CADL Candel Therapeutics Inc.

9.83
+0.03  (+0%)
Previous Close 9.8
Open 9.67
52 Week Low 5.51
52 Week High 14.78
Market Cap $282,021,147
Shares 28,689,842
Float 15,512,000
Enterprise Value $254,783,365
Volume 3,046
Av. Daily Volume 122,369
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Upcoming Catalysts

Drug Stage Catalyst Date
CAN-3110
Glioma
Phase 1
Phase 1
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CAN-2409 with OPDIVO (nivolumab)
Glioma
Phase 1
Phase 1
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CAN-2409
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
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CAN-2409
Pancreatic Cancer
Phase 2
Phase 2
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CAN-2409 combined with Valacyclovir
Prostate cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
CAN-2409 (ULYSSES)
Prostate Cancer (Active Surveillance)
Phase 2
Phase 2
Phase 2 safety data displayed grade 4 events, and 3 hospitalizations due to inflection (n=365), the most common AE was flu-like symptoms reported by 21% of patients, noted September 25, 2021.
CAN-2409
Glioma
Phase 3
Phase 3
Phase 3 trial to be initiated 1H 2022.

Latest News

  1. NEEDHAM, Mass., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced it has appointed Mace L. Rothenberg, MD, as a senior advisor to its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci. Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the company's continued growth and acceleration.

    "I am delighted to welcome Mace as an advisor to Candel Therapeutics to further strengthen our team," said Dr. Tak. "His impressive background as a physician-executive along with his successful track record of regulatory approvals of numerous novel cancer…

    NEEDHAM, Mass., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced it has appointed Mace L. Rothenberg, MD, as a senior advisor to its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci. Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the company's continued growth and acceleration.

    "I am delighted to welcome Mace as an advisor to Candel Therapeutics to further strengthen our team," said Dr. Tak. "His impressive background as a physician-executive along with his successful track record of regulatory approvals of numerous novel cancer therapies will bolster the company as it enters the next phase of development." 

    Prior to joining Candel, Dr. Rothenberg served as Chief Medical Officer of Pfizer. During that time, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine. Prior to that role, Dr. Rothenberg led clinical development for oncology at Pfizer for 10 years. In that period of time, his team developed and obtained regulatory approval for 11 new cancer medicines, including first-in-class medicines: IBRANCE® (palbociclib) for patients with HR+/HER2- advanced breast cancer and XALKORI® (crizotinib) for patients with ALK+ non-small cell lung cancer. Earlier in his career, Dr. Rothenberg was Professor of Medicine at Vanderbilt University and Ingram Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center. He also served as an Associate Professor of Medicine at the University of Texas Health Science Center at San Antonio and Executive Officer of the Southwest Oncology Group.

    Dr. Rothenberg is board-certified in Internal Medicine and Medical Oncology and is a Fellow of the American College of Physicians and the American Society of Clinical Oncology. He received his BA magna cum laude from the University of Pennsylvania and his MD from the New York University School of Medicine. Dr. Rothenberg completed his post-graduate training in internal medicine at Vanderbilt University and in medical oncology at the National Cancer Institute. 

    "Candel is at the forefront of one of the most exciting approaches in cancer immunotherapy," said Dr. Rothenberg. "I am excited by the opportunity to help Paul Peter advance the company's promising oncology pipeline. He has built a terrific clinical development organization and I look forward to working with them in advancing Candel's promising pipeline of compounds."

    About CAN-2409

    CAN-2409, Candel's most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

    Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

    About CAN-3110

    CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.

    Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology Annual Meeting.

    For more information on this clinical study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03152318.

    About Candel Therapeutics

    Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Candel's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neoantigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. New discovery programs are based on the HSV platform.

    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 development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; 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; expectations regarding the therapeutic benefit of the Company's programs; 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, and strategic plans for the Company's business and product candidates, and other risks identified in the Company's SEC filings, including the Company's Registration Statement on Form S-1, the Company's Quarterly Report on Form 10-Q filed on September 8, 2021, 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.

