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$AVRW: Avenir Wellness Solutions has never been in a better position to capitalize on the high intrinsic value of our unique and proprietary skin care formulations. With 15 patents under our control, the highly positive reviews Seratopical DNA Complex is receiving, and more new products in development, 2024 is set up to be a growth year for the Company. We look forward to keeping our shareholders informed of our progress, developments and milestones as we move forward.
Sincerely,
Nancy Duitch, CEO
News Link:
https://finance.yahoo.com/news/avenir-wellness-solutions-issues-2024-140000098.html
$AVRW: Avenir Wellness Solutions has never been in a better position to capitalize on the high intrinsic value of our unique and proprietary skin care formulations. With 15 patents under our control, the highly positive reviews Seratopical DNA Complex is receiving, and more new products in development, 2024 is set up to be a growth year for the Company. We look forward to keeping our shareholders informed of our progress, developments and milestones as we move forward.
Sincerely,
Nancy Duitch, CEO
News Link:
https://finance.yahoo.com/news/avenir-wellness-solutions-issues-2024-140000098.html
News on $MNTS and $ASTI Partnership: Momentus and Ascent Solar Technologies Partner to Bring Leading-Edge Solar Arrays to Market
Innovative solar arrays to address burgeoning demand
SAN JOSE, Calif., April 17, 2024 (GLOBE NEWSWIRE) -- Momentus Inc. (NASDAQ: MNTS) ("Momentus") and Ascent Solar Technologies, (Nasdaq: ASTI) (“Ascent”) today announced a new partnership to jointly market leading-edge solar arrays utilizing the low-cost Tape Spring Solar Array (TASSA) being developed by Momentus and the high performance of Ascent’s flexible, lightweight photovoltaic modules.
The rapid growth in the production and deployment of thousands of satellites in space has led to the burgeoning need for low-cost, reliable and high performing solar arrays. Momentus and Ascent are excited to partner to market a leading-edge solar array designed to provide key advantages to customers such as lower costs, resiliency with less degradation in the harsh environment in space, flexibility, and the ability to efficiently generate large amounts of power.
Building off the successes of the pathfinder demonstration of TASSA that was launched to Low-Earth Orbit on the Vigoride-6 mission one year ago and tested in space for several months, Momentus plans to add a high-power photovoltaic array as a differentiated feature of the next iteration of the TASSA product under development. Last year’s pathfinder TASSA demonstration validated solar blankets from Ascent, as a mass efficient and robust power generation solution. Momentus plans to incorporate in TASSA new higher efficiency solar blankets from Ascent composed of space industry optimized Titan Modules, achieving even lower cost per kW of power.
TASSA will continue to utilize Vigoride hardware with spaceflight heritage to provide customers an entire array subsystem, complete with solar array rotation actuators and controllers. This approach is oriented at streamlining mission schedules and minimizing clean room bottlenecks during spacecraft assembly integration and testing. TASSA is designed for responsive launch as well as more efficient flatpack configurations which allow for more satellites to fit within launch vehicle payload fairings.
“TASSA is designed to generate extensive power at very low cost while minimizing mass and volume,” said Rob Schwarz, Momentus CTO. “TASSA is intended to allow Smallsats to generate kilowatts of power on orbit without breaking their mass, thermal, or cost budgets. This design optimization also facilitates improved satellite packing efficiencies and allows constellations to be fielded quicker and cheaper.”
TASSA is also retractable and re-deployable providing a means for the minimization of cross-sectional area and array exposure if notified of potential conjunction or other orbital hazards such as space weather. This could enable TASSA to facilitate longer mission durations and increased assurance of spacecraft operations on orbit.
“Ascent’s flexible, lightweight photovoltaic modules are ideal for the space environment,” said Paul Warley, CEO of Ascent Solar Technologies. “Our CIGS products are resilient to radiation and other drivers of degradation while operating in orbits between the Earth and the Moon. For those designing space missions, this equates to more end-of-life power with an order of magnitude less mass. We’re excited to be the baseline power generation solution for TASSA, and look forward to continuing to collaborate with the Momentus team to provide long-lived and sustainable solutions for proliferated space architectures.”
ABOUT MOMENTUS
Momentus is a U.S. commercial space company that offers satellite buses and technologies, as well as space services including transportation, hosted payloads, and other in-orbit services.
ABOUT ASCENT SOLAR TECHNOLOGIES, INC.
Backed by 40 years of R&D, 15 years of manufacturing experience, numerous awards, and a comprehensive IP and patent portfolio, Ascent Solar Technologies, Inc. is a leading provider of innovative, high-performance, flexible thin-film solar panels for use in environments where mass, performance, reliability, and resilience matter. Ascent’s photovoltaic (PV) modules have been deployed on space missions, multiple airborne vehicles, agrivoltaic installations, in industrial/commercial construction as well as an extensive range of consumer goods, revolutionizing the use cases and environments for solar power. Ascent Solar’s research and development center and 5-MW nameplate production facility is in Thornton, Colorado. To learn more, visit https://www.ascentsolar.com or follow the Company on LinkedIn and X (formerly Twitter).
Forward-Looking Statements
This press release contains certain statements which may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Momentus or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. The words “may,” “will,” “anticipate,” “believe,” “expect,” “continue,” “could,” “estimate,” “future,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “aim,” “strive,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions.
Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Momentus’ control. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: the ability of the Company to generate revenue and raise capital in order to continue as a going concern; the ability of the Company to obtain licenses and government approvals for its missions, which are essential to its operations; the ability of the Company to effectively market and sell satellite transport services and planned in-orbit services; the ability of the Company to protect its intellectual property and trade secrets; the development of markets for satellite transport and in-orbit services; the ability of the Company to develop, test and validate its technology, including its water plasma propulsion technology; delays or impediments that the Company may face in the development, manufacture and deployment of next generation satellite transport systems; the ability of the Company to convert backlog or inbound inquiries into revenue; changes in applicable laws or regulations and extensive and evolving government regulations that impact operations and business, including export control license requirements; the ability to attract or maintain a qualified workforce with the required security clearances and requisite skills; product service or product or launch failures or delays that could lead customers to use competitors’ services; investigations, claims, disputes, enforcement actions, litigation and/or other regulatory or legal proceedings; the Company’s ability to comply with the terms of its National Security Agreement and any related compliance measures instituted by the director who was approved by the CFIUS Monitoring Agencies; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and/or other risks and uncertainties. These are only some of the factors that may affect the forward-looking statements contained in this press release. For a discussion identifying additional important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, see the company’s filings with the U.S. Securities and Exchange Commission including, but not limited to, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The Company’s filings may be accessed through the Investor Relations page of its website, investors.momentus.space, or through the website maintained by the SEC at www.sec.gov. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
MEDIA CONTACT
Spencer Herrmann
FischTank PR
ascent@fischtankpr.com
INVESTOR RELATIONS CONTACT
ir@ascentsolar.com
$IVDN (16 million float) is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
$IVDN (16 million float) is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
Be sure to follow NRXP on Twitter (X): Results Show Superior Safety & Efficacy for NRX-101; Accelerated FDA Approval sought for Bipolar Depression
Results Show Superior Safety & Efficacy for NRX-101; Accelerated FDA Approval sought for Bipolar Depression
— NRx Pharmaceuticals (@NRxPharma) May 7, 2024
Read More - https://t.co/VzEAskHG4j#PharmaNews #mentalillness #mentalhealth #mentalhealthmatters #depression #ketamine #stress #PTSD #bipolar #NRX101 $NRXP
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
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SOURCE NRx Pharmaceuticals, Inc.
