Core Viewpoint - PDS Biotechnology Corporation has received a new patent in Japan for PDS0101, enhancing its intellectual property portfolio and providing market exclusivity for the product into the 2040s [2][4]. Group 1: Patent and Intellectual Property - The Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims [2]. - This new patent expands previously granted patents in Japan and adds to the company's existing patents in the United States, China, Australia, and Hong Kong [2]. - The company has additional patent applications pending in several other countries, reinforcing its global intellectual property position [4][5]. Group 2: Market Context and Product Development - The incidence of HPV16-related cancers is rapidly increasing in the US and Europe, which highlights the potential market for PDS0101 [3]. - PDS0101 is currently being studied in a Phase 3 trial in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer [3][6]. - The company aims to advance broad intellectual property protections for PDS0101 and its other investigational agents in development [5].

Group 1 - B. Riley has lowered the price target on PDS Biotechnology (PDSB) to $3 from $5 while maintaining a Buy rating on the shares [1] - The shares are considered attractively valued with near-zero enterprise value (EV) that does not reflect the impact of the recent strategic pivot on enrollment size, efficacy endpoint durations, and an enriched p16+ve population with limited competing trials [1]

Group 1: Reviva Pharmaceuticals Holdings, Inc. (RVPH) - RVPH is a clinical-stage biopharmaceutical company focused on therapies for central nervous system, respiratory, and metabolic diseases [1] - The current trading price is $0.44, with a target price of $0.39, indicating a potential downside of approximately -11.09% [1] - The significant gap between the current and target price suggests a pessimistic outlook from investment analysts, leading to its exclusion from coverage [1] Group 2: PDS Biotechnology Corporation (PDSB) - PDSB is trading at $0.93, with a discounted cash flow (DCF) valuation of $0.54, resulting in a price percentage difference of -41.72% [2] - The market cap of PDSB is $43.63 million, and it has an earnings per share (EPS) of -0.91, with a negative price-to-earnings (P/E) ratio of -1.58 [2] - This reflects the company's current unprofitability [2] Group 3: IO Biotech, Inc. (IOBT) - IOBT has a current stock price of $1.17 and a DCF valuation of $0.88, leading to a price percentage difference of -24.60% [3] - The market cap of IOBT is $77.08 million, with an EPS of -1.58 and a P/E ratio of -0.63 [3] - This indicates that IOBT is also trading above its intrinsic value, similar to PDSB, but with a slightly better valuation [3] Group 4: Skye Bioscience, Inc. (SKYE) - SKYE has a current stock price of $1.47 and a DCF valuation of $1.86, resulting in a positive price percentage difference of 26.28% [4] - The market cap of SKYE is $45.71 million, with an EPS of -1.06 and a P/E ratio of -3.89 [4] - This suggests that SKYE is undervalued compared to its intrinsic value, indicating potential growth despite current losses [4]

Core Viewpoint - PDS Biotechnology Corporation is hosting a virtual event to discuss the evolving treatment landscape for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) in light of the Merck KEYNOTE-689 study and the rising incidence of HPV16-positive HNSCC in the US and Europe [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative treatments that enhance the immune system's ability to target and eliminate cancers [7]. - The company's lead investigational therapy, Versamune® HPV, is currently in a Phase 3 clinical trial in combination with pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC [2][7]. Event Details - The event will feature key opinion leaders, including Kevin Harrington and Katharine A. Price, who will discuss the unmet needs in treating HPV16-positive HNSCC and the distinct characteristics of HPV-positive versus HPV-negative HNSCC [1][2][3]. - A live Q&A session will follow the formal presentations, allowing for direct engagement with the experts [3]. Clinical Trials and Research - Versamune® HPV is being evaluated in multiple clinical trials, including a Phase 3 trial in combination with pembrolizumab and Phase 2 trials for various HPV16-positive cancers [2]. - The event will also address the emerging treatment landscape for first-line recurrent/metastatic HNSCC and the differentiation between HPV-positive and HPV-negative cases [2]. Speakers' Expertise - Kevin Harrington is a leading authority on metastatic head and neck cancer and has significant experience in clinical trials related to HNSCC treatments [4]. - Katharine A. Price specializes in head and neck cancers and is involved in research aimed at improving treatment access and awareness regarding HPV vaccination [5].

