PDS Biotechnology Corporation

PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products PDS0101, is an off the shelf immunotherapeutic that is administered by subcutaneous injection. The company was founded by Frank K. Bedu-Addo on March 15, 2019 and is headquartered in Princeton, NJ.

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PDS Biotechnology advances oncology pipeline with promising trial results

PDS Biotechnology's strategic focus on oncology pipeline advancement, strong interim trial results, and financial stability position the company for continued growth and clinical success.
While facing financial challenges and operational complexities, the company's proactive approach to trial designs, regulatory engagements, and commercialization strategies offer promising opportunities for future development.
Overall, PDS Biotechnology's performance in 2022 reflects a balance of achievements, challenges, and opportunities, underscoring a commitment to innovation and clinical progress in the oncology space.

PDS Biotechnology reports Q1 loss, progresses promising cancer therapies

PDS Biotechnology's Q1 performance reflects ongoing investment in clinical development.
Strengths lie in innovative therapies, upcoming Phase 3 trial, and manufacturing progress.
Challenges include financial losses, competition, and meeting trial milestones.
Opportunities exist in clinical advancements, partnerships, market demand, and investor confidence.

PDS Biotechnologies reports Q2 loss, progresses in clinical trials

PDS Biotechnologies faces increased expenses but maintains strong funding for future operations.
Progress in clinical programs and upcoming milestones provide growth opportunities.
Challenges include trial requirements and enrollment timelines, but company is managing well.

PDS Biotechnology reports promising cancer therapy results amidst financial challenges

PDS Biotechnology demonstrates clinical success with PDS0101 and PDS01ADC, while facing financial pressures and operational challenges.
Strategic strengths in oncology programs and proactive clinical development position the company for growth and potential partnerships.
Opportunities lie in diversification with PDS0202, expanding the pipeline, and leveraging positive data from upcoming investigator-initiated trials.
Navigating financial challenges, operational complexities, and maximizing therapeutic potential will be key for PDS Biotechnology's future success.

PDS Biotechnology reports Q4 loss, focuses on innovative cancer trials

PDS Biotechnology's Q4 2023 Earnings Call highlighted financial performance, strategic focus on innovative clinical trials, and promising data-driven decisions.
The company's strengths lie in its collaborations with the National Cancer Institute, advancements in Phase II programs, and a healthy cash balance supporting future funding.
Challenges include managing rising operating expenses, delivering on trial outcomes, and navigating market competition, while opportunities exist in establishing leadership in cancer therapies and attracting investors.
Overall, PDS Biotechnology's emphasis on data-driven strategies, strong financial position, and commitment to advancing cancer treatments position it for potential growth and success in the biopharmaceutical industry.

PDS Biotechnology reports Q3 loss, optimistic on Versamune HPV potential

PDS Biotechnology Corporation's Q3 2024 performance reflected increased R&D expenses and strategic trial design modifications.
Despite financial challenges and competitive pressures, the company remains optimistic about the potential of Versamune HPV.
Opportunities lie in advancing the VERSATILE-003 trial, leveraging positive feedback, and addressing unmet medical needs in the market.

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PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its product, PDS0101, is an off the shelf immunotherapeutic that is administered by subcutaneous injection. The company was founded by Frank K. Bedu-Addo in 2005 and is headquartered in Princeton, NJ.

PDS Biotechnology has achieved positive results in its phase 2 study of PDS0101 in combination with Merck's Keytruda for HPV16-positive head and neck cancer. The interim analysis showed 9 confirmed responses, which increased to 14 in a later update, surpassing the efficacy threshold for the study. PDS plans to submit an amended IND application to the FDA in Q3 2023 to initiate its phase 3 VERSATILE-003 study.

PDS Biotechnology: Interim Data Reinforces Push Towards Phase 3 Study

PDS Biotechnology Corporation has had a volatile stock performance in recent years. The company has made slow and steady progress advancing its pipeline and is well-liked within the analyst firm community. With two registrational studies on the horizon, it seems a good time to 'circle back' on this small developmental, oncology-focused concern.