$IVDN: Our Insultex House Wrap (TM) can make a real contribution to carbon reduction with an R-6 Rating, unmatched by any competitive product. Patented evacuated cell design. Better Insulation = Less demand from carbon emitting energy suppliers. Visit: http://insultexhousewrap.com
$IVDN: Our Insultex House Wrap (TM) can make a real contribution to carbon reduction with an R-6 Rating, unmatched by any competitive product. Patented evacuated cell design. Better Insulation = Less demand from carbon emitting energy suppliers. Visit: https://t.co/LWNDwJcXDh pic.twitter.com/UFm4aZ7fvV
— Innovative Designs, Inc (Stock: $IVDN) (@riccelli_joseph) April 30, 2024
$GTVH CEO Interview: Bell2Bell Podcast featuring Golden Triangle Ventures Inc. CEO Steffan Dalsgaard
Bell2Bell’s latest podcast features Steffan Dalsgaard, President and CEO of Golden Triangle Ventures Inc. (OTC: GTVH), a multifaceted consulting company pursuing ventures in the health, entertainment and technology industries.
https://podcast.bell2bell.com/e/bell2bell-podcast-featuring-golden-triangle-ventures-inc-ceo-steffan-dalsgaard-video-edition/
Nicole Kidman's personal endorsement of the AVRW Seratopical skin care line is an extraordinary asset for the company. She is running a multi-million dollar entertainment career which depends on her skin looking its best. There is no question that Nicole Kidman truly feels that the Seratopical brand is the very best option on the market today or she would not be using it herself. Nicole Kidman found the product on her own and only then decided to take an active role with CEO Nancy Diitch to help bring more awareness to consumers about this life changing product line.
$SRCGF: Spruce Ridge Resources Ltd. Announces the Closing of the Acquisition of the Shamrock Nickel Property in Oregon
Toronto, Ontario –TheNewswire -April 26, 2024 – Spruce Ridge Resources Ltd.(“Spruce”or the“Company”) (TSXV:SHL) is pleased to announce that it has closed the acquisition of the Shamrock Nickel Sulphide Property (the “Property”), located near Medford in southwest Oregon, USA (the “Acquisition”) (see press release dated March 11, 2024).
Steve Balch, President and CEO, stated, “Spruce is increasing its presence in the U.S. critical minerals market with the acquisition of an interesting nickel sulphide property where the grades of nickel and copper are both over 1.0% and where the mineralization is open along strike and at depth. We do not yet know the extent of the mineralization and there is no record of exploration since the 1950s. We believe there are significant platinum group metals present as well.”
The acquisition terms were amended as disclosed below.
Shamrock Property
Information on the Property is taken from a National Instrument 43-101 –Standards of Disclosure for Mineral Projects(“NI 43-101”) report prepared by D.E. Cameron for Northwest Nickel with an effective date of March 1, 2023.
The Property consists of 40 unpatented lode claims, accessible by paved road, covering approximately 758 acres and located 20 miles northwest of Medford, Oregon.
The area was first prospected in the early 1900s, when a 60 ft-deep inclined shaft was excavated to intersect the main Shamrock showing containing nickel (Ni), copper (Cu), cobalt (Co), and platinum (Pt). Underground development occurred during 1949-50 by the U.S. Bureau of Mines (“USBM”). USBM completed eleven diamond drillholes totaling 3,419 ft and outlined a lens of nickel-copper sulphide 325 ft long, 200 ft deep and 3-25 ft thick. A 200-lb composite sample was submitted for metallurgy and assayed 1.3% Ni, 1.1% Cu, 0.07% Co and 0.03 oz/t Pt. In 1952-53 USBM removed 101.5 tons of manganese- (Mn) and iron-rich (Fe) material from previously discovered pods for metallurgical sampling with assays returning 23.1-32.3% Mn and 2.06-3.70% Fe.
Nickel-copper mineralization can be traced along strike for 1,500 ft north-south, 500 ft east-west and contains two mineralized lenses. Ultramafic rocks were intersected in drilling and consist predominantly of peridotite and related serpentinite, as well as norite and diorite. The best mineralization is present in a coarse-grained norite. Sulphide mineralization includes pyrrhotite, pentlandite, chalcopyrite and pyrite. A bulk flotation program recovered 92.3% of the Ni, 89.4% of the Cu and 51.3% of the Pt.
Acquisition Terms
Under the terms of the Acquisition, Spruce acquired a 100% interest in the Property by:
making a cash payment of $148,949 to Northwest Nickel Corp (“Northwest”);
issuing to Northwest an aggregate of 2,500,000 common shares in the capital of Spruce (TSXV:SHL); and
granting to Northwest a 2.0% net smelter returns royalty (NSR”) with the option to repurchase 50% of the NSR for consideration of $1,000,000.
The original terms involved transferring to Northwest 100,000 common shares in the capital of Canada Nickel Company Inc. (TSXV:CNC) held by Spruce, but was amended to be included in the cash payment of $148,949 included above;
The Acquisition is an arm's length transaction for the purposes of the policies of the TSX Venture Exchange (the “TSXV”) and no finder's fees are payable in connection with the Acquisition. The Company expects that the Acquisition will meet the criteria of an “Expedited Acquisition” under TSXV Policy 5.3 –Acquisitions and Dispositions of Non-Cash Assetsand remains subject to the TSXV's finalacceptance. All securities issuable in connection with the Acquisition will be subject to a hold period of four months and one day after closing.
Additional technical information on the Property is available on the Company’s website.
Click Image To View Full Size
Figure 1 -= Location of the massive sulphide lenses and historic workings at Shamrock.
Qualified Person
Stephen J. Balch, P.Geo. (ON), the Company’s President and CEO and a “Qualified Person” under NI 43-101, has reviewed and approved the technical content of this press release.
About Spruce Ridge
Spruce Ridge is a Canadian-based mineral exploration company focused on critical metal resources with nickel projects in Oregon, United States and copper projects in Newfoundland, Canada. The Company also holds a significant portfolio of mining securities including 3.55 million shares of Canada Nickel Company Inc. (TSX-V:CNC), 10.0 million shares of Noble Mineral Exploration Inc. (TSX-V:NOB), 15.0 million shares of Benton Resources Inc. (TSX-V:BEX) and 2.5 million shares of Magna Terra Minerals Inc. (TSX-V:MTT). Spruce’s common shares trade on the TSX Venture Exchange under the symbol “SHL”. More detailed information can be found on the Company’s website at:
http://www.spruceridgeresources.com
Cautionary Statement
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.
This news release contains statements that constitute “forward-looking statements”. Forward-looking statements are statements that are not historical facts and include, but are not limited to, disclosure regarding possible events, that are based on assumptions and courses of action, and in certain cases, can be identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur, or the negative forms of any of these words and other similar expressions. Forward-looking statements include statements related to future plans for the Company, and other forward-looking information. Forward-looking statements are based on various assumptions including with respect to the anticipated actions of securities regulators, stock exchanges, and government entities, management plans and timelines, as well as results of operations, performance, business prospects and opportunities. Although the forward-looking statements contained in this news release are based upon what the management of the Company believes are reasonable assumptions on the date of this news release, such assumptions may prove to be incorrect. Forward-looking statements involve known and unknown risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. A number of factors could cause actual results, performance or achievements to differ materially from the results discussed in the forward-looking statements, including, but not limited to: an inability to develop and successfully implement exploration strategies; general business, economic, competitive, political and social uncertainties; the lack of available capital; impact of the evolving situation in Ukraine on the business of the Company; and other risks detailed from time-to-time in the Company’s ongoing filings with securities regulatory authorities, which filings can be found at www.sedarplus.ca. The Company cannot assure readers that actual results will be consistent with these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements in this press release. These forward-looking statements are made as of the date of this news release and the Company disclaims any intent or obligation to update any forward-looking statement, whether because of new information, future events or otherwise, unless otherwise required by law.
Contact
Stephen Balch, President & CEO
Phone: 905.407.9586
Email: steve@beci.ca
$RENB News: Transforming Cancer Detection: RenovaroCube Introduces Flamingo, a novel AI model based on Fragmentomics
LOS ANGELES and AMSTERDAM, April 30, 2024 (GLOBE NEWSWIRE) -- RenovaroCube, wholly owned subsidiary of Renovaro, Inc. (Nasdaq: RENB), a company at the forefront of AI-driven healthcare innovation, proudly unveils Flamingo, a potentially groundbreaking multi-cancer detection model contributing to its mission to transform early cancer diagnostics. Leveraging ultra-low pass whole genome sequencing (ULP-WGS) of cell-free DNA (cfDNA), Flamingo represents a promising leap forward in the fight against cancer.
Traditional cancer detection methods often fall short in identifying cancers at an early stage when treatment is the most effective. However, Flamingo has the potential to overcome these limitations by harnessing the power of AI to analyze minute amounts of cfDNA data that is highly accurate.
"At RenovaroCube, we believe in pushing the boundaries of possibility," states Daan Vessies, senior scientist at RenovaroCube. "Flamingo undescores our commitment to change cancer diagnostics in a transformative way, ultimately offering clinicians a powerful tool to detect cancer across diverse omic layers."
