Petros Proprietary Technology Platform Aligns with April 15, 2025 President Trump Executive Order Advancing Rx-to-OTC Reclassification Reforms

Rhea-AI Summary

Petros Pharmaceuticals announces strategic alignment with President Trump's April 15, 2025 Executive Order on Rx-to-OTC drug reclassification reforms. The company's proprietary AI and Big Data technology platform is positioned to facilitate the transition of prescription drugs to over-the-counter status.

The platform offers key features including:

• Patient self-selection tools
• Electronic health records integration
• Retail pharmacy integration capabilities
• Robust cybersecurity measures

Target areas for Rx-to-OTC conversion include erectile dysfunction, high cholesterol, migraine, anxiety, and urinary tract infections. Additionally, Petros announced a 1-for-25 reverse stock split effective April 30, 2025, reducing outstanding shares from 53,512,995 to approximately 2,140,520.

Positive

• Company's AI and Big Data platform aligns with new Executive Order on Rx-to-OTC drug reclassification
• Proprietary technology platform positions company for potential partnerships with pharmaceutical companies
• Platform designed to be licensable across multiple high-value drug categories including ED, cholesterol, migraine, anxiety, and UTI treatments

Negative

• 1-for-25 reverse stock split announced, indicating potential share price concerns
• Reduction in total shares from 53.5M to 2.1M may impact stock liquidity
• No current revenue or partnerships mentioned from the technology platform

Insights

Financial Analyst

Petros announces 1-for-25 reverse split while positioning AI platform to capitalize on Trump's drug price executive order.

Petros Pharmaceuticals has announced a significant 1-for-25 reverse stock split effective April 30, 2025, which will reduce outstanding shares from 53.5 million to approximately 2.14 million. This substantial consolidation, while preserving proportional ownership stakes, represents a material corporate action that typically raises concerns among investors, as reverse splits often signal underlying financial challenges.

Concurrently, the company is highlighting strategic alignment with President Trump's April 15, 2025 Executive Order on lowering drug prices through expanded OTC access. Petros is developing an AI and Big Data technology platform specifically designed to facilitate prescription-to-OTC switches, which could create licensing opportunities with pharmaceutical manufacturers looking to extend product lifecycles and increase accessibility.

The technology remains in development phase, focusing on patient self-selection tools, electronic health records integration, and retail pharmacy systems. This platform aims to help pharmaceutical companies navigate the FDA's Additional Condition for Nonprescription Use (ACNU) regulatory framework for OTC conversion more efficiently.

While the strategic positioning in the OTC conversion space presents potential future revenue opportunities through industry partnerships, the article doesn't mention any current revenue from this initiative or existing commercial partnerships. The substantial reverse split ratio, combined with this strategic repositioning, suggests significant corporate restructuring during what appears to be a pre-revenue developmental phase for the company's technology platform.

Pharmaceutical Regulatory Expert

Trump's executive order aligns with Petros' OTC conversion technology, potentially accelerating pharmaceutical partnerships for conditions like ED and high cholesterol.

President Trump's April 15, 2025 Executive Order on "Lowering Drug Prices By Once Again Putting Americans First" signals regulatory support for expanding OTC medication access, creating a potentially favorable environment for companies with relevant technologies. Petros Pharmaceuticals appears strategically positioned with its OTC drug development focus.

The company is developing a Big Data and AI-driven software-as-a-Medical Device platform specifically designed to facilitate prescription-to-OTC conversions. This platform incorporates critical components including patient self-selection tools, electronic health records integration, and robust security measures—all designed to align with FDA's Additional Condition for Nonprescription Use (ACNU) regulatory framework.

Petros identifies several significant therapeutic areas potentially appropriate for Rx-to-OTC switches, including erectile dysfunction, high cholesterol, migraines, anxiety, and urinary tract infections. These conditions represent substantial markets where improved access could benefit uninsured and underinsured populations—a key aim cited in the executive order.

According to the article, Petros has been developing this platform since 2021 and has incorporated periodic FDA feedback to address regulatory concerns. The Executive Order doesn't modify existing regulations but signals political support for expanded OTC access. The company's ability to successfully license this platform to pharmaceutical manufacturers will depend on demonstrating that it can ensure appropriate patient self-selection and safety without physician oversight—the fundamental regulatory hurdle in OTC conversion.

Company's AI and Big Data technology positioned to drive strong industry collaboration

Company also announces certain corporate actions

NEW YORK, NY / ACCESS Newswire / April 29, 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 highlights President Trump's April 15, 2025 Executive Order, titled, "Lowering Drug Prices By Once Again Putting Americans First" (the "Executive Order"), as a demonstration that the Company's recent strategic shift is well timed to the current regulatory climate, where Petros believes it has already made significant advancements. Petros' development of its Big Data and AI-driven software-as-a-Medical Device platform presents an important opportunity for the pharmaceutical industry to contribute to the lowering of drug prices while utilizing an emerging, yet proven, methodology that conforms with FDA guidance to ensure a safe transition from Rx to OTC.

