Djazz schreef op 17 augustus 2021 09:13:
Weinig echt nieuws, misschien meer op de conference call straks:
NRx Pharmaceuticals Announces 2nd Quarter 2021 Financial Update
- Emergency Use Authorization (EUA) Request for ZYESAMI™ (aviptadil) Pending with United States Food and Drug Administration to Treat Patients Suffering from Critical COVID-19 with Respiratory Failure
- Emergency Use Authorization Granted to ZYESAMI in Nation of Georgia to Treat Critical COVID-19 Patients in July; First Orders for ZYESAMI in Georgia Under Discussion
- NRx Pharmaceuticals Initiating Phase 2b Trial in Georgia of the BriLife Vaccine for COVID, Developed in Conjunction with the Israeli Institute for Biological Research
RADNOR, Pa., Aug. 16, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage biopharmaceutical company today provided a business update and financial results for the quarter ended June 30, 2021. NRx will host a conference call Tuesday, August 17, 2021, at 8:30AM Eastern Time to discuss its business update and second quarter financial results. "NRx is pleased to report its first quarterly results as a publicly-traded company. We have continued to make substantial progress as a company with the filing of an EUA request for ZYESAMI in the US on May 31st, and the filing and granting of an EUA in the Nation of Georgia, with first orders expected shortly. We are honored to have been selected by the Israeli Institute for Biological Research to develop and market the BriLife COVID vaccine. Finally, we are looking forward to restarting trials of our psychiatry drug, NRX-101, in the coming months," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.
Business Highlights in Q2
Primary clinical activities during the quarter centered around analysis and regulatory filing of data from the phase 2b/3 trial of intravenous ZYESAMI™ for COVID-19 Respiratory Failure, support of the NIH-sponsored ACTIV3b Critical Care study of ZYESAMI compared to Veklury (remdesivir) alone and in combination, support of the BARDA-sponsored I-SPY trial of inhaled ZYESAMI, and the NRx-sponsored trial of inhaled ZYESAMI.
NRx Pharmaceuticals Announces 2nd Quarter 2021 Financial Update
On the manufacturing front, the Company focused on development of the first shelf-stable formulation of ZYESAMI, which was announced in early Q3, along with engagement in scaling up aviptadil drug substance from 100,000 doses per manufacturing batch to a projected 3 million doses per batch, combined with a 90% reduction in cost per gram of aviptadil drug substance.
On the business development front, NRx engaged in successful collaborative negotiations with the Israeli Institute for Biological Research (IIBR) that resulted in the long-term partnership announced in Q3. The company entered into a collaborative agreement with TFF Pharmaceuticals to develop a dry powder reconstitutable form of ZYESAMI that has now demonstrated initial room temperature stability. This technology has now shown promise for the development of a dry powder version of the BriLife vaccine. Our enthusiasm for this development project is based on nonclinical data suggesting an effective neutralizing antibody response to the Delta and other COVID variants, together with the rapidity with which this vaccine technology can be modified to cover new variants as they emerge. The company further initiated business development interactions with MannKind Corporation to leverage the Technosphere® platform for future inhaled use of ZYESAMI.
On a commercial level, the Company finalized its logistics and drug distribution contract with Cardinal Health, Inc., and its drug launch and commercialization support agreement with IQVIA, Inc. During Q2, NRx began its engagement with Georgia, Ukraine, and other countries around Emergency Use of ZYESAMI and potential clinical trials of the BriLife vaccine.
At a corporate level, much of Q2 was devoted to finalizing the business combination between NeuroRx, Inc. and Big Rock Partners Acquisition Corp (Nasdaq: BRPA) that led to the creation of NRx.
Second Quarter Financial Results
NRx reported a net loss of $16.0 million for the three months ended June 30, 2021, compared to a net loss of $0.1 million for the three months ended June 30, 2020. The increase in net loss was primarily related to increases in R&D expenses, G&A expenses (which were primarily non-cash expenses associated with exercise of warrants and restructuring of the Company's Stock Option Plan) and a reduction in reimbursement of expenses from Relief Therapeutics during the second quarter of 2021 versus the prior year. Research and development expenses were $4.7 million during the three months ended June 30, 2021, compared to $1.4 million during the three months ended June 30, 2020. These costs were primarily associated with the completion of the phase 2b/3 trial of ZYESAMI. General and administrative expenses were $12.5 million for the three months ended June 30, 2021, compared to $0.5 million during the three months ended June 30, 2020. This was driven primarily by $5.5 million of consultant fees (of which $4.9 million relates to non-cash consulting fees) and $4.0 million in stock compensation expense (of which $3.3 million relates to modification of stock options and warrants due to the SPAC merger). As of June 30, 2021, cash and cash equivalents were $13.4 million, compared to $1.9 million as of December 31, 2020. In addition, NRx received $9.2 million subsequent to June 30, 2021 from the exercise of warrants.
As stated in the 10-Q filing, NRx has sufficient core operating funds to support operations through the next 12 months. Clinical trial operations for ACTIV3b and I-SPY are primarily funded by the US Government. We anticipate that the BriLife vaccine development program will be co-funded by a commercial partner with additional partnerships in development.
Conference Call and Webcast Information
NRx will host a conference call and webcast on August 17, 2021 8:30 AM Eastern Time to discuss its results and provide a clinical and corporate update. Management will host the call, followed by a question-and-answer period. Analysts and investors interested in submitting questions must do so in advance of the call,and are encouraged to email questions to the Company's investor relations representative at firstname.lastname@example.org
Investors and the general public are invited to listen to a live audio webcast of the conference call, which may be accessed five minutes prior to the start of the call by dialing (877) 705-6003 (U.S.), (201) 493-6725 (International) Conference ID: 13722418, or through the webcast link public.viavid.com/index.php?id=146267.
A replay will be available from the NRx Pharmaceuticals website following the call at www.nrxpharma.com.
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