Trooperstocks
8 hours ago
$NRXP News: "Here's Why NRx Pharmaceuticals (NRXP) Is a Great 'Buy the Bottom' Stock Now"
Zacks Equity Research
Thu, March 27, 2025
Shares of NRx Pharmaceuticals, Inc. (NRXP) have been struggling lately and have lost 5.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.
The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case for the stock. On the fundamental side, strong agreement among Wall Street analysts in raising earnings estimates for this company enhances its prospects of a trend reversal.
1-month candlestick chart for NRXP
Understanding Hammer Chart and the Technique to Trade It
This is one of the popular price patterns in candlestick charting. A minor difference between the opening and closing prices forms a small candle body, and a higher difference between the low of the day and the open or close forms a long lower wick (or vertical line). The length of the lower wick being at least twice the length of the real body, the candle resembles a 'hammer.'
In simple terms, during a downtrend, with bears having absolute control, a stock usually opens lower compared to the previous day's close, and again closes lower. On the day the hammer pattern is formed, maintaining the downtrend, the stock makes a new low. However, after eventually finding support at the low of the day, some amount of buying interest emerges, pushing the stock up to close the session near or slightly above its opening price.
When it occurs at the bottom of a downtrend, this pattern signals that the bears might have lost control over the price. And, the success of bulls in stopping the price from falling further indicates a potential trend reversal.
Hammer candles can occur on any timeframe -- such as one-minute, daily, weekly -- and are utilized by both short-term as well as long-term investors.
Like every technical indicator, the hammer chart pattern has its limitations. Particularly, as the strength of a hammer depends on its placement on the chart, it should always be used in conjunction with other bullish indicators.
Here's What Increases the Odds of a Turnaround for NRXP
An upward trend in earnings estimate revisions that NRXP has been witnessing lately can certainly be considered a bullish indicator on the fundamental side. That's because empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements.
Over the last 30 days, the consensus EPS estimate for the current year has increased 25%. What it means is that the sell-side analysts covering NRXP are majorly in agreement that the company will report better earnings than they predicted earlier.
If this is not enough, you should note that NRXP currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than the 4,000 stocks that we rank based on trends in earnings estimate revisions and EPS surprises. And stocks carrying a Zacks Rank #1 or 2 usually outperform the market. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
Moreover, a Zacks Rank of 2 for NRx Pharmaceuticals is a more conclusive indication of a potential trend reversal, as the Zacks Rank has proven to be an excellent timing indicator that helps investors identify precisely when a company's prospects are beginning to improve.
Article buy Zacks Investment Research- https://finance.yahoo.com/news/heres-why-nrx-pharmaceuticals-nrxp-135503641.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
Trooperstocks
4 days ago
$NRXP -HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Signing of Binding Letter of Intent with Neurospa TMS Holdings, LLC for Expansion of its Planned International Network of Interventional Psychiatry Clinics
PR Newswire
Mon, March 24, 2025 at 8:02 AM EDT
In This Article:
NRXP
NRXPW
Neurospa currently operates six interventional psychiatry clinics on Florida's Gulf Coast
HOPE to acquire majority interest in Neurospa for a combination of cash and equity
Neurospa clinics deliver a full range of interventional psychiatry services, including Ketamine, Spravato® and Transcranial Magnetic Stimulation (TMS) to patients with severe depression and related conditions
Acquisition to be accretive to HOPE revenue projections for 2025
MIAMI, March 24, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq:NRXP), today announced signing of a binding Letter of Intent to acquire a majority interest in Neurospa TMS Holdings, LLC, LLC (Neurospa). Neurospa operates six interventional psychiatry clinics on Florida's Gulf Coast and will constitute a key element of HOPE's Florida network going forward. Neurospa is revenue generating and EBITDA positive.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
Neurospa leverages state-of-the-art interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), and Spravato®, augmented by traditional psychiatry and talk therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders. TMS is an FDA-approved procedure in which focused electromagnetic treatment has been demonstrated to reduce symptoms of depression. Ketamine and Spravato® are similarly known to reduce symptoms of depression and both forms of treatment are increasingly used in an additive manner.
Neurospa provides a physician-led, welcoming spa-like environment that puts patient's needs and comfort first. Neurospa's outstanding team of dedicated professionals are to become key members of the HOPE team upon closing of the transaction.
"Neurospa was founded with the mission to provide TMS therapy for patients in the Tampa Bay area, and has grown to provide comprehensive, cutting-edge care to patients in our six clinics in west central Florida; the team has made great progress achieving this exceptional level of care. We're eager to accelerate that mission by joining the HOPE Network," said Renier Gobea, Founder of Neurospa.
"We are thrilled to welcome the Neurospa team to the HOPE network and look forward to the contribution they will continue to make to their patients and to the expansion of the HOPE network statewide," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics.
The intended acquisition of Neurospa is subject to the completion of financial audits, execution of definitive agreements, and the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company currently developing a best-in-class network of interventional psychiatry clinics to offer psychedelic medications, including ketamine and Spravato®, combined with Transcranial Magnetic Stimulation (TMS) and other lifesaving, neuroplastic therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia.
NRx recently announced initiation of filing a New Drug Application for NRX-100 (IV ketamine) for 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 data sharing agreements. 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
Trooperstocks
1 week ago
$NRXP -NRX Pharmaceuticals Inc (NRXP) Q4 2024 Earnings Call Highlights: Strategic Moves and Financial Highlights
GuruFocus News
Tue, March 18, 2025 at 3:01 AM EDT
In This Article:
NRXP
+2.91%
NRXPW
+49.38%
Loss from Operations: Reduced by approximately $9.3 million, or 33.5%, to $18.5 million for the year ended December 31, 2024.
Research and Development Expense: Decreased by approximately $7.2 million, or 53.6%, to $6.2 million for the year ended December 31, 2024.
General Administrative Expense: Decreased by approximately $7.7 million to $13.5 million for the year ended December 31, 2024.
Cash and Cash Equivalents: Approximately $1.4 million as of December 31, 2024.
Recent Financing: Completed two financings in January 2025 with aggregate gross proceeds of approximately $8.5 million.
Warning! GuruFocus has detected 2 Warning Signs with NRXP.
Release Date: March 17, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
NRX Pharmaceuticals Inc (NASDAQ:NRXP) has raised new capital and retired toxic debt, positioning itself for potential profitability by the end of 2025.