The Prognosis For PDS Biotechnology

PRINCETON, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company's proprietary T cell activating platforms, today announced that the Company will release financial results for the second quarter of 2023 on Monday, August 14, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

PDS Biotechnology Announces Conference Call and Webcast for Second Quarter 2023 Financial Results

PRINCETON, N.J., Aug. 02, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company's proprietary T cell activating platforms, today announced that Dr. Frank Bedu-Addo, Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2023 being held August 7-8, 2023. Details for the event are as follows:

PDS Biotech to Present at BTIG Virtual Biotechnology Conference 2023

FLORHAM PARK, N.J., July 11, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the Canadian Intellectual Property Office has allowed patent number 2,876,656 titled, “Cationic Lipid Vaccine Combinations and Methods of Use,” governing composition of matter and uses for Versamune® (R-DOTAP) in combination with PDS0301. The intellectual property provides broad protection for treatments utilizing Versamune® based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer. This patent expands PDS Biotech's market coverage and adds to the world-wide patent portfolio including the patent granted by the United States Patent and Trademark Office (USPTO), U.S. Patent No. 11,401,306, covering the combination of Versamune® and cytokines including Interleukin 12 (IL-12).

PDS Biotech Strengthens Intellectual Property Portfolio Governing A Combination of Versamune® and PDS0301

FLORHAM PARK, N.J., June 30, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech”), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced, on June 28, 2023, PDS Biotech granted nonstatutory stock options to purchase a total of 29,900 shares of common stock to four employees as a material inducement to employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech's 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

PDS Biotechnology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FLORHAM PARK, N.J., June 20, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corp. (NASDAQ: PDSB), a clinical-stage company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced today its expected addition to the broad-market Russell 2000® and the Russell 3000® Indexes in accordance with the 2023 Russell indexes annual reconstitution. PDS Biotech's anticipated inclusion in the Russell indexes will be effective after the U.S. market opens on Monday, June 26, 2023.

PDS Biotech to be Added to Russell 2000® and Russell 3000® Indexes Effective June 26, 2023

FLORHAM PARK, N.J., June 05, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will be hosting a conference call and webcast tomorrow, June 6, 2023, to discuss the promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), presented at the 2023 American Society for Clinical Oncology (ASCO) meeting.

PDS Biotechnology Post-ASCO Conference Call Tomorrow, June 6, at 8 a.m. ET

PDS Biotech's Phase 2 study shows potential breakthrough in treating HPV16-positive head and neck cancer. The study shows a 87.1% 12-month survival rate for ICI naive patients, nearly doubling typical rates from similar treatments.

PDS Biotechnology: Promising Interim HNSCC Data Reaffirms Investment Prospects

PDS Biotech's (PDSB) shares gain as it announces encouraging interim data from the VERSATILE-002 study for treating HPV16-positive cancer patients.

PDS Biotech (PDSB) Up 32% on Interim Data From HPV Cancer Study

Interim data being presented at ASCO 2023 Annual Meeting Demonstrated median progression-free survival (PFS) of 10.4 months Demonstrated 12-month overall survival (OS) rate of 87.1% A disease control rate (disease stabilization or tumor shrinkage) of 70.6% Median overall survival not yet met Company to host conference call and webcast on June 6, 2023, at 8:00 am ET FLORHAM PARK, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.

PDS Biotech Announces Interim Data Demonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA® (pembrolizumab) for Head and Neck Cancer Patients

PDS Biotech (PDSB) shares gain as it completes patient enrollment in the second arm of the VERSATILE-002 study for treating HPV16-positive cancer patients.

PDS Biotech (PDSB) Completes Enrollment for HPV Cancer Study

Company plans to initiate VERSATILE-003 Phase 3 clinical trial in late 2023 Company plans to initiate VERSATILE-003 Phase 3 clinical trial in late 2023

PDS Biotech Completes Enrollment in Immune Checkpoint Inhibitor Naïve Arm of VERSATILE-002 Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

PDS Biotechnology Corporation (NASDAQ:PDSB ) Q1 2023 Earnings Conference Call May 15, 2023 8:00 AM ET Company Participants Gabby DeGravina - Investor Relations Frank Bedu-Addo - Chief Executive Officer Matt Hill - Chief Financial Officer Lauren V. Wood - Chief Medical Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Leland Gershell - Oppenheimer Andy Fleszar - B.