Petros President and Chief Commercial Officer Fady Boctor commented, "President Trump's executive order supports the notion that the under-insured, uninsured, and the American population at large will greatly benefit from expanded access to certain drugs that are currently only available via prescription. Since 2021, Petros has been endeavoring toward the development of its proprietary industry-wide technology-assisted platform that centers around consumer's preferences, as well as meeting the pharmaceutical manufacturers' time, cost, and efficiency objectives. We believe that further advancement of this platform could unlock substantial partnership opportunities with pharmaceutical companies seeking to broaden patient access and extend the commercial lifecycle of their products through OTC conversion, and that our work closely supports the intention of the Executive Order, and we anticipate continued progress in development of this service."

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 over-the counter availability.

Petros' system is 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.

According to a 2016 article from the Journal of Research in Pharmacy Practice, there are multiple advantages to switching appropriate therapies from prescription to OTC.¹ These include ease of access to essential medications, speed to therapy, decreased costs, and empowered discretion, which the Company believes are key purposes of the President's recent Executive Order.

Even in light of the Executive Order, over the course of the development of its technology solution, the Company has carefully followed the direction from recently approved guidance on 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.

Reverse Stock Split

Additionally, the Company today announces that it intends to effect a reverse stock split of its common stock, par value $0.0001 per share (the "common stock") at a ratio of 1 post-split share for every 25 pre-split shares. The reverse stock split will become effective at 4:05 p.m. on Wednesday, April 30, 2025. The Company's common stock will continue to be traded on the Nasdaq Capital Market under the symbol "PTPI" and will begin trading on a split-adjusted basis when the market opens on Thursday, May 1, 2025. The new CUSIP number for the common stock following the reverse stock split is 71678J308.

At the 2024 annual meeting of stockholders held on November 20, 2024, the Company's stockholders granted the Company's Board of Directors the discretion to effect a reverse stock split of the Company's common stock through an amendment to its Amended and Restated Certificate of Incorporation, as amended, at a ratio of not less than 1-for-2 and not more than 1-for-25, with such ratio to be determined by the Company's Board of Directors.

At the effective time of the reverse stock split, every twenty-five (25) shares of the Company's issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-25 reverse stock split. It is not necessary for stockholders holding shares of the Company's common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder's percentage interest in the Company's equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of the Company's common stock outstanding from 53,512,995 shares to approximately 2,140,520 shares. Proportional adjustments will be made to the number of shares of the Company's common stock issuable upon exercise or conversion of the Company's equity awards, warrants and other convertible securities, as well as the applicable exercise or conversion price thereof. Stockholders with shares in brokerage accounts should direct any questions concerning the reverse stock split to their broker; all other stockholders may direct questions to the Company's transfer agent, Pacific Stock Transfer Co., at 702-361-3033.

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 and a proprietary SaMD web application 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. Consumers must then 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 recently finalized 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 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; the effect that the reverse stock split may have on the price of the Petros' common stock; Petros' ability to regain and 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

¹ Jongwha Chang, Allison Lizer, Isha Patel, Deepak Bhatia, Xi Tan and Rajesh Balkrishnan.
"Prescription to over‑the‑counter switches in the United States," Journal of Research in Pharmacy Practice, July-September 2016, Vol. 5, Issue 3.

SOURCE: Petros Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

How will Trump's April 2025 Executive Order affect PTPI's Rx-to-OTC technology platform?

Trump's Executive Order on drug price reduction aligns with PTPI's AI and Big Data platform, which facilitates Rx-to-OTC drug conversions. The platform supports pharmaceutical companies in broadening patient access and extending product lifecycles through OTC conversion, directly supporting the Executive Order's goals.

What is the ratio and effective date of PTPI's 2025 reverse stock split?

PTPI's reverse stock split will be effective April 30, 2025, at 4:05 p.m., with a ratio of 1-for-25. Trading on split-adjusted basis begins May 1, 2025, reducing outstanding shares from 53,512,995 to approximately 2,140,520.

Which medical conditions could benefit from PTPI's Rx-to-OTC platform?

PTPI identifies several conditions suitable for Rx-to-OTC switches through their platform: erectile dysfunction, high cholesterol, migraine, anxiety, and urinary tract infection.

What key features does PTPI's OTC conversion platform offer pharmaceutical companies?

PTPI's licensable platform offers patient self-selection tools, electronic health records integration, potential retail pharmacy integration, and robust cybersecurity measures, all designed to meet FDA's ACNU regulatory framework requirements.

What are the benefits of PTPI's Rx-to-OTC drug conversion program?

According to research cited by PTPI, the main benefits include easier access to essential medications, faster treatment initiation, reduced costs, and increased patient discretion in healthcare decisions.