Petros Pharmaceuticals

Petros Pharmaceuticals, Inc. engages in men's health therapeutics. It is involved in sales, marketing, regulatory and medical affairs, finance, trade relations, pharmacovigilance, market access relations, manufacturing, and distribution. It operates through the Prescription Medications and Medical Devices segments. The Prescription Medications segment handles Stendra, a FDA approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction, and H100, a topical formulation candidate for the treatment of acute Peyronie's disease. The Medical Devices segment consists of vacuum erection devices. The company was founded on May 14, 2020 and is headquartered in New York, NY.

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Company positions itself for new innovation utilizing AI and quantum computing to help expand patient access to drugs via OTC access NEW YORK, NY / ACCESSWIRE / December 19, 2024 / 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 announced that in a recent podcast, The Intelligent Leadership Podcast, titled, "The New Era of Healthcare, AI, Data and Consumer Empowerment," Petros President Fady Boctor discussed the Company's concerted efforts to develop its proprietary platform as a prospective technology driven Rx-to-OTC switch solution across a multitude of conditions and existing Rx only therapies. During the podcast, Boctor discussed Petros' technology tool development around a Drug Facts Label to self-select, as well as the utilization of AI to ensure safe engagement and access to a drug that has made the Rx-to-OTC switch.

Petros Pharmaceuticals Featured in “New Era of Healthcare, AI, Data and Consumer Empowerment”

Working to identify quantum computing partnerships to strengthen our AI technology to include critical health records to better enable Rx to OTC switch candidates across multiple indications NEW YORK, NY / ACCESSWIRE / December 17, 2024 / 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 shift in its corporate strategy to focus on the development of its proprietary technology platform as a prospective Rx-to-OTC switch solution across a multitude of conditions and existing Rx only therapies. If this Software as a Service ("SaaS") and Software as a Medical Device (SaMD) concept is ultimately approved by the FDA, it could significantly serve the emerging self-care market currently estimated to be valued over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.

Proprietary Technology Addressing the Rx-to-OTC Switch Self-Care Market Valued at over $38 Billion annually

Company is currently conducting larger scale comprehension test to confirm results in compliance with FDA discussions NEW YORK, NY / ACCESSWIRE / September 11, 2024 / 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 announced results of an initial study to determine consumer comprehension of the messaging in its App Technology ("App Comp"), which has unique differences from the current Drug Facts Label ("DFL"). Of the 31 objectives, 29 scored >90% comprehension Point Estimate ("PE"), 30 scored >86.7% comprehension PE, and all scored > 80% comprehension PE.

Petros Pharmaceuticals Executes Successful Initial Test for App Comprehension as Part of FDA Pathway for Over-the-Counter Access for STENDRA(R) (avanafil)

NEW YORK, NY / ACCESSWIRE / September 3, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter ("OTC") drug development programs, announces today that Fady Boctor, President and Chief Commercial Officer, will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference.

Petros Pharmaceuticals to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Utilization of the Company's proprietary Web App showed improved self-selection utilizing an embedded validated diagnostic questionnaire compared to a live interview furthering the Company's efforts to potentially create a first-ever Rx-to-OTC switch in the ED category NEW YORK, NY / ACCESSWIRE / July 29, 2024 / 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 announced results of a subsequent analysis of its pivotal study aimed at facilitating FDA-approved OTC access of the Company's STENDRA® (avanafil) for consumers. This analysis suggested support for the primary study results and demonstrated improved correct self-selection outcomes resulting from patients using the Company's proprietary Web App Technology and its embedded clinically validated diagnostic tool relative to subsequent verbal interviews that were designed into the study protocol as a form of validation of an ED diagnosis.

Petros Pharmaceuticals' Pivotal Statistically Significant Self Selection Study Shows Stronger Results with Proprietary Technology Application as Part of FDA Pathway for Over-the-Counter Access for STENDRA(R) (avanafil)

Vital study aligned with FDA guidelines shows encouraging performance as Petros continues close FDA contact for a potential technology-centered Rx-to-OTC switch NEW YORK, NY / ACCESSWIRE / July 16, 2024 / 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, announces results of the first of a series of pivotal studies aimed at facilitating FDA-approved OTC access of STENDRA® (avanafil) for consumers. The pivotal self-selection study showed that consumers who used the Company's proprietary Web App Technology, designed to assist in the appropriate consumer self-selection for receiving the drug, had a statistically significant (p

Petros Pharmaceuticals' STENDRA(R) (avanafil) Pivotal Consumer Self-Selection Study for Over-the-Counter Access Demonstrates Statistical Significance

23andMe

Lemonaid Health will offer customers more affordable access to branded ED medication STENDRA that may be taken as early as ~15 minutes prior to sexual activity (100mg and 200mg strengths only) [1] Please see Important Safety Information and study design below NEW YORK, NY / ACCESSWIRE / May 14, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the availability of all strengths of the Company's prescription erectile dysfunction (ED) medication, STENDRA (avanafil) on the telehealth platform Lemonaid Health, Inc. Lemonaid Health is a subsidiary of 23andMe Holding Co. (Nasdaq: ME), and a leading telemedicine provider. "With Lemonaid's nationwide distribution and industry leading track record of treating a significant number of ED patients across the country, we are excited to collaborate with Lemonaid Health in this expanded access initiative for STENDRA.