The company has initiated the filing of a New Drug Application (NDA) for NRX-100, a preservative-free intravenous ketamine, supported by stability data and manufacturing capacity for over 1 million doses per month.
NRX Pharmaceuticals Inc (NASDAQ:NRXP) has received a strategic term sheet for NRX-100, valued at over $300 million in milestones and double-digit royalties, validating their drug development approach.
The company is preparing an accelerated NDA filing for NRX-101, a combination of D-cycloserine and lurasidone, with a potential market exceeding $5 billion.
HOPE Therapeutics, a subsidiary of NRX Pharmaceuticals Inc (NASDAQ:NRXP), is expanding its network of interventional psychiatry clinics, with plans to acquire profitable clinics and generate substantial revenue growth.
Negative Points
NRX Pharmaceuticals Inc (NASDAQ:NRXP) faces challenges in the capital market environment, which has been less supportive of pre-revenue biotechnology companies.
The safety of repeated ketamine use is a concern, with potential toxicity from the preservative benzethonium chloride, leading to a citizen's petition to the FDA.
The company has only $1.4 million in cash and cash equivalents as of December 31, 2024, raising concerns about its financial stability.
The acquisition of clinics involves complex legal and regulatory processes, which could delay the expansion of HOPE Therapeutics.
NRX Pharmaceuticals Inc (NASDAQ:NRXP) is reliant on securing commercial partnerships and financing to support its growth and drug development initiatives.
Q & A Highlights
Q: Jonathan, you made a good argument for removing the preservative from ketamine. If you remove the preservative for ketamine, how does that change the formulation? And for example, what do you do in its place? A: The preservative was originally added to ketamine for multi-use vials to prevent contamination. However, with single-use vials, a preservative is not needed. We've found that preservative-free ketamine can maintain stability and sterility, allowing us to file for two-year shelf stability at room temperature.
Q: Can you talk a little bit about the acquisition strategy to add more clinics this year and what we should expect a year from now? A: Florida is a focus due to clinics already doing it right. Many clinics offer ketamine alongside other treatments, but few integrate it with neuromodulatory technology like TMS. We're working with BTIG to identify and acquire clinics that meet our standards, aiming to build a nationwide network.
Q: In the press release, you talk about a potential ketamine deal with $300 million in milestones and tiered royalties. Can you expand on that? A: As we approach having a marketable drug, commercial partners are showing interest. While a deal is never done until it's done, having a partner with an existing sales force could be more attractive than launching the drug ourselves.
Q: Regarding the ketamine clinic landscape in Florida, is it chunky? Should we look for acquisitions to happen in big chunks? A: Yes, acquisitions will generally represent more than one clinic at a time. While Kadima is a single-site facility, most clinics doing it well operate multiple locations, which will be part of our acquisition strategy.
Q: Regarding the terms with the commercial pharmaceutical company for NRX-100, do you anticipate a second-quarter announcement for the finalization of the deal? A: We hope it may be finalized in the second quarter, but a deal is never done until it's done. We have the resources to continue moving forward without a commercial deal, but we welcome the right partner.
Q: How easy would it be for a competitor to make their own single-use presentations of ketamine for intravenous use? A: Competitors would face challenges, including developing a preservative-free formulation with stability. While we may not have the market to ourselves long-term, our formulation could provide a competitive advantage if it stands up to patent review.
Q: As you may potentially have NRX-100 and NRX-101 approval this year with the FDA, have you thought about international plans for both? A: We've developed relationships in France, where there's a significant focus on suicidal depression. A European filing could resonate throughout Europe, and we expect increased interest from Asia-Pacific entities as we gain momentum.
Q: How does HOPE directly benefit NRx shareholders? A: HOPE is an asset on the NRx balance sheet, and its profits will benefit NRx shareholders. We plan to spin out HOPE shares to NRx stockholders, ensuring any success of HOPE benefits NRx investors.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
Trooperstocks
2 weeks ago
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
PR Newswire
Mon, March 17, 2025 at 8:02 AM EDT
In This Article:
NRXP
+13.53%
NRXPW
+18.83%
Initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025
The Company has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales
Retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride – a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications
HOPE Therapeutics, a wholly owned subsidiary of NRx, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers
The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions
Received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions.
Engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities
Regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement
Substantially reduced operating costs compared to prior year
Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025
WILMINGTON, Del., March 17, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year ended December 31, 2024, and provided a business update.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
"Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx. We also moved NRX-101 toward it's NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE's best-in-class network of Interventional Psychiatry Clinics. Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress. These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country," said Jonathan Javitt, MD, MPH, Chairman, and CEO of NRx Pharmaceuticals. "I would like to thank our team for its dedication and hard work, and thank our shareholders for their ongoing support of our mission to bring hope to life."
Key Research and Development and Corporate Activities
NRX-100 (IV, preservative-free ketamine)
According to the CDC, more than 13 million adults contemplate suicide each year; NRX-100 – IV ketamine for Suicidal Depression - can help address this national crisis.
The Company filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025.
NRX-100 is poised to address the >$3 billion Suicidal Depression market in the US.
The Company has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement.
In December 2024 the company demonstrated long term stability and sterility of a patentable formulation of preservative-free ketamine, despite longstanding commercial practice of adding benzethonium chloride as a preservative to commercially supplied ketamine. This preservative is a known caustic and toxic substance that has previously demonstrated corneal neurotoxicity and conjunctival toxicity in patients, and generalized neurotoxicity in the laboratory at microgram concentrations. The concentration in current ketamine preparations is substantially higher, with an extensive body of scientific literature documenting concern. Additionally, chronic administration of ketamine is known to increase the risk of cystitis ( Ref ); the relationship of this adverse event to benzethonium chloride is unknown. Now that a long-term stable and sterile preservative-free formulation is available, the Company is filing a citizens petition to seek removal of benzethonium chloride from the human and veterinary ketamine drug supply.
The Company believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients and is consistent with evolving federal policy on toxic preservatives in the US food and drug supply chain. Therefore, in addition to the NDA designed to add treatment of depression to the current ketamine label, the Company plans to file an Abbreviated New Drug Application ("ANDA") in the second quarter of 2025 for the use of preservative-free ketamine in all currently indicated human and veterinary applications. The Company believes it has met all requirements of the ANDA approval process, has demonstrated manufacturing capacity in excess of one million vials per month, and is prepared to supply the broad ketamine market.
