Company to integrate industry leading big data technology solutions into its AI-driven platform to expand capabilities in identifying eligible patients to receive formerly Rx medications over the counter

NEW YORK, NY / ACCESS Newswire / March 20, 2025 / 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 a collaboration with renowned Big Data and analytics leader to enhance the development of its proprietary technology solutions designed to facilitate Rx-to-OTC switches for pharmaceutical products. The collaboration will incorporate an automated credentialing solution to help improve the Company's identity verification system, which also encompasses an AI component. The Company believes the collaboration will significantly enhance the capabilities as it develops its Software-as-a-Medical Device (SaMD) concept, which is designed to serve the emerging self-care market.

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to develop our technology incorporating AI and now this important identify verification solution to provide an optimal solution for the pharmaceutical industry to facilitate Rx-to-OTC switches for mature products. The technology partner is among the most respected developers of Big Data and analytics in the industry and their solutions will help to streamline our approach, ensuring that the right customers are requesting the right OTC products to be used safely and correctly. As our proof-of-concept pilot ensues, we plan to reveal the outcomes and name the partner accordingly. One of the biggest hurdles in the Rx-to-OTC switch is ensuring that only the right patients are receiving access to formerly prescription products. We are confident that this collaboration will be instrumental in ensuring that this additional safety measure is executed with precision and speed."

The Company's partner has developed an advanced, automated document capture and authentication system that leverages a patented global ID library to verify identity and eligibility. By analyzing an image of an ID card captured via computer or mobile device, the document capture tool ensures secure and reliable authentication to allow for access to a specific medication for which authentication is appropriate. The solution, when added to the Petros technology, will analyze an expansive international database to ensure the person's ID is authentic and corresponds to the actual patient, providing an additional level of confidence and safety.

Petros is leading the way in its development of a proprietary technology-assisted platform that, based on multiple research studies, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology, could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.

Over the course of the development of its technology solution, the Company has carefully followed the direction from recently approved guidance from the Nonprescription Drug Product with an Additional Condition for Nonprescription Use" ("ACNU") by the United States Food and Drug Administration (the "FDA") for companies seeking Rx-to-OTC switch for pharmaceutical products, as well as incorporating periodic feedback from the FDA to address key FDA concerns.

The emerging self-care market is currently estimated to be valued over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years¹.

1. Rx-to-OTC Switches Market Size, Trends & Forecast 2033 | FMI (futuremarketinsights.com)

About Petros Pharmaceuticals

Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging $38 billion self-care market by providing expanded access to key prescription pharmaceuticals as OTC treatment options. The Company is currently developing a proprietary SaaS platform designed to assist pharmaceutical companies in meeting FDA standards to assist in the Rx-to-OTC switch.

About the Pathway from Rx to OTC

The process of switching a prescription medication to OTC first involves the design of a Drug Facts Label ("DFL") that is well understood by potential consumers. Then, data must show that consumers can make an appropriate informed decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish this, the FDA ordinarily requires a consumer tested OTC DFL. Such testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.

The regulations that the FDA is currently in the process of finalizing introduced Additional Conditions for Nonprescription Use ("ACNU") criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Petros is developing a technology platform (SaaS) to assist companies in navigating this pathway.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its proprietary Rx-to-OTC switch technology Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates, including its proprietary Rx-to-OTC switch technology. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.

The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.

Contacts
Investors:
CORE IR
ir@petrospharma.com

Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com

SOURCE: Petros Pharmaceuticals, Inc.