Suicidal Ideation

Four potential near-term milestones, including data from two clinical trials, an NDA filing and a share dividend RADNOR, Pa., March 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announces its anticipated financial results for the quarter and year ended December 31, 2023 and provides the following summary of its expected annual report to be filed later today. Improvement in negative Earnings per Share to ($0.40) in FY 2023 vs ($0.60) in prior 12 month period. Management projects positive cash flow by year-end 2024 via partnerships and HOPE Therapeutics activities. Raised $9.2 in new capital during FY 2023 with $7.8 million of additions to working capital during Q1 2024. Reduced corporate indebtedness by more than 50% from $11.0 million to approximately $5.4 through Q1 2024. Signed a development partnership with Alvogen, Inc., and Lotus Pharmaceuticals, Inc. (1795.TW) under which the partners take over phase 3 and commercial costs for NRX-101 in bipolar depression and fund $330 million in commercial milestones together with a double digit royalty on sales, contingent on successful clinical trial data and FDA meeting. Completed enrollment and last patient visit of the Phase 2b/3 trial of NRX-101 in Suicidal Bipolar Depression with >94% rater concordance through conclusion of the trial, a measure that substantially exceeds current industry standards. Final Data Lock expected this week with Top line data expected in April 2024. Acceptance of two new Investigational New Drug applications (INDs) by the FDA in Chronic Pain and Complicated Urinary Tract Infection/Pyelonephritis. Final statistical analysis plan achieved this week in 200-person DOD-funded trial in treatment of chronic pain with D-cycloserine (DCS), the key component of NRX-101. The study center has indicated that data-lock will occur next week. Top-line data expected in April 2024. Positive data would support a final registration trial in this multi-billion dollar indication. Incorporated HOPE Therapeutics, Inc. as a specialty pharma company. HOPE is supporting distribution of intravenous ketamine, currently listed by FDA on nationwide drug shortage list to qualified ketamine clinics through nationwide 503a and 503b FDA-inspected pharmacy partners. First manufactured lot released for shipment this week by partner Nephron Pharmaceuticals. Obtained patient-level data from three efficacy studies of ketamine funded by US National Institutes of Health (two trials) and Government of France (one trial). Demonstration statistically significant reduction in severe depression and acute suicidality. US Patient Centered Outcomes Research Initiative (PCORI) trial published in 2023 documents non-inferiority of ketamine vs Electroconvulsive Therapy in treatment of Severe Depression with fewer negative side effects compared to ECT. Completed first commercially-manufactured lot of ketamine (NRX100/HTX-100) in proprietary diversion-resistant presentation and initiated manufacture of two additional commercial batches. Anticipates filing of New Drug Application for treatment of Acute Suicidality by June 2024 upon completion of required 9 month stability and CMC with anticipated 2024 PDUFA date. HOPE has received term sheets for more than $60 million in funding from new investors upon public listing and is expected to be spun out as a separate company to be owned by NRx, current NRx shareholders, and new investors upon completion of final audit and financial statements IND for NRX-101 in the treatment of Complicated Urinary Tract Infection (cUTI) is based on in vitro data just accepted for peer-reviewed publication in Antibiotics, an MDPI journal. On the basis of these findings, FDA granted Qualified Infectious Disease Product (QIDP),Fast Track and Priority Review designations NRx is seeking a clinical phase partner for this multi-hundred million dollar indication. Elected nationally recognized attorney in highly regulated industries, and healthcare specialist, Janet Rehnquist, Esq., to the Company's Board of Directors Management has taken action to restore Nasdaq listing compliance and combat illegal naked shorting of NRx securities Management to host a conference call April 1, 2024 at 8:30am (conference call to be conducted after Easter market holiday. "Over the past year the Company has navigated the most challenging business environment in the history of the biotechnology industry. Despite unprecedented headwinds, we negotiated a critical commercial partnership for our lead compound in bipolar depression, while retaining rights to the far larger indications of chronic pain and PTSD," said Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. "We augmented our intellectual property portfolio to include the use of our lead compound