RespireRx Pharmaceuticals Inc (RSPI)

[senderos]

Letter to Stockholders and Other Stakeholders: A Brief Summary of Our Progress During Past Twelve Months and a Peek Looking Forward
BY GlobeNewswire
— 8:00 AM ET 03/07/2022

Glen Rock, N.J., March 07, 2022 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. ( 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 provide a brief summary of our accomplishments during the prior twelve months as well as a peek looking forward. As we begin this new year, it is appropriate to briefly summarize our progress this past year and describe how we plan to move forward.

To our Stockholders and other Stakeholders:

Thank you for your continued support and shared confidence in the Company’s efforts.

Possibly most visibly, the Company has implemented an internal restructuring plan with the hope of unlocking what we believe is unrealized value, based upon our two research platforms: pharmaceutical cannabinoids and neuromodulators.

ResolutionRx

Cannabinoids/Dronabinol
In ResolutionRx, our pharmaceutical cannabinoid platform, we are developing proprietary compounds based around dronabinol, an already FDA approved drug that targets the CB1 and CB2 receptors of the brain’s endocannabinoid system. While we have successfully completed two clinical trials demonstrating the ability of dronabinol to improve obstructive sleep apnea (OSA), the commercially available form of dronabinol suffers from poor absorption, rapid and extensive liver metabolism and brief duration of action, requiring the use of high doses.

We have been developing novel, proprietary formulations for dronabinol that utilize lipid nanoparticle (LNP) technology and have identified several unique formulations with which we plan to conduct animal and human pharmacokinetic studies. We believe these new LNP formulations have the potential to overcome many of the shortcomings seen with the commercially available form of dronabinol. Overcoming these issues could greatly expand the use of dronabinol for the treatment of disorders that require longer durations of action and less variable blood levels, such as the treatment of obstructive sleep apnea and other conditions.

In support of this program, we have patents pending claiming blood levels, doses, duration of action and intend to submit additional patent applications claiming composition of matter, method of manufacture and method of treatment for dronabinol and other cannabinoids.

EndeavourRx

EndeavourRx, our neuromodulator platform, is made up of two programs: (a) our AMPAkines program, which is developing proprietary compounds that are positive allosteric modulators (“PAMs”) of AMPA-type glutamate receptors and (b) our GABAkines program, which is developing proprietary compounds that are PAMs of GABAA receptors.

AMPAkines

In ongoing studies with Dr. David Fuller, our collaborator at the University of Florida, CX717 and CX1739, our lead clinical stage AMPAkines, continue to show enhancement of motor function in rodents after experiencing spinal injury. Dr. Fuller published the results of last year’s work in two peer-reviewed journals. In particular, the latest paper, published in the Journal of Neurotrauma (http://doi.org/10.1089/neu.2021.0301) describes research conducted for the first time in awake freely moving rats as late as two weeks after having previously undergone unilateral spinal hemi-transection at the C2 spinal level. For the first time, low dose administration of either CX1739 or CX717 was shown to improve not only motor nerve and muscle activity recorded electrophysiologically from the lesioned side, but to significantly improve actual motor functioning and breathing, even under respiratory challenging conditions. The importance of these findings is described in the article by pointing out that the majority of the approximately 500,000 annual spinal cord injury (“SCI”) cases reported globally involve injuries to the cervical spinal cord and, in severe cases, require the use of mechanical ventilation or direct diaphragm pacing to sustain ventilation.

These recent results have provided great impetus to conduct a Phase 2 clinical trial in patients recovering from spinal injury. Clinical sites have been identified and, pending financing, plans have been drafted to update the current CX1739 IND to incorporate a new clinical protocol and conduct the study.

With regard to intellectual property, new patent applications have been filed claiming the use of AMPAkines for the treatment of spinal cord injury and attention deficit hyperactivity disorder.

GABAkines

In our GABAkine program, KRM II-81, our lead GABAkine, is being developed as a potential breakthrough treatment for treatment resistant epilepsy and chronic pain. After our first full year of working with our new research scientists, Drs. Jeffrey Witkin and James Cook, Senior Research Fellows, and Dr. Rok Cerne, Senior Scientist, considerable headway has been made.