Market Overview - The three major U.S. indexes ended the holiday-shortened trading week in the red, with the Nasdaq Composite declining by 0.44%, and both the S&P 500 and Dow Jones Industrial Average losing 0.17% each, attributed to renewed trade tensions with the European Union and China [1] - The Federal Reserve's May meeting minutes indicate that new foreign trade tariff policies could lead to persistent inflation, hinder economic growth, and diminish global confidence in U.S. assets [2] Economic Indicators - The second estimate of Q1 2025 Gross Domestic Product (GDP) showed a contraction at an annual rate of 0.2%, an improvement from the initial estimate of a 0.3% decline, marking the first drop in three years [2] - The labor market remains resilient but shows slight signs of weakening, with jobless aid rising to 240,000 for the week ending May 24th, and Continuing Jobless Claims increasing to 1.92 million [2] Stock Performance - Banco Comercial Português (BPCGY) shares gained 13.9% since being upgraded to Zacks Rank 2 (Buy) on March 31, outperforming the S&P 500's 6.1% increase [3] - PDS Biotechnology Corporation (PDSB) also saw a return of 9.5% since its upgrade to Zacks Rank 2 on March 31 [4] - A hypothetical portfolio of Zacks Rank 1 (Strong Buy) stocks returned -8.32% in 2025 (through May 5), compared to -5.35% for the S&P 500 index [4] Zacks Recommendations - StoneCo Ltd. (STNE) and BlackBerry Limited (BB) advanced 30.9% and 26.1% respectively since their Zacks Recommendation upgrades to Outperform on April 9 and March 4 [7] - The Zacks Focus List portfolio has returned -3.23% through April 30, 2025, compared to -4.92% for the S&P 500 index [11] - The Zacks Earnings Certain Admiral Portfolio (ECAP) returned +3.20% in Q1 2025, outperforming the S&P 500 index's -4.30% decline [15] Long-term Performance - The Zacks Focus List portfolio has produced an annualized return of +11.33% since 2004, compared to +9.95% for the S&P 500 index [13] - The Top 10 portfolio has delivered a cumulative return of +1832.3% since 2012, significantly outperforming the S&P 500 index's +434.2% return [23]

Core Insights - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational therapy Versamune® HPV targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma [4][9] - The company reported a net loss of approximately $8.5 million for Q1 2025, a decrease from $10.6 million in Q1 2024, attributed to lower operating expenses and increased tax benefits [6][7] - PDS Biotech's cash balance as of March 31, 2025, was $40 million, down from $41.7 million at the end of 2024 [8][15] Clinical Updates - The VERSATILE-003 trial is designed to include around 350 patients and is a two-arm controlled trial with a 2:1 randomization [6][4] - The primary endpoint of the trial is median overall survival, with interim readouts included in the study design [6][4] - The FDA has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in treating recurrent/metastatic HNSCC [6][4] Financial Performance - Research and development expenses for Q1 2025 were $5.8 million, down from $6.7 million in Q1 2024, primarily due to reduced clinical trial expenses [7][6] - General and administrative expenses were slightly lower at $3.3 million for Q1 2025 compared to $3.4 million in Q1 2024 [7][6] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [8][6] Corporate Developments - Three abstracts on Versamune® HPV were selected for presentation at the 2025 ASCO Annual Meeting scheduled for May 30-June 3, 2025 [6][4] - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing [6][4]

Core Insights - PDS Biotechnology Corporation announced that preclinical immune response data for a novel Infectimune-based flu vaccine will be presented at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting [1] - The presentation will focus on broadly protective immunity against influenza and opportunities for universal influenza vaccines [2] - PDS Biotech is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] Presentation Details - Title of the presentation: Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines [2] - Session Type: Guest Symposium at the International Society of Influenza and Other Respiratory Viruses (ISIRIV) Symposium [2] - Date and Time: May 4, 2025, from 8:30 to 10:30 a.m. HST [2] - Presenter: Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers [3] - The company is developing its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard-of-care immune checkpoint inhibitors [3] - PDS Biotech is also exploring a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, along with standard-of-care immune checkpoint inhibitors [3]