fair value changes Net Loss Comparison (in thousands) | Period | Net Loss (2025) | Net Loss (2024) | Change (in thousands) | | :----- | :-------------- | :-------------- | :-------------------- | | 3 Months | $(4,796) | $(22,237) | $17,441 | | 6 Months | $2,583 | $(30,458) | $33,041 | Operating Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | R&D | $6,991 | $4,979 | $11,007 | $9,081 | | G&A | $4,186 | $3,592 | $8,300 | $7,392 | | Total Operating Expenses | $11,177 | $8,571 | $19,307 | $16,473 | - The **$33.90 million** positive change in fair value of warrant liability for the six months ended June 30, 2025, was the primary driver for the shift to net income[159](index=159&type=chunk) - Clinical development costs increased by **$2.5 million** for the six months ended June 30, 2025, primarily due to increased manufacturing costs for CAN-2409 programs[155](index=155&type=chunk) - General and administrative expenses increased by **$0.9 million** for the six months ended June 30, 2025, mainly due to a **$0.5 million** increase in commercial readiness costs and a **$0.4 million** increase in professional and consulting fees[156](index=156&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Candel Therapeutics had $100.7 million in cash and cash equivalents as of June 30, 2025, expected to fund operations into Q1 2027, relying on equity and debt financings - Cash and cash equivalents totaled **$100.7 million** as of June 30, 2025, projected to fund operations into the first quarter of 2027[160](index=160&type=chunk) - The company has raised approximately **$291.6 million** in gross proceeds since inception, primarily from government grants, convertible preferred stock, common stock sales, and debt borrowings[161](index=161&type=chunk) - As of June 30, 2025, **$6.7 million** of indebtedness was outstanding under the Loan Agreement with SVB, which matures on January 1, 2026[164](index=164&type=chunk) - Recent capital raises include **$85.9 million** net proceeds from the 2024 Follow-On Offering and **$14.3 million** net proceeds from the June 2025 Registered Direct Offering[166](index=166&type=chunk)[167](index=167&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) Net cash used in operating activities increased to $17.5 million, while net cash provided by financing activities significantly increased from stock offerings, with minimal investing activities Cash Flow Summary (in thousands) | Activity | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------- | :--------------------------- | :--------------------------- | | Operating | $(17,507) | $(14,636) | | Investing | $(34) | $(13) | | Financing | $15,574 | $690 | - Net cash used in operating activities increased to **$17.5 million** for the six months ended June 30, 2025, primarily due to net income of **$2.6 million** offset by non-cash charges of **$18.3 million** (mainly warrant liability fair value change)[171](index=171&type=chunk) - Net cash provided by financing activities was **$15.6 million**, driven by **$15.0 million** from a registered direct offering and **$5.0 million** from ATM offerings, partially offset by **$5.0 million** in term loan principal payments[174](index=174&type=chunk) [Funding Requirements](index=36&type=section&id=Funding%20Requirements) Anticipates substantial increases in operating expenses for R&D and commercialization, requiring significant additional financing beyond current cash to achieve long-term objectives - Operating expenses are expected to increase substantially due to advancing CAN-2409 and CAN-3110 through clinical trials, developing manufacturing capabilities, and preparing for potential commercialization[176](index=176&type=chunk)[178](index=178&type=chunk) - Future funding requirements are highly dependent on the progress and costs of clinical development, regulatory approvals, commercialization activities, and intellectual property protection[178](index=178&type=chunk)[181](index=181&type=chunk) - The company plans to finance future cash needs through public/private equity or debt financings, and collaborations, acknowledging potential dilution or restrictive covenants[179](index=179&type=chunk) [Contractual Obligations and Commitments](index=37&type=section&id=Contractual%20Obligations%20and%20Commitments) As of June 30, 2025, primary contractual obligations total $9.01 million, including operating lease payments, the SVB Loan Agreement, and the Periphagen Note Contractual Obligations (in thousands) as of June 30, 2025 | Obligation | Total (in thousands) | Less Than 1 Year (in thousands) | 1 to 3 Years (in thousands) | | :--------- | :------------------- | :------------------------------ | :-------------------------- | | Operating lease obligation | $724 | $620 | $104 | | Loan Agreement with SVB | $6,931 | $6,931 | $0 | | Periphagen Note | $1,352 | $0 | $1,352 | | Total | $9,007 | $7,551 | $1,456 | [Critical Accounting Estimates](index=38&type=section&id=Critical%20Accounting%20Estimates) No