    Media Contact

    Heidi Chokeir, Ph.D.

    Managing Director

    Canale Communications

    heidi.chokeir@canalecomm.com

    619-203-5391

    Investor Contact 

    Sylvia Wheeler 

    Principal 

    Wheelhouse Life Science Advisors 

    swheeler@wheelhouselsa.com 



    Primary Logo

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  2. NEEDHAM, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that the Company will present novel biomarker data from the ongoing phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting taking place November 10-14, 2021 in Washington D.C., and virtually.

    Poster details:

    Title: Detection of viral antigen and immune activation after intra-tumor injection of CAN-3110 (ICP-34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma
    Abstract Number: 395
    Primary Author/Presenter: Francesca Barone, MD…

    NEEDHAM, Mass., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that the Company will present novel biomarker data from the ongoing phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting taking place November 10-14, 2021 in Washington D.C., and virtually.

    Poster details:

    Title: Detection of viral antigen and immune activation after intra-tumor injection of CAN-3110 (ICP-34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma

    Abstract Number: 395

    Primary Author/Presenter: Francesca Barone, MD, PhD, Vice President, Head of Research, Candel Therapeutics, Inc.

    Date/Time: November 12, 2021, 7:00 am – 8:30 pm ET

    Full text of the abstract will be released on the SITC website at 8:00 a.m. ET on Tuesday, November 9, 2021. Details from the presentation will be available on the Candel website at https://www.candeltx.com/news/.

    About CAN-3110



    CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain.



    Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology Annual Meeting.

    For more information on this clinical study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03152318.

    About CAN-2409



    CAN-2409, Candel's most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the local release of tumor-specific neoantigens. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

    Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

    About Candel Therapeutics



    Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Candel's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. New discovery programs are based on the HSV platform.

    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 development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; 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; expectations regarding the therapeutic benefit of the Company's programs; 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, and strategic plans for the Company's business and product candidates, and other risks identified in the Company's SEC filings, including the Company's Registration Statement on Form S-1, the Company's Quarterly Report on Form 10-Q filed on September 8, 2021, 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.

    Media Contact

    Heidi Chokeir, Ph.D.

    Managing Director

    Canale Communications

    heidi.chokeir@canalecomm.com

    619-203-5391

    Investor Contact

    Nathan Caffo

    Chief Business Officer

    Candel Therapeutics

    investors@candeltx.com

    617-916-5445



    Primary Logo

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  3. NEEDHAM, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci, and E. Antonio Chiocca, MD, PhD, FAANS, an investigator on Candel's clinical trials in brain cancer, will present data and overviews pertaining to oncolytic viral immunotherapies for glioblastoma and other solid tumors at the following upcoming scientific conferences.

    • Cambridge Healthtech Institute's 9th Annual Immuno-Oncology Summit Conference Program: Oncolytic Virus Immunotherapy
      Date and Time: Wednesday, Oct. 6, 2021
      Presenter: Paul Peter Tak, MD, PhD, FMedSci…

    NEEDHAM, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci, and E. Antonio Chiocca, MD, PhD, FAANS, an investigator on Candel's clinical trials in brain cancer, will present data and overviews pertaining to oncolytic viral immunotherapies for glioblastoma and other solid tumors at the following upcoming scientific conferences.

    • Cambridge Healthtech Institute's 9th Annual Immuno-Oncology Summit Conference Program: Oncolytic Virus Immunotherapy

      Date and Time: Wednesday, Oct. 6, 2021

      Presenter: Paul Peter Tak, MD, PhD, FMedSci

      Presentation Title: Novel Oncolytic Viral Immunotherapies for Solid Tumors
    • Hanson Wade's 6th Annual Oncolytic Virotherapy Summit

      Date and Time: Wednesday, Oct. 27, 2021

      Presenter: Paul Peter Tak, MD, PhD, FMedSci

      Presentation Title: Novel Oncolytic Viral Immunotherapies to Immunize Against the Patient's Own Tumor Neo-antigens: CAN-2409 and CAN-3110
    • Hanson Wade's 6th Annual Oncolytic Virotherapy Summit

      Date and Time: Wednesday, Oct. 27, 2021

      Presenter: E. Antonio Chiocca, MD, PhD, FAANS

      Presentation Title: Improving Oncolytic HSV1 for Glioblastoma Therapy

    Details from the presentations will be available on the Candel website at https://www.candeltx.com/news/.

