NRx Pharmaceuticals (NRXP) investor relations material

Company overview and strategic direction

• Focus on developing treatments for depression and suicidality, originating from personal and clinical experiences with psychiatric illness.

• Core assets include NRX-101 (D-cycloserine/lurasidone) and KETAFREE, a preservative-free ketamine formulation.

• Expansion into transcranial magnetic stimulation (TMS) and robotic neuro-navigation, with military partnerships for clinical trials.

• HOPE Therapeutics subsidiary operates clinics and develops new delivery technologies.

• Emphasis on integrating drug and device modalities for more effective psychiatric care.

Product development and regulatory progress

• KETAFREE is a preservative-free ketamine, addressing toxicity concerns of existing formulations.

• FDA review of KETAFREE encountered minor deficiencies, mainly related to packaging, with a decision expected mid-October.

• Real-world evidence is being used to support FDA approval for ketamine in depression and suicidality, potentially expanding insurance reimbursement.

• Patent pending for preservative-free formulation; period of market lead anticipated due to manufacturing and regulatory hurdles for competitors.

• Plans underway for alternative, scalable ketamine delivery methods, including pH-neutral subcutaneous administration.

Commercialization and market strategy

• Commercial team in place to launch KETAFREE, targeting a $750 million market with focus on stable supply for hospitals.

• Blow-fill-seal technology reduces costs and medical waste, enabling competitive pricing and domestic manufacturing.

• Hospitals prioritize supply stability over price, especially amid ongoing ketamine shortages.

• Expectation to achieve profitability by mid-next year, using ketamine revenues to fund further clinical development.