[Corporate Update & Highlights](index=1&type=section&id=Corporate%20Update%20%26%20Highlights) Candel Therapeutics achieved multiple key advancements in Q2 2025, including positive clinical data and regulatory milestones for CAN-2409 across multiple cancer indications [Second Quarter 2025 & Recent Highlights](index=2&type=section&id=Second%20Quarter%202025%20%26%20Recent%20Highlights) Candel Therapeutics achieved multiple key advancements in Q2 2025, including positive clinical data and regulatory milestones for CAN-2409 in prostate, NSCLC, and pancreatic cancer [CAN-2409 – Prostate Cancer](index=2&type=section&id=CAN-2409%20%E2%80%93%20Prostate%20Cancer) CAN-2409 showed statistically significant improvement in progression-free survival and received RMAT designation for prostate cancer - In a Phase III clinical trial for localized prostate cancer, CAN-2409 statistically significantly improved progression-free survival by **30% (HR 0.70, p=0.0155)** compared to placebo[6](index=6&type=chunk) - The FDA granted CAN-2409 Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of newly diagnosed, localized intermediate to high-risk prostate cancer[3](index=3&type=chunk)[4](index=4&type=chunk)[6](index=6&type=chunk) - The company is on track to prepare the Biologics License Application (BLA) for CAN-2409 in prostate cancer, with submission anticipated in **Q4 2026**[3](index=3&type=chunk)[4](index=4&type=chunk)[6](index=6&type=chunk) [CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)](index=3&type=section&id=CAN-2409%20%E2%80%93%20Non-Small%20Cell%20Lung%20Cancer%20(NSCLC)) CAN-2409 demonstrated promising median overall survival in NSCLC patients with inadequate ICI response and induced systemic anti-tumor immunity - In Phase III/IV NSCLC patients (n=46) with inadequate response to ICI therapy, the median overall survival (mOS) was **24.5 months**[7](index=7&type=chunk) - For patients (n=41) who progressed despite ICI treatment, mOS was **21.5 months**, significantly longer than the **9.8–11.8 months** reported in literature for standard docetaxel chemotherapy[7](index=7&type=chunk) - **69%** of patients with multiple lesions observed shrinkage of uninjected tumors, indicating local injection can induce a systemic anti-tumor immune response[7](index=7&type=chunk) [CAN-2409 - Pancreatic Cancer](index=3&type=section&id=CAN-2409%20-%20Pancreatic%20Cancer) CAN-2409 demonstrated extended median overall survival in resectable pancreatic cancer and received EMA Orphan Drug Designation - In a Phase IIa clinical trial for resectable borderline pancreatic ductal adenocarcinoma (PDAC), patients receiving CAN-2409 combined with chemoradiation had an mOS of **31.4 months**, compared to **12.5 months** in the control group[7](index=7&type=chunk) - Three patients in the CAN-2409 group (**66.0, 63.6, and 35.8 months**) were long-term survivors, while only one was in the control group[7](index=7&type=chunk) - The European Medicines Agency (EMA) granted Orphan Drug Designation for CAN-2409 for the treatment of pancreatic cancer in **July 2025**[4](index=4&type=chunk)[10](index=10&type=chunk) [Anticipated Milestones & Recent Corporate Events](index=4&type=section&id=Anticipated%20Milestones%20%26%20Recent%20Corporate%20Events) Candel Therapeutics recently completed a private placement, appointed key executives and board members, and announced upcoming clinical data and corporate events - The company completed a private placement in **June 2025**, issuing approximately **3.2 million** shares of common stock and raising approximately **$15 million** in gross proceeds[10](index=10&type=chunk) - Charles Schoch was appointed Chief Financial Officer (CFO), and Dr Maha Radhakrishnan was appointed to the Board of Directors[3](index=3&type=chunk)[10](index=10&type=chunk) - Additional clinical and biomarker activity data from the Phase Ib clinical trial of CAN-3110 in recurrent high-grade glioma (rHGG) patients is expected in **Q4 2025**[10](index=10&type=chunk) - The company plans to host a virtual R&D event in **Q4 2025**[10](index=10&type=chunk) [Financial Performance](index=4&type=section&id=Financial%20Performance) This section details Candel Therapeutics' financial results, including operating expenses, net loss, and cash position for Q2 2025 [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) Candel Therapeutics experienced increased R&D and G&A expenses in Q2 