Relief Therapeutics is in complex clinical trials with its drug RLF-100, which aims to prevent COVID-19 and oppose its devastating effects.
The effects of the newly published compassionate use have shown astonishing effects: COVID-19 respirator dependent patients with fatal comorities coming out of the respirator and returning home in just five days after the RLF-100 remedy.
Relief Therapeutic’s RLF-100 is simple to manufacture on a large scale and economical, or a successful clinical trial can result in immediate global production and availability.
If ongoing clinical trials reflect the effects of compassionate use, RLF-100 is likely to get quick approval and stocks will accumulate much more.
Relief Therapeutics Holdings AG (OTCPK: RLFTF) is a Swiss-listed U.S. stock exchange company with the U.S. OTC, in addition to its directory on the Swiss Stock Exchange (RLF). Just a week ago, Relief Therapeutics was trading below 0.10 in line with the stock. It is the household rediscovery of their drug RLF-100, an exclusive artificial form of vasoactive intestinal polypeptide (VIP) also known as aviptadil, which has generated a valid interest in the company.
In an earlier article, I described my fundamental reason for following the prospective treatments of Covid-19 as opposed to prospective vaccines, and the progression of viral to immunological disease that served to categorize other approaches to Covid-19 and its effects. I will not repeat this discussion here, because I look forward to getting to the point that Relief Therapeutics is the most promising drug I have encountered in the opposite combat to Covid-19 in 4 months of research.
Let’s start with the latest results, then move on to science, then to the structure, control and balance of Relief Therapeutics.
On August 2, 2020, Relief Therapeutics announced a report through doctors at Houston Methodist Hospital that RLF-100 “showed an immediate recovery from respiratory failure in patients at peak critical condition with COVID-19.”
At the same time, unaffiliated independent researchers operating in Brazil have reported that VIP inhibits replication of sarS-CoV-2 virus in human lung cells and immune cells.
The report describes a 54-year-old man who developed COVID-19 while being treated for the rejection of a double-lung transplant and who came out of a fan in 4 days. Similar effects were observed in more than 15 [emphasized] patients treated as a component of an IND emergency use and an FDA extended access protocol, which is open to patients who are too ill to be admitted to the ongoing FDA phase 2/3 trial.
Patients with coVID-19 critical were found to have a elimination of traditional X-ray lung disease outcomes, accompanied by an improvement in blood oxygen and an average minimum of 50% or more in laboratory markers related to COVID-19 inflammation.
Professor Jonathan Javitt, president and chief executive of Relief NeuroRx’s US partner, said:
No other antiviral agent has demonstrated the cure of a viral infection or demonstrated in the laboratory inhibition of viral replication.
According to the pre-printed report prepared through doctors at the Houston Methist Lung Transplant Center and the Houston Methist’s Department of Academic Pneumology, the patient suffered rejection of his double lung transplant and, in most cases, was diagnosed with COVID-19. Matrix Despite the use of all treatments that have been received lately (with the exception of Remdesivir due to the patient’s chronic kidney disease), the patient’s condition continued to deteriorate. Within 24 hours of treatment, a really significant improvement in oxygen saturation and a radiographic improvement of COVID-19 lung disease characteristic were noticed. He was discharged from intensive care five days after the third infusion and returned home in the air.
I have read this article many times because what is promising for me is the patient’s initial condition and of course their immediate recovery time. Rejection of double lung transplantation and COVID-19 appear to have been defeated at the same time through the RLF-100.
Could this mean that RLF-100 can also play a role in preventing transplant rejection? The authors of the article imply that they believe this. Write:
The VIP would possibly have been in the context of AMR [antibody-mediated rejection] after a lung transplant based on previous reports that THE VIP retains service as lung allografts. VIP is a strong anti-cytokine in the lungs that provides a key defense opposed to many acute lung damage bureaucracies.
If that’s the case, we’re talking about a vital additional role for RLF-100, AMR. This is a scenario in which organ transplants, such as lungs, liver and kidneys, can occur, causing organ failure. But for now, the concentrate will necessarily have to be in COVID-19.
