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.

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

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.

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

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.

Preliminary efficacy results from phase 1/2 Mayo Clinic study, using PDS0101 + KEYTRUDA to treat patients with Oropharyngeal cancer, expected in Q2 2024. The global oral cancer treatment market is expected to reach $2.74 billion by 2030. It is said that nearly 80% to 90% of all oropharynx tumors are HPV-positive.

PDS Biotechnology: Advancement Of PDS0101 Continues With Expansion Data

Board-certified oncologist and hematologist brings over 30 years of medical affairs, clinical operations leadership and commercialization experience to the Company Board-certified oncologist and hematologist brings over 30 years of medical affairs, clinical operations leadership and commercialization experience to the Company

PDS Biotech Announces Retirement of Lauren V. Wood, M.D.

PRINCETON, N.J., Jan. 16, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or “the Company”), 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 Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, will participate in a fireside chat at the B. Riley Securities 4th Annual Oncology Conference taking place virtually on Thursday, January 18, 2024, at 10:00 AM EST. Details are as follows:

PDS Biotech to Participate at B. Riley Securities 4th Annual Oncology Conference

PDS Biotechnology (PDSB) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About PDS Biotechnology (PDSB) Rating Upgrade to Buy

PRINCETON, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or “Company”), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced today that on December 4, 2023, PDS Biotech granted nonstatutory stock options to Lars Boesgaard, the Company's new Chief Financial Officer, to purchase a total of 200,000 shares of the Company's common stock as a material inducement to Mr. Boesgaard's 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 Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), 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 the appointment of Lars Boesgaard as Chief Financial Officer (CFO), effective as of December 4, 2023. Mr. Boesgaard succeeds Matthew Hill, who resigned as PDS Biotech's CFO on November 21, 2023, effective December 1, 2023, to pursue other professional endeavors.

PDS Biotech Appoints Lars Boesgaard as Chief Financial Officer

PDS Biotechnology Corporation (NASDAQ:PDSB ) Q3 2023 Earnings Call Transcript November 14, 2023 8:00 AM ET Company Participants Nicole Jones - Investor Relations Frank Bedu-Addo - Chief Executive Officer Matthew Hill - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Joe Pantginis - HC Wainwright Laura Suriel - Alliance Resource Partners Operator Greetings and welcome to the PDS Biotechnology Third Quarter 2023 Earnings Call and Webcast.

PDS Biotechnology Corporation (PDSB) Q3 2023 Earnings Call Transcript

PRINCETON, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), 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 its financial results for the quarter ended September 30, 2023. The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.

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

PRINCETON, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), 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 updated survival data from the Phase 2 clinical trial investigating the triple combination of PDS0101, PDS0301 (IL-12 antibody-drug conjugate) and an investigational immune checkpoint inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers. The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI resistant group included patients who had not responded to multiple prior treatments, including ICI therapy. Investigators at the National Cancer Institute (NCI), part of the National Institutes of Health, have completed the primary endpoint analysis of the Phase 2 trial.

PDS Biotech Announces Updated Survival Data from NCI-Led Phase 2 Clinical Trial of PDS0101-Based Triple Combination Therapy in Advanced HPV16-Positive Cancer Patients which Show 75% Survival of ICI Naïve Patients at 36 Months

PRINCETON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 third quarter of 2023 on Tuesday, November 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 Third Quarter 2023 Financial Results

PRINCETON, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 immune response data from a preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2 clinical trial evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV)16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.

PDS Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO

PRINCETON, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 interim safety and immune response data for the first-in-human Phase 1/2 clinical trial evaluating PDS0301, a novel investigational tumor-targeting, antibody-conjugated Interleukin 12, in combination with current standard-of-care (SOC) chemotherapy, docetaxel, to treat metastatic castration sensitive (mCSPC) and castration resistant (mCRPC) prostate cancer. The data will be featured in an oral presentation by Ravi A. Madan, MD, Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research of the National Cancer Institute, an Institute of the National Institutes of Health, at the 11th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023) in Athens, Greece.

PDS Biotech Announces Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial Evaluating Novel Antibody Drug Conjugate PDS0301 Combined with Docetaxel to Treat Metastatic Prostate Cancer

PRINCETON, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 updated interim data based on an August 2nd cut off from the VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations whose cancer has returned or spread – ICI naïve and ICI refractory. The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI refractory group included patients who had not responded to multiple prior treatments, including ICI therapy. Data presented at ASCO was based on a January 13th cut off.

PDS Biotech Announces Interim 24-Month Survival Rate of 74% in Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients Treated with PDS0101 in Combination with KEYTRUDA® (pembrolizumab)

PRINCETON, N.J., Oct. 02, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 data demonstrating lead candidate PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) was associated with a rapid decline in human papillomavirus (HPV) circulating cell-free DNA (cfHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation by Aaron Seo, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting in San Diego, CA.

PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

PRINCETON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech, will present at the LD Micro Main Event XVI being held on October 3-5, 2023, in Los Angeles, CA. Details for the event are as follows:

PDS Biotech to Present at the LD Micro Main Event XVI

PRINCETON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 its Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101 will now take place on Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, due to a scheduling conflict. The event was originally scheduled for Wednesday, September 27, 2023.

PDS Biotech Reschedules Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech, will participate in a panel presentation at the 2023 Cantor Fitzgerald Global Healthcare Conference being held September 26-28, 2023, in New York City. Details for the event are as follows:

PDS Biotech to Participate in the 2023 Cantor Fitzgerald Global Healthcare Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA® Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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 of PDS Biotech, will participate and present an overview of the company and its programs at the H.C. Wainwright 25th Annual Global Investment Conference.

PDS Biotech to Participate at the H.C. Wainwright 25th Annual Global Investment Conference

Shares of PDS Biotech (PDSB) show an upward trajectory as the company progresses toward initiating the late-stage development of its lead pipeline candidate.

PDS Biotech's (PDSB) Shares Up 12% in a Month: Here's Why

PDS Biotechnology Corporation (NASDAQ:PDSB ) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Gabby DeGravina - Investor Relations Conference Call Participants Joe Pantginis - HC Wainwright Lucas Duffy - Cantor Fitzgerald Kalpit Patel - B. Riley Leland Gershell - Oppenheimer Robert LaBoyer - Noble Capital Laura Suriel - Alliance Global Partners Operator Hello and welcome to the PDS Biotechnology Second Quarter 2023 Earnings Call and Webcast.

PDS Biotechnology (PDSB) Q2 2023 Earnings Call Transcript

PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), 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, will discuss its financial results for the quarter ended June 30, 2023 and provide a business update on its conference call today.

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

VERSATILE-003 will evaluate PDS0101 in combination with KEYTRUDA® in recurrent or metastatic HPV16-positive head and neck cancer

PDS Biotech Announces Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial

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.

News for PDS Biotechnology Corporation Stock (PDSB)