Drs. Witkin and Cerne have conducted pharmacology, metabolism, pharmacokinetic and safety studies to be included in future FDA filings. Several articles describing the results of these studies have been published in highly regarded peer reviewed journals, including two review articles and a book chapter detailing the anti-epileptic and analgesic properties of KRM II-81 and its importance in the overall field of GABAkines. Two additional manuscripts have been accepted for publication and an additional manuscript has been written.

Dr. Cook has begun scaling up chemical synthesis of KRM II-81 in order to provide sufficient active pharmaceutical ingredient (API) to begin IND enabling preclinical studies, which we plan to conduct this year pending financing. In addition, substituted analogues of KRM II-81 have been made, particularly a soluble analogue that displays a similar pharmacological profile as KRM II-81.

Corporate Presentations

During 2021, our executives presented at multiple conferences, including BioTech Showcase, OTC Ventures Market Podcast, Life Sciences Investor Conference and the June 2021 Access China Biotech Virtual Investor Conference. Due to the COVID epidemic, these conferences were held virtually. In January 2022, Company executives presented at the 2022 Biotech Showcase and participated in multiple one-on-one meetings with prospective strategic partners, prospective investors and prospective relevant service providers. Company executives intend to participate in additional conferences, and to present in other forums.

Financing

Despite the successes of our research and development team, our major challenge has been to raise substantial equity or equity-linked financing to support our research and development plans, while minimizing the dilutive effect to pre-existing stockholders. At present, we believe that we are hindered primarily by our public corporate structure, our common stock not being listed on a national exchange, and low market capitalization as a result of our low stock price. Our shares are quoted on the OTCQB, the OTC Market’s venture market with the ticker symbol RSPI.

For this reason, the Company has implemented an internal restructuring plan through which our two drug platforms have been reorganized into separate business units and may in the future be organized into private subsidiaries of RespireRx. We believe that by creating one or more subsidiaries to further the aims of ResolutionRx and EndeavourRx, it may be possible, through separate finance channels, to optimize their asset values and make them more attractive for capital raising as well as for strategic transactions.

The Company is also involved in business development efforts (licensing/sub-licensing, joint venture and other commercial structures) with a view to securing strategic partnerships that represent strategic and operational infrastructure additions, as well as cash and in-kind funding opportunities. These efforts have focused on, but have not been limited to, engaging with brand and generic pharmaceutical and biopharmaceutical companies as well as companies with potentially useful formulation or manufacturing capabilities, significant subject matter expertise and financial resources.

No assurance can be given that any financing or business development transaction will come to fruition or that if it does, that the terms will be favorable to the Company.

Regulation A Financing

The Company filed a Form 1-A which included an offering circular that was qualified by The Securities and Exchange Commission on December 13, 2021 and subsequently amended. The offering is of the Company’s common stock and is up to $7.5 million at $0.02 per share and allows for multiple closings until October 31, 2023 unless earlier terminated by the Company. With the current stock price below the offering price, to date, no closings have taken place.

Departure of Mr. Timothy Jones

Mr. Timothy Jones submitted a letter of resignation as the Company’s President and Chief Executive Officer and as a member of the Company’s Board of Directors effective January 31, 2022 subject to the execution of a termination and separation agreement with certain conditions precedent to its final effectiveness, which agreement was executed and all of which conditions have been met. Dr. Lippa has agreed to serve as the Company’s Interim President and Interim Chief Executive Officer until a replacement President and CEO is hired, while retaining his titles as Chief Scientific Officer and Executive Chairman of the Board.

Summary

As you have now read, in the past twelve months, we experienced successes in the furtherance of our research and development despite our financing challenges. With the hoped for success of our ongoing financing efforts, we have plans in place for the following major projects in 2022, which we intend to implement if we achieve the hoped for success of our ongoing financing efforts:

1. conduct animal and human pharmacokinetic studies with three new proprietary dronabinol formulations in order to choose the best one for conducting a Phase 3 clinical efficacy study for OSA in 2023.

2. conduct a Phase 2 clinical trial investigating the effects of CX1739 in patients with SCI.

3. conduct sufficient preclinical IND enabling studies to support an IND for KRM II-81, our lead GABAkine, allowing the start of Phase 1 clinical trials in 2023.

And to our shareholders and stakeholders we are grateful for your support and look forward to a successful 2022.

Sincerely,

Arnold S. Lippa, PhD
Interim President, Interim Chief Executive Officer, Executive Chairman and Chief Scientific Officer