Petros Pharmaceuticals Launches U.S. Distribution of Prescription ED Medication STENDRA Through Recently Announced Collaboration With Lemonaid Health, a Subsidiary of 23andMe

Collaboration with leading telemedicine provider to offer marketing and distribution of STENDRA for Lemonaid Health's ED patients (Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 23, 2024 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces a new collaboration with Lemonaid Health, leading telemedicine provider and a subsidiary of 23andMe, serving hundreds of thousands of patients with quality healthcare. As part of the collaboration, prescription STENDRA® (avanafil) in all strengths will be available through Lemonaid Health's telehealth platform.

Petros Pharmaceuticals Expands Online Distribution for Prescription STENDRA(R) (avanafil) Through New Agreement with Lemonaid Health

(Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 16, 2024 / Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has received positive feedback from the U.S. Food and Drug Administration (the "FDA," or the "Agency") following the FDA's informal review of Petros' technology component for self-selection as the Company endeavors to achieve OTC status for STENDRA. The Agency acknowledged that the technology addressed some of its concerns regarding the PDE5 inhibitor class in that context, particularly with regard to nitrate-using patients.

Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil)

Nitrate patients subgroup demonstrated 100% correct self-selection when utilizing the web app technology with the drug facts label compared to 40% when using drug facts label alone (among 86% vs. 56% of all users) underscoring the significant potential benefits of technology assistance in an OTC setting (Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 2, 2024 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces positive results of an initial cohort of its self-selection study comparing the use of a Drug Facts Label (DFL) alone to a DFL in combination with a web app (technology component).

Petros Pharmaceuticals Reports Positive Results in an Initial Cohort Two-Arm Self-Selection (Phase 2-Equivalent) Study for STENDRA(R) (avanafil) as it Pursues OTC Status

Petros begins enrollment in AI integrated Human Factors Study to optimize self-screening, continuing its efforts to make STENDRA (avanafil) the first erectile dysfunction medication to achieve OTC Status (Please see important safety information below) NEW YORK, NY / ACCESSWIRE / March 19, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has successfully launched its artificial intelligence (AI) tool developed as a result of its collaboration with a multi-billion-dollar software developer. The tool is being integrated into the Company's web app being used for patient self-screening, which it is testing in its recently launched Human Factors study.

Petros Pharmaceuticals Successfully Launches AI Tool In Collaboration with Multi-Billion-Dollar Software Provider

AI software expected to further enable Petros's efforts to make STENDRA the first ED product to be offered over the counter NEW YORK, NY / ACCESSWIRE / February 14, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces a new partnership with a leading, multi-billion-dollar AI software provider to adapt its technology for self-screening and other benefits as part of the Company's ongoing efforts to bring STENDRA over the counter. The technology will be integrated into the core tool the Company has already developed as part of its Self-Selection Study, which is currently underway.

Petros Pharmaceuticals Enters into AI Licensing Agreement with Leading Multi-Billion-Dollar Software Provider

FDA requests meeting to review the Company's technology component and discuss further development and requirements NEW YORK, NY / ACCESSWIRE / January 24, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has scheduled two meetings with the U.S. Food and Drug Administration (FDA) to review the Company's progress and path forward in developing STENDRA as the first PDE-5 inhibitor approved as an over-the-counter medication for erectile dysfunction. (Please see Important Safety Information below.

Petros Pharmaceuticals Announces Two Upcoming FDA Meetings to Review Progress and Path Forward for STENDRA(R) (avanafil) Rx-to-OTC Switch

Over 78% of technology-enabled subjects correctly self-selected vs. 56% using drug facts label alone demonstrating continued progress toward STENDRA® working to become the first erectile dysfunction medication to successfully achieve OTC status NEW YORK, NY / ACCESSWIRE / January 17, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the successful completion of the initial cohort of a Phase 2 equivalent Self-Selection Study (SSS).

Petros Pharmaceuticals Demonstrates Positive Results Following Successful Completion of Initial Cohort of Phase 2 Equivalent Self-Selection Study for STENDRA (avanafil) Rx-to-OTC Switch

Human Factor Study represents important component of FDA requirements for technology to pave way for STENDRA OTC approval NEW YORK, NY / ACCESSWIRE / December 12, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the completion of a Human Factors Study, whose objective was to assess the technology component developed to facilitate patient's access to its erectile dysfunction drug, STENDRA® (avanafil), associated with the Company's intended FDA application for prescription to OTC switch. The objective of the study was to determine the strengths and weaknesses of the interface of a developmental technology tool, as well as potential use errors in critical tasks, such as navigating and reporting medical history, entering birth date and other key call to action prompts.