The Company believes that no single model or molecular modality will reach the requisite sensitivity and specificity throughout the entire patient journey for personalized, precision medicine, from early detection, to predicting the effectiveness of various treatment options, to monitoring the response to therapy within days of starting it, to detecting recurrence at the earliest possible moment. Therefore, our AI/machine learning platform, The Cube, integrates multi-omic data, offering a uniquely comprehensive approach to cancer detection by leveraging a library of trained models for multiple omic layers. One such model Flamingo focuses on is the detection of cancer from ultra-low pass whole genome sequencing (ULP-WGS) cfDNA data using fragmentomics.
Flamingo's development marks a significant milestone in the quest for early cancer detection with RenovaroCube’s engine. By utilizing as few as only 200,000 cell-free DNA fragments per sample, integrating fragment lengths, sequence motifs and employing a meticulously designed neural network, Flamingo achieves remarkable performance in distinguishing cancer from healthy samples.
By augmenting The Cube's arsenal of models operating across various omic layers, Flamingo contributes to the development of non-invasive diagnostics to detect cancer early, enabling timely interventions and improving patient outcomes.
"Adding Flamingo to our Cube will accelerate our efforts to realize a paradigm shift in cancer detection," affirms Frank van Asch, CTO, RenovaroCube. "With its introduction, we are one step closer to realizing our vision of a world where cancer is detected and treated swiftly, saving countless lives in the process."
RenovaroCube invites interested doctors and scientists from international research institutions, clinical cancer centers and all stakeholders to join in the early research use application of our AI/machine learning platform to advance cancer diagnostics and pave the way for a healthier future.
About Renovaro:
Please see a recent interview with Avram Miller, Member of, and Advisor to, the Board of Directors, former co-founder of Intel Capital and SVP of Business Development for Intel:
https://techbullion.com/avram-miller-talks-ab...es-with-ai
Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroBio, with its advanced cell-gene immunotherapy company, and RenovaroCube. RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in cancer care.
Upon the closing of the previously announced acquisition of Cyclomics (winner of the Health Holland Venture Challenge), RenovaroCube will be capable of performing liquid biopsies using proprietary technologies to identify single cancer DNA molecules in only one vial of blood. In combination with Oxford Nanopore Technology, genetic information can be retrieved over multiple genetic layers to develop the next generation of cancer diagnostics. This will transform cancer care by enabling faster and more accurate diagnosis throughout the patient journey.
https://www.renovarogroup.com
https://www.renovarobio.com
https://www.renovarocube.com
About Cyclomics:
Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.
https://www.cyclomics.com/
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline and platform. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For media inquiries, please contact: karen@renovarocube.com
Source: Renovaro Inc.
$RENB News: Transforming Cancer Detection: RenovaroCube Introduces Flamingo, a novel AI model based on Fragmentomics
LOS ANGELES and AMSTERDAM, April 30, 2024 (GLOBE NEWSWIRE) -- RenovaroCube, wholly owned subsidiary of Renovaro, Inc. (Nasdaq: RENB), a company at the forefront of AI-driven healthcare innovation, proudly unveils Flamingo, a potentially groundbreaking multi-cancer detection model contributing to its mission to transform early cancer diagnostics. Leveraging ultra-low pass whole genome sequencing (ULP-WGS) of cell-free DNA (cfDNA), Flamingo represents a promising leap forward in the fight against cancer.
Traditional cancer detection methods often fall short in identifying cancers at an early stage when treatment is the most effective. However, Flamingo has the potential to overcome these limitations by harnessing the power of AI to analyze minute amounts of cfDNA data that is highly accurate.
"At RenovaroCube, we believe in pushing the boundaries of possibility," states Daan Vessies, senior scientist at RenovaroCube. "Flamingo undescores our commitment to change cancer diagnostics in a transformative way, ultimately offering clinicians a powerful tool to detect cancer across diverse omic layers."
The Company believes that no single model or molecular modality will reach the requisite sensitivity and specificity throughout the entire patient journey for personalized, precision medicine, from early detection, to predicting the effectiveness of various treatment options, to monitoring the response to therapy within days of starting it, to detecting recurrence at the earliest possible moment. Therefore, our AI/machine learning platform, The Cube, integrates multi-omic data, offering a uniquely comprehensive approach to cancer detection by leveraging a library of trained models for multiple omic layers. One such model Flamingo focuses on is the detection of cancer from ultra-low pass whole genome sequencing (ULP-WGS) cfDNA data using fragmentomics.
Flamingo's development marks a significant milestone in the quest for early cancer detection with RenovaroCube’s engine. By utilizing as few as only 200,000 cell-free DNA fragments per sample, integrating fragment lengths, sequence motifs and employing a meticulously designed neural network, Flamingo achieves remarkable performance in distinguishing cancer from healthy samples.
By augmenting The Cube's arsenal of models operating across various omic layers, Flamingo contributes to the development of non-invasive diagnostics to detect cancer early, enabling timely interventions and improving patient outcomes.
"Adding Flamingo to our Cube will accelerate our efforts to realize a paradigm shift in cancer detection," affirms Frank van Asch, CTO, RenovaroCube. "With its introduction, we are one step closer to realizing our vision of a world where cancer is detected and treated swiftly, saving countless lives in the process."
RenovaroCube invites interested doctors and scientists from international research institutions, clinical cancer centers and all stakeholders to join in the early research use application of our AI/machine learning platform to advance cancer diagnostics and pave the way for a healthier future.
About Renovaro:
Please see a recent interview with Avram Miller, Member of, and Advisor to, the Board of Directors, former co-founder of Intel Capital and SVP of Business Development for Intel:
https://techbullion.com/avram-miller-talks-ab...es-with-ai
Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroBio, with its advanced cell-gene immunotherapy company, and RenovaroCube. RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in cancer care.
Upon the closing of the previously announced acquisition of Cyclomics (winner of the Health Holland Venture Challenge), RenovaroCube will be capable of performing liquid biopsies using proprietary technologies to identify single cancer DNA molecules in only one vial of blood. In combination with Oxford Nanopore Technology, genetic information can be retrieved over multiple genetic layers to develop the next generation of cancer diagnostics. This will transform cancer care by enabling faster and more accurate diagnosis throughout the patient journey.
https://www.renovarogroup.com
https://www.renovarobio.com
https://www.renovarocube.com
About Cyclomics:
Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.
https://www.cyclomics.com/
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline and platform. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For media inquiries, please contact: karen@renovarocube.com
Source: Renovaro Inc.
$NCL News: Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product Wins Multiple Prestigious Awards in 2024
ELK GROVE, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Northann Corp. (NYSE American: NCL), a leader in innovative sustainable solutions, today announced that its Blue11-Ocean Plastic Flooring and Wall Panels Product has been recognized this year with industry awards for outstanding design, commitment to sustainability, and impeccable craftsmanship.
These awards include:
American Good Design Award 2024
French Design Award 2024
IDA Design Awards 2024
New York Product Design Awards
Green Product Award
Best Surfaces in TISE 2024
"We are truly honored to receive these prestigious awards, which underscore our commitment to creating products that are not only visually captivating but also environmentally conscious," remarked Northann Corp. CEO Lin Li. "This recognition fuels our passion to continue delivering innovative and sustainable solutions that resonate with our customers and contribute positively to the environment.
“Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product stands as a shining example of our company's enduring pursuit of excellence and sustainability.”
To learn more about this award-winning product and Northann Corp.'s comprehensive range of sustainable solutions, please visit www.northann.com and www.benchwick.com.
About Northann Corp.
Northann specializes in 3D-printed flooring solutions under its flagship brand, "Benchwick." The Company's operations span the full spectrum of additive manufacturing, from sourcing recycled ocean plastics to the final production of intricate flooring designs. Northann offers its 3D printing ecosystem as an extensive range of proprietary solutions, including Infinite Glass, DSE, TruBevel, and MattMaster, primarily through its sales network in North America and Europe. The Company aims to redefine the essence of modern flooring and wall panels by offering stylish, durable, and ecologically conscious solutions.
For more information about Northann, please visit http://www.northann.com.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
For investor and media inquiries, please contact:
Investor Relations
Northann Corp.