    About CAN-2409



    CAN-2409, Candel's most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the local release of tumor-specific neo-antigens. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

    Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

    About CAN-3110



    CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.



    Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology Annual Meeting.

    For more information on this clinical study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03152318.

    About Candel Therapeutics



    Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Candel's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. New discovery programs are based on the HSV platform.

    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 development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; 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; expectations regarding the therapeutic benefit of the Company's programs; 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, and strategic plans for the Company's business and product candidates, and other risks identified in the Company's SEC filings, including the Company's Registration Statement on Form S-1, the Company's Quarterly Report on Form 10-Q filed on September 8, 2021, 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.

    Media Contact

    Heidi Chokeir, PhD

    Managing Director

    Canale Communications

    heidi.chokeir@canalecomm.com

    619-203-5391

    Investor Contact

    Nathan Caffo

    Chief Business Officer

    Candel Therapeutics

    investors@candeltx.com

    617-916-5445



    Primary Logo

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    • Dr. Scott E. Eggener to present safety data from phase 2 clinical trial of CAN-2409 in patients with localized, low to intermediate risk prostate cancer undergoing active surveillance at AdMeTech Foundation's Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer

    • Dr. E. Antonio Chiocca to present clinical and immunological biomarker data from phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the 16th Meeting of the European Association of Neuro-Oncology

    NEEDHAM, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), today announced upcoming presentations of clinical data supporting continued clinical advancement of its prostate cancer and brain cancer programs…

    • Dr. Scott E. Eggener to present safety data from phase 2 clinical trial of CAN-2409 in patients with localized, low to intermediate risk prostate cancer undergoing active surveillance at AdMeTech Foundation's Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer



    • Dr. E. Antonio Chiocca to present clinical and immunological biomarker data from phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the 16th Meeting of the European Association of Neuro-Oncology

    NEEDHAM, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (NASDAQ:CADL), today announced upcoming presentations of clinical data supporting continued clinical advancement of its prostate cancer and brain cancer programs at the following medical conferences in September 2021.

    • AdMeTech Foundation's Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer

      Date and Time: September 25, 2021, at 8:00 am ET

      Presenter: Scott E. Eggener, MD

      Presentation Title: Safety and Feasibility of Intraprostatic Injection of CAN-2409 or Placebo followed by Valacyclovir in Patients on Active Surveillance for Prostate Cancer (ULYSSES Trial)

    Details from the clinical data presentations will be available on the Candel website at https://www.candeltx.com/news/.

    About CAN-2409



    CAN-2409, Candel's most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

    Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

    About CAN-3110



    CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.



    Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology Annual Meeting.

    For more information on this clinical study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03152318.

    About Candel Therapeutics



    Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Candel's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. New discovery programs are based on the HSV platform.

    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 development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; 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; expectations regarding the therapeutic benefit of the Company's programs; 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, and strategic plans for the Company's business and product candidates, and other risks identified in the Company's SEC filings, including the Company's Registration Statement on Form S-1, the Company's Quarterly Report on Form 10-Q to be filed on or about the date of this press release, 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.

    Media Contact

    Heidi Chokeir, Ph.D.

