Petros Pharmaceuticals, Inc (PTPI) partners with Innolitics

Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over the counter ("OTC") drug development programs, today announces its partnership with Innolitics, a leading developer in the Software-as-a-Medical Device space. The collaboration is intended to integrate many of the Company's emerging capabilities in the ongoing development of its first-in-industry SaaS platform designed to complement its proprietary web application (also known as a Software as a Medical Device, or "SaMD"). Utilizing the same knowledge management system as multiple Fortune 100 companies and having developed software for more than 70 medical devices, Innolitics is expected to be integrating many of the Company's recently announced cloud-based components. These enhancements include AI, cybersecurity, and others to provide potential prescription treatments and pharmaceutical sponsors with a commercially viable and enterprise scaled platform.

Innolitics specializes in medical device software development, cybersecurity, and FDA regulatory submissions. It is expected to be integral to integrations with the Company's Big Data partner and consumer user interface experience. Their team comprises a multi-faceted array of talent including software engineers, cybersecurity experts, regulatory consultants, and AI and machine learning processing experts.

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to make incremental progress in the development of our enterprise system designed to take advantage of what we believe represents a significant shift in the pharmaceutical industry. We believe that our $10 million cash position, coupled with a significantly reduced burn rate compared to Q4 2024, puts us in good stead to complete this development and create a much-needed resource for the pharmaceutical industry in an age where new alternatives to expand access are in demand.

"As manufacturers face critical lifecycle management decisions, and the federal government has mandated new and better solutions for access to medical care, we believe our SaaS program will be key to overcoming longstanding challenges such as retail integration, electronic health record interoperability and the commercial scalability necessary for a true over-the-counter experience. This collaboration with Innolitics represents continued progress in the development of this system, and we are confident in both our approach and its potential in the larger market," concluded Mr. Boctor.

Petros' enterprise platform is being designed within the United States Food and Drug Administration's (the "FDA") Additional Conditions for Nonprescription Use ("ACNU") guidelines to facilitate bringing prescription products over the counter, and is intended to help industry comply with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative.

The Company is developing this intended licensable platform to provide a variety of services, including patient self-selection tools, electronic health records integration to support appropriate patient use, possible integration with retail pharmacies, and robust cybersecurity and privacy safeguards. The ACNU regulatory framework provides guidelines that are designed to expand access as pharmaceutical companies evaluate various potential switches from prescription to OTC availability.

Petros' system is being designed to meet these stipulations in an efficient, commercially viable, licensable single framework. The Company believes there are multiple indications that may be appropriate for an Rx-to-OTC switch, including erectile dysfunction, hypercholesterolemia (high cholesterol), migraine, anxiety and urinary tract infection.

The emerging self-care market is currently estimated to be valued at over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.¹​

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