Newsfile Corp.Newsfile Corp
Phoenix, Arizona(Newsfile Corp. August 17, 2020) The Stock Day Podcast welcomed RespireRX Pharmaceuticals Inc. (OTCQB: RSPI) (the Company), a leader in the development of medicines for respiratory disorders and CNS indications, with a focus on obstructive sleep apnea (OSA), attention deficit hyperactivity disorder (ADHD), spinal cord injury and other neurological conditions. CEO of the Company, Tim Jones, joined Stock Day host Everett Jolly.
Jolly began the interview by asking about the Companys background and current projects. RespireRX Pharmaceuticals, also known as RSPI, is a small publicly traded company that was originally formed in 1987 under the name Cortex Pharmaceuticals, Inc., to engage in the discovery, development, and commercialization of brand pharmaceuticals for various neurological and psychiatric disorders, explained Jones. We are actively right now developing certain drug products within this platform, he added. The company mission is to develop innovative and revolutionary treatments to combat disorders caused by the disruption of neurological signaling.
He then shared that the Company has consolidated its various drug platforms into two business units: ResolutionRx for the development and commercialization of pharmaceutical cannabinoids, particularly dronabinol, for the treatment of obstructive sleep apnea (OSA) and EndeavourRx for the development and commercialization of ampakines and GABAkines, neuromodulators for the treatment of spinal cord injury, ADHD, epilepsy, neuropathic pain and certain other disorders.
Jolly then noted that the Company appears highly undervalued given their current market capitalization and asked for a quick overview of their products. Jones began by detailing the Companys development of dronabinol, -9-tetrahydrocannabinol (-9-THC) for the treatment of OSA. Weve had two successful Phase II clinical studies, shared Jones. Were Phase III ready, pending completion of a new, controlled release dose formulation, he added.
This is a potential multi-billion dollar market for obstructive sleep apnea (OSA). Theres an estimated 30 million US patients with comparable amounts of patients in the UK and Germany combined, said Jones. There are currently no approved drugs available for OSA in the US or in other key territories.
Jones then discussed EndeavourRx, the Companys business unit developing neuromodulators. EndeavourRx is developing two distinct drug platforms: ampakines and GABAkines, explained Jones. With ampakines, we have a very powerful intellectual property portfolio with patents claiming composition of matter and use, as well as pending patents claiming methods of treating ADHD and spinal cord injury, he shared, noting that the Company has had successful clinical trials with the ampakines demonstrating target site engagement and clinical improvement in ADHD and certain cognitive disorders.
The conversation then turned to the Companys third platform of proprietary medicines, GABAkines, which are being developed to treat disorders like epilepsy and neuropathic pain. These compounds, licensed from the University of Wisconsin Medical Research Foundation, have a strong patent portfolio claiming composition of matter and use.
Jolly then asked about the Companys expansion strategy, as well as their revenue model. Jones shared that the Companys two new business units, ResolutionRx and EndeavourRx, will operate as independent, stand-alone units. These business units will reside under the holding company, RespireRX Pharmaceuticals, said Jones. He then shared that the Company recently secured a $2 million funding commitment and is expecting additional sources of funding within the next 3-6 months. These are rooted across several different investor sources.
In the meantime, Jones shared that the Company will remain aggressively active in searching for additional sources of financial investments, as well as strategic relationships and partnerships.
Jones closed the interview by sharing the potential of the Companys advanced pharmaceutical platforms, which represent safe, efficacious and non-habit forming treatments for disorders that currently have no existing or effective solutions.
To hear the entire interview with Tim Jones, follow the link to the podcast here:https://audioboom.com/posts/7658851-ceo-of-respirerx-pharmaceuticals-inc-tim-jones-is-featured-on-the-stock-day-podcast
Investors Hangoutis a proud sponsor of Stock Day, and Stock Day Media encourages listeners to visit the companys message board athttps://investorshangout.com/
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders and CNS indications, with a focus on obstructive sleep apnea, attention deficit hyperactivity disorder (ADHD), spinal cord injury and other neurological conditions. The Company owns and has exclusive rights to patents and patent applications for certain families of chemical compounds that claim the chemical structures, formulations and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
Cannabinoids.RespireRx is developing dronabinol, -9-tetrahydrocannabinol (-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.
Pending the outcome of an intended meeting with the FDA, RespireRx believes that it will be able to commence a pharmacokinetic study for a to-be-developed new formulation followed by a Phase 3 clinical study for the treatment of OSA with the new formulation. 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.
Project Endeavor
Ampakines.The second platform of proprietary medicines being developed by RespireRx are ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of CNS disorders. In clinical studies of respiratory function, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of certain orphan disorders, such as Pompe Disease, Retts Syndrome and perinatal respiratory distress, certain ampakines have been shown to improve breathing function. Although the Company does not intend to pursue respiratory indications for ampakines at the present time, we view these findings as proof of target engagement and signals of clinical efficacy.
Ampakines have shown potential as possible therapeutic agents for the treatment of certain neuropsychiatric and neurological disorders. 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 adults with ADHD. At present, the major pharmacotherapies available for ADHD are made up of two types of drugs. Stimulants, such as amphetamine, rapidly produce robust effects, but suffer from side effects typical of stimulants, including tolerance, dependence, withdrawal and abuse. For these reasons, stimulants are scheduled by the FDA. Non-stimulants, such as Straterra (atomoxetine) tend to be less effective than stimulants, with a much longer (approximately 4 8 week) latency to onset of action. In a number of animal and human studies, CX717 and other ampakines did not display any stimulant properties typically associated with drugs like amphetamine. In the Phase 2 ADHD clinical trial, statistically significant therapeutic effects were observed within one week. Therefore, we believe ampakines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non-stimulant treatment options. RespireRx owns certain composition of matter and use patents and patent applications with respect to ampakines CX1739, CX717 and other ampakines.
GABAkines. The third platform of proprietary medicines, added to the Project Endeavor portfolio via the License Agreement are the GABAkines described above.
Additional information about the Company and the matters discussed herein can be obtained on the Companys web-site atwww.RespireRx.comor in the Companys filings with the Securities and Exchange Commission atwww.sec.gov.
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Companys future plans, targets, estimates, assumptions, financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors. In some cases, forward-looking statements may be identified by words including anticipates, believes, intends, estimates, expects, plans, contemplates, targets, continues, budgets, may, and similar expressions and such statements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Companys proposed products, (iv) reorganization plans, and (v) the need for, and availability of, additional financing. The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions regarding the Companys business and technology, which involve judgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions, collaborations with third parties, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Companys control. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward- looking statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the Companys objectives or plans will be achieved. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available cash, research and development results, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic factors. For more information about the risks and uncertainties the Company faces, see Item 1A. Risk Factors of the RespireRx Pharmaceuticals Inc. Annual Report of Form 10-K as of December 31, 2018. For more current information about the Company, see the Companys Quarterly Report on Form 10-Q as of September 30, 2019. Forward-looking statements speak only as of the date they are made. The Company does not undertake and specifically declines any obligation to update any forward-obligation to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments.
Company Contact:
Jeff Margolis Senior Vice President, Chief Financial Officer, Treasurer and Secretary Telephone: (917) 834-7206 E-mail:jmargolis@respirerx.com
RespireRx Pharmaceuticals, Inc. 126 Valley Road, Suite C, Glen Rock, NJ 07452
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CEO of RespireRX Pharmaceuticals Inc., Tim Jones, is Featured on The Stock Day Podcast (RSPI) August 17, 2020 - Stock Day Media
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