As a next-generation product, the Company has developed a novel, patentable pH neutral formulation of ketamine (designed as HTX-100) based on a proprietary excipient that overcomes ketamine's insolubility, that will be suitable for both intravenous and subcutaneous administration. Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed. Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause pain and skin ulcers. This product is expected to undergo clinical testing in 2025/2026 and be ready for FDA approval in late 2026. Oral forms of ketamine and intranasal racemic ketamine have failed to demonstrate sufficiently stable blood levels to replace intravenous ketamine. However, a ketamine formulation capable of achieving clinical benefit via subcutaneous use – in the manner that diabetes drugs are currently administered – could facilitate far broader clinical use of ketamine to treat life-threatening CNS diseases.
The Company has retained a leading regulatory law firm to file the citizen's petition with the US Food and Drug Administration to remove benzethonium chloride, a known neurotoxic substance, from presentations of ketamine intended for intravenous use. The Company believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of benzethonium chloride in current generic products.
NRX-101 (oral D-cycloserine/lurasidone)
Bipolar depression affects approximately seven million people in the US. Current treatment options all carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently.
The Company announced its intention to file an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now complete with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to December 31, 2025.
The Company estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion.
HOPE Therapeutics
HOPE Therapeutics, a wholly owned subsidiary of NRx Pharmaceuticals, is developing a new clinical paradigm for the treatment of depression, PTSD, obsessive-compulsive disorder, and related CNS conditions. While there is clinical evidence that NMDA-targeted drugs such as NRX-100 and NRX-101 have the potential to offer clinical benefit, many patients additionally require neuromodulatory techniques, such as Transcranial Magnetic Stimulation ("TMS"), digital therapeutics, traditional psychotherapy and medication management to achieve long-term remission from suicidal depression and PTSD. Despite the proliferation of "ketamine clinics" in the US, few psychiatrist-led entities are successful in offering a comprehensive solution to patients and families.
During the second half of 2024, the Company began outlining the plan for HOPE Therapeutics as a national and ultimately international network of Interventional Psychiatry centers that will combine NMDA-targeted and future psychedelic drugs with neuroplastic treatments in an integrated and reproducible manner. The business model for HOPE Therapeutics is similar to that of leading national dialysis providers, companies that were instrumental in making kidney dialysis reliable and reproducible in a manner that transformed the industry and routinely trade at double digit P/E multiples.
In 2024, the Company announced a non-binding Letter of Intent to acquire Kadima, LLC, a pioneering interventional psychiatry clinic in La Jolla, CA. Kadima's founder, Dr. David Feifel agreed to serve as HOPE's Chief Medical Innovation Officer post-acquisition. He is one of the first academic psychiatrists to move ketamine and TMS therapy to the community care model and was recently featured on Dr. Sanjay Gupta's broadcast entitled "The Wild West of Ketamine Treatment" as an advocate for how ketamine therapy can be delivered reliably and responsibly. Link: Wild West of Ketamine.
Subsequent to the Kadima commitment, the Company has, or anticipates, contracting to acquire and/or partner with eight facilities in Florida, aiming for 15-20 facilities in Florida by year-end 2025.
The clinical centers that are being incorporated in the 2025 acquisition program are currently operating and profitable centers that the Company believes can experience substantial revenue growth through the addition of a broader array of comprehensive services. Management estimates that the acquisition of 20 clinic networks, each with current revenue of approximately $5 million will be required to meet its 2025 growth target.
Financings
The Company has consummated a series of financing agreements with an institutional investor for up to $16.3 million in debt capital, for which we closed on $10.9 million in 2024 and subsequently closed $8.5 million in a combination of convertible debt and an above-market common stock and warrant offering in January 2025. Subsequently, we terminated a planned $2 million investment from a smaller fund with less favorable terms.
The Company has also received and is currently negotiating a term sheet with a publicly-traded entity engaged in the manufacture of FDA-cleared devices for Transcranial Magnetic Stimulation to provide acquisition capital to support the expansion of HOPE Therapeutics clinics. In addition, it is negotiating with several commercial lenders to support expansion of HOPE clinics with standard commercial loans. Although business plans are subject to change, assuming consummation of the financings on terms currently contemplated by management, the Company would achieve its objective of financing less than 50% of the proposed acquisition costs, thereby enabling the Company to optimize its cost of acquisition capital as it expands the HOPE clinic network.
Our current financing activities are intended to supplant the previously announced equity investment in HOPE on more favorable terms.
Financial Results for the Quarter and Year Ended December 31, 2024
For the three months ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $2.0 million to $2.4 million from $4.4 million in the fourth quarter of 2023, representing nearly a 45% improvement quarter over quarter primarily driven by lower research and development costs and a settlement gain, which were partially offset by an increase in general and administrative expense. For the three months ended December 31, 2024, research and development expense decreased by approximately $1.5 million to $1.0 million as compared to $2.5 million during the fourth quarter ended December 31, 2023. The $1.5 million decrease is primarily related to a decrease in clinical trial and development expense due to the conclusion of the phase 2b/3 study for NRX-101. Finally, general and administrative expense for the three month period ended December 31, 2024 increased by approximately $0.7 million to $2.6 million as compared to approximately $1.9 million for the three month period ended December 31, 2023, which was primarily driven by higher consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics.
For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million from $27.8 million for the year ended December 31, 2023, which was primarily driven by a decrease in research and development expense. For the year ended December 31, 2024, research and development expense decreased by approximately $7.2 million, or 53.6%, to $6.2 million as compared to $13.4 million for the year ended December 31, 2023 primarily driven by a decrease in clinical trial and development expense due to the conclusion of the phase 2b/3 study for NRX-101. Finally, general and administrative expense for the year ended December 31, 2024 decreased by approximately $0.7 million to $13.5 million as compared to $14.2 million for the year ended December 31, 2023 primarily driven by a reduction in insurance and employee costs, and partially offset by an increase in consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics.
As of December 31, 2024, we had approximately $1.4 million in cash and cash equivalents. As noted above, in January 2025, the Company completed two financings with aggregate gross proceeds of approximately $8.5 million. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025.
NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.