material changes to critical accounting estimates were reported for the three and six months ended June 30, 2025 - No material changes to critical accounting estimates were reported for the three and six months ended June 30, 2025[185](index=185&type=chunk) [Recent Accounting Pronouncements](index=38&type=section&id=Recent%20Accounting%20Pronouncements) The company is evaluating the impact of recent accounting pronouncements, including ASUs 2023-06, 2023-09, and 2024-03, on its financial statements - The company adopted ASU 2023-07 (Segment Reporting) on an interim basis starting January 1, 2025[48](index=48&type=chunk) - The company is evaluating the potential impact of ASU 2023-06 (Disclosure Improvements), ASU 2023-09 (Income Tax Disclosures), and ASU 2024-03 (Expense Disaggregation Disclosures)[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) [Emerging Growth Company Status](index=38&type=section&id=Emerging%20Growth%20Company%20Status) Candel Therapeutics' "emerging growth company" and "smaller reporting company" status allows reduced disclosure, potentially impacting investor perception and stock price - Candel Therapeutics qualifies as an "emerging growth company" and "smaller reporting company," enabling it to use reduced disclosure requirements and an extended transition period for new accounting standards[187](index=187&type=chunk)[192](index=192&type=chunk) - The company will remain an EGC until the earliest of exceeding **$1.235 billion** in annual revenue, qualifying as a large accelerated filer, issuing over **$1 billion** in non-convertible debt, or December 31, 2026[188](index=188&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Candel Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Candel Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk[189](index=189&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of Candel Therapeutics' disclosure controls and procedures as of June 30, 2025, concluding they were effective - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[192](index=192&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this Form 10-Q[193](index=193&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) Provides additional information beyond financial statements, covering legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in material legal proceedings, but litigation, regardless of outcome, could negatively impact its business - The company is not currently involved in any litigation or legal proceedings deemed to have a material adverse effect on its business[195](index=195&type=chunk) - Litigation, even if successfully defended, can adversely impact business due to defense and settlement costs and diversion of management resources[195](index=195&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Details numerous risks, including limited operating history, funding needs, product candidate dependence, clinical trial challenges, competition, and legal/IP risks [Risks Related to Our Business, Financial Position and Capital Requirements](index=40&type=section&id=Risks%20Related%20to%20Our%20Business,%20Financial%20Position%20and%20Capital%20Requirements) Highlights risks from limited operating history, no product revenue, significant accumulated deficit, need for substantial additional funding, and potential impacts from financial services industry developments - The company has a limited operating history, no product sales revenue, and an accumulated deficit of **$189.6 million** as of June 30, 2025, expecting continued significant operating losses[198](index=198&type=chunk)[200](index=200&type=chunk) - Substantial additional funding is required, and inability to raise capital could force delays, reductions, or elimination of product development programs or commercialization efforts[207](index=207&type=chunk) - Indebtedness, including a **$20.0 million** term loan with SVB (with **$6.7 million** outstanding as of June 30, 2025), could adversely affect financial condition and limit flexibility[214](index=214&type=chunk)[164](index=164&type=chunk) - Adverse developments in the financial services industry, such as bank failures (e.g., SVB), could impair access to funding, increase borrowing costs, and negatively impact business operations and financial condition[219](index=219&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) [Risks Related to Product Development](index=45&type=section&id=Risks%20Related%20to%20Product%20Development) Success depends on CAN-2409 and CAN-3110, facing risks in clinical trials, regulatory approval, potential side effects, patient enrollment, and competition due to novel immunotherapy development - Business success is dependent on CAN-2409 and CAN-3110, which require additional development, regulatory approval, and market acceptance; failure would significantly harm the company[225](index=225&type=chunk)[227](index=227&type=chunk) - Preclinical studies and clinical trials may fail to adequately demonstrate safety and