Petros Pharmaceuticals Successfully Completes Important Study in Effort to Make STENDRA(R) (avanafil) the First Erectile Dysfunction Medication to Achieve OTC Status

Idea Evolver is the only provider to successfully complete Actual Use Trial for FDA review for Rx-to-OTC Switch Approval NEW YORK, NY / ACCESSWIRE / December 12, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces its partnership with Idea Evolver (IE), a Technology platform for Rx-to-OTC switches and digital pharmaceutical launch solutions. The partnership will focus on developing an application to help facilitate the technology element for the Company's prescription to OTC switch for its erectile dysfunction drug STENDRA® (avanafil).

Petros Pharmaceuticals Partners with Blockbuster Cholesterol Drug(1) Crestor's (rosuvastatin) OTC Switch Technology Provider

New AI/machine learning tool designed to help potential users more effectively self-select in the effort to make STENDRA the first erectile dysfunction (ED) medication available OTC Petros in discussions with third-party technology partners NEW YORK, NY / ACCESSWIRE / October 30, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), ), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the development of a technological component of its self-selection study utilizing machine learning/artificial intelligence (AI), which the Company plans to integrate into its self-selection studies for its erectile dysfunction drug STENDRAÒ (avanafil). The development of the technology and study design will continue to follow direct U.S. Food and Drug Administration (FDA) recommendations as well as published proposed guidelines currently being finalized by the Agency.

Petros Pharmaceuticals Petros Pharmaceuticals Developing Artificial Intelligence Technology for Phase 2 Equivalent Study for STENDRA(R)

Important step towards STENDRA potentially becoming the first erectile dysfunction medication to successfully achieve OTC Status NEW YORK, NY / ACCESSWIRE / October 19, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs, announces initiation of a self-selection study using the Drug Facts Label (DFL) tested during its previously announced label comprehension study (LCS). Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to collaborate with the FDA as we pursue an emerging pathway to expand access to STENDRA as the first potential OTC prescription-grade therapeutic option for erectile dysfunction (ED).

Following Encouraging FDA Feedback Petros Pharmaceuticals Initiates Self-Selection (Phase 2-Equivalent) Study for STENDRA

Company well positioned to continue collaboration with FDA toward pursuit of OTC pathway for STENDRA NEW YORK, NY / ACCESSWIRE / October 4, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over the counter (OTC) nonprescription pathways, announces completion of a pivotal label comprehension study (LCS). Using FDA guidance provided to the company in 2022, the LCS is expected to satisfy a critical step in the organization's progress towards a possible non-prescription version of STENDRA, the Company's prescription erectile dysfunction drug.

Petros Pharmaceuticals Announces Positive Outcomes in Label Comprehension Study for Potential OTC STENDRA Label

NEW YORK, NY / ACCESSWIRE / September 28, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over the counter (OTC) pathway, announces today that Fady Boctor, President and Chief Commercial Officer, will present a corporate overview at the LD Micro Main Event XVI. The conference is being held on October 3 - 5, 2023 at the Luxe Sunset Boulevard Hotel in Los Angeles.

Petros Pharmaceuticals to Present at the LD Micro Main Event XVI

NEW YORK, NY / ACCESSWIRE / September 11, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over the counter (OTC) pathway provides the below Letter to Shareholders: To our valued shareholders, As we approach the fourth quarter of 2023, Petros has been quietly undergoing a change in approach to our business. As we have previously announced, our evolving focus has shifted from prioritizing the commercialization of prescription STENDRA, which continues to be a source of revenue for us, to developing and executing on a new pathway toward non-prescription or potentially over-the-counter access for our current lead product.

Petros Pharmaceuticals Provides Letter to Shareholders

NEW YORK, NY / ACCESSWIRE / September 6, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a pioneer in expanding consumer access to medication through over the counter (OTC) pathways, announces today that Fady Boctor, President and Chief Commercial Officer, will present a corporate overview at the H.C. Wainwright 25th Annual Global Investment Conference.

Petros Pharmaceuticals to Present at the H.C. Wainwright 25th Annual Global Investment Conference

Provides Update on Progress Toward Over the Counter (non-prescription) Development of STENDRA NEW YORK, NY / ACCESSWIRE / July 13, 2023 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI) ("Petros" or "the Company"), a pioneer in expanding consumer access to medication through the over the counter (OTC) pathway, today announces a $15 million private placement financing that will support its continued progress towards bringing its erectile dysfunction (ED) drug, STENDRA, to non-prescription OTC status. Petros raised $15 million from this private placement, which was led by its largest existing shareholders.

Petros Pharmaceuticals Announces Capital Raise of $15 Million

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