PDS Biotechnology Corporation (PDSB) Q1 2023 Earnings Call Transcript

Updated data from VERSATILE-002 Phase 2 trial to be presented at ASCO 2023 Company to host conference call and webcast today, May 15, 2023, at 8:00 AM ET FLORHAM PARK, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, will discuss its financial results for the quarter ended March 31, 2023, and provide a business update on its conference call today.

PDS Biotech Provides Business Update and Reports First Quarter 2023 Financial Results

FLORHAM PARK, N.J., May 04, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that the Company will release financial results for the first quarter of 2023 on Monday, May 15, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

PDS Biotechnology Announces Conference Call and Webcast for First Quarter 2023 Financial Results

Initiation of phase 3 study using PDS0101 in combination with Keytruda for the treatment of patients with unresectable, recurrent/metastatic Human Papillomavirus positive head and neck cancer expected Q4 of 2023.

PDS Biotechnology: Late-Stage Biotech With Enormous Potential

FLORHAM PARK, N.J., April 24, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease announced the Company received $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company's participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.

PDS Biotech Receives $1.4 Million After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.

PDS Biotech to Host Interleukin 12 (IL-12) Immunocytokine-Focused KOL Roundtable on April 21, 2023

PDS0101, an innovative immunotherapy, targets HPV-positive cancers, including recurrent or metastatic head and neck cancer with high-risk HPV16 infection. VERSATILE-002 Phase 2 clinical trial demonstrates improved efficacy and a favorable safety profile compared to historical data for this patient population.

PDS Biotechnology's PDS0101 Shows Potential In HPV-Positive Head And Neck Cancers

PDS Biotech prepares to advance PDS0101 into a Phase 3 registrational clinical trial – VERSATILE-003 – in HPV16-positive recurrent and/or metastatic head and neck cancer in 2023 PDS Biotech prepares to advance PDS0101 into a Phase 3 registrational clinical trial – VERSATILE-003 – in HPV16-positive recurrent and/or metastatic head and neck cancer in 2023

PDS Biotech Supports Oral, Head & Neck Cancer Awareness Month During April and Oral, Head & Neck Cancer Awareness Week from April 16-22, 2023

Company has completed Phase 3 manufacturing of PDS0101 for randomized, controlled, registrational trial in recurrent/metastatic HPV16-positive head and neck cancer Company has completed Phase 3 manufacturing of PDS0101 for randomized, controlled, registrational trial in recurrent/metastatic HPV16-positive head and neck cancer

PDS Biotech Announces Plan to Initiate Phase 3 Study Evaluating PDS0101 in Combination with KEYTRUDA® in Head and Neck Cancer in 2023

FLORHAM PARK, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, will participate in Cantor's Future of Oncology Virtual Symposium being held on April 3-5, 2023.

PDS Biotech to Participate in Cantor's Future of Oncology Virtual Symposium

PDS Biotechnology Corporation (NASDAQ:PDSB ) Q4 2022 Results Earnings Conference Call March 28, 2023 8:00 AM ET Company Participants Gabrielle DeGravina - Investor Relations, CG Capital Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Conference Call Participants Leland Gershell - Oppenheimer & Co. Louise Chen - Cantor Fitzgerald Andrew Fleszar - B. Riley Securities James Molloy - Alliance Global Partners Robert LeBoyer - Noble Capital Markets Operator Greetings.

PDS Biotechnology Corporation (PDSB) Q4 2022 Earnings Call Transcript

FLORHAM PARK, N.J., March 28, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today provided a business update and announced its financial results for the year ended December 31, 2022.

News for PDS Biotechnology Corporation Stock (PDSB)