Email: ir@northann.com
Phone: +1 (916) 573-3803
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor New York, NY, 10036
Office: (646) 893-5835 x2
Email: info@skylineccg.com
$NCL News: Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product Wins Multiple Prestigious Awards in 2024
ELK GROVE, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Northann Corp. (NYSE American: NCL), a leader in innovative sustainable solutions, today announced that its Blue11-Ocean Plastic Flooring and Wall Panels Product has been recognized this year with industry awards for outstanding design, commitment to sustainability, and impeccable craftsmanship.
These awards include:
American Good Design Award 2024
French Design Award 2024
IDA Design Awards 2024
New York Product Design Awards
Green Product Award
Best Surfaces in TISE 2024
"We are truly honored to receive these prestigious awards, which underscore our commitment to creating products that are not only visually captivating but also environmentally conscious," remarked Northann Corp. CEO Lin Li. "This recognition fuels our passion to continue delivering innovative and sustainable solutions that resonate with our customers and contribute positively to the environment.
“Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product stands as a shining example of our company's enduring pursuit of excellence and sustainability.”
To learn more about this award-winning product and Northann Corp.'s comprehensive range of sustainable solutions, please visit www.northann.com and www.benchwick.com.
About Northann Corp.
Northann specializes in 3D-printed flooring solutions under its flagship brand, "Benchwick." The Company's operations span the full spectrum of additive manufacturing, from sourcing recycled ocean plastics to the final production of intricate flooring designs. Northann offers its 3D printing ecosystem as an extensive range of proprietary solutions, including Infinite Glass, DSE, TruBevel, and MattMaster, primarily through its sales network in North America and Europe. The Company aims to redefine the essence of modern flooring and wall panels by offering stylish, durable, and ecologically conscious solutions.
For more information about Northann, please visit http://www.northann.com.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
For investor and media inquiries, please contact:
Investor Relations
Northann Corp.
Email: ir@northann.com
Phone: +1 (916) 573-3803
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor New York, NY, 10036
Office: (646) 893-5835 x2
Email: info@skylineccg.com
$IVDN (16 million float) is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
$IVDN (16 million float) is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
Excellent reference article, well worth the read for real investors. Lindus Construction has also posted an extremely positive review and endorsement of the IVDN Insultex House Wrap product on their own company website.
See the Lindus website with their commentary here: https://lindusconstruction.com/blog/insultex-house-wrap-future-home-weatherization/
IVDN clearly has the best house wrap product available today and with its patented evacuated cell design, no competitor can match it for energy saving performance and other important advantages.
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
https://c212.net/c/img/favicon.png?sn=CL05849&sd=2024-05-06 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-announces-final-clinical-trial-results-superior-safety-combined-with-similar-efficacy-in-the-trial-of-nrx-101-compared-to-lurasidone-in-suicidal-bipolar-depression-302136430.html
SOURCE NRx Pharmaceuticals, Inc.
$AVRW: Avenir Wellness Solutions has never been in a better position to capitalize on the high intrinsic value of our unique and proprietary skin care formulations. With 15 patents under our control, the highly positive reviews Seratopical DNA Complex is receiving, and more new products in development, 2024 is set up to be a growth year for the Company. We look forward to keeping our shareholders informed of our progress, developments and milestones as we move forward.
Sincerely,
Nancy Duitch, CEO
News Link:
https://finance.yahoo.com/news/avenir-wellness-solutions-issues-2024-140000098.html
$IVDN is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
$IVDN is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is making steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
Cemtrex, Inc. Announces Closing of $10 Million Upsized Underwritten Public Offering
Hauppauge, NY, May 03, 2024 (GLOBE NEWSWIRE) -- – Cemtrex, Inc. (Nasdaq: CETX) (the “Company”), an advanced security technology and industrial services company, today announced the closing of a firm commitment underwritten public offering with gross proceeds to the Company of approximately $10 million, before deducting underwriting discounts and other estimated expenses payable by the Company. The offering was upsized from $9 million. The base offering consisted of 11,764,705 Common Units or Pre-Funded Units, each consisting of one share of common stock (“Common Share”) or one Pre-Funded Warrant, one Series A Warrant to purchase one Common Share at an exercise price of $0.85 per share or pursuant to an alternative cashless exercise option, which warrant will expire two-and-a-half years from the closing date of this offering (the “Series A Warrant”) and one Series B Warrant to purchase one Common Share at an exercise price of $0.85 per share, which warrant will expire on the five-year anniversary of the closing date of this offering (the “Series B Warrants” and together with the Series A Warrants, the “Warrants”). The purchase price of each Common Unit was $0.85, and the purchase price of each Pre-Funded Unit was $0.849 (which is equal to the public offering price per Common Unit minus $0.001). The Pre-Funded Warrants will be immediately exercisable and may be exercised at any time until all the Pre-Funded Warrants are exercised in full.
The Company intends to use the net proceeds from this offering to conduct operations, increase marketing efforts, invest in existing business initiatives and products, and for the partial repayment of indebtedness. The Company may also use a portion of the net proceeds of this offering to acquire or invest in complementary businesses, products, or technologies, or to obtain the right to use such complementary technologies.
In addition, the Company granted Aegis Capital Corp. a 45-day option to purchase additional Common Shares and/or Warrants, representing up to 15% of the number of securities sold in the offering, solely to cover over-allotments, if any.
The closing of the offering occurred on May 3, 2024, subject to the satisfaction of customary closing conditions.
Aegis Capital Corp. acted as the sole book-running manager for the Offering. The Doney Law Firm acted as counsel to the Company for the offering. Kaufman & Canoles, P.C. served as counsel to Aegis Capital Corp. for the offering.
The offering was made pursuant to an effective registration statement on Form S-1 (No. 333-276556) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on April 30, 2024. A preliminary prospectus (the “Preliminary Prospectus”) describing the terms of the proposed offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. A final prospectus (the “Final Prospectus”) relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the Preliminary Prospectus and Final Prospectus, when available, may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at syndicate @RAREBREED. Before investing in this offering, interested parties should read in their entirety the registration statement and the Preliminary Prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such registration statement and the Preliminary Prospectus, which provide more information about the Company and the offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 Cemtrex
Cemtrex Inc. (CETX) is a company that owns two operating subsidiaries: Vicon Industries, Inc. (“Vicon”) and Advanced Industrial Services, Inc. (“AIS”).
Vicon is a global leader in advanced security and surveillance technology to safeguard businesses, schools, municipalities, hospitals and cities. Since 1967, Vicon has delivered mission-critical security surveillance systems, specializing in engineering complete security solutions that simplify deployment, operation and ongoing maintenance. Vicon provides security solutions for some of the largest municipalities and businesses in the U.S. and around the world, offering a wide range of cutting-edge and compliant security technologies, from AI-driven video analytics to fully integrated access control solutions. For more information visit http://www.vicon-security.com.
AIS is a premier provider of industrial contracting services including millwrighting, rigging, piping, electrical, welding. AIS installs high precision equipment in a wide variety of industrial markets including automotive, printing & graphics, industrial automation, packaging, and chemicals. AIS owns and operates a modern fleet of custom-designed specialty equipment to assure safe and quick installation of production equipment. AIS staff participates in recurring instructional training, provided to ensure that the most current industry methods are being utilized to provide an efficient and safe working environment. For more information visit http://www.ais-york.com.
For more information visit http://www.cemtrex.com.
Forward-Looking Statements
The information contained herein may contain “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this press release relating to anticipated use of proceeds. Forward-looking statements are based on the Company’s current expectations and assumptions regarding its business, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Preliminary Prospectus. The Company’s actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Readers are cautioned against relying on any of these forward-looking statements. Factors or events that could cause the Company’s actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them. The Company cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release.
https://www.globenewswire.com/newsroom/ti?nf=OTExMDk0MiM2MjMzNDQwIzIwNDk3MDg=
https://ml.globenewswire.com/media/NjQzYzY5ZTEtOTc4NS00MmQyLWFiNzQtNWIyMGM3NTk0ZWY3LTEwNjEyNzk=/tiny/Cemtrex-Inc-.png
Company Contact:
Investor Relations
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
CETX@mzgroup.us
www.mzgroup.us
Source: Cemtrex Inc.
