Pharma Focus America

ResolutionRx Ltd and RespireRx Pharmaceuticals Inc. Announce ResolutionRx’s Entry into a Services Agreement with iNGENu CRO Pty Ltd

Thursday, March 02, 2023

ResolutionRx Ltd, an unlisted public Australian company, and a wholly-owned subsidiary of RespireRx Pharmaceuticals Inc., are pleased to jointly announce that on February 27, 2023, ResolutionRx entered into a services agreement (“Services Agreement”) for clinical research and other related services with iNGENu CRO Pty Ltd (“iNGENu”), a contract research organization (“CRO”) with headquarters in Melbourne, Australia. Collectively, ResolutionRx and RespireRx are leaders in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling. iNGENu is a bespoke contract research organization focused on cannabinoid and psychedelic clinical research.

This press release contains forward looking statements. Please carefully read the sections below entitled “Not a Securities Offering” and “Cautionary Note Regarding Forward-Looking Statements.”

Under the Services Agreement, iNGENu will act as a full-service CRO in support of ResolutionRx’s research and development (“R&D”) program, which is developing a proprietary formulation of dronabinol for the treatment of obstructive sleep apnea and anorexia. iNGENu will be responsible for conducting laboratory experiments to determine a final optimum dronabinol formulation, scaling up and manufacturing the chosen formulation for clinical use, preparing and submitting regulatory documents and designing and conducting clinical trials, including pharmacokinetic/pharmacodynamic, safety and pivotal efficacy studies.

Under the Services Agreement, ResolutionRx will be required to make a US$50,000 deposit with iNGENu within 30 days of the rendering of the first invoice by iNGENu, which invoice is anticipated to be received within the next few days. The deposit is to be applied to the final research and development budget of approximately US$16.5 million, which has now been agreed and which deposit shall be credited against the first invoice.

The entry into this Services Agreement is one step in a series of transactions some of which have been completed, some of which are in process and others which are anticipated to be completed in the near future:

Completed

  • Formation of ResolutionRx as an Australian subsidiary of RespireRx, and all that was required in the formation process, including, among other things, the establishment of a board of directors, the appointment of officers and the engagement of accountants, as well as the opening of both Australian dollar and US dollar bank accounts.
  • Entry into the Services Agreement with iNGENu.
  • Entry into a letter of intent and term sheet with Radium Capital (“Radium”) for a series of debt financings of the Australian Research and Development Tax Incentive (“R&DTI”), a tax credit or rebate available for the component of R&D activities that are qualified core and supporting activities. In the case of ResolutionRx, this is anticipated to be a 43.5% tax rebate, with up to, and at the discretion of ResolutionRx, 80% of which would be financed by Radium and collateralized by the rebate.
  • Engagement of Australian counsel subject to the execution of an engagement agreement.

In Process

  • Sub-licensing and licensing or otherwise making available certain dronabinol assets by RespireRx to ResolutionRx.
  • ResolutionRx’s financing of the first iNGENu research and development invoice by Radium or otherwise.
  • Obtaining an independent valuation report of the assets contributed to ResolutionRx.
  • If consummated, of which no assurance can be provided, an equity or equity-linked financing of approximately US$3 million, which is approximately 18% of the total research and development budget.
  • Due diligence with one or more Australian fund-raising agents or advisors to raise additional unlisted finance in Australia, the completion of which cannot be assured, to support the balance of the anticipated R&D expenditures as well as non-R&D expenses, overhead and working capital.

Anticipated

  • ResolutionRx’s commencement of research and development activities in Australia, with iNGENu as the CRO, including, but not limited to initial manufacturing and bench testing of at least one new formulation of dronabinol, scale up of manufacturing for clinical grade materials for the new formulation for the anticipated initial pharmacokinetic/pharmacodynamic study and regulatory matters.
  • Hiring of a limited number of ResolutionRx employees and/or consultants in Australia.
  • ResolutionRx’s formal engagement of counsel.
  • ResolutionRx’s engagement of independent auditors.
  • ResolutionRx’s formal engagement of placement agent for a contemplated offering in Australia, the completion of which cannot be assured.
  • ResolutionRx’s execution of a term sheet with respect to the approximate US$3 million financing described above, the completion of which cannot be assured.
  • ResolutionRx’s formal application for registration for the R&DTI.
  • Additional R&DTI financings with Radium.
  • Filing in Australia for Overseas Finding(s) to enable access to the R&DTI for qualified research and development activities taking place outside of Australia.
  • Early preparation for a ResolutionRx initial public offering in Australia, and possibly other international markets at an appropriate future date.
ROUQETTE - Pharma Virtual LabSino Biological || Baculovirus - Insect Cell Expression Platform