Please see detailed financials on our Form 10-K, filed with the SEC and available on our website.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the Company's website at 8:30 a.m. ET Monday March 17, 2025, at https://ir.nrxpharma.com/events. An archive of the webcast will be available on the Company's website for 30 days. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally 1-646-307-1865.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiated a New Drug Application filing for NRX-100 (IV ketamine) for 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. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, 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. 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, including risks arising from uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
Trooperstocks
2 weeks ago
NEWS: $NRXP NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) to Report Fourth Quarter and Full Year 2024 Financial Results and Provide a Corporate Update on March 17, 2025
PR Newswire
Wed, March 12, 2025 at 8:01 AM EDT
In This Article:
NRXP, NRXPW
Conference call to take place at 8:30am ET -
WILMINGTON, Del., March 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its fourth quarter and full year 2024 financial results before the market opens on Monday, March 17, 2025 via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provide a corporate update at 8:30am ET the same day.
A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiated a New Drug Application filing for NRX-100 (IV ketamine) for 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. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, 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. 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, including risks arising from uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaq-nrxp-to-report-fourth-quarter-and-full-year-2024-financial-results-and-provide-a-corporate-update-on-march-17-2025-302399503.html
SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
2 months ago
NEWS: $NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics™, Inc. to Present at the Oppenheimer 35th Annual Healthcare Conference on February 12, 2025
PR Newswire
Thu, February 6, 2025 at 8:03 AM EST
In This Article:
NRXP, NRXPW
• Management will also participate in the 2025 BIO CEO & Investor Conference and be available for one-on-one meetings in New York February 10th-12th
WILMINGTON, Del., Feb. 6, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", or the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., ("HOPE"), a medical and technology driven company and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. announced today that Jonathan Javitt, MD, MPH, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals will be presenting a Company update at the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference, taking place virtually on February 11th-12th.
The presentation is scheduled for Wednesday, February 12th, from 9:20 – 9:50 AM EST. A live webcast will be accessible on NRX Events, within the Investor Relations section of the Company's website. A replay of the webcast will also be available for 30 days following the event.
Management will also be available for one-on-one meetings in New York from February 10th-12th. To schedule meetings in New York or at the BIO CEO & Investor Conference, please contact sebastian.gomez@astrpartners.com.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiated a New Drug Application filing for NRX-100 (IV ketamine) for 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. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, 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. 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, including risks arising from uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-and-hope-therapeutics-inc-to-present-at-the-oppenheimer-35th-annual-healthcare-conference-on-february-12-2025-302369970.html
SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
2 months ago
$NRXP NEWS: HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Engage BTIG as Financial Advisor
PR Newswire
Mon, February 3, 2025 at 8:59 AM EST
In This Article:
NRXP +1.00%
NRXPW +18.60%
HOPE has announced plans to assemble a best-in-class global network of interventional psychiatry clinics combining ketamine treatment with transcranial magnetic stimulation, and digital therapeutics to treat severe depression and PTSD
BTIG is a leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services
Advisory to include identification and evaluation of clinic partners and strategic assets and investment banking services in connection with financing initiatives to accelerate the Company's business plan
MIAMI, Feb. 3, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx", and collectively with HOPE, the "Company") (Nasdaq:NRXP), today announced engagement of BTIG, a leading global financial services firm specializing in investment banking, institutional trading, research and related brokerage services. The scope of the engagement includes advisory and assistance in evaluating strategic and financing options available to the Company and identification, evaluation and negotiation of potential acquisition targets for the HOPE network of clinics, as well as equity and debt financing structures.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
The Company has recently announced execution of an agreement for $27 million in funding for HOPE Clinic Acquisition. Upon closing of the first tranche of the anticipated financing, the Company currently intends to leverage the investment with proposed bank debt and similar instruments to fund its initial rollup of Interventional Psychiatry Clinics. The Company has now engaged BTIG to advise the Company on clinical partners to acquire and to facilitate acquisition capital financing.
"We are excited to partner with NRx and HOPE to accelerate the Company's business strategy of assembling a global network of Interventional Psychiatry Clinics," said Robert Dentice, Managing Director Investment Banking, BTIG. "Addressing the mental health crisis in this country and abroad is a vital need which we are honored to help address."
"We are pleased to engage with BTIG to build our HOPE network and work to establish HOPE as a leading provider of world-class care for patients suffering from suicidal depression, PTSD and related conditions," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "BTIG is exceptionally well positioned to propel HOPE to achieve our goals, and we look forward to working with the firm to execute on our plan."
The information in this press release is for informational purposes only and is neither an offer to purchase, nor a solicitation of an offer to sell, subscribe for or buy any securities in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
About BTIG
BTIG is a global financial services firm specializing in investment banking, institutional trading, research and related brokerage services. With an extensive global footprint and more than 700 employees, BTIG, LLC and its affiliates operate out of 20 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities. The firm's core capabilities include global execution, portfolio, electronic and outsource trading, investment banking, prime brokerage, capital introduction, corporate access, research and strategy, commission management and more.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiated a New Drug Application filing for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding the consummation of the $27 million in financing necessary to consummate the acquisitions of Hope's clinics, entering into binding documentation necessary to consummate the acquisitions, and the Company's ability to raise equity or debt financing. 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, including the risk that the transactions contemplated by the LOI are not consummated, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-engage-btig-as-financial-advisor-302366415.html
SOURCE NRx Pharmaceuticals, Inc.
ProfitScout
2 months ago
$NRXP News: HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Execute Agreement for $27 Million Funding Transaction for HOPE Clinic Acquisition
$25 million investment in HOPE to consist of Series A (non-dilutive to NRx shareholders) convertible into 1/3 of fully diluted HOPE equity, with a 15% current preferred dividend (non-callable for 2 years) for planned HOPE clinic acquisitions
Initial funding of $2.0 million for purchase of NRx common stock anticipated to close on or before January 29, with the first tranche of $6.75 million of $25.0 million investment to be invested in HOPE Therapeutics, Inc. on or before February 7, 2025, and the balance of $18.25 million by April 1, 2025
Funds will be used in conjunction with anticipated bank financing to initiate nationwide rollup strategy of interventional psychiatry clinics, starting with Kadima Neuropsychiatry (La Jolla, CA)
HOPE intends to initiate nationwide acquisition program in partnership with leading investment bank on or around February 1, 2025.
