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[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)

[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].

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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]