Latest news with #Petros'
Borneo Post
27-05-2025
- Business
- Borneo Post
SUPP: Joint declaration clears all doubts on Distribution of Gas Ordinance, Petros' status
Tiang (seated centre) during the press conference. – Ukas photo KUCHING (May 26): The recent joint declaration between the federal government and Sarawak government in reaching an understanding on matters involving Petroliam Nasional Bhd (Petronas) and Petroleum Sarawak Bhd (Petros) has cleared any doubts on Sarawak's Distribution of Gas Ordinance and Petros' status as the sole gas aggregator. The Sarawak United People's Party (SUPP) said the joint declaration has successfully solved the disputes over the governance of oil and gas distribution within Sarawak. 'Utility and Telecommunication Minister Dato Sri Julaihi Narawi had sent a very clear message in his ministerial winding-up speech at the State Legislative Assembly (DUN) Sitting yesterday, stating that with such a joint declaration, Petros' appointment as gas aggregator must be respected by everyone undertaking the business of gas distribution in Sarawak. 'All agreements and arrangements pertaining to the supply and sale of natural gas in Sarawak must align with Petros' role as gas aggregator,' SUPP vice president Datuk Michael Tiang told a press conference today. Describing the joint declaration as another milestone for Sarawak and its people, he said SUPP commended Prime Minister Datuk Seri Anwar Ibrahim and Premier Datuk Patinggi Tan Sri Abang Johari Tun Openg for their wisdom and firm stand in reaching this understanding and agreement for the way forward. 'It is also pertinent to understand that all gas industry players including Petronas must respect and comply with Section 7 of the Distribution of Gas Ordinance, 2016 (DGO 2016), which is to apply for a licence as well as to comply with all Sarawak state laws when conduct their business of gas distribution in Sarawak,' he said. He criticised the Democratic Action Party (DAP) for attempting to politicise the issue, especially when both Anwar and Abang Johari have stood firm on the same ground. 'Needless to say, DAP showed absolutely no interest in the real facts and Sarawak's achievements. 'Instead, they resorted to accuse SUPP of being silent on Petros and Petronas matters to divert public attention from their bankruptcy of ideas,' added Tiang. joint declaration lead Michael Tiang Petronas Petros sole aggregator
Associated Press
20-05-2025
- Business
- Associated Press
Petros Pharmaceuticals Partners with Innolitics, a Leading Software-as-a-Medical-Device Developer
With more than $10m in cash, and a significantly reduced burn rate, the Company is positioned to fully fund the development of its technology platform. NEW YORK, NY / ACCESS Newswire / May 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 its partnership with Innolitics, a leading developer in the Software-as-a-Medical Device space. The collaboration is intended to integrate many of the Company's emerging capabilities in the ongoing development of its first-in-industry SaaS platform designed to complement its proprietary web application (also known as a Software as a Medical Device, or 'SaMD'). Utilizing the same knowledge management system as multiple Fortune 100 companies and having developed software for more than 70 medical devices, Innolitics is expected to be integrating many of the Company's recently announced cloud-based components. These enhancements include AI, cybersecurity, and others to provide potential prescription treatments and pharmaceutical sponsors with a commercially viable and enterprise scaled platform. Innolitics specializes in medical device software development, cybersecurity, and FDA regulatory submissions. It is expected to be integral to integrations with the Company's Big Data partner and consumer user interface experience. Their team comprises a multi-faceted array of talent including software engineers, cybersecurity experts, regulatory consultants, and AI and machine learning processing experts. Fady Boctor, Petros' President and Chief Commercial Officer, commented, 'We continue to make incremental progress in the development of our enterprise system designed to take advantage of what we believe represents a significant shift in the pharmaceutical industry. We believe that our $10 million cash position, coupled with a significantly reduced burn rate compared to Q4 2024, puts us in good stead to complete this development and create a much-needed resource for the pharmaceutical industry in an age where new alternatives to expand access are in demand. 'As manufacturers face critical lifecycle management decisions, and the federal government has mandated new and better solutions for access to medical care, we believe our SaaS program will be key to overcoming longstanding challenges such as retail integration, electronic health record interoperability and the commercial scalability necessary for a true over-the-counter experience. This collaboration with Innolitics represents continued progress in the development of this system, and we are confident in both our approach and its potential in the larger market,' concluded Mr. Boctor. Petros' enterprise platform is being designed within the United States Food and Drug Administration's (the 'FDA') Additional Conditions for Nonprescription Use ('ACNU') guidelines to facilitate bringing prescription products over the counter, and is intended to help industry comply with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative. 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 OTC availability. Petros' system is being 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. The emerging self-care market is currently estimated to be valued at over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.1 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 regulation 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; Petros' expectations related to the Company's partnership with Innolitics; 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] SOURCE: Petros Pharmaceuticals, Inc. press release
Associated Press
01-05-2025
- Business
- Associated Press
Petros Pharmaceuticals Developing First-in-Industry SaaS Platform Utilizing AI and Electronic Health Records Intended to Facilitate Rx-OTC Switches
Licensable platform intended to facilitate industry compliance with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative NEW YORK, NY / ACCESS Newswire / May 1, 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 concerted effort toward evolving into a smart healthcare technology company through the development of a SaaS platform designed to complement its proprietary web application (also known as a Software as a Medical Device, or SaMD). The licensable platform is being designed to integrate key cloud-based components, including AI, electronic health records, cybersecurity and others to provide potential prescription treatments and pharmaceutical sponsors with a commercially viable and enterprise scaled platform. The enterprise platform is being designed within the United States Food and Drug Administration's (the 'FDA') Additional Conditions for Nonprescription Use ('ACNU') guidelines to facilitate bringing prescription products over the counter, and is intended to help industry comply with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative. 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 OTC availability. Petros' system is being 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. Fady Boctor, Petros' President and Chief Commercial Officer, commented, 'We believe this significant shift in our business strategy may fill an important role as many blockbuster drugs and their manufacturers face critical lifecycle management decisions. Further, as previously announced, we believe it is consistent with a recent Executive Order from President Trump, which highlights the need to create more pathways for expanded access to pharmaceutical products to help control rising healthcare costs. Finally, the expansion of access is important regardless of how it is achieved, and we believe our SaaS program will be key to overcoming longstanding challenges such as retail integration, electronic health record interoperability and the commercial scalability necessary for a true over-the-counter experience. Our developmental SaaS platform is intended to integrate seamlessly with the other key component of our strategy, the Software as a Medical Device (SaMD), which serves as the consumer interface and design engine customized to a particular therapeutic indication. We look forward to updating the progress of the development and integration of this platform.' Petros is leading the way in its development of a proprietary technology-assisted platform that, based on multiple research studies1, 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 been carefully following the direction from recently approved guidance on the Nonprescription Drug Product with an ACNU by 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 at over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.2 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 regulation 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; 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] SOURCE: Petros Pharmaceuticals, Inc. press release
Associated Press
29-04-2025
- Business
- Associated Press
Petros Proprietary Technology Platform Aligns with April 15, 2025 President Trump Executive Order Advancing Rx-to-OTC Reclassification Reforms
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 [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. press release
Associated Press
20-03-2025
- Business
- Associated Press
Petros Pharmaceuticals to Partner with Renowned Big Data Provider to Enable Rx-to-OTC Switch Across Multiple Indications
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. 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 CORE IR Media: Jules Abraham 917-885-7378
