Blood Coagulation Disorders

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. Fady Boctor, Petros' President and Chief Commercial Officer, commented, "The utilization of AI is a logical progression as we aim to optimize the safe administration of STENDRA (avanafil), in development for OTC availability. In addition, based on our recent interaction with the FDA on our technology approach, we believe the AI component directly addresses requests made by the Agency in order to optimize selection. Ultimately, we believe the AI will help us to gather information to ensure that the patient is appropriate to receive the drug. Importantly, we continue to believe that we have sufficient funding to achieve our development goals as well as significant near-term clinical milestones for STENDRA." The Human Factors Study, which incorporates the AI tool, is designed to assess whether the web tool developed by the company can be used safely and effectively by its intended users. Subjects will be asked to perform critical tasks with the web app without any guidance from the study staff. The study is based on applicable FDA guidance for human factors studies. The outcomes from this study will further contribute to discussions with the U.S. Food and Drug Administration (FDA) regarding the need for the Additional Condition of Nonprescription Use (ACNU) with regard to the web app and the Company's endeavors to develop STENDRA into the first erectile dysfunction medication to go OTC. About Petros Pharmaceuticals Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics. About the OTC Pathway The process of switching a prescription medication to over the counter (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 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 these things, the FDA ordinarily requires a consumer tested OTC DFL. This 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 FDA is currently 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. Important Safety Information about STENDRA® (avanafil) STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. STENDRA® was designed and developed expressly for erectile dysfunction. STENDRA is contraindicated with any form of organic nitrates, in patients with known hypersensitivity to any component of the tablet, and in patients who are using a guanylate cyclase stimulator. Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason. Before taking STENDRA tell your doctor if you have had any kind of heart issues including heart attack, heart failure, angina and irregular heartbeat or have elevated or low blood pressure. Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension. Patients should seek emergency treatment if an erection lasts greater than 4 hours. Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss with patients the increased risk of NAION in patients with a history of NAION. Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing. STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use STENDRA. Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended. The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases. The most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain. For more information about STENDRA, call 844-458-4887. If you would like to report an adverse event or product complaint, please contact us at 844-458-4887. You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at . Please see the full Prescribing Information and Patient Information. 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," "pursuit," "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, including, without limitation, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to receive clearance from the FDA to sell STENDRA as an Over-the-Counter treatment; 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; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. 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 or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws. Contacts Investors: CORE IR ir@petrospharma.com Media: Jules Abraham CORE IR 917-885-7378 pr@coreir.com SOURCE: Petros Pharmaceuticals, Inc. View the original press release on accesswire.com

Trial met the primary efficacy endpoint demonstrating non-inferiority of the incidence of acute kidney injury for INTERCEPT Red Blood Cells compared to conventional red blood cells CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury (AKI) following transfusion of study RBCs. AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery. In transfused subjects, by modified intent to treat (mITT pre-specified primary endpoint population) the incidence of AKI was 29.3% (46/157) for INTERCEPT RBC recipients compared to 28.0% (45/161) for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14.0% (p = 0.001). The safety endpoint of the proportion of patients with any related treatment-emergent adverse events (TEAEs) within 28 days of last transfusion was not significantly different for INTERCEPT RBCs (2.5%) compared to conventional RBCs (0.6%) (p = 0.130). There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs. The trial’s independent Data Safety and Monitoring Board (DSMB) evaluated these patients and was supportive of continued transfusion, having found no adverse health effects from trial transfusions. This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs. Cerus plans to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular premarket approval (PMA) submission. “We are extremely pleased by the positive topline results of the ReCePI clinical trial,” stated Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer and principal investigator for the ReCePI clinical trial. “The ReCePI clinical trial is a pioneering trial in the field of transfusion medicine, providing critical information about pathogen reduced INTERCEPT RBCs compared to conventional RBCs. We continue to look forward to completing the RedeS clinical trial, Cerus’ ongoing pivotal Phase 3 clinical trial for INTERCEPT RBCs enrolling a broader patient population requiring RBC transfusion for acute and chronic anemia.” “Today’s news from the ReCePI clinical trial is