Tag: PDS Biotechnology Corp.

PDS Biotechnology Corp. (PDSB) – ASCO Abstracts Show Continued Efficacy and Durability

Posted on by cpereira@noblefcm.com


Tuesday, May 30, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

ASCO Abstracts Contain Positive Data Update. On Friday, May 26, abstracts for the Annual Meeting of the American Society of Clinical Oncology (ASCO) were released. As we expected, the data update from the Phase 2 VERSATILE-002 trial showed consistent or improved response rates, overall survival, and progression free survival, with continued safety and tolerability. We believe these data support our expectations of efficacy in the Phase 3 trial, expected to begin in late 2023.

Data Updates Confirm and Support Preliminary Findings. The abstract contains updated interim results from the Phase 2 VERSATILE-002 trial testing the combination of PDS0101 with Keytruda (an anti-PD-1 immune checkpoint inhibitor from Merck). The data presentation will include 34 patients that have reached the 12-month evaluation point, compared with the data from 17 patients evaluated after 9 months presented at ASCO 2022. These new data show strong improvements over ICI monotherapy, the current standard of care, as well as efficacy and strong duration of benefits. 


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PDS Biotechnology Corp. (PDSB) – 1Q23 Reported With Clinical Data Update Coming Soon

Posted on by cpereira@noblefcm.com


Tuesday, May 16, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Summary.  PDS Biotech reported 1Q23 loss of $9.7 million or $(0.32) per share. The company ended the quarter with $65.2 million in cash, which it expects to be sufficient to fund operations through 3Q24. The Phase 3 trial testing PDS0101 is expected to begin in 4Q23, and additional data from the Phase 2 VERSATILE-002 trial has been accepted for presentation at the ASCO meeting June 2 through June 6. The data will be also included in an expert panel discussion on head and neck cancer. 

Phase 3 Trial Expected To Begin In 4Q23. An amended IND is expected to be filed in 3Q23 to begin the Phase 3 trial for PDS0101 in 4Q23 in patients with recurrent or metastatic head and neck cancer. The trial is designed to test the combination of PDS0101 and Keytruda against Keytruda monotherapy with primary endpoints of Overall Survival and PFS. Two interim analysis points are planned, which we anticipate may be designed to permit discussion of early application for approval with the FDA.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp. (PDSB) – Roundtable on IL-12 Highlights PDS0301

Posted on by cpereira@noblefcm.com


Monday, April 24, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

KOL Discussion Of IL-12. PDL Biotechnology held a Roundtable Discussion on cancer therapy with IL-12 and its proprietary, tumor-seeking version, PDS0301. The panel was moderated by Dr. Lauren Wood, Chief Medical Officer, and featured two distinguished scientists from the National Cancer Institute. The presentations highlighted the distinctions between PDL0301 and recombinant IL-12, with clinical data from trials testing both drugs.

Comparisons Between IL-12 and PDS0301. The presentations pointed out the differences between IL-12 and PDS0301, the proprietary version developed by the NCI and licensed by PDS. One of the key points is that PDS0301 is an antibody linked to IL-12. The antibody domain targets and binds to cancer cell DNA that has been released from dead or dying cancer cells. This concentrates PDS0301 in the tumor, then the IL-12 portion stimulates an immune response. This differs from other trials that have used recombinant IL-12 to stimulate an immune response. In comparison, systemic rIL-12 delivery or targeting technologies have resulted in lack of efficacy, systemic side effects, or both.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp. (PDSB) – 4Q22 Results Reported With Clinical Plan Updates For 2023

Posted on by cpereira@noblefcm.com


Wednesday, March 29, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2022 Reported With Clinical Progress Updates. PDS Biotech reported a 4Q22 loss of $19.1 million or $(0.61) per share and a FY2022 loss of $40.9 million or $(1.43) per share. The loss included $10 million in licensing fees for PDS0301, paid with $5 million in cash and $5 million in stock.  Management updated its plans for Phase 3 trials for PDS0101 and PDS0301 during 2023. Cash on hand on December 31, 2022 was $73.8 million, which is expected to fund operations through 3Q24.

PDS Expects To Begin VERSATILE-003 In 4Q23. The Phase 2 VERSATILE-002 trial has reported strong results testing PDS0101 with Keytruda (pembrolizumab, a checkpoint inhibitor) for recurrent or metastatic head and neck cancer. Based on this data, PDS has received FDA guidance for the Phase 3 VERSATILE-003 trial. The trial protocols are being finalized with an IND submission expected in 2H23 and start of enrollment in 4Q23.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp. (PDSB) – Peer-Reviewed Journal Published PDS0301 Studies

Posted on by cpereira@noblefcm.com


Thursday, March 02, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

PDS0301 Data Published. The peer-reviewed journal International Immunopharmacology published a paper from scientists at the National Institutes of Health describing studies with PDS0301. The paper provides data showing how PDS0301 stimulates an immune response and its correlation with efficacy in Phase 2 studies.  We see the publication as a positive that supports the clinical progress and use of PDS0301 in immuno-oncology.