    Managing Director

    Canale Communications

    heidi.chokeir@canalecomm.com

    619-203-5391

    Investor Contact

    Nathan Caffo

    Chief Business Officer

    Candel Therapeutics

    investors@candeltx.com

    617-916-5445



    Primary Logo

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  4. NEEDHAM, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. ("the Company") (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    "This has been a transformational year for Candel Therapeutics as we continue to execute on our corporate strategy by advancing the development of our lead product candidate from our adenovirus platform, CAN-2409, and our lead product candidate from our HSV platform, CAN-3110, both in areas of significant unmet need," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "With…

    NEEDHAM, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. ("the Company") (NASDAQ:CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    "This has been a transformational year for Candel Therapeutics as we continue to execute on our corporate strategy by advancing the development of our lead product candidate from our adenovirus platform, CAN-2409, and our lead product candidate from our HSV platform, CAN-3110, both in areas of significant unmet need," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "With the completion of our IPO in August and multiple data readouts across our broad pipeline over the next 12 months, we are in a strong position to advance our strategy and well-capitalized to support achievement of important milestones toward bringing novel immunotherapies to patients with cancer."

    Second Quarter 2021 & Recent Highlights

    • On April 13, the Company announced formation of its new Research Advisory Board that included 2018 Nobel Laureate, James Allison, Ph.D. (MD Anderson Cancer Center), Henry Brem, M.D. (Johns Hopkins University), Roy S. Herbst, M.D., Ph.D. (Yale Cancer Center), Elizabeth Jaffee, M.D. (Johns Hopkins University), Philip Kantoff, M.D. (formerly Memorial Sloan Kettering Cancer Center), and Padmanee Sharma, M.D., Ph.D. (MD Anderson Cancer Center).
    • On April 22, the Company announced it completed enrollment in a phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with Opdivo® (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients who have a methylated MGMT promoter. 
    • On June 4, the Company reported data from an ongoing phase 1 clinical trial of its oncolytic virus, CAN-3110, in patients with high-grade glioma that has recurred after initial treatment. The data presented at the 2021 American Society of Clinical Oncology (ASCO) demonstrated a favorable safety and tolerability profile and durable responses in a number of patients.
    • On June 22, the U.S. Food and Drug Administration granted Fast Track designation for CAN-2409 in combination with standard-of-care surgery and chemoradiation to improve survival in adults with newly diagnosed high-grade glioma.
    • On July 15, the Company announced the appointment of Diem Nguyen, Ph.D., M.B.A. to its Board of Directors.
    • On August 17, the Company announced the completion of its Initial Public Offering, raising gross proceeds of $79.1 million, before deducting underwriting discounts and commissions and offering expenses, to support ongoing research and development efforts.
    • On September 7, the Company announced it completed enrollment in its phase 3 clinical trial of CAN-2409 in combination with valacyclovir for the treatment of intermediate- to high-risk localized prostate cancer.

    Key Upcoming Milestones

    • Initial efficacy and safety data from a phase 1 clinical trial of CAN-2409 in combination with Opdivo® (nivolumab) in patients with high-grade glioma are expected to be presented in the fourth quarter of 2021.
    • Blinded safety data from a phase 2 clinical trial of CAN-2409 in patients undergoing active surveillance for prostate cancer are expected to be presented in the third quarter of 2021.
    • Biomarker results from a phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma are expected to be presented in the fourth quarter of 2021.

    Financial Results for the Second Quarter Ended June 30, 2021

    Cash Position: Cash and cash equivalents as of June 30, 2021, were $24.3 million, as compared to $35.1 million as of December 31, 2020. In August 2021, Candel completed its initial public offering in which the Company issued 9,887,994 shares of common stock at a price of $8.00 per share, including the partial exercise of the underwriters' overallotment option, for net proceeds of $71.5 million after deducting underwriting discounts and commissions and offering expenses. Based on current plans and assumptions, the Company expects its existing cash and cash equivalents, including the net proceeds of the IPO, will be sufficient to fund its operations into the second quarter of 2023.

    Research & Development Expenses: Research and development expenses were $3.3 million and $6.0 million for the three and six months ended June 30, 2021, respectively, as compared to $1.8 million and $3.4 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs for additional headcount to support the ongoing clinical trials for Candel's product candidates as well as increased clinical development costs. Excluding stock-based compensation expense of $0.4 million for the three months ended June 30, 2021, and $0.5 million for the six months ended June 30, 2021, research and development expenses for the three and six months ended June 30, 2021, were $2.9 million and $5.5 million, respectively.