efficacy, leading to delays or prevention of regulatory approval and commercialization[229](index=229&type=chunk) - Product candidates have caused side effects (e.g., flu-like symptoms, injection site reactions, blood abnormalities), which could delay or prevent approval or limit commercialization[232](index=232&type=chunk) - Interim, topline, and preliminary clinical data are subject to change and regulatory verification, and may not be predictive of final results, potentially harming business prospects[233](index=233&type=chunk)[235](index=235&type=chunk) - The novel approach of viral immunotherapies makes development time and cost difficult to predict, and regulatory approval processes may be lengthy and complex due to limited precedents[242](index=242&type=chunk)[244](index=244&type=chunk) - Difficulty in identifying and enrolling sufficient eligible patients, especially for rare cancers like brain cancer, could delay or prevent clinical trials and regulatory approval[254](index=254&type=chunk)[255](index=255&type=chunk) - Substantial competition from major pharmaceutical and biotechnology companies, including those developing similar or different immuno-oncology therapies, poses a risk to market share and profitability[261](index=261&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk) [Risks Related to Government Regulation and Commercialization of Our Product Candidates](index=51&type=section&id=Risks%20Related%20to%20Government%20Regulation%20and%20Commercialization%20of%20Our%20Product%20Candidates) Regulatory approval is lengthy and uncertain, with post-approval scrutiny, healthcare reform impacts, commercialization challenges, and compliance risks from fraud/abuse and data privacy laws - Regulatory approval processes are lengthy, unpredictable, and may be delayed or denied, materially impairing the ability to generate revenue[266](index=266&type=chunk)[267](index=267&type=chunk) - FDA's Special Protocol Assessment (SPA) for CAN-2409 in prostate cancer does not guarantee approval and can be revoked or altered[272](index=272&type=chunk)[273](index=273&type=chunk) - Fast Track and Regenerative Medicine Advanced Therapy (RMAT) Designations do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[276](index=276&type=chunk)[281](index=281&type=chunk) - Orphan Drug Designation for CAN-2409 (pancreatic cancer) and CAN-3110 (recurrent HGG) may not provide market exclusivity if approval is broader or if certain conditions are not met[280](index=280&type=chunk) - Post-approval, products are subject to extensive ongoing regulatory requirements (cGMP, labeling, reporting), and non-compliance or new safety information could lead to restrictions, withdrawal of approval, or significant penalties[291](index=291&type=chunk)[294](index=294&type=chunk) - Promoting products for unapproved ("off-label") uses or in a manner inconsistent with approved labeling could result in substantial fines, criminal penalties, and reputational harm[297](index=297&type=chunk)[301](index=301&type=chunk) - Healthcare reform measures, including the Inflation Reduction Act and executive orders on drug pricing, could lead to downward pressure on prices, reduced reimbursement, and adverse effects on profitability[309](index=309&type=chunk)[312](index=312&type=chunk)[314](index=314&type=chunk) - Failure to establish effective sales, marketing, and patient support capabilities, or to secure favorable third-party agreements, could limit commercialization success and revenue generation[316](index=316&type=chunk)[318](index=318&type=chunk) - Compliance with complex and evolving healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Acts) and data privacy laws (HIPAA, GDPR, CCPA) is critical, with potential for significant penalties and reputational damage for non-compliance[325](index=325&type=chunk)[326](index=326&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk)[335](index=335&type=chunk)[337](index=337&type=chunk) [Risks Related to Employee Matters, Managing Growth and General Business Operations](index=65&type=section&id=Risks%20Related%20to%20Employee%20Matters,%20Managing%20Growth%20and%20General%20Business%20Operations) Success depends on retaining key personnel and managing growth, while facing risks from social media, AI, cybersecurity, natural disasters, and geopolitical conflicts - Future success is highly dependent on retaining key executives and attracting/motivating qualified scientific, clinical, manufacturing, and management personnel[350](index=350&type=chunk)[351](index=351&type=chunk) - Expansion of development, manufacturing, and regulatory capabilities, along with potential sales/marketing, may lead to difficulties in managing growth, diverting resources and disrupting operations[353](index=353&type=chunk) - Increasing use of social media and evolving AI technologies introduce risks such as reputational damage, data security breaches, and compliance challenges with new regulations (e.g., EU AI