rQNestin 34.5

Announced positive survival data from the phase 2 randomized controlled clinical trial of CAN-2409 in borderline resectable pancreatic cancerPresented positive topline overall survival data from the phase 2 clinical trial of CAN-2409 in non-small cell lung cancer (NSCLC) at 2024 American Society of Clinical Oncology (ASCO) Annual MeetingReceived orphan drug designation from the U.S. Food and Drug Administration (FDA) for both CAN-2409 and CAN-3110, for the treatment of pancreatic cancer and recurrent high-grade glioma (rHGG), respectivelyOn track for topline disease-free survival data from the phase 3 randomized controlled clinical trial of CAN-2409 in localized intermediate/high risk prostate cancer, expected in Q4 2024On track for topline progression-free survival data from the phase 2b randomized controlled clinical trial of CAN-2409 in the active surveillance population with localized low/intermediate risk prostate cancer, expected in Q4 2024The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into Q1 2025 NEEDHAM, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update. “The second quarter of 2024 represented a pivotal period for Candel, characterized by robust clinical advancements and key regulatory successes, that further validate our innovative approach to cancer immunotherapy,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “Our encouraging overall survival phase 2 data for CAN-2409 highlights the potential of our lead candidate to address a significant unmet need for non-small cell lung cancer patients, who are non-responsive to immune checkpoint inhibitor treatment, and for patients with borderline resectable pancreatic cancer. In addition, the FDA granting orphan drug designation for CAN-3110 in recurrent high-grade glioma underscores the promise of this first-in-class, novel asset developed for difficult-to-treat cancers.” Dr. Tak continued, “Our inclusion in the Russell 3000 Index also marks a significant milestone in Candel’s growth and offers an opportunity to increase our recognition within the investment community. These achievements, coupled with a successful R&D event at ASCO, have set a strong foundation as we approach several key readouts in the latter half of 2024.” Second Quarter 2024 & Recent Highlights Program Updates CAN-2409 – Pancreatic Cancer In early April, announced positive updated survival data from the phase 2 randomized controlled clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, in borderline resectable pancreatic ductal adenocarcinoma (PDAC).Data showed notable improvements in estimated median overall survival (mOS) of 28.8 months after experimental treatment with CAN-2409 versus 12.5 months in control group.At 24 months, survival rate was 71.4% in CAN-2409 treated patients after chemoradiation and prior to surgery versus 16.7% in the control group. At 36 months, estimated survival was 47.6% in the CAN-2409 group after chemoradiation and prior to surgery versus 16.7% in the control group.No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well-tolerated to date, with no dose-limiting toxicities and no cases of pancreatitis reported.Analysis of resected tumors showed the formation of dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, within the tumor microenvironment after CAN-2409 administration, confirming the activation of a robust antitumoral immune response.Received orphan drug designation from the FDA for CAN-2409 for the treatment of pancreatic cancer. CAN-2409 – Non-Small Cell Lung Cancer Presented topline overall survival data from the phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) therapy in patients with stage III/IV NSCLC inadequately responding to ICI therapy at the 2024 ASCO Annual Meeting.Data showed mOS of 20.6 months in patients with progressive disease despite ICI treatment compared to published results of less than 12 months with SoC docetaxel-based chemotherapy in similar patient populations.1CAN-2409 treatment resulted in activation of the systemic immune response after two administrations of CAN-2409, including increased numbers of circulating cytotoxic and memory T cells associated with subsequent prolonged survival.As of the April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile. CAN-3110 – Recurrent High-Grade Glioma Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG.Presented a Trial-in-Progress poster at the 2024 ASCO Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG. enLIGHTEN™ Discovery Platform Presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors. Corporate Updates Hosted successful NSCLC Research and Development panel during the 2024 ASCO Annual Meeting, featuring prominent scientific and medical thought leaders discussing the topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC.Announced inclusion in the Russell 3000 Index, effective July 