FDA Orphan Designation provides CAN-3110 certain developmental financial incentives, with potential for up to 7 years of marketing exclusivity in the United States, if approved CAN-3110 phase 1b data on the feasibility and safety of multiple doses of CAN-3110 will be featured in poster presentation at 2024 ASCO Annual Meeting NEEDHAM, Mass., May 30, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing mult ...

FDA Orphan Designation provides CAN-3110 certain developmental financial incentives, with potential for up to 7 years of marketing exclusivity in the United States, if approved CAN-3110 phase 1b data on the feasibility and safety of multiple doses of CAN-3110 will be featured in poster presentation at 2024 ASCO Annual Meeting NEEDHAM, Mass., May 30, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing mult ...

Core Insights - Candel Therapeutics is focused on developing two novel therapeutics, CAN-2409 and CAN-3110, for various cancer indications [1] - The company has seen a significant stock price increase of 430.6% year-to-date, driven by positive clinical updates for CAN-2409 [2] Product Development - CAN-2409 is an investigational adenovirus immunotherapy candidate being studied in mid to late-stage trials for prostate cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer [1] - CAN-3110 is an HSV-1-based immunotherapy candidate currently in an early-stage study for recurrent high-grade glioma (HGG) [2] Clinical Trial Results - Positive interim data from a phase II study showed that CAN-2409 combined with valacyclovir and standard of care led to a median overall survival of 28.8 months in borderline resectable pancreatic ductal adenocarcinoma (PDAC) patients, compared to 12.5 months in the control group [4] - The survival rate for patients treated with CAN-2409 was 71.4% at 24 months and 47.6% at 36 months, significantly higher than the control group's rates of 16.7% [5] Regulatory Designations - The FDA granted orphan drug designation to CAN-2409 for PDAC, enhancing its market exclusivity potential [8] - CAN-2409 also received Fast Track designation from the FDA, which expedites its development timeline due to the unmet medical need [10] Future Expectations - Candel is evaluating CAN-2409 for newly diagnosed localized prostate cancer and expects to report top-line data from these studies in Q4 2024, which could serve as a significant catalyst for the stock [11]

Image Source: Zacks Investment Research Apart from NSCLC, CAN-2409 is also being developed for several cancer indications, including pancreatic ductal adenocarcinoma (PDAC) and prostate cancer. Last month, CADL announced positive interim data from the phase II study evaluating CAN-2409 plus valacyclovir, together with SoC chemoradiation, followed by resection for borderline resectable PDAC. The updated interim data from the ongoing phase II study showed that experimental treatment with CAN-2409 led to notab ...

A live webcast will be available by selecting Events and Presentations, under the News & Events tab, in the Investors section on Candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date. NEEDHAM, Mass., May 20, 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 announced it will be hosting ...

NEEDHAM, Mass., May 20, 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 announced it will be hosting a webcasted R&D breakfast panel featuring prominent scientific and medical thought leaders to discuss topline overall survival data from its phase 2 clinical trial of CAN-2409, its multimodal biological immunotherapy candidate, ...

i The accompanying notes are an integral part of these condensed consolidated financial statements. | --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------|-------|------------------------------|-------|-------|--------| | Assets | | MARCH 31, 2024 (Unaudited) | | 2023 | | | Current assets: | | | | | | | Cash and cash equivalents | $ | 25,713 | $ | | 35,413 | | Prepaid expenses and other current assets | | 1,423 | | | 1,384 | | Total current assets | | 27,1 ...