2025, but net loss significantly narrowed due to changes in warrant liabilities' fair value | Metric (thousand dollars) | Q2 2025 | Q2 2024 | Year-over-Year Change | | :--------------------- | :------------- | :------------- | :------- | | Research and Development Expenses | $6,991 | $4,979 | +$2,012 | | General and Administrative Expenses | $4,186 | $3,592 | +$594 | | Total Operating Expenses | $11,177 | $8,571 | +$2,606 | | Operating Loss | $(11,177) | $(8,571) | -$2,606 | | Net Loss | $(4,796) | $(22,237) | +$17,441 | | Basic Net Loss Per Share | $(0.09) | $(0.74) | +$0.65 | - The increase in research and development expenses was primarily due to higher manufacturing costs supporting the CAN-2409 program[8](index=8&type=chunk) - The increase in general and administrative expenses was primarily due to commercialization readiness costs and increased professional and consulting fees[9](index=9&type=chunk) - The decrease in net loss was primarily related to changes in the fair value of the company's warrant liabilities[11](index=11&type=chunk) [Cash Position](index=5&type=section&id=Cash%20Position) As of June 30, 2025, Candel Therapeutics held **$100.7 million** in cash and cash equivalents, projected to fund operations through Q1 2027 | Metric (thousand dollars) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------- | :------------- | | Cash and Cash Equivalents | $100,687 | $102,654 | - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations through **Q1 2027**, including the BLA submission for CAN-2409 in prostate cancer[4](index=4&type=chunk)[12](index=12&type=chunk) [Product Pipeline](index=5&type=section&id=Product%20Pipeline) This section provides an overview of Candel Therapeutics' lead product candidates, CAN-2409 and CAN-3110, detailing their mechanisms of action and clinical progress [About CAN-2409](index=5&type=section&id=About%20CAN-2409) CAN-2409 is Candel's most advanced multimodal biologic immunotherapy, a replication-deficient adenovirus inducing immunogenic cell death and systemic anti-tumor immune responses - CAN-2409 is an investigational, off-the-shelf, replication-deficient adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient's tumor[13](index=13&type=chunk) - Its mechanism of action involves the HSV-tk enzyme activity converting a prodrug (valacyclovir) into a DNA-integrating nucleoside analog, leading to immunogenic cell death and inducing individualized, specific CD8+ T-cell mediated responses against both injected and uninjected distant metastases[13](index=13&type=chunk) - Over **1,000 patients** have been treated with CAN-2409 to date, demonstrating a favorable tolerability profile[13](index=13&type=chunk) [About CAN-3110](index=5&type=section&id=About%20CAN-3110) CAN-3110 is a first-in-class, replication-competent HSV-1 next-generation oncolytic viral immunotherapy designed for dual activity through oncolysis and immune activation - CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate[14](index=14&type=chunk) - It is designed for dual activity through oncolysis and immune activation[14](index=14&type=chunk) - In a Phase Ib clinical trial for rHGG patients, a single injection of CAN-3110 showed improved median overall survival compared to historical controls and was well-tolerated[14](index=14&type=chunk) [Company Overview & Disclosures](index=6&type=section&id=Company%20Overview%20%26%20Disclosures) This section provides an overview of Candel Therapeutics, its therapeutic platforms, regulatory designations, and important forward-looking statements [About Candel Therapeutics](index=6&type=section&id=About%20Candel%20Therapeutics) Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biologic immunotherapies to elicit individualized, systemic anti-tumor immune responses - Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biologic immunotherapies[16](index=16&type=chunk) - The company has established two clinical-stage multimodal biologic immunotherapy platforms based on novel genetically modified adenovirus and herpes simplex virus (HSV) gene constructs[16](index=16&type=chunk) - CAN-2409 has received RMAT, Fast Track, and Orphan Drug designations, while CAN-3110 has received Fast Track and Orphan Drug designations[17](index=17&type=chunk)[18](index=18&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future development plans, regulatory approvals, therapeutic benefits, and cash flow expectations, subject