Clinical Development and Drug Discovery

The Company’s small molecule platform includes various drug candidates and non-clinical formulations made from pharmaceutical-grade RBS using different concentrations and delivered by different routes of administration for different diseases and indications.

Clinical Development Programs

• Oncology: Intratumoral PV-10 has undergone and is undergoing multiple monotherapy and combination therapy early-to-late-stage clinical trials, expanded access programs, and quality of life studies for the treatment of Stage III and IV melanoma, different types of liver cancers, and breast cancer. PV-10 has also undergone clinical studies of mechanisms of action and immune response for melanoma, metastatic uveal melanoma, and metastatic neuroendocrine tumors. The lead indication for intratumoral PV-10 is FOLRINOX-refractory pancreatic ductal adenocarcinoma (mPDAC), where patients would receive the combination therapy of PV-10 and systemically administered gemcitabine and nab-paclitaxel.

• Dermatology: Topical PH-10, a formulation of PV-10, has undergone multiple mid-stage monotherapy clinical trials for the treatment of psoriasis and atopic dermatitis. PH-10 has also undergone clinical studies of mechanism of action and immune response for psoriasis.

• Ophthalmology: The Company believes that clinical proof-of-concept of topical administration of non-pharmaceutical grade rose bengal in combination with a light source medical device for the treatment of infectious keratitis has been shown by clinicians and researchers at the University of Miami’s Bascom Palmer Eye Institute. Topical formulation PV-305, a formulation of PV-10, has undergone non-clinical combination therapy study for diseases and disorders of the eye, such as infectious keratitis.

Proof-of-Concept Programs

• Oncology: Intratumoral PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of relapsed and refractory pediatric solid tumor cancers at the University of Calgary’s Cumming School of Medicine. Oral (PO) formulations of PV-10 have undergone non-clinical monotherapy study for high-risk and refractory adult solid tumor cancers at the University of Calgary.

• Hematology: PO formulations of PV-10 have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric and other blood cancers, including leukemias, at the University of Calgary.

• Wound Healing: The Company believes that monotherapy in vivo proof-of-concept of topical administration of non-pharmaceutical grade rose bengal for the treatment of wound healing has been shown by researchers at the University of Texas Medical Branch, who are now collaborating with the Company to use the Company’s pharmaceutical-grade RBS. Topical formulations of PV-10 are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds at the University of Texas Medical Branch.

• Animal Health: PV-10 formulations have undergone non-clinical monotherapy study for the treatment of cutaneous canine cancers at the University of Tennessee’s College of Veterinary Medicine, and the Company believes it has achieved monotherapy proof-of-concept of intratumoral administration for canine cancers.

Early Drug Discovery Programs

• Immune vaccine adjuvant: Different formulations of PV-10 have undergone non-clinical study as a vaccine adjuvant to enhance T cell responses for anti-viral and anti-cancer vaccines.

• Infectious Diseases: PO and intranasal (IN) formulations of PV-10 have undergone non-clinical monotherapy study for the treatment of SARS-CoV-2 at the University of Calgary, the University of Tennessee Health Science Center, and a U.S. contract research organization. Different formulations of PV-10 have also undergone non-clinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug-resistant strains) and non-clinical monotherapy study for the treatment of oral bacterial infections and fungal infections at the University of Tennessee Health Science Center.

• Tissue Regeneration and Repair: Different formulations of PV-10 have undergone non-clinical monotherapy study for vertebrate development, wound healing, and tissue regrowth at the University of Nevada, Las Vegas.

• Proprietary: Different formulations of PV-10 are undergoing non-clinical study for proprietary diseases at an academic medical center.

Computer Modeling Programs

• Computer-based molecular docking of RBS has been done and is being done for amyotrophic lateral sclerosis and other disease targets.

Business Strategy

The Company’s key business strategies include:

1. Continuing and initiating new monotherapy and combination therapy intratumoral PV-10 clinical trials in melanoma and liver cancer to generate more clinical data and pursue drug approval pathways or co-development relationships.

2. Developing a systemically administered formulation of pharmaceutical-grade RBS for cancer treatment, with the goal of filing an IND and taking an initial systemic drug candidate into an early-stage clinical trial or pursuing a co-development collaboration or out-license arrangement.