an important milestone for the INTERCEPT RBC program,” stated William “Obi” Greenman, Cerus’ president and chief executive officer. “We are now one meaningful step closer to potentially making pathogen reduction available for RBCs, the most commonly transfused blood component in the U.S., with approximately 11 million transfused units annually. If approved, pathogen reduced RBCs would complement our existing commercial portfolio of INTERCEPT Systems for Platelets, Plasma, and Fibrinogen Complex, providing clinicians and patients access to the benefits of pathogen inactivation across all transfused components. We are grateful to all the patients, blood centers, and physicians who participated in the ReCePI clinical trial.” Cerus anticipates initiating a modular PMA application to the U.S. Food and Drug Administration (FDA) in the second half of 2025, with the final PMA module submission planned for the second half of 2026, upon the anticipated completion of the RedeS clinical trial. Data from preclinical studies, manufacturing information, previously reported Phase 1 and Phase 2 clinical trials in the U.S., and the successfully completed Phase 3 clinical trials in the EU (STARS and SPARC) will be included in the modular PMA submission. Cerus expects the data from the ReCePI clinical trial to be presented at upcoming medical conferences as well as to be submitted for peer reviewed publication. Webcast The Company will host a webcast at 9:00 A.M. EDT this morning, during which management will discuss the results of the ReCePI clinical trial. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at A replay will be available on Cerus’ website approximately three hours after the call through April 2, 2024. ABOUT ReCePI The ReCePI Phase 3 clinical trial was a prospective, multicenter, randomized, double-blinded, controlled, non-inferiority design trial (ClinicalTrials.gov: NCT03459287) to evaluate the efficacy and safety of RBCs prepared with the INTERCEPT RBC System in patients requiring transfusion for acute blood loss during complex cardiac surgery. Adult subjects at high risk of need for RBC transfusion received either conventional (control) or INTERCEPT RBCs during and for 7 days after complex cardiovascular surgery (CVS), including thoracic aorta surgery. The primary efficacy endpoint was the proportion of transfused patients with acute kidney injury (AKI) defined by increased serum creatinine (≥0.3 mg/dL or 26.5 µmol/L) from pre-transfusion baseline, within 48 hours of surgery. Safety endpoints were defined as related TEAEs through 28 days after enrollment; or antibodies with confirmed specificity to INTERCEPT RBCs through 75 days after enrollment. The ReCePI trial enrolled and randomized a total of 581 patients across 18 clinical study sites. The mITT population included 321 patients requiring RBC transfusions in the trial. Not all enrolled patients required RBC transfusion. INTERCEPT RBCs used in the ReCePI trial were produced by several blood centers in the U.S. The development program of the INTERCEPT Red Blood Cell System has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number HHSO100201600009C. ABOUT THE INTERCEPT BLOOD SYSTEM FOR RED BLOOD CELLS The INTERCEPT Blood System for Red Blood Cells is designed to inactivate blood-borne pathogens and donor leukocytes in RBCs intended for transfusion. The RBC system is designed to prevent pathogen replication by using a small molecule compound added to RBC concentrates to form bonds within nucleic acids in pathogens and leukocytes that may be present in donated RBC collections. The nucleic acid targeted mechanism of action is designed to preserve the therapeutic qualities of the RBCs. RBCs, platelets, and plasma do not require nucleic acid replication for therapeutic efficacy. The RBC system is under development and is not yet approved anywhere in the world. Cerus has filed for a CE Mark for the RBC system under the Medical Device Regulation and anticipates initiating a modular PMA application submission to the FDA in the second half of 2025. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Forward Looking Statements Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to: the therapeutic and commercial potential of INTERCEPT RBCs, including Cerus potentially making pathogen reduction available for RBCs; Cerus’ planned modular premarket approval (PMA) submission and the anticipated timing thereof, including Cerus’ plan to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular PMA submission; the anticipated completion of the RedeS clinical trial and the anticipated timing thereof; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain and time-consuming development and regulatory process, including the risks that (a) the topline results reported herein and related findings and conclusions are subject to change following a more comprehensive review of the data from the ReCePI clinical trial, (b) Cerus’ planned modular PMA submission for INTERCEPT RBCs may be delayed or may not occur for a variety reasons, including those outside of the control of Cerus, (c) Cerus may be unable to report data from its RedeS clinical trial in a timely manner or at all and that even if reported, such data may not be supportive of Cerus’ planned modular PMA submission for INTERCEPT RBCs, (d) even if submitted, Cerus’ planned modular PMA submission for INTERCEPT RBCs may not be accepted by the FDA for review in a timely manner or at all or if accepted for review, may not be approved by the FDA in a timely manner or at all, (e) Cerus’ expectation that, if Cerus’ planned modular PMA submission for INTERCEPT RBCs is approved, the FDA would require a post marketing study, (f) Cerus may be unable to obtain CE Mark approval of INTERCEPT RBCs in a timely manner or at all, and (g) Cerus may otherwise be unable to obtain the requisite regulatory approvals to advance its pipeline programs and bring them to market in a timely manner or at all; risks related to product safety, including the occurrence of antibody reactivity to INTERCEPT RBCs; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus’ supply chain could be negatively impacted as a result of the evolving impact of macroeconomic developments, including the ongoing military conflicts in Ukraine and Israel, rising interest rates, inflation and the evolving effects of the COVID-19 pandemic, (b) Cerus’ manufacturers could be unable to comply with extensive FDA and foreign regulatory agency requirements, and (c) Cerus may be unable to maintain its supply agreements with its third party suppliers; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction is safe, effective and economical; risks associated with Cerus’ need for additional funding; risks associated with macroeconomic developments, including ongoing military conflicts in Ukraine and Israel and the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus’ business operations; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC March 5, 2024. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Specialty pharmacy serves patients with chronic illnesses who require complex care CINCINNATI, March 18, 2024 /PRNewswire/ -- The Kroger Co. (NYSE: KR) announced that it has entered into a definitive agreement for the sale of its specialty pharmacy business to CarelonRx, a subsidiary of Elevance Health. "Kroger Specialty Pharmacy has been part of our company since 2012, and we want to thank our management team and associates for their enduring commitment to their patients," said Colleen Lindholz, President of Kroger Health. "As part of our regular review of assets, it became clear that our strong specialty pharmacy business unit will better meet its full potential outside of our business. One of the most important considerations was continued operations to ensure minimal disruption to our associates and patients. We are confident this transaction will help the business to grow and deliver better results for patients. We look forward to working toward a smooth transition for associates and patients." The retailer's specialty pharmacy serves patients with chronic illness that requires complex care. Skilled clinicians and superior therapy programs allow patients and prescribers to benefit from education and resources, counseling, side effect management, financial assistance, personalized care and administrative expertise. The specialty pharmacy business supports patients facing diseases including rheumatoid arthritis, growth hormone deficiencies, multiple sclerosis and bleeding disorders. Kroger Specialty Pharmacy is separate from other Kroger Family of Pharmacies, including in-store retail pharmacies and The Little Clinics, and therefore in-store retail pharmacies and The Little Clinics are not included in this transaction. This transaction is subject to customary closing conditions, including regulatory approvals and is expected to close in the second half of 2024; it is not expected to have an impact on Kroger's 2024 guidance. Advisors RBC Capital Markets, LLC is serving as financial advisor and Weil, Gotshal & Manges LLP and Arnold & Porter Kaye Scholer LLP are serving as legal advisors to Kroger. About Kroger At The Kroger Co., we are dedicated to our Purpose: To Feed the Human Spirit™. We are, across our family of companies nearly half a million associates who serve over 11 million customers daily through a seamless digital shopping experience and retail food stores under a variety of banner names, serving America through food inspiration and uplift, and creating #ZeroHungerZeroWaste communities by 2025. To learn more about us, visit our newsroom and investor relations site. Forward Looking Statements This press release contains certain statements that constitute "forward-looking statements" within the meaning of federal securities laws, including statements regarding the effects of the proposed transaction. These statements are based on the assumptions and beliefs of Kroger management in light of the information currently available to them. Such statements are indicated by words or phrases such as "accelerate," "anticipates," "create," "committed," "confident," "continue," "deliver," "driving," "expect," "future," "guidance," "positioned," "strategy," "target," "synergies," "trends," and "will." Various uncertainties and other factors could cause actual results to differ materially from those contained in the forward-looking statements. These include the specific risk factors identified in "Risk Factors" in Kroger's annual report on Form 10-K for the last fiscal year and any subsequent filings, as well as the following: the expected timing and likelihood of completion of the proposed transaction, including the timing, receipt and terms and conditions of any required governmental and regulatory clearance of the proposed transaction; the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement; the outcome of any legal proceedings that may be instituted against the parties and others following announcement of the transaction agreement and proposed transaction; the inability to consummate the proposed transaction plan due to the failure to satisfy other conditions to complete the proposed transaction; risks that the proposed transaction disrupts current plans and operations of Kroger; the ability to identify and recognize the anticipated benefits of the proposed transaction; the amount of the costs, fees, expenses and charges related to the proposed transaction; the ability of Kroger to maintain an investment grade credit rating; risks related to the potential impact of general economic, political and market factors on the companies or the proposed transaction. The ability of Kroger to achieve the goals for the proposed transaction may also be affected by its ability to manage the factors identified above. The forward-looking statements by Kroger included in this press release speak only as of the date the statements were made. Kroger does not assume the obligation to update the information contained herein unless required by applicable law. Please refer to the reports and filings of Kroger with the Securities and Exchange Commission for a further discussion of the risks and uncertainties that affect it and it business. SOURCE The Kroger Co.