RespireRx Pharmaceuticals Inc interim CEO Arnold S Lippa has updated shareholders about the company’s progress in 2021, its internal restructuring, and how it plans to move forward in the current year.
In a letter to shareholders, Lippa noted that the company has implemented an internal restructuring plan through which its two-drug platforms have been reorganized into separate business units and may in the future be organized into private subsidiaries of RespireRx.
Lippa also said the company has implemented an internal restructuring plan with the hope of unlocking what it believes is unrealized value, based upon its two research platforms -- pharmaceutical cannabinoids and neuromodulators.
For 2022, the company is planning to conduct animal and human pharmacokinetic studies with three new proprietary dronabinol formulations in order to choose the best one for conducting a Phase III clinical efficacy study for obstructive sleep apnea (OSA) in 2023.
Moreover, the company is hoping to conduct a Phase II clinical trial investigating the effects of CX1739 in patients with spinal cord injury (SCI).
RespireRX will also conduct sufficient preclinical IND enabling studies to support an IND for KRM II-81, its lead GABAkine, allowing the start of Phase I clinical trials in 2023.
Recounting developments in 2021, Lippa said that the company's cannabinoid-focused subsidiary, ResolutionRx, is developing proprietary compounds based around dronabinol, a drug already approved by the US Food & Drug Administration (FDA) that targets the CB1 and CB2 receptors of the brain's endocannabinoid system.
In support of this program, the company has patents pending claiming blood levels, doses, duration of action and intends to submit additional patent applications claiming composition of matter, method of manufacture, and method of treatment for dronabinol and other cannabinoids.
Its neuromodulator platform, EndeavourRx, is made up of two programs -- an AMPAkines program, which is developing proprietary compounds that are positive allosteric modulators of AMPA-type glutamate receptors; and a GABAkines program, which is developing proprietary compounds that are PAMs of GABAA receptors.
Lippa noted that recent results from the AMPAkines program have provided a "great impetus" to conduct a Phase II clinical trial in patients recovering from a 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.
In another program, samples are being developed as a potential breakthrough treatment for treatment-resistant epilepsy and chronic pain.
Despite the successes for the research and development team, Lippa noted that the company's “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.”
He added: “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. 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 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 engaging with the 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.
Contact Ritika at ritika@proactiveinvestors.com