in chronic pain and anticipate results of a 200-person efficacy trial that could open a multibillion dollar opportunity in this therapeutic area. We have acquired sufficient data on safety and efficacy of ketamine to support a New Drug Application for ketamine in acute suicidality. We established the foundation of a specialty pharmaceutical business around ketamine that we expect to yield positive cash flow by the end of 2024. Finally, we received unanticipated data supporting the use of our lead compound to treat complicated Urinary Tract Infection and Pyelonephritis, a condition that affects 3 million Americans and results in more than 15,000 deaths annually. We believe that NRx is poised for substantial growth in 2024 look forward sharing further results in our upcoming filing and conference call." A final press release on the 10-k filing will be issued Monday April 1, following the market holiday. About NRx Pharmaceuticals NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. ( ) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, including statements about the planned dividend of shares of HOPE Therapeutics, the potential effects of the Company's reverse stock split, potential future stock splits, data from clinical trials that have not yet been released, and planned filings with the FDA. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: NASDAQ-NMS:NRXP

FOLX Health, an LGBTQIA+ digital health provider, is working with Crisis Text Line to provide 24/7 text-based mental health support to its members, the company announced Tuesday. Boston-based FOLX Health is a telehealth platform designed for the LGBTQIA+ community that works with insurers and employers. Its services include gender-affirming care, primary care, sexual and reproductive health, family building and mental health care. Crisis Text Line is a nonprofit that offers 24/7 text-based mental health support. Its services are in English and Spanish and are free and confidential. Since it launched in 2013, Crisis Text Line has had more than 9 million crisis conversations and has trained more than 65,000 volunteers. Through the partnership, FOLX members can gain access to crisis counselors through Crisis Text Line in addition to their support from the FOLX Health care team. These members can text FOLX to 741741, and will then be connected to a volunteer crisis counselor. In the future, this partnership may be expanded so that Crisis Text Line counselors can also refer people to FOLX if they need the company’s care, said John Moore, FOLX Health’s VP of engineering. The partnership was initiated by Moore, who is a volunteer counselor at Crisis Text Line. As a volunteer, he said he witnessed the unique challenges the LGBTQIA+ community faces. In fact, more than 50% of those who reach out to Crisis Text Line identify as LGBTQIA+. “It could be anything from they’re getting bullied at school because they’re transgender or gay … or they’re getting beat by their parents in some cases,” Moore said. “It’s across this giant spectrum and it happens every day all day. You’ll see it on just about any shift.” Moore added that there are several benefits to communicating via text. “I enjoy the texting aspect of it as opposed to a phone line,” Moore stated. “Because I think it gives the counselors a little more time to collect themselves before responding and having a meaningful response. Plus, texting these days is just such a popular medium for communication. And that makes everyone more comfortable in my opinion.” According to Mental Health America, more than 39% of people who identify as LGBTQ+ report having a mental illness. FOLX Health recently collected data on its members over a six-month period, which revealed that 59% of members who had previously experienced suicidal ideation before coming to FOLX no longer reported such thoughts during follow-up assessments, according to a news release. “At FOLX Health, we recognize the disproportionate challenges our members face, with mental health issues occurring at rates 4-5 times higher than the general population, and yet, we’ve found that our affirming and expert care focused on the needs of the queer community has led to transformative outcomes,” said Liana Douillet Guzmán, CEO of FOLX Health, in a statement. “In a healthcare landscape ill-equipped to meet our needs, FOLX is committed to forging a comprehensive healthcare haven accessible to all. Our partnership with Crisis Text Line ensures that no matter what the circumstance or where you are, our members have a direct line to trained, mental health counselors when they need it.” Another company that serves the LGBTQIA+ population is Included Health. It offers virtual and in-person urgent care, primary care, behavioral health and specialty care.

