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Great news!!
ResolutionRx Ltd, a wholly owned subsidiary of RespireRx Pharmaceuticals Inc. Enters into LOI and Term Sheet with Radium Capital for the financing of anticipated Research and Development Credits
Glen Rock, N.J., February 1, 2023 /Globe Newswire - RespireRx Pharmaceuticals Inc. (OTC Markets: RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that, on January 27, 2023, ResolutionRx Ltd (“ResolutionRx”), a newly formed Australian unlisted public company, and initially, a wholly-owned subsidiary of RespireRx, entered into a Letter of Intent (“LOI”) and Term Sheet (“Term Sheet”) with Radium Capital (“Radium”). The LOI and Term Sheet summarize the background and principal terms of a series of planned financing arrangements between Radium Capital (“Radium”) and ResolutionRx Ltd, in order to unlock research and development tax credits available in Australia to companies like ResolutionRx.
ResolutionRx and Radium have agreed to enter into a series of loan agreements which in the United States may be considered to be analogous to a line of credit designed to finance research and development (R&D) efforts prior to receipt of The Research and Development Tax Incentive (“R&DTI”) funding from the Australian government. According to the Australia government website https://business.gov.au/grants-and-programs/research-and-development-tax-incentive, “The Research and Development Tax Incentive (R&D Tax Incentive or R&DTI) helps companies innovate and grow by offsetting some of the costs of eligible research and development (R&D).”
The R&DTI is the sum of the R&D company’s corporate tax rate and an incentive rate, subject to certain limitations. In the case of ResolutionRx, the R&DTI is expected to be comprised of a corporate tax rate of 25% plus the incentive rate of 18.5% for a total of 43.5% and would represent an annual refund after the filing of ResolutionRx’s annual tax return as of 30th June of each year. Subject to an Overseas Finding, certain R&D expenditures outside Australia will be eligible.
“The LOI and Term Sheet announced today creates a means of realizing the R&DTI funds well in advance of the annual cash receipt from the Australian government and, as such, create a very valuable non-dilutive means of supporting our R&D efforts towards the commercialization of dronabinol for the treatment of obstructive sleep apnea (OSA),” said Jeff Margolis, Director and Senior Financial Officer of ResolutionRx and Director and Chief Financial Officer of RespireRx.”
IMO, it is about time that we broke out of these doldrums. Every stock I own or that I watch has done next to nothing for almost 4 years. This stagnation has got to end sometime.
IMO, you may be correct.
RespireRx Pharmaceuticals Inc. Establishes ResolutionRx Ltd in Australia to Develop Its Pharmaceutical Cannabinoid Platform
Glen Rock, N.J., January 12, 2023 /Globe Newswire - RespireRx Pharmaceuticals Inc. (OTC Markets: RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that, on January 11, 2023, it established ResolutionRx Ltd (“ResolutionRx”), a new, currently wholly-owned, unlisted public company in Australia, as the first in a series of steps that include, but are not limited to financings, research and clinical development, manufacturing, regulatory and compliance, all for the purpose of developing compounds that target the body’s endocannabinoid system, and in particular, the re-purposing of dronabinol, an endocannabinoid CB1 and CB2 receptor agonist, for the treatment of obstructive sleep apnea (“OSA”). The Company will contribute certain dronabinol assets and certain liabilities to ResolutionRx.
One of the main purposes for the creation of ResolutionRx was to allow it to participate in the Australian research and development tax credit which in the case of ResolutionRx, is a refund of 43.5% of qualified research and development expenditures as reported on ResolutionRx’s Australian tax return. ResolutionRx is in late stage discussions with an Australia based fund to establish a finance facility secured by the tax credits in order to finance a substantial percentage of the credit associated with the qualified expenditiures over the course of the research and development timeline in advance of the final receipt of the tax credit funds. In addition, ResolutionRx is in late stage negotiations for an equity or equity-linked financing of up to 25% of the research and development budget to be used exclusively to support the research and development budget. Inherent in this financing is a commitment to list ResolutionRx on the Australian Stock Exchange (ASX). ResolutionRx’s intent is to list on the ASX and one or more public exchanges outside of Australia, including the United States.
As the Company has previously announced, in support of ResolutionRx, we have entered into a letter of intent and is preparing a final, definitive agreement with an Australian headquartered, bespoke specialty contract research organization (“CRO”) exclusively focused on cannabinoid and psychedelic clinical research. This CRO is expected to provide full service CRO services, including regulatory, compliance and manufacturing services, either directly or through sub-contractors, in addition to conducting human pharmacokinetic and pivotal efficacy and safety studies of dronabinol. It is anticipated that RespireRx will use, at least initially, its management personnel to provide management, operational and oversight services to ResolutionRx.
According to Jeff Margolis, Chief Financial officer of RespireRx and a Director of ResolutionRx, “We believe that creating ResolutionRx has made it possible to access finance channels separate from and possibly in addition to those of the Company, in order to unlock the unrealized asset values of our pharmaceutical cannabinoid program. We also believe that this will enable us to accelerate the development of dronabinol for OSA with cost effective access to capital while accessing certain financial incentives available in Australia.”
