NRx Pharmaceuticals Provides Business Update and Reports Second Quarter 2022 Results

NRx Pharmaceuticals

RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently announced its financial results for the second quarter of 2022 and provided a business and clinical update.

“During our second quarter, we reactivated clinical development in our psychiatry franchise around our lead compound, NRX-101. NRX-101 has been awarded Breakthrough Therapy designation and a Special Protocol Agreement for severe bipolar depression with acute suicidal ideation and behavior (ASIB) by the U.S. Food and Drug Administration (FDA), said Stephen Willard, Chief Executive Officer of the Company. “We anticipate initiation of the study in severe bipolar depression with acute suicidal ideation and behavior (ASIB) to commence at the end of 2022 or at the beginning of 2023.

During this quarter, we commenced enrollment in our Phase 2 trial of NRX-101 in patients with Bipolar Depression and Sub-Acute Suicidal Ideation & Behavior (SSIB)”, said Willard. “The purpose of this trial is to expand our potential indication from bipolar depression in patients with acute suicidality to the significantly larger population of patients with bipolar depression and sub-acute suicidality, who are being treated in the ambulatory setting.  We are evaluating the adequacy of the protocol to support approval for the treatment of the larger SSIB population.  We project a readout of the data from this trial by the end of the year or early Q1 of next year”.

“We expect to release commercial-stage material of NRX-101 in the coming weeks. This material will be used in our phase 2b/3 trial of NRX-101 for severe bipolar depression in patients with acute suicidal ideation & behavior (ASIB) under the FDA Special Protocol Agreement, which we expect to start in Q4,” said Mr. Willard.

Many approved drugs for bipolar depression have warning labels for increased risk of suicide.  The Copnat states that to its knowledge, NRX-101 is the only oral antidepressant in the bipolar segment that targets patients with active suicidality, which typically is an exclusion criterion in clinical studies of depression and PTSD.  Phase 2 STABIL-B trial1 data of NRX-101 demonstrated a significant reduction in both depression and suicidality compared to standard therapy in acutely suicidal patients who were first stabilized with ketamine. The Company states that its has released non-clinical findings demonstrating that, unlike ketamine, both components in NRX-101 have not shown potential for addiction and are not neurotoxic (i.e., do not cause death of brain cells in FDA-required assays).2

READ:  Shapiro Announces Relief for Delaware County Man Serving 41 Years for Murder

In Q2, the Company repatriated the manufacture of NRX-101 drug supply to North Carolina and is currently manufacturing clinical supplies for P3 as part of the commercial readiness program.

The Company states that its psychiatry franchise builds on a strong scientific and intellectual property foundation with 47 granted patents and 43 pending applications around the world. The Company states that its focus is to address this major unmet medical need for which the only currently approved treatment is electroshock therapy.  It is estimated that 50% of individuals with bipolar disorder attempt suicide over their lifetime.  The Company states that it believes NRX-101 is a potentially life-saving medicine that could change the treatment paradigm for individuals with bipolar depression that are also experiencing suicidality.”

The Company reportedly expects to evaluate the options for ZYESAMI® in COVID-19 Respiratory Failure and other lung disorders once its receive the full data set from NIH towards the end of Q3 or early Q4 and have conducted its own analysis.

Although the Company states that it is not funding additional clinical trials of ZYESAMI® at this time, it has completed the manufacture of phase 3/commercial ready ZYESAMI®.  The Company states that it also received an independent assessment of chest X-ray data from a sub-study that included a subgroup of approximately 80 patients that had survived to day 10 in its Phase 2b/3 study of ZYESAMI®. The sub-study showed a statistically significant improvement in chest X-rays using the RALES score in patients with COVID-19 respiratory failure, compared to a worsening in patients treated with placebo (P<.05).  This exploratory data will further guide its assessment of future options for ZYESAMI®.