WOONSOCKET, R.I., March 27, 2024 /PRNewswire/ -- CVS Health® (NYSE: CVS) today announced more than $3 million in new grants to support organizations in Phoenix working to increase equitable access to health care, address social determinants of health and educate the community on the effects of air pollution. This announcement was made during a Project Health event in Phoenix and included CVS Health leaders, community organizations and local officials. "No two communities are the same," said Sheryl Burke, Senior Vice President of Corporate Social Responsibility and Chief Sustainability Officer at CVS Health. "That's why we are constantly looking for ways to pull together all our community-based and sustainability efforts – like here in Phoenix – to make a meaningful impact and collaborate with organizations who know the community best to address the unique barriers to improving health outcomes. With nearly 12,000 employees working across the state who deliver care through 187 pharmacies, dozens of MinuteClinic®, specialty pharmacy and Oak Street Health® locations, and for a million Aetna® members, this is also a part of our continued work to invest in the communities where we live and work." Bridging a critical gap in the health care and social systems With 65% of South Phoenix residents overweight or obese and knowing that 80% of health care costs are primarily due to preventable chronic diseases, CVS Health saw an opportunity to tailor its Health Zones initiative in Phoenix to address the high levels of diabetes and hypertension. The CVS Health Foundation is investing $2.1 million over three years between Valleywise Health, Home Assist Health and Advance to support integrated diabetes management services, including home health and monitoring, medically tailored food boxes and educational resources. By encouraging this more connected, coordinated use of resources between each Health Zone organization, the company aims to help simplify a complex care navigation process and bridge a critical gap in the health care and social systems. "We believe that the right resources can transform health outcomes for individuals, families, and communities, greatly reducing or eliminating generational health inequities for improved quality of life for patients in the Greater South Phoenix community," said Dr. Michelle Barker, Senior Vice President of Ambulatory Services and Chief Executive Officer of FQHC, Valleywise Health. "This visionary investment from CVS Health will allow our clinical teams and valued community partners, Home Assist Health and Advance, to wrap our arms around our most vulnerable patients and provide them with the care, education and resources they need to live healthy lives." Collaborating to educate the community about air pollution One in three Americans lives in a community with unhealthy air levels, and Phoenix ranks among the most polluted cities in the U.S. for ozone and particulate pollution. Through a new collaboration with the American Lung Association, CVS Health is investing $3.5 million over four years nationwide to combat this health issue and will pilot it first in Phoenix. The company will distribute nearly $1 million of the $3.5 million project to support Phoenix health care providers and organizations working to expand educational resources, increase access to care and supportive services for individuals with lung disease and leverage local air quality data to raise awareness of where pollution is most concentrated. The Phoenix health care providers and organizations will be named in April. "Every day, we work with people whose lung health has been impacted by climate change," said Harold Wimmer, President and CEO of the American Lung Association. "It is critical to address this in the communities that are seeing the greatest impact, like Phoenix, and we're thankful to be working with the CVS Health Foundation on this innovative project to improve the health of people in Phoenix who are living with lung disease." Increasing access to mental health and free screening services CVS Health also recently awarded a $100,000 grant over two years to support the Phoenix Indian Center's efforts to fund its Suicide-Safer Communities project, which will expand its suicide prevention services for Native Americans living in Phoenix. As studies continue to show that suicide is among the leading causes of death in the United States, bolstering the Phoenix Indian Center's efforts is part of the company's continued commitment to supporting organizations that improve the quality and availability of mental health services in under-resourced communities. In addition to these new grants, CVS Health will offer free health screenings to the Phoenix community through its Project Health program, starting in March. Project Health mobile unit events are hosted at CVS Pharmacy parking lots and a vast network of local organizations to help ensure transportation is not a barrier to receiving health services. They offer free biometric screenings, including blood pressure, cholesterol, glucose level and body mass index to detect early risks of chronic conditions such as diabetes, hypertension and heart disease. The screenings also offer a PHQ-2 assessment to help identify people who require additional evaluation for depression. All individuals have an on-site consult with a nurse practitioner and are provided a directory of local health care providers and resources. In 2023, CVS Health hosted 109 events in Phoenix and screened 2,814 participants, including 1,022 depression, 715 osteoporosis bone density, 581 mini-cognitive and 126 smoking cessation consultations. The full schedule of Project Health events can be found online. "A person's zip code shouldn't determine how long they'll live or whether they'll develop preventable chronic diseases," said Phoenix Councilwoman Laura Pastor. "That's why I'm proud of the over $3 million investment CVS Health is making over the next three years to support diabetes management services and increase access to care and education for individuals with lung diseases throughout Phoenix. As someone who has always advocated for equitable access to health care, I am impressed by the commitment CVS Health continues to show the community by removing barriers and meeting people where they're at to deliver health care." About CVS Health CVS Health® is the leading health solutions company, delivering care like no one else can. We reach more people and improve the health of communities across America through our local presence, digital channels and over 300,000 dedicated colleagues — including more than 40,000 physicians, pharmacists, nurses and nurse practitioners. Wherever and whenever people need us, we help them with their health — whether that's managing chronic diseases, staying compliant with their medications or accessing affordable health and wellness services in the most convenient ways. We help people navigate the health care system — and their personal health care — by improving access, lowering costs and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day. Follow @CVSHealth on social media. Media contacts Courtney Tavener 401-712-3698 [email protected] Monica Prinzing 831-241-8294 [email protected] SOURCE CVS Health