NRx Pharmaceuticals (NRXP) investor relations material

Recent developments and strategic focus

• Intends to generate revenue starting this year, with growth expected over the next two years, driven by three lead programs.

• NRX-100 (IV ketamine) is being advanced for FDA approval for suicidal ideation and depression, with a broad fast-track indication and a potential $2 billion market.

• NRX-101, a combination therapy, has breakthrough therapy designation and is the first oral drug shown to reduce suicidality in akathisia.

• Building a network of HOPE Therapeutics clinics to integrate neuroplastic therapies for depression, PTSD, autism, and brain injury.

• Developing a preservative-free generic ketamine (KETAFREE) for anesthesia and pain control, targeting a $750 million market.

Clinical and scientific advancements

• Real-world and clinical trial data show IV ketamine significantly reduces suicidality and depression, with new evidence supporting its use in PTSD.

• D-cycloserine, especially at low doses, enhances the effect of transcranial magnetic stimulation (TMS) for depression and suicidality.

• Hyperbaric oxygen therapy and digital therapeutics are being integrated as additional neuroplastic interventions.

• Combining neuroplastic drugs, TMS, and other therapies is believed to offer a durable path to recovery for suicidal depression and PTSD.

• Treatments are cost-effective, with full courses delivered for less than $10,000, significantly lower than other major interventions.

Regulatory and market landscape

• FDA granted a fast-track designation and a filing fee waiver for NRX-100; a Commissioner's National Priority Voucher (CNPV) could accelerate approval.

• KETAFREE is back on file with the FDA after reformulation to match generic standards.

• No FDA-approved drugs currently exist for suicidal ideation; current treatments like ECT have significant drawbacks.

• The administration and federal agencies have made veteran suicide and mental health a top priority, with strong support for innovative treatments.

• If granted, a CNPV would significantly speed up the regulatory timeline for NRX-100; otherwise, a six-month NDA review is expected.