3. Developing different formulations of pharmaceutical-grade RBS for other disease areas, with the goal of filing INDs and taking initial drug candidates into early-stage clinical trials or pursuing co-development collaborations or out-license arrangements.

4. Endeavoring to fully elucidate the traits and characteristics of the RBS molecule using academic medical centers to gain and communicate additional knowledge about its targeting, mechanism, signaling, immune response, and other features.

5. Conducting rigorous chemical analytical comparisons of non-pharmaceutical grades of rose bengal against the Company’s pharmaceutical-grade RBS to demonstrate its proprietary nature and compliance with pharmaceutical requirements.

RBS API and Drug Candidate Manufacturing

The Company has developed a proprietary, patented, commercial-scale process to synthesize and utilize the RBS molecule into a viable active pharmaceutical ingredient (API) for commercial pharmaceutical use. The Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice (cGMP) regulations, and ICH guidelines, with controls to eliminate historical impurities and avoid the introduction of potentially hazardous impurities.

The Company’s RBS API and drug candidate manufacturing processes and CMC data have been reviewed and accepted by multiple national drug regulatory agencies, including the U.S. FDA, for use in prior clinical trials.

RBS Non-proprietary Name

The RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (WHO) Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.

Non-Pharmaceutical Grades of Rose Bengal

The Company has identified two non-pharmaceutical grades of rose bengal:

1. Commercial grade rose bengal, which can be purchased from specialty chemical suppliers and appears to have reported purities varying between 80% and 95% with substantial amounts of unreported impurities and/or gross contaminants.

2. Diagnostic grade rose bengal, which is used in ophthalmic solutions, strips, and devices, or in other non-ophthalmic diagnostic tests, and may have undergone some purification but still possess questionable purity and lot-to-lot variability.

The Company has conducted chemical analytical comparisons of commercial grade rose bengal from three different suppliers against its pharmaceutical-grade RBS, and the preliminary results indicate that the commercial grade materials had drastically different purity levels than represented and contained gross contaminants.

Potential Barriers to Entry

The Company believes its proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over non-pharmaceutical-grade rose bengal, which may suffer from uncontrolled impurities, substantial lot-to-lot variability, inaccurate purity reporting, and lack of reproducible CMC specifications and documentation. The Company believes these issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological, and economic challenges to overcome and validate for compliance with modern drug regulatory standards.

Components of Operating Results

• Grant Revenue: Grant revenue is recognized when qualifying costs are incurred, and there is reasonable assurance that the conditions of the grant have been met.

• Research and Development Expenses: These expenses include costs of conducting clinical trials, salaries and related expenses for personnel, contract manufacturing, supplies and reagents, and occupancy and depreciation charges.

• General and Administrative Expenses: These expenses consist primarily of salaries, stock-based compensation, and other costs for personnel in executive, finance, accounting, and other administrative functions, as well as professional fees, insurance, and other corporate expenses.

Results of Operations

For the three months ended March 31, 2025 compared to the three months ended March 31, 2024:

• Grant revenue increased by 17.0% to $278,628.
• Total operating expenses increased by 100.9% to $1,376,569, primarily due to a 661.0% increase in general and administrative expenses.
• Research and development expenses decreased by 30.0% to $388,810, mainly due to lower clinical trial costs, insurance, and depreciation.
• General and administrative expenses increased by 661.0% to $987,759, primarily due to increases in directors’ fees, payroll, donations, and stock-based compensation.
• Net loss attributable to common stockholders increased by 126.2% to $1,140,108.

Liquidity and Going Concern

The Company had $469,454 in cash and restricted cash as of March 31, 2025, and a working capital deficit of $5,085,769. The Company has continuing net losses and negative cash flows from operations, and an accumulated deficit of $258,563,069, which raise substantial doubt about its ability to continue as a going concern.

The Company plans to access capital resources through possible public or private equity offerings, debt financings, corporate collaborations, or other means to fund its operations and ongoing clinical trials. However, there can be no assurance that the Company will be successful in these efforts, and it may need to seek additional funds to meet its current and long-term requirements.

Critical Accounting Estimates

The Company’s critical accounting estimates include those related to the recognition of grant revenue, the valuation of research and development expenses, and the assessment of the Company’s ability to continue as a going concern.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements, financings, or relationships with special purpose entities.