Act)[354](index=354&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) - Internal computer systems and those of third-party contractors are vulnerable to cybersecurity incidents and data breaches, which could disrupt development programs, lead to data loss, and incur significant costs and liabilities[355](index=355&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk)[359](index=359&type=chunk) - Operations are susceptible to disruptions from natural disasters, pandemics, wars (e.g., Russia-Ukraine, Israel-Hamas conflicts), or other catastrophic events, potentially impacting research, clinical trials, and supply chains[360](index=360&type=chunk) - Disclosure controls and procedures, while designed for reasonable assurance, may not prevent or detect all errors or fraud, and future material weaknesses in internal control over financial reporting could adversely affect financial reporting and stock price[362](index=362&type=chunk)[363](index=363&type=chunk)[365](index=365&type=chunk) [Risks Related to Legal and Compliance Matters](index=68&type=section&id=Risks%20Related%20to%20Legal%20and%20Compliance%20Matters) Faces product liability exposure, anti-corruption, trade control, healthcare fraud, and environmental law compliance risks, with potential for significant penalties and reputational damage - Product liability exposure from clinical trials and future commercial sales poses a risk of substantial liability, potential limits on commercialization, and reputational damage, with insurance coverage potentially inadequate[367](index=367&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk) - Non-compliance with anti-corruption laws (e.g., FCPA) and trade control laws could lead to civil/criminal penalties, sanctions, and adverse impacts on business and reputation[370](index=370&type=chunk)[372](index=372&type=chunk) - Failure to comply with federal and state healthcare laws (e.g., Anti-Kickback Statute, False Claims Acts) could result in substantial penalties, exclusion from government programs, and harm to business and financial condition[375](index=375&type=chunk)[376](index=376&type=chunk)[378](index=378&type=chunk) - Changes in tax laws (e.g., Section 174 of the Code, OBBBA) or their interpretation may adversely affect business and financial condition, including limitations on net operating loss (NOL) carryforwards[379](index=379&type=chunk)[381](index=381&type=chunk) - Violations of environmental, health, and safety laws and regulations could subject the company to fines, penalties, or significant cleanup costs, potentially exceeding resources[390](index=390&type=chunk)[391](index=391&type=chunk) [Risks Related to Our Reliance on Third Parties](index=73&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Heavy reliance on third-party collaborators, clinical investigators, and CDMOs for development and manufacturing poses risks of delays, non-compliance, and intellectual property issues - Dependence on development and commercialization collaborators (e.g., MGB, Periphagen) means their failure to perform or fulfill responsibilities could significantly reduce future revenue and harm the business[393](index=393&type=chunk)[394](index=394&type=chunk) - Reliance on independent clinical investigators and CROs to conduct trials means their non-compliance with GCPs or failure to meet deadlines could delay or impair regulatory approval[398](index=398&type=chunk)[402](index=402&type=chunk)[403](index=403&type=chunk) - Reliance on third-party manufacturers (CDMOs) for product candidates carries risks of production delays, quality control issues, non-compliance with cGMP, and supply interruptions, which could delay development and commercialization[405](index=405&type=chunk)[408](index=408&type=chunk)[409](index=409&type=chunk)[410](index=410&type=chunk) - Geopolitical tensions with China and potential sanctions (e.g., BIOSECURE Act) could impact current partners like WuXi and affect contractual relationships[412](index=412&type=chunk) - Sharing trade secrets with third parties increases the risk of discovery by competitors, misappropriation, or unauthorized disclosure, harming the company's competitive position[420](index=420&type=chunk)[421](index=421&type=chunk)[422](index=422&type=chunk) [Risks Related to Intellectual Property](index=78&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Success depends on protecting IP through patents, trademarks, and trade secrets, facing risks from third-party licenses, patent challenges, infringement claims, and limited foreign rights - Reliance on third-party licenses (e.g., MGB, Periphagen) for key patent rights means non-compliance with obligations could lead to termination of licenses and loss of development/commercialization rights[423](index=423&type=chunk)[424](index=424&type=chunk)[425](index=425&type=chunk) - Disputes over license agreement interpretations or intellectual property ownership could narrow rights or increase obligations, adversely affecting