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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), (“NRx Pharmaceuticals” or the “Company”), a clinical-stage biopharmaceutical company, today announced its financial results for the second quarter of 2022 and provided an update. commercial and clinical day.
“In our second quarter, we reactivated clinical development for our psychiatric franchise around our lead compound, NRX-101. NRX-101 has received Breakthrough Therapy designation and special protocol approval for bipolar depression. 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 that the severe bipolar depression study with acute suicidal behavior (ASIB) will begin in late 2022 or early 2023.
During this quarter, we began enrollment in our Phase 2 trial of NRX-101 in patients with bipolar depression and subacute suicidal ideation and behavior (SSIB),” Willard said. “The purpose of this trial is to extend our potential indication of bipolar depression in patients with acute suicidal tendencies to the significantly larger population of patients with bipolar depression and subacute suicidal tendencies, who are treated in an outpatient setting. We are evaluating the adequacy of the protocol to support treatment approval of the larger SSIB population. We anticipate reading data from this trial by the end of the year or early in the first quarter of next year.”
“We expect to publish 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 presenting with suicidal ideation and behavior. (ASIB) under the special protocol agreement of the FDA, which we expect to start in the fourth quarter,” said Mr. Willard.
Many medications approved for bipolar depression have warning labels for an increased risk of suicide. To our knowledge, NRX-101 is the only oral antidepressant in the bipolar segment that targets active suicidal patients, which is usually an exclusion criterion in clinical studies for depression and PTSD. Data from the Phase 2 STABIL-B1 trial of NRX-101 demonstrated a significant reduction in depression and suicidal tendencies compared to standard treatment in acute suicidal patients who were first stabilized with ketamine. We have published non-clinical results demonstrating that, unlike ketamine, both components of NRX-101 did not show addictive potential and are not neurotoxic (i.e. they do not cause brain cell death in tests required by the FDA).2
In the second quarter, we repatriated manufacturing of the NRX-101 drug supply to North Carolina and we are currently manufacturing clinical supplies for P3 under the commercial readiness program.
Our psychiatry franchise is built on a solid foundation of scientific and intellectual property with 47 issued patents and 43 pending applications worldwide. Our goal is to address this major unmet medical need for which the only currently approved treatment is electroconvulsive therapy. It is estimated that 50% of people with bipolar disorder attempt suicide in their lifetime. We believe NRX-101 is a potentially life-saving drug that could change the treatment paradigm for people with bipolar depression who also experience suicidal tendencies. »
We plan to evaluate options for ZYESAMI® in COVID-19 respiratory failure and other lung disorders once we receive the full NIH dataset late in the third quarter or early in the fourth quarter. and that we will have done our own analysis.
Although we are not funding additional clinical trials of ZYESAMI® at this time, we have completed manufacturing of Phase 3/Commercial ZYESAMI®. We also received independent assessment of chest x-ray data from a sub-study that included a subset of approximately 80 patients who survived to day 10 in our Phase 2b/3 study of ZYESAMI®. The substudy showed a statistically significant improvement in chest X-rays using the RALES score in patients with COVID-19 respiratory failure, compared to worsening in patients treated with placebo (P<.05 this="" exploratory="" data="" will="" further="" guide="" our="" assessment="" of="" future="" options="" for="" zyesami="" wp_automatic_readability="18">
Major Business and Clinical Highlights
- Announcing 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 chief financial officer
- Company repositioned to focus on psychiatric franchise and our drug NRX-101 designated as breakthrough therapy for bipolar depression in suicidal patients. NRX-101 has additionally received special protocol clearance from the FDA
- Repatriation of NRX-101 manufacturing to a leading North Carolina-based manufacturer, completion of technology transfer and manufacturing of first batch of Phase 3/commercial NRX-101 capsules
- Launch of a phase 2b trial of NRX-101 in patients with bipolar depression and subacute suicidality (SSIB); 10 planned clinical sites are activated and actively recruiting patients, with a key data readout scheduled for the end of Q4 22/Q1 23
- Received independent evaluation of chest x-rays from a subset of patients who survived through day 10 of the ZYESAMI® intravenous trial. First-line analysis shows a statistically significant change from baseline to Day 10 in the RALES score (i.e., improvement in ZYESAMI®-treated patients and worsening in placebo-treated patients). Ongoing data analysis continues.
Financial results for the quarter ended June 30, 2022
- Research and development expenses for the quarter 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 is mainly related to a decrease in clinical trial and development costs related to ZYESAMI®.
- General and administrative expenses for the quarter ended June 30, 2022 totaled $6.6 million, compared to $12.5 million for the quarter ended June 30, 2021. The decrease of $5.8 million is primarily related to a decrease in stock-based compensation and expenses, partially offset by an increase in higher insurance costs.
- Other income for the quarter ended June 30, 2022 totaled $2.6 million, compared to $17.0 million for the quarter ended June 30, 2021. The decrease of $14.4 million is mainly related to a decline in the fair value of certain Substitute Warrants and the Supported Warrant Offering pursuant to the Merger Agreement due to the decline in share prices.
- Net loss for the three months ended June 30, 2022 was $7.0 million compared to a net loss of $0.1 million for the three months ended June 30, 2021.
Financial results for the 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 $0.9 million increase is mainly related 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 is mainly related to an increase in legal, professional and insurance costs. partially offset by lower consultant fees and stock-based compensation expense.
- 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 is primarily related to a decrease in the fair value of certain substitute warrants and placement warrants assumed under the merger agreement due to the decline in share prices.
- Net loss for the six months ended June 30, 2022 was $20.4 million compared to 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. We believe we have sufficient funds and, if necessary, the ability to reduce expenses, to support operations until August 2023. The Company may also seek to reduce certain expenses if necessary to reduce cash consumption in support of operations.
Conference call and webcast details
Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prior to the start of the call by dialing (844) 826-3033 (US), (412) 317-5185 (International) Conference ID: 10170239, or via webcast link NRx Pharmaceuticals Second Quarter 2022 Earnings Call. A replay will be available on the NRx Pharmaceuticals website for thirty days following the call to www.nrxpharma.com.