MIAMI, Jan. 28, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx", and collectively with HOPE, the "Company") (Nasdaq:NRXP), today announced the signing and of a Stock Purchase Agreement ("SPA") with Smith & Sauer, LLC, as the first step in a $27.0 million financing to fund the planned acquisition of HOPE clinics. The agreement signed today provides for the immediate funding of $2.0 million in NRx common stock and commits Smith and Sauer to purchase an additional $25 million in newly issued Series A Preferred Stock of HOPE, the proceeds of which are intended to be used to initiate a nationwide rollup of Interventional Psychiatry Clinics to treat patients with severe, suicidal depression and PTSD. The first $6.75 million tranche is committed by February 7, 2025, with the full $25 million committed on or before April 1, 2025.
The Company anticipates leveraging the Smith and Sauer investment with bank debt and similar instruments to fund an initial rollup of Interventional Psychiatry Clinics with anticipated revenues of approximately $100 million on a pro-forma basis by the end of 2025. Unlike "ketamine clinics" that are frequently operated by non-mental health professionals, HOPE anticipates building a best-in-class nationwide chain of facilities that combine treatment with ketamine and other psychedelic medications with Transcranial Magnetic Stimulation (TMS) and recently FDA-approved Digital Therapeutics to best serve patients with life-threatening depression, PTSD, and related disorders.
"Today's transaction caps several months of intensive work as we have identified best-in-class interventional psychiatry clinics and assembled the capital from both Anson Funds and Smith and Sauer to consummate the initial acquisitions. The resources committed today are anticipated to bring the Company to the $100 million revenue threshold. We have initiated a financial advisory relationship with a leading investment bank to assemble the next $400 million of capital required to build a national and international presence," said Jonathan Javitt, MD MPH Chairman of NRx Pharmaceuticals. "Psychedelic Medications such as ketamine, neuromodulation technologies such as TMS, and digital therapeutics have sparked a revolution in psychiatry where for the first time patients with life threatening conditions such as depression and PTSD hope for a brighter future. As we develop HOPE Therapeutics, we aim to bring that future to the 16 million Americans who consider ending their lives each year and the 45 million Americans who suffer from depression and PTSD."
"We are honored to partner with NRx and HOPE to tackle the pressing mental health challenges facing our nation, particularly within the military and veteran communities," said Dallas Sauer, Co-Founder of Smith & Sauer.
"This partnership underscores the critical importance of addressing mental health with innovative and accessible solutions," said Anita Nunes, Co-Founder of Smith & Sauer. "We are proud to support HOPE and NRx in their mission to bring transformative care to underserved communities, including our veterans and military families."
Readers are advised to consult the Current Report on Form 8-K that NRx intends to file with the Securities and Exchange Commission on or before January 31, 2025 for a complete description of the Stock Purchase Agreement Although no assurances can be given, closing of the additional $25 million investment in HOPE's Series A Preferred Stock remains subject to execution of definitive agreements and the satisfaction of standard closing conditions.
The information in this press release is for informational purposes only and is neither an offer to purchase, nor a solicitation of an offer to sell, subscribe for or buy any securities in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
About Smith & Sauer
Founded by Dallas Sauer and Anita Nunes, Smith & Sauer, LLC is a private investment firm specializing in strategic partnerships and capital investments across healthcare, technology, and emerging industries. With decades of experience in operational leadership, financial structuring, and technological innovation, Smith & Sauer is committed to fostering growth in mission-driven organizations. The firm's investment philosophy centers on long-term value creation, aligning financial performance with societal impact. By leveraging its expertise in health information technology and clinic integration, Smith & Sauer plays a pivotal role in advancing cutting-edge solutions to address critical healthcare challenges.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiated a New Drug Application filing for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima and Dura, and obtaining financing necessary to consummate the acquisitions. 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, including the risk that the transactions contemplated by the LOI are not consummated, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
https://c212.net/c/img/favicon.png?sn=CL05942&sd=2025-01-28 View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-execute-agreement-for-27-million-funding-transaction-for-hope-clinic-acquisition-302361736.html
SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
2 months ago
NEWS: HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Alert Investors to Sanjay Gupta/CNN Program on Ketamine, Featuring Kadima Neuropsychiatry Institute Founder Dr. David Feifel
PR Newswire
Tue, January 14, 2025 at 8:03 AM EST
In This Article:
NRXP, NRXPW
"'Special K': The Science & Stigma of Ketamine" on CNN, hosted by Dr. Sanjay Gupta
David Feifel MD PHD, Founder of Kadima, is a global thought leader in the interventional psychiatry field
Kadima Neuropsychiatry Institute identified as planned HOPE Flagship Clinic pending acquisition closing
Dr. Feifel is expected to join HOPE as Chief Medical Innovation Officer
MIAMI, Jan. 14, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc., ("HOPE"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx", and collectively with HOPE, the "Company") (Nasdaq:NRXP), today alerted investors that Kadima Neuropsychiatry Institute's Founder David Feifel, MD PHD was featured as an expert in a program on ketamine entitled "'Special K': The Science & Stigma of Ketamine" on CNN, hosted by Dr. Sanjay Gupta. HOPE previously announced that Kadima is identified as the Company's planned flagship clinic acquisition, upon closing of the transaction.
Dr. Feifel, a global leader in interventional psychiatry, has accepted a future role as Chief Medical Innovation Officer in conjunction with the previously announced planned acquisition of Kadima by HOPE. The acquisition is subject to completion of financial audits and standard closing conditions.
In his comments, Dr. Feifel supported use the of ketamine in appropriate patients but emphasized the need for appropriate psychiatric supervision in a controlled setting - a view that HOPE wholeheartedly shares. This appearance with Dr. Gupta follows his appearance on another of Dr. Gupta's programs, "The Wild West of Ketamine Treatment" in August of last year.
"The recent, tragic death of Mathew Perry underscores the need for people with depression to have access to psychiatric centers of excellence where they can receive ketamine and other advanced treatments at the highest standard of medical care," said David Feifel. "I plan to bring this same vision for use of ketamine and other interventional psychiatry treatment methods that made my clinic, Kadima, an industry gold-standard, to the HOPE network, upon joining the Company."
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetic stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiation of filing a New Drug Application for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding closing the acquisition of Kadima and obtaining financing necessary to consummate the acquisition. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund the Hope Therapeutics acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-alert-investors-to-sanjay-guptacnn-program-on-ketamine-featuring-kadima-neuropsychiatry-institute-founder-dr-david-feifel-302350245.html
SOURCE NRx Pharmaceuticals, Inc.