business[426](index=426&type=chunk)[427](index=427&type=chunk) - Protecting intellectual property through patents, trademarks, and trade secrets is difficult and costly, with risks of patent applications failing to issue, being challenged, or competitors designing around claims[432](index=432&type=chunk)[435](index=435&type=chunk)[438](index=438&type=chunk) - Changes in patent laws (e.g., America Invents Act, IRA) or their interpretation, including the establishment of the Unified Patent Court (UPC) in Europe, could diminish patent value and increase prosecution/enforcement costs[440](index=440&type=chunk)[442](index=442&type=chunk) - Third-party claims of intellectual property infringement could lead to expensive litigation, injunctions, substantial damages, and diversion of management attention[455](index=455&type=chunk)[456](index=456&type=chunk)[460](index=460&type=chunk) - Inability to protect trade secrets, either through misappropriation or independent development by competitors, would harm the company's competitive position[452](index=452&type=chunk) - Limited foreign intellectual property rights mean the company may not be able to prevent third parties from practicing inventions or selling competing products in all countries[478](index=478&type=chunk) - Patent terms may be inadequate to protect competitive position, as patents could expire before or shortly after product commercialization, leading to competition from generic products[480](index=480&type=chunk) [Risks Related to Our Common Stock](index=88&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Common stock price is volatile, influenced by clinical results, competition, and regulatory factors, with dilution risks from future equity sales and significant insider influence - The price of common stock is volatile and influenced by factors such as clinical trial results, competition, regulatory developments, and general market conditions, potentially leading to substantial losses for stockholders[484](index=484&type=chunk) - Raising additional capital through equity sales (e.g., ATM Program, future offerings) will dilute existing stockholders and could cause the stock price to decline[485](index=485&type=chunk) - As an "emerging growth company" and "smaller reporting company," the company utilizes reduced disclosure requirements, which may make its common stock less attractive to some investors and increase stock price volatility[488](index=488&type=chunk)[493](index=493&type=chunk) - Executive officers, directors, and principal stockholders (e.g., PBM Capital Group, LLC) collectively hold significant influence (approx. **25.5%** of outstanding common stock), limiting other stockholders' ability to influence corporate matters[501](index=501&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of common stock[502](index=502&type=chunk)[504](index=504&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gain for stockholders[500](index=500&type=chunk) - The potential exercise of outstanding warrants (e.g., Series B and Conditional Series B Warrants for **7,344,968 shares**) could result in substantial dilution to stockholders[511](index=511&type=chunk)[512](index=512&type=chunk)[514](index=514&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=95&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or issuer purchases were reported, and the use of proceeds section is not applicable - No unregistered sales of equity securities or issuer purchases of equity securities were reported[516](index=516&type=chunk)[518](index=518&type=chunk) - The section on "Use of Proceeds" is not applicable for this reporting period[517](index=517&type=chunk) [Item 3. Defaults Upon Senior Securities](index=95&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - No defaults upon senior securities were reported[519](index=519&type=chunk) [Item 4. Mine Safety Disclosures](index=95&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to Candel Therapeutics' business operations - Mine safety disclosures are not applicable to the company's operations[520](index=520&type=chunk) [Item 5. Other Information](index=95&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading agreements during the three months ended June 30, 2025[521](index=521&type=chunk) [Item 6. Exhibits](index=96&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including corporate documents, agreements, and certifications from executive officers - Key exhibits include the Amended and Restated Certificate of Incorporation, Bylaws, Specimen Common Stock Certificate, Securities Purchase Agreement, and certifications from the Principal Executive Officer and Principal Financial Officer[523](index=523&type=chunk) [Signatures](index=97&type=section&id=Signatures) The report was duly signed by Candel Therapeutics' President and CEO, and Chief Financial Officer on August 14, 2025 - The report was signed by Paul Peter Tak (President and CEO) and Charles Schoch (CFO) on August 14, 2025[528](index=528&type=chunk)