to risks and uncertainties - Forward-looking statements include, but are not limited to, expectations regarding the timing and progress of current and future development plans, anticipated BLA submission, early biological readouts as predictive indicators of clinical response, anticipated therapeutic benefits of platforms, and expectations regarding cash flow and expenditures[19](index=19&type=chunk) - These statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied in the forward-looking statements[20](index=20&type=chunk) [Investor & Media Contact](index=7&type=section&id=Investor%20%26%20Media%20Contact) This section provides Candel Therapeutics' investor relations and media contact information - Investor Contact: Theodore Jenkins, Vice President of Investor Relations and Business Development[21](index=21&type=chunk) - Media Contact: Ben Shannon, Vice President, ICR Healthcare[21](index=21&type=chunk) [Consolidated Financial Statements](index=8&type=section&id=Consolidated%20Financial%20Statements) This section presents Candel Therapeutics' unaudited consolidated financial statements, including statements of operations and balance sheet data [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents Candel Therapeutics' unaudited consolidated statements of operations for Q2 and six months of 2025 and 2024, detailing key financial metrics | Metric (thousand dollars) | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :---------------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and Development Expenses | $6,991 | $4,979 | $11,007 | $9,081 | | General and Administrative Expenses | $4,186 | $3,592 | $8,300 | $7,392 | | Total Operating Expenses | $11,177 | $8,571 | $19,307 | $16,473 |\ | Operating Loss | $(11,177) | $(8,571) | $(19,307) | $(16,473) |\ | Net Other Income (Expense) | $6,381 | $(13,666) | $21,890 | $(13,985) |\ | Net Income (Loss) | $(4,796) | $(22,237) | $2,583 | $(30,458) |\ | Basic Net Income (Loss) Per Share | $(0.09) | $(0.74) | $0.05 | $(1.03) |\ | Weighted Average Common Shares Outstanding (Basic) | 51,489,929 | 29,878,210 | 50,988,887 | 29,537,874 | [Consolidated Balance Sheet Data](index=9&type=section&id=Consolidated%20Balance%20Sheet%20Data) This section provides Candel Therapeutics' unaudited key consolidated balance sheet data as of June 30, 2025, and December 31, 2024 | Metric (thousand dollars) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------- | :------------- | | Cash and Cash Equivalents | $100,687 | $102,654 |\ | Working Capital | $88,893 | $66,275 |\ | Total Assets | $105,968 | $106,866 |\ | Warrant Liabilities | $1,146 | $21,718 |\ | Total Stockholders' Equity | $90,210 | $66,327 | - Working capital increased from **$66,275 thousand** as of December 31, 2024, to **$88,893 thousand** as of June 30, 2025[25](index=25&type=chunk) - Warrant liabilities significantly decreased from **$21,718 thousand** to **$1,146 thousand**[25](index=25&type=chunk) - Total stockholders' equity increased from **$66,327 thousand** to **$90,210 thousand**[25](index=25&type=chunk)

Core Insights - Candel Therapeutics, Inc. reported significant advancements in its clinical programs, particularly for CAN-2409, which received FDA RMAT Designation for prostate cancer treatment and was presented at ASCO [2][4][17] - The company is preparing for a Biologics License Application (BLA) submission for CAN-2409, expected in Q4 2026, and has strengthened its leadership team with new appointments [2][4][12] - Financial results indicate a net loss reduction, with cash reserves sufficient to fund operations into Q1 2027, supporting ongoing clinical development [11][12] Clinical Developments - Positive results from a phase 3 trial of CAN-2409 in localized prostate cancer showed a 30% improvement in disease-free survival compared to placebo [5][17] - CAN-2409 also demonstrated promising outcomes in phase 2a trials for non-small cell lung cancer (NSCLC) and pancreatic cancer, with median overall survival of 24.5 months and 31.4 months, respectively [8][9][17] - The FDA has granted multiple designations to CAN-2409, including Fast Track and Orphan Drug Designation for various cancer indications [4][17] Financial Performance - Research and development expenses increased to $7.0 million in Q2 2025 from $5.0 million in Q2 2024, primarily due to higher manufacturing costs [9] - General and administrative expenses rose to $4.2 million