$IVDN: Remodel with our R-6 Rated Insultex House Wrap (TM) that outperforms all competitive products for energy efficiency savings. A patented evacuated cell design makes this possible. Plus, we add a moisture barrier. Visit: http://insultexhousewrap.com #insulation
$IVDN: Remodel with our R-6 Rated Insultex House Wrap (TM) that outperforms all competitive products for energy efficiency savings. A patented evacuated cell design makes this possible. Plus, we add a moisture barrier. Visit: https://t.co/7DxiK13HDH #insulation pic.twitter.com/q5JH7xr4WX
— Innovative Designs, Inc (Stock: $IVDN) (@riccelli_joseph) May 3, 2024
$AVRW: Avenir Wellness Solutions has never been in a better position to capitalize on the high intrinsic value of our unique and proprietary skin care formulations. With 15 patents under our control, the highly positive reviews Seratopical DNA Complex is receiving, and more new products in development, 2024 is set up to be a growth year for the Company. We look forward to keeping our shareholders informed of our progress, developments and milestones as we move forward.
Sincerely,
Nancy Duitch, CEO
News Link:
https://finance.yahoo.com/news/avenir-wellness-solutions-issues-2024-140000098.html
$AVRW: Avenir Wellness Solutions has never been in a better position to capitalize on the high intrinsic value of our unique and proprietary skin care formulations. With 15 patents under our control, the highly positive reviews Seratopical DNA Complex is receiving, and more new products in development, 2024 is set up to be a growth year for the Company. We look forward to keeping our shareholders informed of our progress, developments and milestones as we move forward.
Sincerely,
Nancy Duitch, CEO
News Link:
https://finance.yahoo.com/news/avenir-wellness-solutions-issues-2024-140000098.html
$IVDN is on track for a record sales and revenue growth year in 2024, as detailed in official company news below. IVDN management is clearly making strong and steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
$IVDN: On track for a record sales and revenue growth year in 2024, as detailed in the latest company news below. IVDN management is making strong and steady progress to grow market share and also protect the very valuable patent rights of its unique Insultex product line which is the only evacuated cell insulation on the market with energy saving performance that no competitor can match.
IVDN is now starting to see accelerating sales success as word is spreading about Insultex House Wrap as described on the dedicated website at http://www.insultexhousewrap.com. Add to this advantage, the fact that the IVDN product meets or exceeds new building codes going into effect this year requiring continuous insulation while competitors are failing this critical criteria.
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
World International Patent Organization (WIPO) Application Accepted on Superior Insulation Advancement to Maximize Global Marketing Opportunities for Innovative Designs, Inc.
Dec. 27, 2023
https://www.newmediawire.com/news/world-international-patent-organization-wipo-application-accepted-on-superior-insulation-advancement-to-maximize-global-marketing-opportunities-for-innovative-designs-inc-7071640
LIG Assets, Inc. Announces Agreement With Insultex House Wrap
October 30, 2023
https://www.globenewswire.com/en/news-release/2023/10/30/2769422/0/en/LIG-Assets-Inc-Announces-Agreement-With-Insultex-House-Wrap.html
Innovative Designs Inc. Receiving Orders From Numerous New Client Accounts for Top Performing Insultex House Wrap With Unmatched R-6 Insulation Value
October 26, 2023
https://www.globenewswire.com/news-release/2023/10/26/2767843/0/en/Innovative-Designs-Inc-Receiving-Orders-From-Numerous-New-Client-Accounts-for-Top-Performing-Insultex-House-Wrap-With-Unmatched-R-6-Insulation-Value.html
Innovative Designs Adds New Accounts
October 2, 2023
https://www.globenewswire.com/news-release/2023/10/02/2752606/0/en/Innovative-Designs-Adds-New-Accounts.html
$RENB News: Transforming Cancer Detection: RenovaroCube Introduces Flamingo, a novel AI model based on Fragmentomics
LOS ANGELES and AMSTERDAM, April 30, 2024 (GLOBE NEWSWIRE) -- RenovaroCube, wholly owned subsidiary of Renovaro, Inc. (Nasdaq: RENB), a company at the forefront of AI-driven healthcare innovation, proudly unveils Flamingo, a potentially groundbreaking multi-cancer detection model contributing to its mission to transform early cancer diagnostics. Leveraging ultra-low pass whole genome sequencing (ULP-WGS) of cell-free DNA (cfDNA), Flamingo represents a promising leap forward in the fight against cancer.
Traditional cancer detection methods often fall short in identifying cancers at an early stage when treatment is the most effective. However, Flamingo has the potential to overcome these limitations by harnessing the power of AI to analyze minute amounts of cfDNA data that is highly accurate.
"At RenovaroCube, we believe in pushing the boundaries of possibility," states Daan Vessies, senior scientist at RenovaroCube. "Flamingo undescores our commitment to change cancer diagnostics in a transformative way, ultimately offering clinicians a powerful tool to detect cancer across diverse omic layers."
The Company believes that no single model or molecular modality will reach the requisite sensitivity and specificity throughout the entire patient journey for personalized, precision medicine, from early detection, to predicting the effectiveness of various treatment options, to monitoring the response to therapy within days of starting it, to detecting recurrence at the earliest possible moment. Therefore, our AI/machine learning platform, The Cube, integrates multi-omic data, offering a uniquely comprehensive approach to cancer detection by leveraging a library of trained models for multiple omic layers. One such model Flamingo focuses on is the detection of cancer from ultra-low pass whole genome sequencing (ULP-WGS) cfDNA data using fragmentomics.
Flamingo's development marks a significant milestone in the quest for early cancer detection with RenovaroCube’s engine. By utilizing as few as only 200,000 cell-free DNA fragments per sample, integrating fragment lengths, sequence motifs and employing a meticulously designed neural network, Flamingo achieves remarkable performance in distinguishing cancer from healthy samples.
By augmenting The Cube's arsenal of models operating across various omic layers, Flamingo contributes to the development of non-invasive diagnostics to detect cancer early, enabling timely interventions and improving patient outcomes.
"Adding Flamingo to our Cube will accelerate our efforts to realize a paradigm shift in cancer detection," affirms Frank van Asch, CTO, RenovaroCube. "With its introduction, we are one step closer to realizing our vision of a world where cancer is detected and treated swiftly, saving countless lives in the process."
RenovaroCube invites interested doctors and scientists from international research institutions, clinical cancer centers and all stakeholders to join in the early research use application of our AI/machine learning platform to advance cancer diagnostics and pave the way for a healthier future.
About Renovaro:
Please see a recent interview with Avram Miller, Member of, and Advisor to, the Board of Directors, former co-founder of Intel Capital and SVP of Business Development for Intel:
https://techbullion.com/avram-miller-talks-ab...es-with-ai
Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroBio, with its advanced cell-gene immunotherapy company, and RenovaroCube. RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in cancer care.
Upon the closing of the previously announced acquisition of Cyclomics (winner of the Health Holland Venture Challenge), RenovaroCube will be capable of performing liquid biopsies using proprietary technologies to identify single cancer DNA molecules in only one vial of blood. In combination with Oxford Nanopore Technology, genetic information can be retrieved over multiple genetic layers to develop the next generation of cancer diagnostics. This will transform cancer care by enabling faster and more accurate diagnosis throughout the patient journey.
https://www.renovarogroup.com
https://www.renovarobio.com
https://www.renovarocube.com
About Cyclomics:
Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.
https://www.cyclomics.com/
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline and platform. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For media inquiries, please contact: karen@renovarocube.com
Source: Renovaro Inc.
$RENB News: Transforming Cancer Detection: RenovaroCube Introduces Flamingo, a novel AI model based on Fragmentomics
LOS ANGELES and AMSTERDAM, April 30, 2024 (GLOBE NEWSWIRE) -- RenovaroCube, wholly owned subsidiary of Renovaro, Inc. (Nasdaq: RENB), a company at the forefront of AI-driven healthcare innovation, proudly unveils Flamingo, a potentially groundbreaking multi-cancer detection model contributing to its mission to transform early cancer diagnostics. Leveraging ultra-low pass whole genome sequencing (ULP-WGS) of cell-free DNA (cfDNA), Flamingo represents a promising leap forward in the fight against cancer.
Traditional cancer detection methods often fall short in identifying cancers at an early stage when treatment is the most effective. However, Flamingo has the potential to overcome these limitations by harnessing the power of AI to analyze minute amounts of cfDNA data that is highly accurate.
"At RenovaroCube, we believe in pushing the boundaries of possibility," states Daan Vessies, senior scientist at RenovaroCube. "Flamingo undescores our commitment to change cancer diagnostics in a transformative way, ultimately offering clinicians a powerful tool to detect cancer across diverse omic layers."