Arnold Lippa, Executive Chairman, Interim CEO and Interim President and Chief Scientific Officer of RespireRx and a Director of ResolutionRx, “I look forward to building this new company and working with our new Australian colleagues. I hope that this approach might interest other small biotech companies to seek novel approaches for overcoming some of the limitations experienced in the United States financial markets.”
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the discovery and development of medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including obstructive sleep apnea (“OSA”), attention deficit hyperactivity disorder (“ADHD”), epilepsy, pain, recovery from spinal cord injury (“SCI”), and certain neurological orphan diseases . RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ?9-tetrahydrocannabinol (“?9-THC”) that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”) AMPA-type glutamate receptors and GABAA receptors, respectively.
The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
ResolutionRx: Pharmaceutical Cannabinoids.
Dronabinol. RespireRx’s ResolutionRx subsidiary is developing dronabinol, ?-9-THC, a synthetic version of the naturally occurring substance in the cannabis plant, for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine (“AASM”), published in August 2016. OSA has been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the United States of $162 billion according to the AASM. There are no approved drug treatments for OSA.
Two Phase 2 clinical trials have been completed demonstrating the ability of dronabinol to significantly reduce the symptoms of OSA and, subject to raising sufficient financing (of which no assurance can be provided) ResolutionRx believes that it will be able to commence a pharmacokinetic study, which it intends to conduct in Australia for a recently discovered formulation followed by a Phase 3 international clinical study for the treatment of OSA with the new formulation. Some or all of the human clinical studies are pending the the outcome of an intended meeting with the US FDA. Because dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, the Company further believes that its re-purposing strategy would only require approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway that allows the use of publicly available data.
EndeavourRx: Neuromodulators
GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. (“UWMRF”) and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. The Company currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.
KRM-II-81 has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop to its anti-convulsant properties. These latter results are particularly important because pharmaco-resistance occurs when medications that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability of KRM-II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment resistant epileptic patients undergoing surgery.
In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic.
AMPAkines. Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, the Company has developed a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven neurobehavioral and cognitive disorders, spinal cord injury, neurological diseases, and certain orphan indications. Our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression.
AMPAkines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic effects were observed within one week. We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non stimulants, such as Straterra® (atomoxetine), and without the drawbacks of amphetamine-type stimulants.
In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, Dr. David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, the Company’s lead AMPAkines, to improve motor nerve activity and muscle function in animal models of spinal cord injury (SCI).
Additional information about RespireRx and the matters discussed herein can be obtained on the Company’s web-site at www.RespireRx.com or in the Company’s filings with the Securities and Exchange Commission at www.sec.gov.
Company Contact:
Jeff Margolis
Senior Vice President, Chief Financial Officer, Treasurer and Secretary
Telephone: 917-834-7206
Email: jmargolis@respirerx.com
RespireRx Pharmaceuticals Inc.
126 Valley Road, Suite C
Glen Rock, NJ 07452
www.respirerx.com
Looking really good here. Let's light this candle.
We all know that the number of shares outstanding here is huge. But given the volumes we see daily, the number of shares in the float must be much, much less than the O/S. Do we know for sure what the float actually is?
NEWS out!
Good interview. Everyone should watch this one.
RespireRx Pharmaceuticals Inc. Enters a Collaboration With National Institute for Neurological Disorders and Stroke to Advance its Lead GABAkine Toward Clinical Development
Glen Rock, N.J., December 5, 2022 /Globe Newswire - RespireRx Pharmaceuticals Inc. (OTC Markets: RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that RespireRx has been accepted into the NIH HEAL Initiative® NINDS Preclinical Screening Platform for Pain (PSPP) program.
The Company’s lead GABAkine, KRM-II-81, has been shown to be effective in relieving acute, chronic, and neuropathic pain in a number of models without tolerance development or sedation.
The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.
The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide. For more information, visit: https://heal.nih.gov/research/preclinical-translational/screening-platform.
The RespireRx team is led by Dr. Arnold Lippa, RespireRx Executive Chairman and Chief Scientific Officer and Drs. James M. Cook, Jeffrey M. Witkin and Rok Cerne, all of whom are RespireRx Research Fellows in addition to their academic affiliations at University of Wisconsin-Milwaukee, Ascension St. Vincent and Indiana University/Purdue University, respectively. The team has extensive expertise in drug discovery and development including the development of novel analgesic drugs and an extensive publication record with a combined total of over 1,000 scientific publications. The team has already profiled KRM-II-81 activity in a broad range of preclinical studies where it has displayed a high degree of analgesic activity and is excited at the prospect of advancing the Companay’s lead GABAkine toward clinical development. In cellular studies, KRM-II-81 preferentially bound to specific subtypes of GABAA receptors and boosted the ability of GABA to inhibit pain sensory neurons in the spinal dorsal root ganglia. In intact animal models of acute and chronic pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression, or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic.