ProfitScout
2 months ago
$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces it has Filed an Application with NASDAQ to Uplist to the NASDAQ Global Market from the NASDAQ Capital Market
Management believes uplisting has the potential to provide shareholders with improved liquidity
Requires NRx Pharmaceuticals to meet certain listing requirements
Company has advised NASDAQ that current shares outstanding is 15.7 million
WILMINGTON, Del., Jan. 13, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) ("NRx", the "Company"), a clinical-stage biopharmaceutical company, today announced it has applied to NASDAQ to uplist the Company's securities to the NASDAQ Global Market (NASDAQ GM).
Listing on the NASDAQ Global Market requires the Company to meet published requirements to successfully list on the NASDAQ Global Market, including maintaining a market value of listed securities (MVLS) above $75 million and a minimum bid price of at least $4.00 for 90 consecutive trading days. The Company has advised NASDAQ that it currently has 15.7 million outstanding shares of common stock, which will inform the calculation of the Company's market capitalization.
"We have applied for this uplisting to the NASDAQ Global Market, which is subject to meeting published listing requirements, with the goals of enhancing liquidity for NRx shareholders and meeting the investment requirements of institutional funds that require listing on the Global Market," said Dr. Jonathan Javitt, Founder, Chairman and CEO. "Our aim remains to address suicidal depression and PTSD in the US and elsewhere, and to bring hope to life."
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiation of filing a New Drug Application for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding closing the acquisition of Kadima and obtaining financing necessary to consummate the acquisition. 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, liquidity, and the Company's ability to meet the listing standards of the NASDAQ Global Market, including maintaining a minimum bid price of at least $4.00 per share for at least 90 consecutive days. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
https://c212.net/c/img/favicon.png?sn=CL94467&sd=2025-01-13 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-it-has-filed-an-application-with-nasdaq-to-uplist-to-the-nasdaq-global-market-from-the-nasdaq-capital-market-302349056.html
SOURCE NRx Pharmaceuticals, Inc.
ProfitScout
3 months ago
$NRXP News: HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Conduct Investor Workshop at the Mar-A-Lago Club
MIAMI, Jan. 10, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc., ("HOPE"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx", and collectively with HOPE, the "Company") (Nasdaq:NRXP), today announced it conducted an investor workshop to support planned expansion of HOPE's network of interventional psychiatry practices focused on the treatment of suicidal depression and PTSD, at the Mar-A-Lago Club in Palm Beach, FL.
The event was attended by Qualified Institutional Buyers as defined by the Securities and Exchange Commission and included Jonathan Javitt, MD, MPH, Chairman and CEO of NRx together with Dallas Sauer, Founder of Smith and Sauer, the private investment firm that recently committed to invest in both NRx and HOPE. No formal meetings were conducted with members of the incoming administration.
Key areas of investor discussions included:
HOPE's mission to build an international network of best-in class, EBITDA positive, interventional psychiatry clinics
$25 million financing committed by Smith and Sauer (JGS Holdings LLC) to leverage anticipated bank financing projected to secure $100 million in HOPE clinic revenue stream on a pro-forma basis
Recently announced progress for HOPE's initial clinic acquisitions
Potential mechanisms for follow-on non-dilutive financing to expand HOPE's network by an additional 50 clinics in 2026 and 100 clinics in 2027
Plans for integration of new technologies and a CRM-based information technology and telepsychiatry umbrella to span the HOPE network
Based on the results of today's meeting, NRx has been invited to return to Mar-A-Lago for an expanded meeting during the last week of January 2025 that will include both Qualified Institutional Buyers and Accredited Investors. Individuals interested in attending are invited to contact Matthew Duffy, Co-CEO of HOPE Therapeutics.
"We were gratified by the enthusiastic response and inciteful questions we received from this group of sophisticated attendees and look forward to future discussions," said Jonathan Javitt, MD MPH, Founder, Chairman & CEO of NRx, and Co-CEO HOPE Therapeutics. "Our mission to treat and prevent suicidality in our society in general, and our military/veteran communities in particular, clearly resonated with those who joined us this evening."
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 initiation of filing a New Drug Application for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding closing the acquisition of Kadima and obtaining financing necessary to consummate the acquisition. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund the Hope Therapeutics acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
https://c212.net/c/img/favicon.png?sn=CL93422&sd=2025-01-10 View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-conduct-investor-workshop-at-the-mar-a-lago-club-302347792.html
SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
3 months ago
NEWS: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Announce Dura Medical as the Expected Initial Florida Acquisition for its Planned International Network of Interventional Psychiatry Clinics
PR Newswire
Mon, January 6, 2025 at 8:03 AM EST
In This Article:
NRXP, NRXPW
Dura Medical, with initial clinics in Naples and Fort Myers, to anchor the HOPE network in Florida
Delivers a full range of precision psychiatry services, including Ketamine and Transcranial Magnetic Stimulation (TMS), to veteran and civilian residents of Florida
Stephen Durand, founder of Dura, to serve as Director of Clinic Growth for HOPE in Florida
Acquisition expected to be immediately accretive to revenue and EBITDA for NRx
MIAMI, Jan. 6, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced the planned acquisition of Dura Medical (Dura), under a non-binding Letter of Intent. Dura is expected to be the first Florida acquisition for HOPE and serve as a cornerstone for the Southeastern States. Dura is revenue generating and EBITDA positive with immediate expansion opportunity to Florida's East Coast and beyond.
Dura was founded in 2018 to offer a gold-standard, precision approach to treating mental health and chronic pain. The clinics were the first in Florida leverage the latest interventional psychiatry procedures, including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato® and Stellate Ganglion Blocks, augmented by traditional psychiatry and therapy to provide a full continuum of care for people with depression, suicidality, PTSD, anxiety, and related disorders.
As a US Army Veteran, Mr. Durand and Dura Medical are proud to partner with the Veterans Affairs Community Cares Network (VA CCN) which ensures that military veterans have full access to treatment for suicidal depression, PTSD, and Traumatic Incident Reduction (TIR).