The Company believes that no single model or molecular modality will reach the requisite sensitivity and specificity throughout the entire patient journey for personalized, precision medicine, from early detection, to predicting the effectiveness of various treatment options, to monitoring the response to therapy within days of starting it, to detecting recurrence at the earliest possible moment. Therefore, our AI/machine learning platform, The Cube, integrates multi-omic data, offering a uniquely comprehensive approach to cancer detection by leveraging a library of trained models for multiple omic layers. One such model Flamingo focuses on is the detection of cancer from ultra-low pass whole genome sequencing (ULP-WGS) cfDNA data using fragmentomics.
Flamingo's development marks a significant milestone in the quest for early cancer detection with RenovaroCube’s engine. By utilizing as few as only 200,000 cell-free DNA fragments per sample, integrating fragment lengths, sequence motifs and employing a meticulously designed neural network, Flamingo achieves remarkable performance in distinguishing cancer from healthy samples.
By augmenting The Cube's arsenal of models operating across various omic layers, Flamingo contributes to the development of non-invasive diagnostics to detect cancer early, enabling timely interventions and improving patient outcomes.
"Adding Flamingo to our Cube will accelerate our efforts to realize a paradigm shift in cancer detection," affirms Frank van Asch, CTO, RenovaroCube. "With its introduction, we are one step closer to realizing our vision of a world where cancer is detected and treated swiftly, saving countless lives in the process."
RenovaroCube invites interested doctors and scientists from international research institutions, clinical cancer centers and all stakeholders to join in the early research use application of our AI/machine learning platform to advance cancer diagnostics and pave the way for a healthier future.
About Renovaro:
Please see a recent interview with Avram Miller, Member of, and Advisor to, the Board of Directors, former co-founder of Intel Capital and SVP of Business Development for Intel:
https://techbullion.com/avram-miller-talks-ab...es-with-ai
Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroBio, with its advanced cell-gene immunotherapy company, and RenovaroCube. RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in cancer care.
Upon the closing of the previously announced acquisition of Cyclomics (winner of the Health Holland Venture Challenge), RenovaroCube will be capable of performing liquid biopsies using proprietary technologies to identify single cancer DNA molecules in only one vial of blood. In combination with Oxford Nanopore Technology, genetic information can be retrieved over multiple genetic layers to develop the next generation of cancer diagnostics. This will transform cancer care by enabling faster and more accurate diagnosis throughout the patient journey.
https://www.renovarogroup.com
https://www.renovarobio.com
https://www.renovarocube.com
About Cyclomics:
Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.
https://www.cyclomics.com/
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline and platform. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For media inquiries, please contact: karen@renovarocube.com
Source: Renovaro Inc.
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression
NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076)
Both NRX-101 and lurasidone, an accepted standard of care in Bipolar Depression, demonstrated approximately 50% reduction in symptoms of depression
These data are comparable to previous statistically-significant finding of reduced suicidality and in the published STABIL-B trial and support an approval pathway via a 300-person registrational trial with sustained remission in suicidality as the primary endpoint
Company believes that an oral antidepressant that demonstrates reduction in suicidality has potential to become standard of care for treatment of bipolar depression.
Data from this study expand the potential utility of NRx-101 to treat both patients with suicidal bipolar depression (who will require prior use of ketamine) and those without subacute suicidality (nearly 7 million patients in the US).
RADNOR, Pa., April 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company today that its Breakthrough Therapy designated investigational drug NRX-101 vs lurasidone demonstrated a promising, though not yet statistically significant 33% reduction in suicidality together with a 70% reduction (P=.076) reduction in symptoms of akathisia – a side effect of antidepressants that is closely linked to suicide and considered a medical emergency. Because of the high-risk nature of these patients, a placebo group could not be employed, and NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone, was compared to lurasidone alone (the standard of care). In the Company's previously published STABIL-B trial (STABIL-B), NRX-101 was demonstrated to be superior to lurasidone in reducing both depression and suicidality after ketamine while showing a trend towards reducing akathisia (a side effect involving restlessness and agitation that is considered a warning sign of impending suicide). In this trial, without prior use of ketamine, NRX-101 and lurasidone were comparable in their effect on depression. The trial was a randomized, prospective, double-blind study conducted at multiple sites in the Unites States whose protocol and statistical analysis plan may be viewed on www.clinicaltrials.gov (NCT03395392).
"We are gratified by these results, which extend the findings of the STABIL-B trial in suggesting that NRX-101 has the potential to be the first oral antidepressant to decrease potential for suicide, whereas all currently approved oral antidepressants are known to increase the risk of suicide," said Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist. "Should these findings be confirmed in a registrational trial of 300 patients, NRX-101 has the potential to represent a paradigm-changing blockbuster drug. The finding of a dramatic difference in akathisia was also seen in the STABIL-B trial and provides important mechanistic support for the difference seen on the Columbia Suicide Severity Rating Scale. Many of the patients who tragically die from suicide in bipolar depression are taking traditional antidepressants at the time of their death, a tragedy we have seen within the families of our investors and board members, as well as the many patients we have known. If today's findings are replicated in a registration-sized trial, we will change the world for patients who currently have a 50% lifetime risk of suicide attempt, a 20% lifetime risk of death by suicide, and whose only approved treatment option today is electroshock therapy."
"These findings are consistent with our original Phase 2 objectives and promising zone methodology in terms of a demonstrable advantage of NRX-101 compared to the standard of care in treating patients with bipolar depression who are known to be at high risk of suicide. We originally proposed to test suicidality, rather than depression as the primary endpoint for this trial and took the advice of senior FDA leadership that demonstrating a difference in suicidality might be too challenging. Today's findings demonstrate that differences in suicidality and akathisia can be demonstrated compared to best available antidepressant therapy in a properly sized registration trial and that superiority over placebo on the depression scale may readily be demonstrated in a less acute patient population where it would be safe to do so," said Dr. Philip Lavin, the study's Lead Methodologist. Dr. Lavin is one of the world's most widely published statisticians who has led the approval/clearance of more than 80 drugs, devices, and biologics.
In the current study, without prior use of ketamine, NRX-101 and lurasidone exhibited comparable antidepressant effects, each reducing depression (the primary endpoint) on the Montgomery Asberg Depression Rating Scale (MADRS) by about 50% from baseline. Lurasidone is known to reduce symptoms of depression by approximately 4 points in multiple registration trials compared to placebo.
Analysis of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) demonstrated a sustained 33% advantage in remission from suicidality favoring NRX-101 (see figure). This difference was not statistically significant at the phase 2 sample size but met the study's original promising zone criteria and, if sustained in a registration trial of 300 or more patients, would be powered to yield a statistically significant result. The reduction in suicidality is comparable to that demonstrated after ketamine, both in the Company's STABIL-B trial and in an independently conducted trial comparing DCS to placebo after ketamine (Chen, et. al.). A meaningful remission in suicidality has not been demonstrated with any prior oral antidepressant drug – indeed, antidepressant drugs carry a Black Box warning of increased suicide risk.
Reduction in akathisia was first identified in the laboratory as a distinguishing feature of DCS and is the basis of the approved claims in the Company's Composition of Matter patents. Akathisia is often characterized as a state of agitation and motor restlessness that is associated with particularly impulsive and tragically effective attempts at suicide, such as hanging, shooting, jumping from buildings and in front of vehicles and trains. In this trial, a 75% relative difference was seen on the Barnes Akathisia Rating Scale (BARS), with two-sided P=0.076, which would be expected to achieve significance in a properly powered registration-sized trial. While reduction in akathisia is not proposed as a primary labeled indication, continued finding of a statistically significant reduction in this side effect would be highly supportive of a demonstrated primary endpoint of reduced suicidality and would provide clinical corroboration.
Based on these findings and widespread adoption of ketamine as initial treatment for suicidal depression, the Company believes that NRX-101 may become the drug of choice for potentiating the effect of ketamine in patients with acute and subacute suicidality. The FDA recently affirmed to the Company that the Special Protocol Agreement for this indication remains in place, subject to the Company filing a New Drug Approval for ketamine, which is expected by July 2024. Moreover the Company aims to explore the role of NRX-101 as primary treatment for the much larger population (approximately 7 million in the US) of patients with bipolar depression who do not have active suicidality and, therefore, do not require prior treatment with intravenous ketamine.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
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SOURCE NRx Pharmaceuticals
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression
NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076)
Both NRX-101 and lurasidone, an accepted standard of care in Bipolar Depression, demonstrated approximately 50% reduction in symptoms of depression
These data are comparable to previous statistically-significant finding of reduced suicidality and in the published STABIL-B trial and support an approval pathway via a 300-person registrational trial with sustained remission in suicidality as the primary endpoint
Company believes that an oral antidepressant that demonstrates reduction in suicidality has potential to become standard of care for treatment of bipolar depression.