in Q2 2025, up from $3.6 million in Q2 2024, driven by increased commercial readiness costs [10] - The net loss for Q2 2025 was $4.8 million, a significant decrease from $22.2 million in Q2 2024, attributed to changes in the fair value of the company's warrant liability [11] Cash Position - As of June 30, 2025, cash and cash equivalents stood at $100.7 million, slightly down from $102.7 million at the end of 2024, expected to fund operations into Q1 2027 [12][24] - The company completed a direct offering in June 2025, raising approximately $15 million to support pre-commercialization activities [8][17] Corporate Updates - The appointment of Charles Schoch as CFO and Dr. Maha Radhakrishnan to the Board of Directors is expected to enhance the company's strategic direction and operational capabilities [2][8] - Candel plans to host a virtual R&D event in Q4 2025 to discuss ongoing clinical trials and future developments [8]

Summary of Candel Therapeutics (CADL) FY Conference Call - August 13, 2025 Company Overview - **Company**: Candel Therapeutics (CADL) - **Industry**: Biotechnology, specifically focused on cancer immunotherapy Key Points and Arguments Vaccine Approach - Candel's approach involves a novel vaccine strategy that immunizes patients against their own tumors without needing to identify specific antigens [3][4] - Utilizes a replication-defective adenovirus to deliver the HSV thymidine kinase gene, leading to localized enzyme expression and subsequent tumor cell death [4][5] - The process induces a strong pro-inflammatory response, creating optimal conditions for T cell activation against tumors [5][6] Pipeline Focus - Current focus on three main indications: - Early localized nonmetastatic prostate cancer - Borderline resectable pancreatic cancer - Therapy-resistant non-small cell lung cancer (NSCLC) [7][8] Prostate Cancer Data - Positive Phase 3 trial results with a primary endpoint of disease-free survival, showing a 30% improvement in disease-free survival rates [10][12] - Secondary endpoint showed a 38% improvement in prostate cancer-specific disease-free survival [13] - Plans to submit a Biologics License Application (BLA) by 2026 [9][10] Commercial Launch Preparation - Scaling up commercial manufacturing with partner SAFC in California [16][17] - Positive feedback from urologists and radiation oncologists regarding the adoption of CAN 2409 in combination with standard care [18][20] - Initial payer feedback has been favorable, indicating potential cost savings for healthcare systems [21] Non-Small Cell Lung Cancer (NSCLC) Data - Focus on patients with unresectable stage 3 or stage 4 NSCLC who have failed standard treatments [23] - Median overall survival of over 24 months in treated patients, doubling the expected survival [24] - Fast track designation received from the FDA based on these results [26][27] Pancreatic Cancer Data - Conducted a small randomized trial showing a median overall survival of over 32 months compared to 12.5 months in the control group [34] - Fast track and orphan drug designations received from the FDA and EMA [35] Manufacturing and Capacity - Manufacturing process involves replication-defective adenoviruses, similar to COVID-19 vaccines, with established industry capacity [38][39] - Product stability confirmed for over ten years under refrigeration [40] Future Directions - Candel is preparing for a potential registrational Phase 3 trial in therapy-resistant NSCLC and pancreatic cancer [27][35] - Ongoing exploration of CAN 3110, a next-generation oncolytic virus for glioblastoma, showing promising early results [42][45] Financial Position - Current cash runway extends into Q1 2027, with upcoming data announcements expected [53] Additional Important Information - Candel emphasizes the importance of a strong scientific rationale and unmet clinical needs in prioritizing its pipeline [36] - The company aims to advance multiple programs in parallel to maximize commercial value [37]