    General and Administrative Expenses: General and administrative expenses were $2.0 million and $4.0 million for the three and six months ended June 30, 2021, respectively, as compared to $0.9 million and $1.6 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, additional headcount required to support the growth of the Company, and an increase in professional fees associated with Candel's preparation for the IPO completed in August 2021. Excluding stock-based compensation expense of $0.7 million for the three months ended June 30, 2021, and $ 1.0 million for the six months ended June 30, 2021, general and administrative expenses for the three and six months ended June 30, 2021, were $1.3 million and $3.0 million, respectively.

    Total Operating Expenses: Total operating expenses were $5.3 million and $10.0 million for the three and six months ended June 30, 2021, respectively, as compared to $2.7 million and $5.0 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company, an increase in professional fees associated with Candel's preparation for the IPO completed in August 2021 and increased clinical development costs. Excluding stock-based compensation expense of $1.1 million for the three months ended June 30, 2021, and $1.5 million for the six months ended June 30, 2021, total operating expenses for the three and six months ended June 30, 2021, were $4.2 million and $8.5 million, respectively.

    Net Loss: Net loss was $17.1 million and $21.6 million for the three and six months ended June 30, 2021, respectively, as compared to $2.9 million and $4.6 million for the comparable periods of 2020. The net loss for the three and six months ended June 30, 2021, includes a noncash charge of $12.4 million for the change in the fair value of the Company's warrant liability and stock-based compensation of $1.1 million and $1.5 million, respectively. Excluding the noncash charges for the change in the warrant liability and stock-based compensation, the net loss for the three and six months ended June 30, 2021, was $3.6 million and $7.7 million, respectively.



    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,
       2021   2020   2021   2020 
    Research and development service revenue, related party $31  $31  $63  $63 
    Operating expenses:        
    Research and development  3,292   1,795   6,048   3,417 
    General and administrative  2,040   855   3,972   1,583 
    Total operating expenses  5,332   2,650   10,020   5,000 
    Loss from operations  (5,301)  (2,619)  (9,957)  (4,937)
    Other income (expense):        
    Grant income  605   156   796   319 
    Interest, dividend and investment income (expense), net  (15)  94   (28)  22 
    Change in fair value of warrant liability  (12,369)  (507)  (12,369)  (52)
    Total other income (expense), net  (11,779)  (257)  (11,601)  289 
    Net loss $(17,080) $(2,876) $(21,558) $(4,648)
    Other comprehensive gain:        
    Unrealized gain on available-for-sale securities     307      73 
    Comprehensive loss $(17,080) $(2,569) $(21,558) $(4,575)
    Net loss per share attributable to common stockholders, basic and diluted $(1.46) $(0.25) $(1.85) $(0.40)
    Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted  11,720,530   11,614,754   11,684,374   11,614,551 
             

    Candel Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

      JUNE 30, 2021  DECEMBER 31, 2020
    Cash, cash equivalents and marketable securities $24,316  $35,053 
    Working capital  19,932   30,433 
    Total assets  30,744   38,282 
    Warrant liability  19,200   6,831 
    Total other liabilities  5,659   5,953 
    Accumulated deficit $(65,729) $(44,171)
    Total stockholder deficit  (43,175)  (23,562)
         

    About Candel Therapeutics

    Candel is a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies. Candel's engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. Candel has established two oncolytic viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. New discovery programs are based on the HSV platform.

    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 development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; 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; expectations regarding the therapeutic benefit of the Company's programs; 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, and strategic plans for the Company's business and product candidates, and other risks identified in the Company's SEC filings, including the Company's Registration Statement on Form S-1, the Company's Quarterly Report on Form 10-Q to be filed on or about the date of this press release, 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.

    Media Contact

    Heidi Chokeir, Ph.D.

    Managing Director

    Canale Communications

    heidi.chokeir@canalecomm.com

    619-203-5391

    Investor Contact

    Nathan Caffo

    Chief Business Officer

    Candel Therapeutics

    investors@candeltx.com

    617-916-5445



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