[Corporate Highlights and Outlook](index=1&type=section&id=Corporate%20Highlights%20and%20Outlook) Candel Therapeutics achieved significant clinical and preclinical advancements in Q1 2024, highlighted by positive long-term survival data for CAN-2409 and upcoming ASCO presentations - The company reported a period of significant progress, with maturing clinical data showing highly differentiated results in long-term patient survival[14](index=14&type=chunk) - The FDA granted CAN-2409 both Fast Track Designation and Orphan Drug Designation for the treatment of pancreatic cancer, signaling regulatory momentum[14](index=14&type=chunk)[1](index=1&type=chunk) - Topline overall survival data from the phase 2 trial of CAN-2409 in non-small cell lung cancer (NSCLC) is scheduled for presentation at the ASCO meeting on June 3, 2024[26](index=26&type=chunk)[25](index=25&type=chunk) - Progress was also made with the enLIGHTEN™ Discovery Platform, with the presentation of a second drug candidate at the AACR Annual Meeting[11](index=11&type=chunk)[15](index=15&type=chunk) [Clinical Program Updates and Milestones](index=2&type=section&id=Clinical%20Program%20Updates%20and%20Milestones) Candel provided updates on CAN-2409's survival data in pancreatic cancer, CAN-3110's safety profile, and new enLIGHTEN™ platform candidates, with key 2024 milestones outlined [CAN-2409 Program](index=2&type=section&id=CAN-2409%20Program) The CAN-2409 program showed significant survival benefits in pancreatic cancer, received Orphan Drug Designation, and will present NSCLC overall survival data at ASCO CAN-2409 Pancreatic Cancer Survival Data | Metric | CAN-2409 Group | Control Group | | :--- | :--- | :--- | | **Median Overall Survival** | 28.8 months | 12.5 months | | **24-Month Survival Rate** | 71.4% | 16.7% | | **36-Month Estimated Survival** | 47.6% | 16.7% | - Received Orphan Drug Designation from the U.S. FDA for CAN-2409 for the treatment of pancreatic cancer[1](index=1&type=chunk) - Multiple injections of CAN-2409 were generally well tolerated, with no new safety signals, dose-limiting toxicities, or cases of pancreatitis reported[28](index=28&type=chunk) - Overall survival data for CAN-2409 in patients with stage III/IV NSCLC will be presented at the ASCO Annual Meeting on June 3, 2024[35](index=35&type=chunk) [CAN-3110 Program (rHGG)](index=3&type=section&id=CAN-3110%20Program%20%28rHGG%29) The CAN-3110 program for recurrent high-grade glioma received FDA Fast Track Designation and demonstrated a favorable safety profile in its ongoing Phase 1b trial - Received Fast Track Designation from the FDA for CAN-3110 for the treatment of patients with recurrent high-grade glioma (rHGG) to improve overall survival[2](index=2&type=chunk) - In the ongoing phase 1b trial, multiple injections (up to six) of CAN-3110 have shown a favorable safety and tolerability profile[18](index=18&type=chunk) - A Trial-in-Progress poster for the CAN-3110 study will be presented at the 2024 ASCO Annual Meeting[36](index=36&type=chunk) [enLIGHTEN™ Discovery Platform](index=3&type=section&id=enLIGHTEN%E2%84%A2%20Discovery%20Platform) The enLIGHTEN™ Discovery Platform unveiled its second candidate, a first-in-class multimodal immunotherapy designed to induce tertiary lymphoid structures for solid tumors - Unveiled the second candidate from the platform, a first-in-class multimodal immunotherapy designed to induce tertiary lymphoid structures (TLS) for treating solid tumors[3](index=3&type=chunk) - The enLIGHTEN™ platform is a systematic, HSV-based discovery platform that uses human biology and advanced analytics to create new viral immunotherapies[6](index=6&type=chunk) [Anticipated Milestones](index=3&type=section&id=Anticipated%20Milestones) Candel Therapeutics anticipates key 2024 data readouts, including CAN-2409 NSCLC overall survival at ASCO, updated CAN-3110 rHGG data, and CAN-2409 prostate cancer data - **June 3, 2024:** Phase 2 topline overall survival data for CAN-2409 in NSCLC to be presented at ASCO[37](index=37&type=chunk) - **H2 2024:** Updated Phase 1b data for CAN-3110 in rHGG expected[29](index=29&type=chunk) - **Q4 2024:** Phase 3 topline disease-free survival data for CAN-2409 in localized prostate cancer expected[19](index=19&type=chunk) - **Q4 