Development and Actions.  The article describes how PDS0301 was developed as a fusion protein, consisting of an antibody conjugated to Interleukin 12 (IL-12). Its targeting mechanism directs PDS0301 to the DNA/histones in tumor-necrotic regions of the tumor, avoiding the bloodstream and concentrating IL-12 in the tumor microenvironment. This avoids the systemic toxicity and serious adverse events that have limited dosing and efficacy of recombinant IL-12.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp. (PDSB) – Triple Therapy Registration Trial Requirements Announced

Posted on by cpereira@noblefcm.com


Tuesday, February 28, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Triple Therapy Advances.  PDS Biotech announced that the FDA has agreed to requirements for a registration trial using PDS0101 “Triple Combination” therapy in head and neck cancer. The study will test the combination of PDS0101, PDS0301, and a commercially available checkpoint inhibitor. We believe the changes from the previous trial should make regulatory approval faster, with additional tumor types added after market entry.

New Combination Eliminates An Unapproved Checkpoint Inhibitor. The new Triple Combination uses PDS010 to stimulate an immune response against the HPV antigen, PDS0301 to stimulate a robust immune response, and a checkpoint inhibitor to allow the immune system to recognize the tumor cells. The previous trial included bintrafusp alfa, an experimental checkpoint inhibitor. We believe the change to an approved checkpoint inhibitor simplifies the regulatory path.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp. (PDSB) – PDS Licenses Merck’s IL-12 Used In Its Combination Studies

Posted on by cpereira@noblefcm.com


Wednesday, January 04, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

License Gives Exclusive Rights To M9241. PDS Bio announced a licensing agreement with Merck KGaA covering M9241, the proprietary IL-12 tumor-targeting cytokine used in its Phase 2 Triple Therapy combination study. As discussed in our Research Note on December 29, most recent results have shown significant improvement in outcomes for these patients. Since PDS did not have commercial rights to M9241 before the licensing agreement, we believe this is a highly positive development.

Licensing Terms Are Favorable For Both Companies. The license agreement gives PDS exclusive worldwide rights to M9241. PDS will take over all development, manufacturing, and commercialization, while Merck continues to supply the drug during the transition. PDS will pay Merck a licensing fee of $5 million in cash and $5 million in its common stock, consisting of 378,787 shares or about 1.3% of the shares outstanding. Merck will receive development and regulatory milestones of up to $11 million for the first two indications, as well as commercial milestones of up to $105 million plus 10% royalties on initial sales.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotechnology Corp (PDSB) – Raising Price Target to $19 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, November 28, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Raising Our Price Target to $19 Per Share. Data presentations from clinical trials for PDS0101 have driven PDSB within 10% of our previous price target. We continue to see PDS0101 as a highly promising treatment for HPV-positive cancers and see several important milestones to drive the stock higher in the coming year.

Price Target Is Based On PDS010 Sales Potential.  Our new price target is based on discounted sales estimates for PDS010 sales in HPV-positive cancer. Following an End-of-Phase 2 meeting with the FDA following the June 2022 VERSATILE-002 data presentation, the company announced that it was accelerating its timetable for the pivotal trial for PDS0101. We expect this trial to begin in 2023 and project product launch in 2026.


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PDS Biotechnology Corp. (PDSB) – PDS Bio Reports 3Q22 and Reviews Full SITC Data

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financial Results Reported With Full Data. PDS Biotech reported a 3Q22 loss of $7.4 million or $(0.26) per share, with cash on September 30 of $71.6 million. PDS Management reviewed two presentations at last week’s Society for Immunotherapy of Cancer (SITC) meeting, providing additional information to the data published in the abstracts. These data continue to show improved efficacy for PDS0101 over current treatments.

Data From Two Studies Was Presented At SITC. As discussed in our Research Note on November 8, the response rate and patient survival for the Phase 2 IMMUNOCERV trial in cervical cancer exceeded the standard of care.  Data presented from the Phase 2 Triple Therapy trial showed anti-tumor action by PDS0101, with increases in immune response markers against the tumors and decreases in markers of immune suppression.


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PDS Biotechnology Corp (PDSB) – KOL Event Held To Discuss Head and Neck Cancer

Posted on by cpereira@noblefcm.com


Thursday, October 27, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Roundtable Discussion of Head and Neck Cancer.  PDS Biotech held a Head and Neck Cancer Roundtable with KOLs to discuss treatments and PDS0101.  Although no new data was released, there was a discussion of the cancer, its prognosis, the drugs, and adverse events that showed the need for a new treatment like PDS0101.

Head and Neck Cancer Discussion Included Incidence and Market Size.  The presentations discussed the patient population, current drugs, survival and recurrence rates.  Newly diagnosed cases of head and neck cancer are often associated with HPV, in contrast to previous generations when it was associated with tobacco and alcohol.  Although vaccinations against HPV have  been introduced, millions have been already been exposed so that incidence is expected to rise in the coming decades.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.