Petros Pharmaceuticals PTPI

Petros Pharmaceuticals, Inc. is a healthcare technology company focused on developing and licensing a proprietary integrated technology platform designed to assist pharmaceutical companies in transitioning prescription medications to over-the-counter (OTC) status. The company is working toward becoming a leading innovator in the emerging self-care market by enabling expanded access to nonprescription pharmaceuticals through its platform, which includes Software as a Service (SaaS) and Software as a Medical Device (SaMD) components. Petros previously commercialized Stendra®, an FDA-approved PDE-5 inhibitor for erectile dysfunction, and marketed vacuum erection devices under the Osbon ErecAid and PosTVac brands through its subsidiaries Timm Medical and Pos-T-Vac, LLC, but discontinued these operations in 2024 and 2025 following an assignment of those assets for the benefit of creditors.

Petros generates revenue primarily through licensing fees for its proprietary technology platform, which is intended to be out-licensed to pharmaceutical companies seeking to operationalize and commercialize Rx-to-OTC switches. The company does not currently generate revenue from manufacturing, distribution, or direct sales of medications, as its business model is designed to avoid responsibility for production costs and supply chain management. Instead, Petros focuses on developing and supporting its technology platform, with revenue expected to stem from agreements that grant licensees access to its SaaS and SaMD capabilities, including secure data exchanges, regulatory compliance management, labeling guidance, and consumer interface tools for appropriate self-selection of OTC products.

Petros Pharmaceuticals, Inc. operates through a single operational segment dedicated to the development and licensing of its proprietary technology platform for Rx-to-OTC switches.

• Technology Platform: This segment encompasses the research, development, and licensing of Petros’ integrated technology solution comprising SaaS and SaMD components designed to assist pharmaceutical companies in navigating the FDA’s Rx-to-OTC switch process, particularly under the ACNU Rule. The SaaS component is intended to provide secure data exchanges, regulatory compliance management, labeling and usage guidance, and market access optimization. The SaMD component is being developed as a consumer interface that guides appropriate self-selection or deselection of OTC medications through clinically established algorithmic logic, with potential integration of electronic health records and longitudinal data for real-time patient qualification. The platform is being designed to be scalable, licensable, and customizable to specific pharmaceutical therapies, supporting various classes of medications across the industry.

Petros positions itself as an innovator in the nascent market for technology-assisted Rx-to-OTC switches, particularly those involving nonprescription drug products with an additional condition for nonprescription use (ACNU Products). While most current ACNU technology platforms rely solely on questionnaire-based models, Petros differentiates its approach by integrating artificial intelligence, electronic health records, and population longitudinal data to enable more objective and multifaceted patient qualification. The company believes its platform could be the first of its kind to combine these elements in a scalable, licensable format, offering a competitive advantage in a market where few companies are developing proprietary, licensable technology solutions for regulatory and consumer engagement challenges in the OTC switch process.

Petros targets pharmaceutical innovative label owners and exclusive OTC commercial licensees interested in switching prescription products to OTC, including traditional pharmaceutical companies with established prescription portfolios and self-care consumer companies seeking to diversify product lines and increase direct-to-consumer engagement. The company also identifies emerging health technology firms as potential partners interested in combining digital platforms with OTC treatment solutions. Petros engages in industry conferences and business development presentations to promote awareness of its technology and attract prospective customers, with the expectation that successful commercialization among initial partners will expand its customer base through joint announcements and increased industry visibility.