Pds Biotechnology Corporation Stock Price, News & Analysis

PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced two significant upcoming presentations by CEO Frank Bedu-Addo, PhD.

The presentations are scheduled for:

• Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 2:30 PM ET, featuring an investor presentation
• 2025 CAGLA NeauxCancer Conference in New Orleans at The Roosevelt Hotel, scheduled for March 28, 2025, at 4:00 PM ET, where a scientific presentation will be delivered as part of the Innovation Track

Both events offer virtual attendance options through their respective registration platforms, providing accessibility to investors and stakeholders interested in PDS Biotech's developments in cancer immunotherapy.

PDS Biotech (PDSB) has initiated VERSATILE-003, a groundbreaking Phase 3 clinical trial evaluating Versamune® HPV in combination with pembrolizumab for HPV16-positive head and neck cancer treatment. This global, multi-center study represents the first-ever Phase 3 trial for this specific cancer type.

The trial will enroll approximately 350 patients in a 2:1 ratio, comparing the combination therapy against pembrolizumab alone as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The study's primary endpoint is overall survival, with secondary endpoints including objective response rate and progression-free survival.

Following promising results from the VERSATILE-002 Phase 2 trial, Versamune® HPV received Fast Track designation from the FDA, making it eligible for Priority Review upon Biologics License Application submission. Dr. Katharine Price from Mayo Clinic Comprehensive Cancer Center will serve as the Principal Investigator.

PDS Biotechnology (PDSB), a late-stage immunotherapy company, has announced a registered direct offering priced at-the-market under Nasdaq rules. The offering includes 7,330,121 shares of common stock and warrants at a combined purchase price of $1.50 for institutional investors and $1.66 for company directors.

The deal structure includes $11 million in immediate funding upon closing, expected around February 28, 2025, with potential for an additional $11 million through warrant exercises. The warrants, exercisable at $1.50 per share, will be immediately available upon issuance with a 5-year expiration term.

The offering, managed by A.G.P./Alliance Global Partners as sole placement agent, will provide funds for research and development expenses and general corporate purposes. Both new and existing healthcare-focused institutional investors, along with company directors, are participating in this capital raise.

PDS Biotech (PDSB) has published promising clinical results in JAMA Oncology for its triple combination therapy treating recurrent/metastatic HPV-associated cancers. The therapy combines Versamune® HPV, PDS01ADC, and a PD-L1 immune checkpoint inhibitor.

Key findings include:

• 42.4 months median Overall Survival in checkpoint inhibitor naïve patients (vs. 7-12 months historical)
• 75% confirmed objective response rate in HPV16-positive checkpoint inhibitor naïve patients (vs. 11-24% historical)
• 17 months median survival in HPV16-positive checkpoint inhibitor resistant patients (vs. 3-4 months historical)

The trial included 50 patients with various HPV-associated cancers. Grade 3 and 4 treatment-related adverse events occurred in 52% of patients, with no treatment-related deaths. The company plans to begin VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab in HPV16-positive head and neck cancer.

PDS Biotech (NASDAQ: PDSB) has published promising results for its Versamune® HPV immunotherapy in Clinical Cancer Research. The study showed that combining Versamune® HPV with chemoradiation therapy (CRT) led to superior clearance of HPV16-positive cancer cells from patients' bloodstream compared to CRT alone.

Key findings include:

• 100% of patients receiving Versamune® HPV + CRT showed no detectable HPV16 ctDNA at 3-4 months vs. 50% for CRT alone
• Patients with undetectable HPV ctDNA at 3-4 months demonstrated 93% 2-year recurrence-free survival vs. 30% in those with detectable ctDNA
• 36-month overall survival rate was 100% for patients receiving 5 doses of Versamune® HPV + CRT

The company plans to initiate a Phase 3 trial for Versamune® HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in Q1 2025.

PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced its participation in the B. Riley Securities Precision Oncology & Radiopharma Conference 2025. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat session on Friday, February 28, 2025.

The presentation is scheduled for 11:30-12:00 PM ET in the Holmes II – Precision Oncology Track at the Lotte New York Palace Hotel. Company leadership will also conduct one-on-one meetings during the conference. Interested parties can register through B. Riley Securities representatives, and a transcript of the fireside chat will be available on PDS Biotech's website one week after the event.

PDS Biotechnology (NASDAQ: PDSB) has confirmed its plans to initiate the VERSATILE-003 Phase 3 clinical trial in Q1 2025. The trial will evaluate Versamune® HPV plus pembrolizumab as a first-line treatment for recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).

The company submitted its updated clinical protocol on November 15, 2024, amending the IND application. The FDA's comment period has concluded, and the company has received Fast Track designation for the combination therapy. The trial will utilize a newly validated companion diagnostic to confirm HPV16-positive HNSCC during patient screening, marking the first investigational use of this type of diagnostic in a Phase 3 HNSCC trial.

HPV16-positive patients represent a growing subgroup requiring targeted therapies, with HPV16-positive HNSCC expected to become the dominant type in the US and EU.

PDS Biotechnology (Nasdaq: PDSB) announced the granting of nonstatutory stock options to a new clinical department employee. The grant includes options to purchase 7,000 shares of common stock at an exercise price of $2.25 per share, matching the closing price on December 3, 2024. The stock options vest over four years, with 25% vesting after the first year and the remaining shares vesting monthly over the following 36 months, contingent on continued employment. This grant was made under Nasdaq Listing Rule 5635(c)(4) and PDS Biotech's 2019 Inducement Plan.

PDS Biotech (Nasdaq: PDSB) announced a Key Opinion Leader (KOL) event scheduled for December 17, 2024, at 12 p.m. ET. The event will focus on HPV16-positive head and neck squamous cell carcinoma (HNSCC) and the company's upcoming VERSATILE-003 Phase 3 clinical trial of Versamune® HPV combined with pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC.

The panel will feature experts Dr. Francis Worden from Rogel Cancer Center and Dr. Kevin Harrington from The Institute of Cancer Research, UK, with moderation by PDS Biotech's Chief Medical Officer, Dr. Kirk Shepard. The 90-minute webcast will discuss disease pathology, prevalence, and trial design.