At the Last Futurist, we’ve never seen PR that echoes partner disagreements with corporate partners across the pond. But if anything, this looks to be a clash of Swiss and American values and business practices.
$RLFTF was down 15% today. Less than 5,000 watchers on Stocktwits. A potentially impactful drug vs. Covid-19. $BRPA was down 14% today too.
- Relief published this.
- Then NeuroRX published this response.
NeuroRx has elected to make statements in the Amendment with respect to pending disputes between Relief and NeuroRx under the terms of the Collaboration Agreement. It’s highly unusual to take this kind of bickering public and could impact the stock until the issues are resolved. $RLFTF is already significantly down at $0.23.
NeuroRx has repeatedly advised Relief that it will share all clinical trial data with European and other international regulators as soon as those data are released to the US FDA.
- NeuroRx stated in the Amendment that Relief owes it approximately $4,000,000 in unpaid invoices.
- Relief intends to exercise its rights under the Collaboration Agreement to conduct a forensic audit of NeuroRx’s books and records in order to determine the accuracy of the expense information that has been provided.
Relief intends to continue its efforts to resolve amicably the pending disputes with NeuroRx over the Collaboration Agreement and it’s somewhat interesting they made all of this public.
Now take a look at the paper about their recent study of their Covid-19 therapy. The 2b/3 trials seem very positive.
There is currently no approved drug for critically ill patients with respiratory failure caused by COVID-19. Vasoactive Intestinal Peptide (VIP) blocks replication of the SARS-CoV-2 virus in alveolar type II cells, inhibits cytokine synthesis, prevents cytopathy, and upregulates surfactant production.
- Relief also recently provided a Business update that summarizes their activities nicely.
Aviptadil, drug name: Zyesami could be really important for dealing with patients in the ICU this Fall and next year in 2022. They would not be fighting this much if this drug didn’t have enormous potential.
Relief’s lead drug candidate RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. In any dispute, we have to assume they have the edge. The LinkedIn account of NeuroRX’s CEO is here.
In fact $RLFTF’s Clinical Developments are pretty significantly recently:
Clinical Development Highlights (RLF-100)
- In March 2020, a U.S. phase 2b/3 trial of RLF-100(IV) for the treatment of patients with critical COVID-19 with respiratory failure commenced.
- In June 2020, RLF-100 (IV) was awarded Fast Track designation by the U.S. FDA for the treatment of acute lung injury (ALI) /acute respiratory distress syndrome (ARDS) associated with COVID-19.
- In July 2020, the FDA granted Expanded Access Protocol (EAP) designation for the treatment of respiratory failure induced by COVID-19 with RLF-100 (IV). Treatment was made available to patients who had exhausted standard therapies and were not eligible for the phase 2b/3 trial due to confounding medical conditions. Data from the first 21 patients in the EAP showed promising results demonstrating that some critically ill patients with COVID-19 experienced substantial clinical improvement when treated with RLF-100.
- In January 2021, Relief, its partner NeuroRx, and the Quantum Leap Healthcare Collaborative (QLHC) of San Francisco announced that NeuroRx and QLHC had signed a Clinical Trial Participation Agreement for the inclusion of inhaled RLF-100 in the I-SPY COVID-19 Clinical Trial. Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with critical COVID-19 who are hospitalized or in intensive care units.
- In January 2021, Relief and AdVita Lifescience GmbH signed a binding term sheet for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100 inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and Pulmonary Sarcoidosis.
- In February 2021, Relief’s partner NeuroRx announced the initiation of a U.S. phase 2b/3 trial evaluating inhaled RLF-100 in patients with moderate to severe COVID-19 in order to prevent progression to respiratory failure.
- In March 2021, Relief’s partner NeuroRx reported topline results (28-day and 60-day) from the U.S. phase 2b/3 trial evaluating RLF-100 (IV) for the treatment of patients with critical COVID-19 with respiratory failure. On the basis of the findings, NeuroRx plans to apply to the U.S. FDA for Emergency Use Authorization (EUA) and subsequently plans to submit a New Drug Application (NDA).
- In March 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), a phase 3 multicenter clinical trial that will include the United States and multiple foreign countries, that is being sponsored by the U.S. National Institutes of Health (NIH).
NeuroRX is being acquired by $BRPA but their conduct and assessment of the situation is very odd. They say that NeuroRx has declined to provide unreleased clinical trial data to Relief in a manner that could compromise study integrity.
Relief’s nonpayment of costs for the recently completed 60-day phase 2b/3 trial has not impeded NeuroRx’s path to seeking Emergency Use Authorization or progressing towards New Drug Approval.
There seems to be some cultural mismatch at work here and misunderstandings between the two companies. To read about them in press releases is beyond belief. NeuroRx is by far the less important partner with a smaller stake in the profits (scroll down to Geography). NeuroRx is responsible for United States, Canada and Israel regions, but the profits even in those regions is split 50/50.
Relief and NeuroRx have also taken steps to increase manufacturing of RLF-100™ to prepare for commercialization in case of FDA approval. The companies have contracted with Nephron Pharmaceuticals, Inc. to manufacture, fill & finish, commercial supplies of RLF-100™ in order to ensure that adequate drug inventory will be immediately available.
By withhold critical data, we think NeuroRx is slowing down development of Zyesami, that could actually cost the world lives. As a physician himself, Mr. Javitt should know better. I even encourage you to contact him directly.
Reuters report on the “fight” didn’t help the cause. Relief Therapeutics’ market cap has fallen about 70% from a high in the third quarter of 2020. The fight in summary Relief saying on Monday (April 19th) that its U.S. partner, NeuroRx, and it are fighting over issues including sharing of trial data, invoices totaling about $4 million that NeuroRx contends Relief must pay, funding for clinical trials, the allocation of potential profits, and other issues.
I’m not sure this is the best work of Reuters and might have forced these rather small companies to take their disputes public which has severely impacted the stocks. If I was $BRPA I would also not be happy with the conduct of both parties. I think when American rashness combines with Swiss perfectionism, Swiss perfectionism will usually win out.