Data from this study expand the potential utility of NRx-101 to treat both patients with suicidal bipolar depression (who will require prior use of ketamine) and those without subacute suicidality (nearly 7 million patients in the US).
RADNOR, Pa., April 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company today that its Breakthrough Therapy designated investigational drug NRX-101 vs lurasidone demonstrated a promising, though not yet statistically significant 33% reduction in suicidality together with a 70% reduction (P=.076) reduction in symptoms of akathisia – a side effect of antidepressants that is closely linked to suicide and considered a medical emergency. Because of the high-risk nature of these patients, a placebo group could not be employed, and NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone, was compared to lurasidone alone (the standard of care). In the Company's previously published STABIL-B trial (STABIL-B), NRX-101 was demonstrated to be superior to lurasidone in reducing both depression and suicidality after ketamine while showing a trend towards reducing akathisia (a side effect involving restlessness and agitation that is considered a warning sign of impending suicide). In this trial, without prior use of ketamine, NRX-101 and lurasidone were comparable in their effect on depression. The trial was a randomized, prospective, double-blind study conducted at multiple sites in the Unites States whose protocol and statistical analysis plan may be viewed on www.clinicaltrials.gov (NCT03395392).
"We are gratified by these results, which extend the findings of the STABIL-B trial in suggesting that NRX-101 has the potential to be the first oral antidepressant to decrease potential for suicide, whereas all currently approved oral antidepressants are known to increase the risk of suicide," said Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist. "Should these findings be confirmed in a registrational trial of 300 patients, NRX-101 has the potential to represent a paradigm-changing blockbuster drug. The finding of a dramatic difference in akathisia was also seen in the STABIL-B trial and provides important mechanistic support for the difference seen on the Columbia Suicide Severity Rating Scale. Many of the patients who tragically die from suicide in bipolar depression are taking traditional antidepressants at the time of their death, a tragedy we have seen within the families of our investors and board members, as well as the many patients we have known. If today's findings are replicated in a registration-sized trial, we will change the world for patients who currently have a 50% lifetime risk of suicide attempt, a 20% lifetime risk of death by suicide, and whose only approved treatment option today is electroshock therapy."
"These findings are consistent with our original Phase 2 objectives and promising zone methodology in terms of a demonstrable advantage of NRX-101 compared to the standard of care in treating patients with bipolar depression who are known to be at high risk of suicide. We originally proposed to test suicidality, rather than depression as the primary endpoint for this trial and took the advice of senior FDA leadership that demonstrating a difference in suicidality might be too challenging. Today's findings demonstrate that differences in suicidality and akathisia can be demonstrated compared to best available antidepressant therapy in a properly sized registration trial and that superiority over placebo on the depression scale may readily be demonstrated in a less acute patient population where it would be safe to do so," said Dr. Philip Lavin, the study's Lead Methodologist. Dr. Lavin is one of the world's most widely published statisticians who has led the approval/clearance of more than 80 drugs, devices, and biologics.
In the current study, without prior use of ketamine, NRX-101 and lurasidone exhibited comparable antidepressant effects, each reducing depression (the primary endpoint) on the Montgomery Asberg Depression Rating Scale (MADRS) by about 50% from baseline. Lurasidone is known to reduce symptoms of depression by approximately 4 points in multiple registration trials compared to placebo.
Analysis of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) demonstrated a sustained 33% advantage in remission from suicidality favoring NRX-101 (see figure). This difference was not statistically significant at the phase 2 sample size but met the study's original promising zone criteria and, if sustained in a registration trial of 300 or more patients, would be powered to yield a statistically significant result. The reduction in suicidality is comparable to that demonstrated after ketamine, both in the Company's STABIL-B trial and in an independently conducted trial comparing DCS to placebo after ketamine (Chen, et. al.). A meaningful remission in suicidality has not been demonstrated with any prior oral antidepressant drug – indeed, antidepressant drugs carry a Black Box warning of increased suicide risk.
Reduction in akathisia was first identified in the laboratory as a distinguishing feature of DCS and is the basis of the approved claims in the Company's Composition of Matter patents. Akathisia is often characterized as a state of agitation and motor restlessness that is associated with particularly impulsive and tragically effective attempts at suicide, such as hanging, shooting, jumping from buildings and in front of vehicles and trains. In this trial, a 75% relative difference was seen on the Barnes Akathisia Rating Scale (BARS), with two-sided P=0.076, which would be expected to achieve significance in a properly powered registration-sized trial. While reduction in akathisia is not proposed as a primary labeled indication, continued finding of a statistically significant reduction in this side effect would be highly supportive of a demonstrated primary endpoint of reduced suicidality and would provide clinical corroboration.
Based on these findings and widespread adoption of ketamine as initial treatment for suicidal depression, the Company believes that NRX-101 may become the drug of choice for potentiating the effect of ketamine in patients with acute and subacute suicidality. The FDA recently affirmed to the Company that the Special Protocol Agreement for this indication remains in place, subject to the Company filing a New Drug Approval for ketamine, which is expected by July 2024. Moreover the Company aims to explore the role of NRX-101 as primary treatment for the much larger population (approximately 7 million in the US) of patients with bipolar depression who do not have active suicidality and, therefore, do not require prior treatment with intravenous ketamine.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at 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.
https://c212.net/c/img/favicon.png?sn=CL01020&sd=2024-04-30 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-announces-promising-findings-in-phase-2b3-clinical-trial-of-nrx-101-vs-lurasidone-for-treatment-of-suicidal-bipolar-depression-302131482.html
SOURCE NRx Pharmaceuticals
$GCEH News: Louis Dreyfus Company (LDC), Global Clean Energy Holdings, Inc., and Bayer Announce Strategic Collaboration to Promote Camelina Cultivation in Argentina as Part of Bayer's PRO Carbono Program
Press Release | 05/02/2024
Louis Dreyfus Company (LDC), Global Clean Energy Holdings, Inc., and Bayer announced today a strategic collaboration to promote camelina cultivation as part of Argentina Bayer's PRO Carbono Program, in line with the companies' efforts to drive decarbonization in the supply chain and, ultimately, more efficient and sustainable agricultural production.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240502159694/en/
Camelina is used as an ultra-low carbon feedstock for advanced biofuels production. It is an “intermediate crop” planted between main crops in Argentina during winter, helping to preserve soil health, especially between summer crops of soy and corn. It is already promoted in Argentina by LDC and Global Clean Energy, as part of their strategic collaboration since 2023.
The collaboration announced today is aligned with LDC's global sustainability strategy, a key focus of which is to contribute to global climate goals by driving decarbonization in its operations and supply chains, including through efforts to drive adoption of regenerative agriculture practices in key supply sheds.
“This collaboration is an important step toward more sustainable agricultural production in Argentina and is in line with LDC’s collaborative approach to sustainable business, taking into account the needs and challenges of all value chain participants - particularly producers, on whom the global food and agricultural system depends and whose actions have such an important role in mitigating climate change,” said Juan José Blanchard, LDC’s Group COO and Head of Latin America.
Global Clean Energy is the world’s leading camelina producer, with over 18 years of camelina breeding history and more than 65,000 acres contracted in the US, South America, and Europe in 2023. Global Clean Energy is dedicated to developing and offering the most adaptable and high-yielding camelina varieties for producers, with an exclusive collection of 20 camelina varieties, including those suited for both spring and winter planting. The company is currently developing new traits (including herbicide tolerance) to introduce camelina cultivation across a wide range of geographies and crop rotations.
Global Clean Energy has partnered with LDC to advance camelina production in South America through superior genetics delivery, camelina seed production, crop promotion, and technical support to producers through its Camelina Company brand.
"We are excited to expand our work in Argentina with LDC by joining forces with Bayer's PRO Carbono program," said Noah Verleun, President and CEO of Global Clean Energy. "This strategic collaboration brings us one step closer to making camelina a key contributor to regenerative agriculture, while scaling sustainable feedstock production for advanced biofuels globally."