1, 2024, as part of FTSE Russell’s annual reconstitution of its U.S. equity indexes. Anticipated Milestones Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024. Financial Results for Second Quarter Ended June 30, 2024 Research and Development Expenses: Research and development expenses were $5.0 million for the second quarter of 2024 compared to $5.9 million for the second quarter of 2023. The decrease was primarily due to lower clinical development costs driven by a reduction in regulatory, manufacturing and clinical trial costs for CAN-2409 programs and lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. These decreases were partially offset by increased stock-based compensation expense. Research and development expenses included non-cash stock compensation expense of $1.3 million for the second quarter of 2024 compared to $0.3 million for the second quarter of 2023. General and Administrative Expenses: General and administrative expenses were $3.6 million for both the second quarter of 2024 and the second quarter of 2023. There was a small decrease, primarily due to lower insurance costs and recruiting costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the second quarter of 2024 compared to $0.4 million for the second quarter of 2023. Net Loss: Net loss for the second quarter of 2024 was $22.2 million, compared to a net loss of $9.6 million for the second quarter of 2023, and included other expense, net of $13.7 million and $35,000, respectively, primarily due to the change in the fair value of the Company’s warrant liability. Cash Position: Cash and cash equivalents, as of June 30, 2024, were $21.5 million, as compared to $35.4 million as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2025. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic ductal adenocarcinoma (PDAC) (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1b clinical trial in recurrent high-grade glioma (rHGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including key data readout milestones and presentations; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s programs, including the ability of CAN-2409 to improve overall survival of patients with NSCLC who are non-responsive to immune checkpoint inhibitor therapy and of patients with borderline resectable pancreatic cancer; the ability of CAN-3110 to treat difficult-to-treat cancers; expectations regarding the potential benefits conferred by orphan drug designation and fast track designation; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; the Company’s ability to continue as a going concern; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC) including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor ContactTheodore JenkinsVice President, Investor Relations, and Business DevelopmentCandel Therapeutics, Inc.tjenkins@candeltx.com Media ContactBen ShannonVice PresidentICR Westwicke CandelPR@westwicke.com ____________________ Reckamp KL, et al. J Clin Oncol. 2022;40(21):2295-2306. Candel Therapeutics, Inc.Consolidated Statements of Operations(in thousands, except share and per share amounts)(Unaudited) THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30, 2024 2023 2024 2023Operating expenses: Research and development $4,979 $5,934 $9,081 $11,403 General and administrative 3,592 3,645 7,392 7,809 Total operating expenses 8,571 9,579 16,473 19,212 Loss from operations (8,571) (9,579) (16,473) (19,212)Other income (expense): Grant income — 12 — 24 Interest income 240 453 560 1,164 Interest expense (567) (644) (1,213) (1,253)Change in fair value of warrant liability (13,339) 144 (13,332) 868 Total other income (expense), net (13,666) (35) (13,985) 803 Net loss and comprehensive loss $(22,237) $(9,614) $(30,458) $(18,409)Net loss per share, basic and diluted $(0.74) $(0.33) $(1.03) $(0.64)Weighted-average common shares outstanding, basic and diluted 29,878,210 28,919,810 29,537,874 28,919,810 Candel Therapeutics, Inc.Condensed Consolidated Balance Sheet Data(in thousands) JUNE 30,2024(Unaudited) DECEMBER 31,2023Cash and cash equivalents $21,454 $35,413 Working capital (1) 8,739 22,613 Total assets 26,485 41,201 Warrant liability 14,248 916 Total other liabilities 22,209 27,540 Accumulated deficit (167,486) (137,028)Total stockholders equity (deficit) $(9,972) $12,745 1) Working capital is calculated as current assets less current liabilities