2024:** Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized prostate cancer expected[4](index=4&type=chunk) [Financial Results for First Quarter 2024](index=4&type=section&id=Financial%20Results%20for%20First%20Quarter%202024) Candel Therapeutics reported reduced Q1 2024 R&D and G&A expenses, leading to a lower net loss, with **$25.7 million** in cash expected to fund operations into Q4 2024 Q1 2024 Key Financials (vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **R&D Expenses** | $4.1 million | $5.5 million | | **G&A Expenses** | $3.8 million | $4.2 million | | **Net Loss** | $8.2 million | $8.8 million | - Cash and cash equivalents were **$25.7 million** as of March 31, 2024, down from **$35.4 million** at year-end 2023[39](index=39&type=chunk) - The current cash position is expected to be sufficient to fund the operating plan into the **fourth quarter of 2024**[39](index=39&type=chunk) - The decrease in operating expenses was primarily driven by lower employee-related costs following a corporate restructuring and reduced clinical development costs[30](index=30&type=chunk)[5](index=5&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents Candel Therapeutics' unaudited condensed consolidated financial statements, including the Q1 2024 statement of operations and balance sheet data [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) For Q1 2024, Candel Therapeutics reported total operating expenses of **$7.9 million** and a net loss of **$8.2 million**, or **$0.28** per share Consolidated Statements of Operations (Unaudited, in thousands, except per share amounts) | | **Three Months Ended March 31,** | | :--- | :--- | :--- | | | **2024** | **2023** | | **Operating expenses:** | | | | Research and development | $ 4,102 | $ 5,469 | | General and administrative | 3,800 | 4,164 | | **Total operating expenses** | **7,902** | **9,633** | | **Loss from operations** | **(7,902)** | **(9,633)** | | Total other income (expense), net | (319) | 838 | | **Net loss and comprehensive loss** | **$ (8,221)** | **$ (8,795)** | | **Net loss per share, basic and diluted** | **$ (0.28)** | **$ (0.30)** | [Condensed Consolidated Balance Sheet Data](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of March 31, 2024, Candel Therapeutics reported **$25.7 million** in cash and cash equivalents and **$31.2 million** in total assets, with total stockholders' equity at **$6.0 million** Condensed Consolidated Balance Sheet Data (in thousands) | | **March 31, 2024 (Unaudited)** | **December 31, 2023** | | :--- | :--- | :--- | | Cash and cash equivalents | $ 25,713 | $ 35,413 | | Working capital | 13,599 | 22,613 | | Total assets | 31,217 | 41,201 | | Total stockholders' equity | $ 5,979 | $ 12,745 | [About Candel Therapeutics](index=4&type=section&id=About%20Candel%20Therapeutics) Candel Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf multimodal biological immunotherapies for cancer, utilizing adenovirus and HSV platforms, including lead candidates CAN-2409 and CAN-3110 - Candel is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to elicit a systemic anti-tumor immune response[31](index=31&type=chunk) - The company has two main clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV)[31](index=31&type=chunk) - Lead product candidates include CAN-2409 (adenovirus platform) for NSCLC, pancreatic, and prostate cancer, and CAN-3110 (HSV platform) for recurrent high-grade glioma[31](index=31&type=chunk)

NEEDHAM, Mass., May 14, 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 first quarter ended March 31, 2024, and provided a corporate update. Program Updates CAN-2409 – Pancreatic Cancer In early April, announced positive updated survival data, from the ongoing randomized phase 2 clinical trial ...

KanawatTH/iStock via Getty Images Candel Therapeutics, Inc. (NASDAQ:CADL) was able to report positive interim results from its phase 2 randomized study using CAN-2409 plus valacyclovir [prodrug] together with standard of care [SOC] chemoradiation, following by resection in patients with borderline respectable pancreatic ductal adenocarcinoma [PDAC]. Not only that, but it also achieved Orphan Drug Designation [ODD] of CAN-2409 for the treatment of this patient population. Both of these events have led to ...