In conjunction with the planned acquisition, Mr. Durand has agreed to serve as HOPE's Director of Clinical Growth for Florida, helping drive expansion throughout the state. He will be joined by David Feifel, MD, PhD (ref) and NRx's Chief Strategy Officer, CAPT Dennis K. McBride, PhD (US Navy Ret., SES-4 National Defense University, Ret.) a Clinical Psychologist who most recently served in the Office of the Secretary of Defense retiring at a civilian 3 star rank and has led relevant initiatives within the Defense Advanced Research Projects Agency (DARPA).
"Dura Medical was founded with the mission to reduce suicide in our community and aims to treat more than 10,000 people by 2026. We're excited to accelerate that mission by joining the HOPE Network and leading HOPE's expansion in Florida and beyond," said Stephen Durand, Founder of Dura Medical.
"We are delighted to welcome Dura to the HOPE family and look forward to working together to grow both Dura and the HOPE Florida network together," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "In an era where over 13 million Americans seriously consider suicide every year, and an American dies from suicide every 11 minutes1, Dura will serve as a leader in setting the standard of care within our enterprise."
The intended acquisition of Dura is subject to obtaining necessary financing, the completion of financial audits, execution of definitive agreements, and the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx recently announced initiation of filing a New Drug Application for NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima and Dura, and obtaining financing necessary to consummate the acquisitions. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
1 https://www.cdc.gov/suicide/facts/data.html
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
Cision
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaq-nrxp-announce-dura-medical-as-the-expected-initial-florida-acquisition-for-its-planned-international-network-of-interventional-psychiatry-clinics-302342666.html
SOURCE NRx Pharmaceuticals, Inc.
barnyarddog
3 months ago
MIAMI, Jan. 2, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced the planned acquisition of the Kadima Neuropsychiatry Institute (Kadima) of La Jolla, CA, per the previously announced Letter of Intent, for the HOPE network. Kadima is expected to serve as the flagship clinic for HOPE's planned international network of interventional psychiatry clinics, designed to provide advanced treatments for debilitating diseases such as depression, anxiety and PTSD.
Kadima is one of the world's premier interventional psychiatry clinics and was among the first to introduce Ketamine Therapy for Central Nervous System (CNS) disorders at scale in the clinic setting. The clinic offers a full range of cutting-edge treatments for suicidal depression, anxiety, Post Traumatic Stress Disorder (PTSD) and other CNS disorders. Those treatment options include Ketamine Therapy, Spravato® (nasal esketamine), Transcranial Magnetic Stimulation as well as medication management.
Kadima also has a robust research division and is a leading investigative site for innovative CNS treatments, specializing in psychedelic research, for which it has served as a leading site in nearly all major clinical trials in this area. Kadima has contracts in place with the US Department of Veterans Affairs and also treats active-duty military personnel in the US Department of Defense under Tricare and other treatment programs.
Kadima's founder and CEO, Prof. David Feifel, MD PHD, has been a pioneer and international thought leader for advanced interventional treatment of psychiatric disorders such as depression, anxiety, PTSD and related disorders for more than three decades. Among other things, he is a co-author on a recent landmark expert consensus paper for treating depression with TMS, endorsed by three leading organizations in the field (ref). He also established the first clinical program to use subanesthetic dose ketamine infusions for neuropsychiatric disorders at UC San Diego, where he is currently Professor Emeritus of Psychiatry. His 150 peer-reviewed publications and several patents have provided global thought leadership on advanced approaches to treating psychiatric conditions, including integration of medicines like ketamine with neuromodulation such as, Transcranial Magnetic Stimulation and Digital Therapeutics. Kadima's experience will guide the growing network of HOPE Therapeutics clinics to an integrated, multi-modal approach to treating suicidal depression, anxiety and PTSD that is far more effective than ketamine alone.
Upon consummation of the proposed acquisition, Dr. Feifel will serve as HOPE's Chief Medical Innovation Officer (CMIO), focused on identifying and evaluating new developments in the treatment of CNS disorders and insuring Hope clinics are at the forefront of interventional psychiatry delivery, and leading global clinical trials to continue to advance the ability to treat these lethal diseases.
Dr. Feifel will join NRx's Chairman, Prof. Jonathan Javitt in presenting a Keynote address at the 8th Annual Neuroscience Innovation Forum during the JP Morgan Healthcare Conference in San Francisco, CA on the 12th of January 2025, and will join in meeting investors over the following week.
"I am thrilled to join the leadership of HOPE at this exciting juncture," said Dr. David Feifel. "In a world where nearly 60 million Americans suffer from a mental illness in any given year (ref), our dream has been to expand the successes and learnings of Kadima to an international stage, where we can continue to innovate and refine treatments that will create a world in which suicidal depression and PTSD are 100% treatable conditions, from which patients and their families should expect to return to empowered and productive lives."
"We are honored to welcome David and the Kadima team to the HOPE family. David has helped pioneer the field of interventional psychiatry and is one of the few global thought leaders who has been able to span the worlds of academia and community health care delivery, serving the residents of his community as well as active-duty military and veterans in a town known for hosting some of America's most elite warriors. We are thrilled to count David as our partner for expanding the success of Kadima across the globe," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics.
The acquisition of Kadima is subject to the completion of financial audits, execution of definitive agreements, the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 NRX-100 (IV ketamine) for 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.
https://ir.nrxpharma.com/2025-01-02-Hope-Therapeutics,-Inc-and-NRx-Pharmaceuticals,-Inc-NASDAQ-NRXP-Announce-Kadima-Neuropsychiatry-Institute-as-the-Expected-First-Acquisition-for-its-International-Network-of-Interventional-Psychiatry-Clinics
ProfitScout
3 months ago
$NRXP News: Hope Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Kadima Neuropsychiatry Institute as the Expected First Acquisition for its International Network of Interventional Psychiatry Clinics
Kadima Neuropsychiatry Institute in La Jolla, CA to serve as flagship for an international network of clinics dedicated to treating depression and PTSD
Kadima's founder, David Feifel, MD, PhD, Professor Emeritus of Psychiatry at University of California San Diego, a pioneer in advanced interventional treatments for neuropsychiatric conditions such as depression and PTSD, to join Hope as Chief Medical Innovation Officer
Kadima is a leading investigative site for CNS and psychedelic research, and has served as the lead site in nearly all major clinical trials in this area
Acquisition expected to be immediately accretive to revenue and EBITDA for NRx
MIAMI, Jan. 2, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced the planned acquisition of the Kadima Neuropsychiatry Institute (Kadima) of La Jolla, CA, per the previously announced Letter of Intent, for the HOPE network. Kadima is expected to serve as the flagship clinic for HOPE's planned international network of interventional psychiatry clinics, designed to provide advanced treatments for debilitating diseases such as depression, anxiety and PTSD.
