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

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
[email protected]

Media:
Jules Abraham
CORE IR
917-885-7378
[email protected]

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

D.Nelson--RTC