Core Insights - Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer treatment [3][4] - The company will present at the Canaccord Genuity 45th Annual Growth Conference from August 12-14, 2025 [1][2] Company Overview - Candel Therapeutics specializes in off-the-shelf multimodal biological immunotherapies that aim to elicit individualized systemic anti-tumor immune responses [3] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [3] Product Development - CAN-2409 is the lead product candidate from the adenovirus platform, which has completed successful phase 2a trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - A pivotal phase 3 trial of CAN-2409 in localized prostate cancer has been conducted under a Special Protocol Assessment (SPA) with the FDA, and it received Regenerative Medicine Advanced Therapy (RMAT) Designation in May 2025 [4] - CAN-3110 is the lead candidate from the HSV platform, currently in a phase 1b trial for recurrent high-grade glioma (rHGG), and has received Fast Track and Orphan Drug Designations from the FDA [5] Discovery Platform - Candel's enLIGHTEN™ Discovery Platform utilizes human biology and advanced analytics to develop new viral immunotherapies for solid tumors [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]

Core Viewpoint - Candel Therapeutics has received Orphan Designation from the European Medicines Agency (EMA) for its investigational drug CAN-2409 for the treatment of pancreatic cancer, complementing its existing FDA designations, highlighting the significant unmet medical need in this area [1][5]. Group 1: Regulatory Designations - CAN-2409 has received Orphan Drug Designation and Fast Track Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) [1][5]. - The EMA's Orphan Designation provides benefits such as reduced regulatory fees, clinical protocol assistance, and up to 10 years of market exclusivity in the EU if approved [4]. Group 2: Clinical Trial Results - In a phase 2a clinical trial, CAN-2409 plus valacyclovir showed a median overall survival (OS) of 31.4 months compared to 12.5 months in the control arm, indicating significant survival benefits [3]. - Three out of seven patients treated with CAN-2409 were alive at the data cut-off, with survival times of 66.0, 63.6, and 35.8 months, suggesting a long tail of survival [3]. Group 3: Mechanism of Action - CAN-2409 is a replication-defective adenovirus designed to deliver the HSV-tk gene to tumor cells, leading to immunogenic cell death and the release of tumor antigens [2][6]. - The treatment aims to induce a systemic immune response against multiple therapy-resistant solid tumors, including prostate cancer and non-small cell lung cancer (NSCLC) [2][7]. Group 4: Company Overview - Candel Therapeutics focuses on developing off-the-shelf multimodal biological immunotherapies to elicit individualized anti-tumor immune responses [8]. - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [8].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Candel Therapeutics, Inc. has been added to multiple Russell indexes as part of the 2025 Russell US Indexes annual reconstitution, effective June 30, 2025, which reflects the company's progress in clinical programs and discovery efforts in cancer immunotherapy [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to elicit systemic anti-tumor immune responses [4] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4] Clinical Development - Candel's lead product candidate, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5] - A pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer is ongoing under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including treatment-resistant PDAC and localized prostate cancer [5] Strategic Importance of Index Inclusion - Inclusion in the Russell Value indexes is expected to enhance Candel's engagement with the investment community and support its pre-commercialization efforts for CAN-2409 [3] - Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them [3] Future Prospects - The company is preparing for a potential submission of a Biologics License Application for CAN-2409 and continues to advance its innovative immunotherapy platform across various solid tumors [3] - Candel's enLIGHTEN™ Discovery Platform aims to leverage human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]

Core Viewpoint - Candel Therapeutics, Inc. (CADL) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years [2]. - Candel Therapeutics is expected to earn -$0.92 per share for the fiscal year ending December 2025, unchanged from the previous year, but analysts have raised their estimates by 17.5% over the past three months [9]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [5]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - Candel Therapeutics' upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]