NRX Pharmaceuticals Inc. (NASDAQ: NRXP) Q2 2025 Earnings | 08/20/2025

NRX Pharmaceuticals reported significant progress across its drug development programs and its interventional psychiatry clinic network, Hope Therapeutics. The company is advancing three potential drug approvals and has strengthened its balance sheet with a strategic investment. Management emphasized a focus on reducing operating losses while positioning for near-term revenue.

Key Program Updates:

1. NRX-100 (Preservative-free IV Ketamine):

   • The drug is pursuing two FDA approval pathways: a New Drug Application (NDA) for suicidal depression and an Abbreviated New Drug Application (ANDA) for existing ketamine indications.

   • The company filed a citizen's petition to remove the preservative benzethonium chloride (BZT) from all ketamine formulations, arguing it is toxic and unsafe for repeated use. A favorable ruling could grant NRX a significant share of the ~$750M generic ketamine market.

   • The FDA recently expanded its Fast-Track designation to cover all patients with suicidal ideation in depression (not just bipolar), vastly increasing the potential patient population.

   • The company is seeking a Commissioner’s National Priority Voucher (CNPV) for accelerated review (1-2 months instead of 10-12).

   • The ANDA filing received minor feedback from the FDA, which the company does not believe will cause significant delays.

2. NRX-101 (Oral Therapy for Suicidal Bipolar Depression):

   • The company filed the initial Chemistry, Manufacturing, and Controls (CMC) module with the FDA under its Breakthrough Therapy designation.

   • The drug aims to address akathisia (a severe side effect of current treatments linked to suicide) in addition to depression and suicidality.

   • The strategy is to seek accelerated approval based on its effect on akathisia and suicidity (intermediate endpoints), followed by a confirmatory trial to prove its effect on depression.

3. Hope Therapeutics (Clinic Network):

   • The company received state regulatory approval to acquire Duramedical and is finalizing acquisition financing.

   • The long-term vision is to build a national network of "best-in-breed" interventional psychiatry clinics offering a range of neuroplasticity-inducing treatments (e.g., ketamine, TMS, potential future therapies) under consistent, high-quality standards.

   • The goal is for Hope to eventually become an independent company.

Financial Highlights:

• Operating Loss: The loss from operations improved significantly to $3.7 million, down 47% from $7.1 million in Q2 2024, reflecting stringent cost management.

• Net Loss: The reported net loss of $17.5 million was heavily impacted by a $12 million non-cash charge related to fair value accounting of previously issued convertible notes and warrants.

• Cash Position: The company ended the quarter with $2.9 million in cash. Subsequently, it closed a registered direct offering, raising $6.5 million in net proceeds. Management believes its current cash position will fund operations well into 2026.

• PDUFA Fee Waiver: The FDA granted a waiver, saving the company $4.3 million in filing fees.

Commercial Strategy:

For both NRX-100 and NRX-101, the company plans focused, efficient commercial launches targeting specific prescriber groups:

• NRX-100: Target ~600-1,000 mental health clinics, requiring a commercial team of ~20 people.

• NRX-101: Target ~1,500-1,600 psychiatrists who specialize in treating bipolar patients, also requiring a small, focused team.

Outlook:

NRX stands at several major inflection points with potential near-term drug approvals and the build-out of its clinic network. The company is managed for efficiency and is positioned to leverage upcoming catalysts to create long-term value.