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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(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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Petros Pharmaceuticals (NASDAQ: PTPI ) stock is rocketing higher on Friday despite a lack of news from the men's health pharmaceutical company. That includes no press releases from Petros Pharmaceuticals that explain why its stock is on the rise today.

Why Is Petros Pharmaceuticals (PTPI) Stock Up 101% Today?

Common Stock Will Begin Trading on Split-Adjusted Basis on December 1, 2022 NEW YORK, NY / ACCESSWIRE / November 30, 2022 / Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (Nasdaq:PTPI), a leading provider of therapeutics for men's health, today announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 10 pre-split shares. The reverse stock split will become effective at 4:05 p.m.

Petros Pharmaceuticals Announces Reverse Stock Split

NEW YORK, NY / ACCESSWIRE / November 15, 2022 / Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (NASDAQ:PTPI), a leading provider of therapeutics for men's health, today announced financial results for the third quarter ended September 30, 2022. Recent Highlights: Company reported results of an Indian study published in the International Journal of Urology , in which patients reported improvement in erectile function compared to sildenafil and baseline after 12 weeks of therapy, onset of action within 15 minutes and a significant percentage of patients reaching normal erectile function according to their IIEF-EF score FDA approval of an expansion of the STENDRA label that now includes positive clinical trial data on STENDRA ® (avanafil) use by men with ED who have undergone radical prostatectomy.

Petros Pharmaceuticals Reports Third Quarter 2022 Financial Results and Corporate Update

Expanded STENDRA Labeling Now Includes Data on a Significant Population of Men Not Previously Included Following Submission of Additional Clinical Trial Data NEW YORK, NY / ACCESSWIRE / October 25, 2022 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a leading provider of therapeutics for men's health, today announces the expansion of the FDA labeling for its oral erectile dysfunction (ED) drug, STENDRA® (avanafil), marketed by its subsidiary, Metuchen Pharmaceuticals. The expanded label now includes positive clinical trial data on STENDRA® (avanafil) use by men with ED who have undergone radical prostatectomy.

New FDA-Approved Labeling for Petros Pharmaceuticals' STENDRA (avanafil) Now Includes Efficacy Data Regarding Use in Men Who Have Undergone Radical Prostatectomy

NEW YORK, NY / ACCESSWIRE / October 21, 2022 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leading provider of therapeutics for men's health, announces today that President and Chief Commercial Officer Fady Boctor will participate in two October 2022 conferences. LD Micro Main Event XV (Los Angeles, CA) Presentation Date: Tuesday, October 25Time: 4:30 pm PT (Track 4) The conference is being held on October 25 - 27, 2022 at the Luxe Sunset Boulevard Hotel in Los Angeles.

Petros Pharmaceuticals to Participate in Two October 2022 Conferences

Data Published in the "International Journal of Urology" Also Showed Secondary Endpoints, Such as Onset of action in 15 Minutes and Percentage of Patients Reaching Normal Erectile Function According to the IIEF-EF Score NEW YORK, NY / ACCESSWIRE / September 8, 2022 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leading provider of therapeutics for men's health, today announces newly published third party data in the International Journal of Urology Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction by Kumar, Pathade, Gupta, Goyal, Rath, Thakre, Sanmukhani, and Mittal, detailing the Company's PDE 5 inhibitor STENDRA® (avanafil) tablets in a non-inferiority, head-to-head study compared to sildenafil (Viagra) which was conducted in India. The primary efficacy endpoint was improvement in erectile function based on domain score of the International Index of Erectile Function (IIEF).

Internationally Published, Head-to-Head Data From India of Petros Pharmaceuticals' STENDRA(R) (Avanafil) Tablets Reported Improvement in Erectile Function Compared to Sildenafil and Baseline After 12 Weeks of Therapy

NEW YORK, NY / ACCESSWIRE / August 15, 2022 / Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (NASDAQ:PTPI), a leading provider of therapeutics for men's health, today announced financial results for the second quarter ended June 30, 2022. Highlights include: Reported Net Sales for Q2 of $4.2 million Achieved first positive quarter of Adjusted EBITDA over $200,000 Announced positive results of over-the-counter (OTC) label comprehension study for erectile dysfunction drug STENDRA® Engaged Massachusetts General Hospital (MGH) in sponsored research agreement for tissue-specific oxygenation sensor device technology Announced the Company is pursuing the 505(b)(2) pathway for its investigational agent H-100 for Peyronie's disease Launched social media campaign with celebrity Physician Dr. Drew Pinsky.

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