Unrelated to the NINDS project, KRM-II-81 has also shown promising results in multiple animal models of treatment resistant epilepsy and in human translational studies by reducing epileptiform electrical signaling in brain tissue removed from treatment resistant epileptic patients undergoing surgery.
Dr. Cerne commented “We believe that the expansion of our understanding of GABAA receptor structure and function has created a new surge in the discovery and development of GABAkines that target such receptors in a unique manner. This opens the promise of improved medicines for pain, epilepsy and other disorders caused by disruption of neuronal signaling.”
Dr. Lippa added, “We are very excited about developing KRM-II-81 and expanding the IND enabling studies so as to begin human studies. Pending clinical validation, we believe that KRM-II-81 has the potential to represent a breakthrough treatment for pain, epilepsy, and other neuropsychiatric disorders.”
I agree.
I have thought the same for a couple of years now.
Link to presentation slides that Margolis will give this week. Pretty impressive, IMO.
link to presentation
Nov 02, 2022
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
NORTHVALE, NJ / November 2, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. IQVIA reported annual revenue for the twelve months ending August 2022 of $12 million for the generic market for this product.
The studies were single-dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasting states. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.
Adderall shortage, as mentioned here several times lately.
https://www.webmd.com/add-adhd/news/20220916/adderall-shortage-reported-pharmacies-patients
Bologna. Try to short it and report back.
Exactly. Basically, you cannot short OTC stocks. Just ask your broker.
I agree. And that letter was very well written.
Excellent letter, as usual. I am very optimistic about the future. How long? No idea.
And it is the same on every board. I have never understood. What a waste of time that behavior is.
8s are falling.
A bit of a gap up this am.
I realize that it has actually happened, but I have been trading these stocks for about 20 years now. Most CEOs claim they intend to go to the NAS, but it happens to only about 1 in a 1000 companies.
These pinkies NEVER make it to the NASDAQ, and I mean never.
In time, this stock will bust open. No doubt in my mind.
IMO, this RS can't hurt the pps of this stock very much, if at all. After the split, there should only be about 1.5 million shares O/S.
There is "no one" who can bring it down. Just us sellers.
Why the bump today? Anyone see anything?
RespireRx Pharmaceuticals Inc. Announces that Sleep Review has Discussed the RespireRx Dronabinol Obstructive Sleep Apnea (OSA) Program in its June 13, 2022 Edition
Glen Rock, N.J., August 8, 2022 / Globe Newswire – RespireRx Pharmaceuticals Inc. (OTCQ:RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that Sleep Review Magazine has published, in its June 13, 2022 edition, a free e-book entitled “How Close Are We to Drug Therapy for Obstructive Sleep Apnea?”, in which it discusses the RespireRx dronabinol OSA program as one of four emerging drug treatments for the treatment of OSA. (https://sleepreviewmag.com/sleep-disorders/breathing-disorders/obstructive-sleep-apnea/how-close-drug-therapy-obstructive-sleep-apnea/).
Editor Sree Roy stated, “For decades, scientists have been searching for a drug therapy for obstructive sleep apnea (OSA)… An oral pharmacologic treatment that keeps airways open during sleep would be a game-changer… An oral pharmacologic treatment would represent a shift in the perception of sleep apnea therapy, likely resolving adherence obstacles associated with medical device-based treatments for many patients. It could also lead to increased willingness among people with OSA symptoms to undergo sleep testing. I wonder how many people who experience excessive daytime sleepiness refuse diagnosis because they are intimidated by currently available sleep apnea treatment options (or at least by their limited knowledge of available treatments)? Sleep specialists too would also welcome another treatment option—more thera¬pies mean more opportunities to find a therapy most compat¬ible to every patient.”
Two Phase 2 clinical trials have been completed demonstrating the ability of dronabinol to significantly reduce the symptoms of OSA and, subject to raising sufficient financing (of which no assurance can be provided) and pending the outcome of an intended meeting with the FDA, RespireRx believes that it will be able to commence a pharmacokinetic study for a recently discovered and to-be-developed formulation followed by a Phase 3 clinical study for the treatment of OSA with the new formulation.
“Dronabinol is being developed by ResolutionRx, a business unit of the RespireRx. It will be my pleasure to discuss with colleagues the latest developments in pharmaceutical cannabinoids and meet with potential business partners,” said Dr. Lippa
Amen. I am tired of the "pissy" attitude also. Is everyone here new to the OTC market? This frustration is nothing.
I, for one, am really ready for something good to happen here.
I looked into that broker years ago. Yes, they let you short, but you have to maintain a cash balance in your account of $2.50 for every share you want to short. Do the math. No one would do this.
Long story. Not what you think. YOU and I can not short an OTC stock.
Right. In fact, you can't short any OTC stock, but we have discussed this a thousand times on iHub.
We seem solid at this level. New base.
After a couple of years, I am finally even at this moment.
Fridays are always a slow/down day for OTC stocks. If we finish at all green today, I would consider that very bullish for next week.
The upside possibilities here are simply too good not to take a chance. In a week, we will hear more about the two companies that will merge into this ticker.
I love this new base, which is several hundred % higher than it was for months until a week ago.
Great news!!!