Bayer promotes regenerative agriculture by combining sustainable solutions and digital tools to produce more with fewer resources while restoring nature, seeking not only to improve harvests but also to deliver positive results for the environment. As such, and in collaboration with other industry players, Bayer’s PRO Carbono program helps producers to implement sustainable agronomic practices that increase productivity, reduce emissions and capture more carbon from the soil, in particular direct sowing, increased crop rotation, and cover crop incorporation to keep soils covered for most of the year.
“At Bayer, we are committed to generating transformative change to achieve a carbon neutral future for agriculture. This collaboration marks a significant milestone on the path toward more sustainable agriculture that is resilient to climate change, especially in the current global context that demands food and other products, such as fuel, with a low carbon footprint,” said Juan Farinati, President and CEO of Bayer Cono Sur and Head of the Crop Science Cono Sur Division. "Leading the change towards a more responsible agricultural model that restores soils is possible. In this case, by incorporating camelina as a winter cash cover crop alternative, in line with the goals of the PRO Carbono program," he concluded.
About Louis Dreyfus Company
Louis Dreyfus Company is a leading merchant and processor of agricultural goods, founded in 1851. We leverage our global reach and extensive asset network to serve our customers and consumers around the world, delivering the right products to the right location, at the right time - safely, reliably and responsibly. Our activities span the entire value chain, from farm to fork, across a broad range of business lines (platforms): Carbon Solutions, Coffee, Cotton, Food & Feed Solutions, Freight, Global Markets, Grains & Oilseeds, Juice, Rice and Sugar. We help feed and clothe some 500 million people every year by originating, processing and transporting approximately 80 million tons of products. Louis Dreyfus Company is active in over 100 countries across six geographical regions, and employs approximately 18,000 people globally. For more information, visit www.ldc.com and follow us on LinkedIn, X and WeChat (ID: we_are_ldc).
About Global Clean Energy Holdings
Global Clean Energy Holdings, Inc. (OTCQB:GCEH) is a vertically integrated renewable fuels company specializing in the development and cultivation of camelina, a nonfood, regenerative, intermediate oilseed crop, which is used for the production of advanced biofuels and biomaterials. With a vision that begins in the laboratory, moves through the farm gate, and finishes with renewable fuels, GCEH’s farm-to-fuels value chain integration provides unrivaled access to reliable, ultra-low carbon feedstocks and is unparalleled in the sustainable fuels industry. To learn more, visit www.GCEholdings.com. For information about growing camelina in South America visit http://www.CamelinaCompany.ar.
About Bayer
Bayer is a global company with core competencies in the life sciences fields of healthcare and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to address the key challenges posed by a growing and aging global population. Bayer is committed to driving sustainable development and making a positive impact through its business activities. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand is synonymous with trust, reliability, and quality worldwide. In fiscal year 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. Research and development expenses before special items amounted to 6.2 billion euros. For more information, visit www.bayer.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240502159694/en/
$NCL News: Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product Wins Multiple Prestigious Awards in 2024
ELK GROVE, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Northann Corp. (NYSE American: NCL), a leader in innovative sustainable solutions, today announced that its Blue11-Ocean Plastic Flooring and Wall Panels Product has been recognized this year with industry awards for outstanding design, commitment to sustainability, and impeccable craftsmanship.
These awards include:
American Good Design Award 2024
French Design Award 2024
IDA Design Awards 2024
New York Product Design Awards
Green Product Award
Best Surfaces in TISE 2024
"We are truly honored to receive these prestigious awards, which underscore our commitment to creating products that are not only visually captivating but also environmentally conscious," remarked Northann Corp. CEO Lin Li. "This recognition fuels our passion to continue delivering innovative and sustainable solutions that resonate with our customers and contribute positively to the environment.
“Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product stands as a shining example of our company's enduring pursuit of excellence and sustainability.”
To learn more about this award-winning product and Northann Corp.'s comprehensive range of sustainable solutions, please visit www.northann.com and www.benchwick.com.
About Northann Corp.
Northann specializes in 3D-printed flooring solutions under its flagship brand, "Benchwick." The Company's operations span the full spectrum of additive manufacturing, from sourcing recycled ocean plastics to the final production of intricate flooring designs. Northann offers its 3D printing ecosystem as an extensive range of proprietary solutions, including Infinite Glass, DSE, TruBevel, and MattMaster, primarily through its sales network in North America and Europe. The Company aims to redefine the essence of modern flooring and wall panels by offering stylish, durable, and ecologically conscious solutions.
For more information about Northann, please visit http://www.northann.com.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
For investor and media inquiries, please contact:
Investor Relations
Northann Corp.
Email: ir@northann.com
Phone: +1 (916) 573-3803
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor New York, NY, 10036
Office: (646) 893-5835 x2
Email: info@skylineccg.com
$NCL News: Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product Wins Multiple Prestigious Awards in 2024
ELK GROVE, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Northann Corp. (NYSE American: NCL), a leader in innovative sustainable solutions, today announced that its Blue11-Ocean Plastic Flooring and Wall Panels Product has been recognized this year with industry awards for outstanding design, commitment to sustainability, and impeccable craftsmanship.
These awards include:
American Good Design Award 2024
French Design Award 2024
IDA Design Awards 2024
New York Product Design Awards
Green Product Award
Best Surfaces in TISE 2024
"We are truly honored to receive these prestigious awards, which underscore our commitment to creating products that are not only visually captivating but also environmentally conscious," remarked Northann Corp. CEO Lin Li. "This recognition fuels our passion to continue delivering innovative and sustainable solutions that resonate with our customers and contribute positively to the environment.
“Northann Corp.'s Blue11-Ocean Plastic Flooring and Wall Panels Product stands as a shining example of our company's enduring pursuit of excellence and sustainability.”
To learn more about this award-winning product and Northann Corp.'s comprehensive range of sustainable solutions, please visit www.northann.com and www.benchwick.com.
About Northann Corp.
Northann specializes in 3D-printed flooring solutions under its flagship brand, "Benchwick." The Company's operations span the full spectrum of additive manufacturing, from sourcing recycled ocean plastics to the final production of intricate flooring designs. Northann offers its 3D printing ecosystem as an extensive range of proprietary solutions, including Infinite Glass, DSE, TruBevel, and MattMaster, primarily through its sales network in North America and Europe. The Company aims to redefine the essence of modern flooring and wall panels by offering stylish, durable, and ecologically conscious solutions.
For more information about Northann, please visit http://www.northann.com.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
For investor and media inquiries, please contact:
Investor Relations
Northann Corp.
Email: ir@northann.com
Phone: +1 (916) 573-3803
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor New York, NY, 10036
Office: (646) 893-5835 x2
Email: info@skylineccg.com
$IVDN: Our R-6 Rated Insultex House Wrap (TM) meets or exceeds the standards in new building codes taking effect in 2024. A patented evacuated cell design outperforms all competitive products for energy efficiency. Plus, we add a moisture barrier. Visit: http://insultexhousewrap.com
$IVDN: Our R-6 Rated Insultex House Wrap (TM) meets or exceeds the standards in new building codes taking effect in 2024. A patented evacuated cell design outperforms all competitive products for energy efficiency. Plus, we add a moisture barrier. Visit: https://t.co/LWNDwJcXDh https://t.co/cpzRpf93uy pic.twitter.com/lVTRv8wUXY
— Innovative Designs, Inc (Stock: $IVDN) (@riccelli_joseph) May 1, 2024
$IVDN: Our R-6 Rated Insultex House Wrap (TM) meets or exceeds the standards in new building codes taking effect in 2024. A patented evacuated cell design outperforms all competitive products for energy efficiency. Plus, we add a moisture barrier. Visit: http://insultexhousewrap.com
$IVDN: Our R-6 Rated Insultex House Wrap (TM) meets or exceeds the standards in new building codes taking effect in 2024. A patented evacuated cell design outperforms all competitive products for energy efficiency. Plus, we add a moisture barrier. Visit: https://t.co/LWNDwJcXDh https://t.co/cpzRpf93uy pic.twitter.com/lVTRv8wUXY
— Innovative Designs, Inc (Stock: $IVDN) (@riccelli_joseph) May 1, 2024
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Over the past few months we have made some huuuge changes.We have assembled a team of well connected consultants & a great sales team. Many huuuge meetings set up, every deal will close will be millions in revenue!Once FINRA approves the name change we will put out big news $GMPR pic.twitter.com/PPxTFlG3xW
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