As Starmer takes over as UK Prime Minister, the pharmaceutical industry has asked for increased investment, and a focus on talent attraction within immigration laws. Credit: Carl Court via Getty Images. “Change begins now,” said the UK’s new prime minister , Sir Keir Starmer, in his 5 July victory speech. Ending the 14-year Conservative party reign, the Labour Party has pledged to bolster the UK pharmaceutical sector through increased investment and regulatory action. Starmer’s government is expected to appoint cabinet members in the coming days while junior ministers will be announced today and early into next week. The new members of parliament (MPs) will soon be sworn in from 9 to 11 July. In his final speech as prime minister, Conservative Party leader Rishi Sunak hailed his party’s work to achieve a decreased inflation rate and implement the Windsor Framework for trade in and out of Northern Ireland. However, in a 5 July speech, Starmer said: “Our work is urgent – and we begin it today.” The Labour Party has already promised extensive change to the UK’s life sciences sector, setting forth plans for faster regulatory timelines, more investment and National Health Service (NHS) reform among other things. The pharmaceutical sector has been outspoken about the need for change to cement the UK as a life sciences superpower, bolster the healthcare system, and attract talent to the industry. “During its campaign, Labour was right to single out the UK’s life sciences sector as a critical partner for their plans to deliver positive change and economic growth. A strong industry-government partnership will be vital to ensure that we continue to discover breakthrough medical innovation in the UK and ensure NHS patients are among the first people in the world to benefit from the latest medicines and vaccines,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry in a statement responding to Starmer’s election win. Life sciences investment In Labour’s 13 June manifesto , the party committed to set spending plans for the next ten years, pledging money to research agencies such as UK Research and Innovation (UKRI), the nation’s main public science funder. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval The party departed from the usual standard three-year timespan for budgeting plans of this nature to “allow meaningful partnerships with industry to keep the UK at the forefront of global innovation,” according to Labour’s manifesto. The Labour government intends to invest at least 3% of gross domestic product (GDP) in research and development (R&D) in both the public and private sectors, said the shadow sciences minister Chi Onwurah in a May 2024 interview with the Financial Times. She added that the Labour government would also increase annual R&D expenditure by £10bn ($12.7bn). In October 2023, the Labour Party declared plans for a new Regulatory Innovation Office (RIO) to address Medicines and Healthcare products Regulatory Agency (MHRA) backlogs. The new RIO aims to set and monitor goals for regulatory approval timelines, analyse areas for prioritisation and assist a “beefed-up” regulatory council. “New technology can be used to grow the economy and deliver better treatments to patients. Good regulation is essential to build safety and public trust, but decisions need to be made quickly,” said Peter Kyle, the shadow science, innovation and technology secretary in a press release. “Commitments to speeding up the clinical trials process by embracing technology and standardising documentation will be welcomed by the life sciences industry and should help to attract new investment and market entrants,” says Charlotte Harpin, partner in the health and life sciences team at UK and Ireland law firm Browne Jacobson. Talent attraction versus immigration In a 22 May statement, health research charitable organisation Wellcome said: “Long-term funding, an immigration regime that can attract top talent, and world-class infrastructure will unlock R&D investment and maximise the impact of science for the UK’s economy and place in the world.” The organisation has asked the government to reduce up-front fees for scientists seeking work in the UK. The Royal Society and the Physiology Society added to these pleas, calling for streamlined visa processes for researchers. The Labour Party has so far promised to uphaul the points-based immigration system to reduce migration and form a partnership between the government and the Migration Advisory Committee (MAC). This collaboration aims to “ensure joined-up action to deliver the skills needed for growth, including priority sectors for our industrial strategy,” as per a May 10 press release. However, the party has also stated that it aims to reduce the need for international recruitment. In January, Cancer Research UK reported that due to expensive Brexit-related visa fees over 75% of respondents to a survey said that they have faced challenges in recruitment and retention due to the changed EU-UK relationship. In a previous government report, it was predicted that the UK would need 380,000 new researchers in the next four years, and the charitable organisation argues that this will not be possible with domestic talent alone. “There’s a global competition for talent and we’re losing out,” said the cancer charity in a January statement.