Kadima is one of the world's premier interventional psychiatry clinics and was among the first to introduce Ketamine Therapy for Central Nervous System (CNS) disorders at scale in the clinic setting. The clinic offers a full range of cutting-edge treatments for suicidal depression, anxiety, Post Traumatic Stress Disorder (PTSD) and other CNS disorders. Those treatment options include Ketamine Therapy, Spravato® (nasal esketamine), Transcranial Magnetic Stimulation as well as medication management.
Kadima also has a robust research division and is a leading investigative site for innovative CNS treatments, specializing in psychedelic research, for which it has served as a leading site in nearly all major clinical trials in this area. Kadima has contracts in place with the US Department of Veterans Affairs and also treats active-duty military personnel in the US Department of Defense under Tricare and other treatment programs.
Kadima's founder and CEO, Prof. David Feifel, MD PHD, has been a pioneer and international thought leader for advanced interventional treatment of psychiatric disorders such as depression, anxiety, PTSD and related disorders for more than three decades. Among other things, he is a co-author on a recent landmark expert consensus paper for treating depression with TMS, endorsed by three leading organizations in the field (ref). He also established the first clinical program to use subanesthetic dose ketamine infusions for neuropsychiatric disorders at UC San Diego, where he is currently Professor Emeritus of Psychiatry. His 150 peer-reviewed publications and several patents have provided global thought leadership on advanced approaches to treating psychiatric conditions, including integration of medicines like ketamine with neuromodulation such as, Transcranial Magnetic Stimulation and Digital Therapeutics. Kadima's experience will guide the growing network of HOPE Therapeutics clinics to an integrated, multi-modal approach to treating suicidal depression, anxiety and PTSD that is far more effective than ketamine alone.
Upon consummation of the proposed acquisition, Dr. Feifel will serve as HOPE's Chief Medical Innovation Officer (CMIO), focused on identifying and evaluating new developments in the treatment of CNS disorders and insuring Hope clinics are at the forefront of interventional psychiatry delivery, and leading global clinical trials to continue to advance the ability to treat these lethal diseases.
Dr. Feifel will join NRx's Chairman, Prof. Jonathan Javitt in presenting a Keynote address at the 8th Annual Neuroscience Innovation Forum during the JP Morgan Healthcare Conference in San Francisco, CA on the 12th of January 2025, and will join in meeting investors over the following week.
"I am thrilled to join the leadership of HOPE at this exciting juncture," said Dr. David Feifel. "In a world where nearly 60 million Americans suffer from a mental illness in any given year (ref), our dream has been to expand the successes and learnings of Kadima to an international stage, where we can continue to innovate and refine treatments that will create a world in which suicidal depression and PTSD are 100% treatable conditions, from which patients and their families should expect to return to empowered and productive lives."
"We are honored to welcome David and the Kadima team to the HOPE family. David has helped pioneer the field of interventional psychiatry and is one of the few global thought leaders who has been able to span the worlds of academia and community health care delivery, serving the residents of his community as well as active-duty military and veterans in a town known for hosting some of America's most elite warriors. We are thrilled to count David as our partner for expanding the success of Kadima across the globe," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics.
The acquisition of Kadima is subject to the completion of financial audits, execution of definitive agreements, the satisfaction of standard closing conditions.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of interventional psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 NRX-100 (IV ketamine) for 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.
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. These statements include, among others, statements regarding closing the acquisition of Kadima and obtaining financing necessary to consummate the acquisition. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund the Hope Therapeutics acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew DuffyChief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
https://c212.net/c/img/favicon.png?sn=CL87779&sd=2025-01-02 View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-announce-kadima-neuropsychiatry-institute-as-the-expected-first-acquisition-for-its-international-network-of-interventional-psychiatry-clinics-302341062.html
SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
3 months ago
$NRXP NEWS: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression
PR Newswire
Mon, December 30, 2024 at 8:03 AM EST 6 min read
In This Article:
NRXP NRXPW
Aiming to be the first FDA-approved medication to treat suicidal depression
Designed to help address the needs of the more than 13 million Americans who seriously consider suicide each year (CDC)
Completion of NDA filing expected in the first quarter of 2025
Company to participate in 1x1 meetings in San Francisco during the Annual J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA. To schedule meetings, please contact jpm@astrpartners.com
WILMINGTON, Del., Dec. 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx", the "Company"), a clinical-stage biopharmaceutical company, today announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for treatment of suicidal bipolar depression. The Company is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression, based on data from NIH- and European Government-funded trials that have been summarized on the Company's website.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
While assembly of the clinical data sections is being completed, FDA has asked the Company to submit the 1800-page manufacturing section (Module 3) of the NDA to enable immediate review prior to submission of final efficacy data and other sections of the NDA expected in the first quarter of 2025.
The NRx presentation of ketamine differs from the form of ketamine used in anesthesia in that it contains no potentially toxic preservatives and utilizes diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential.
Suicidal depression is considered a national crisis. According to the CDC over 13 million Americans seriously consider suicide each year and 3.8 million make a plan to do so.
"New treatment options are urgently needed for people at risk with acute suicidal depression," said Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist. "Ketamine is already widely-used for the treatment of suicidal depression on an off-label basis and is funded by the Department of Defense and the Department of Veterans Affairs. However, without FDA approval, its use is largely unreimbursed by health insurers, with the exception of VA and DOD."
NRx thanks its shareholders, its clinical team, and the many patients and caregivers who have participated in the clinical trials.
NRX-100 (IV ketamine) for Suicidal Depression
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 begun submission of a New Drug Application for NRX-100 (IV ketamine) for 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. (www.hopetherapeutics.com) is a development stage healthcare delivery company that intends to develop a best-in-class network of precision psychiatry clinics to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, 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. 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, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund the Hope Therapeutics acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 http://www.sec.gov. 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.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
Trade like a pro: Leverage real-time discussions and market-moving ideas to outperform.
glenn1919
2 months ago
OldJames
3 months ago
Hot Features
Premium