Key Business & Clinical Highlights

  • Announced new leadership with the appointment of Stephen Willard, JD, as CEO and member of the Board of Directors, and Seth Van Voorhees, PhD, MBA, as CFO

  • Repositioned company to focus on psychiatry franchise and its Breakthrough Therapy designated drug NRX-101 for Bipolar Depression in Patients with Suicidality. NRX-101 has additionally been awarded a Special Protocol Agreement by the FDA

  • Repatriated manufacture of NRX-101 to a leading North Carolina-based manufacturer, completed technology transfer, and manufactured first batch of phase 3/commercial-ready NRX-101 capsules

  • Initiated a Phase 2b trial of NRX-101 in patients with Bipolar Depression and Sub-Acute Suicidality (SSIB); 10 planned clinical sites are activated and are actively enrolling patients, with topline data readout anticipated at the end of Q4 22/Q1 23

  • Received independent grading of chest x-rays from a subgroup of patients that survived to day 10 from the intravenous ZYESAMI® trial. Top line analysis shows a statistically significant change between baseline and day 10 on the RALES score (i.e., improvement in ZYESAMI®-treated patients and worsening in placebo-treated patients). Ongoing data analysis is continuing.
READ:  I-95, I-76 Among Several State Highways Restricted in Philadelphia, Delaware County

Financial Results for Quarter ended June 30, 2022

  • Research and development expenses for the three months ended June 30, 2022, totaled $3.0 million, compared to $4.7 million for the quarter ended June 30, 2021. The decrease of $1.7 million related primarily to a decrease clinical trials and development expenses related to ZYESAMI®.

  • General and administrative expenses for the three months ended June 30, 2022, totaled $6.6 million, compared to $12.5 million for the three months ended June 30, 2021. The decrease of $5.8 million was primarily related to a decrease in stock-based compensation and consultant fees, partially offset by an increase in higher insurance related expenses.

  • Other income for the three months ended June 30, 2022, totaled $2.6 million, compared to $17.0 million for the three months ended June 30, 2021. The decrease of $14.4 million primarily related to a decrease in the fair value of certain Substitute Warrants and the Placement Warrants assumed pursuant to the Merger Agreement because of lower stock price levels.

  • Net loss for the three months ended June 30, 2022, was $7.0 million compared with a net loss of $0.1 million for the three months ended June 30, 2021.

Financial Results for Six Months ended June 30, 2022

  • Research and development expenses for the six months ended June 30, 2022, totaled $8.4 million, compared to $7.6 million for the six months ended June 30, 2021. The increase of $0.9 million related primarily to an increase in regulatory and process development expenses.

  • General and administrative expenses for the six months ended June 30, 2022, totaled $16.9 million, compared to $14.6 million for the six months ended June 30, 2021. The increase of $2.3 million was primarily related to an increase in legal, professional and insurance expenses partially offset by a decrease in consultant fees and stock-based compensation expenses.

  • Other Income for the six months ended June 30, 2022, totaled $4.9 million, compared to $17.1 million for the recently restated six months ended June 30, 2021. The decrease of $12.2 million primarily related to a decrease in the fair value of certain Substitute Warrants and the Placement Warrants assumed pursuant to the Merger Agreement because of lower stock price levels.

  • Net loss for the six months ended June 30, 2022, was $20.4 million compared with a net loss of $25.6 million for the three months ended June 30, 2021.

  • As of June 30, 2022, cash was $24.5 million compared to $27.6 million as of December 31, 2021. The Company believes that it has sufficient funds and if necessary, the ability to reduce expenditures, to support operations through August 2023. The Company may also seek to reduce certain expenditures if needed to reduce cash consumption in support of operations.
READ:  Senator Kearney: The Decision to Close Emergency Department at Delaware County Memorial Hospital Is Reprehensible

More information and additional details can be found at www.nrxpharma.com.

More For You

For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News.

Thanks for visiting! Looking for some Chester County pride? We got you covered! Shop our MyChesCo store and show your love for Chester County, Pennsylvania. We got shirts, hats, and more – all with a unique ChesCo flair. Plus, proceeds from each purchase helps support our mission of bringing reliable information and resources to the people of Chester County.