We want the effects of clinical trials to take an informed resolution on whether RLF-100 can effectively combat COVID-19. The recent effects of extended access control have been astonishing and very exciting. Greater confirmation can be an absolute victory for the world. Not only can we have a drug that can particularly decrease coVID-19 mortality and disability, but Relief Therapeutics also reports that RLF-100 is simple to produce and much less expensive than many competing curative products. This means a drug with immediate global availability and accessibility, even poor countries with a high need for cost-effective medicines.
Aviptadil has had good fortune in sepsis-induced LRA, according to Relief Therapeutics. The corporation claims that in a Phase I trial
… 8 patients with severe SDRA mechanical ventilation were treated with increasing doses of VIPs. Seven of the 8 patients were effectively extubated and were alive after five days. Six left the hospital and one died from an unrelated center event. [source: Relief Therapeutics website]
On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee had conducted a planned review of the first 30 patients treated in the Accelerated Phase II/III trial (Intravenous Aviptadil for COVID-19 Critical Respiratory Deficiency (COVID-AIV).) According to the press release:
The committee decided that the review gave the impression that it was able to achieve a statistically significant endpoint in the length of its pattern of 144 patients and voted to continue the review until its next planned evaluation in 4 weeks.
VIP binds to VPAC1 receptors on alveolar type II pulmonary mobile (ATII). ATII mobiles make up only 5% of pulmonary epithelial mobiles, but are essential for oxygen transfer, surfactant production and maintenance of type 1 alveolar mobiles. 70% of VIPs adhere to this receiver. The Type II mobile is also the selectively attacked mobile through the SARS-CoV-2 virus, the ACE2 surface receiver.
Non-clinical studies show that the VIP is highly concentrated in the lung and in particular similar to the ATII cell, where it prevents activation of NMDA-induced caspasa-3 in the lung, inhibits the production of IL6 and TNFa, protects against HCl -induced pulmonary edema and regulates the upward production of surfactant. These and other effects have been observed in many animal-style lung injury systems in mice, rats, guinea pigs, sheep and pigs. In those styles, Aviptadil restores the barrier that serves the endothelial/alveolar interface and therefore protects the lung and other organs from failure. “[Source: clinical trial NCT04311697]
In its latest clinical trial description for “Inhaled Aviptadil for Moderate and Severe COVID-19 Remedy”, NeuroRx and State Relief:
Vasoactive intestinal peptide (VIP) is known to target the VPAC1 receptor in the ATII mobile and to the mobile of all types of lesions, adding smoke inhalation, exposure to gastric acid and exposure to infectious agents. VIP prevents apoptosis, blocks cytokines, reduces NFT levels, reverses CD4/CD8 ratio and reduces cough and dyspnoea in clinical and non-clinical studies.
According to the recent discovery through Brazilian scientists that VIP suppresses the ability of SARS-CoV-2 to reflect on human lung cells [1], the RLF-100 can necessarily return impotent to COVID-19.
The action of the RLF-100 can be summarized as follows:
After binding to THE AT-II epithelial lung cells in cell receptors, RLF-100 performs the following operations:
Source: Javitt: Vasoactive intestinal peptide treats COVID-19 respiratory failure by saving alveolar cell II
Is the delight of physicians treating patients with COVID-19 parallel to the theoretical progression of the disease and providing a justification for the use of RLF-100?
By Dr. Javitt:
Early lung injury due to COVID-19 is characterized by a remarkable degree of hypoxia in the absence of overwhelming pneumonia, suggesting a number one injury to the lung fuel exchange mechanism. Patients report “crunching” when looking to breathe, according to the theory that surfactant loss and alveolar fuel exchange is an early feature of COVID-19. Unlike artificial anticytokins, such as anti-IL6 drugs, THE VIP plays an express role in preserving surfactant production in the lungs (Li 2004, Li 2010) and in the coverage of alveolar type 2 cells.
Patients with critical COVID-19 and respiratory failure who are not eligible for NCT04311697 registration, who live more than 50 miles from an existing participation study center or who are already hospitalized and cannot be safely transferred to a participation study center. possibly access through the sponsor.
Vip… conducted toxicology and pharmacology studies to protect 4 species in intravenous and inhaled doses. Phase 2 trials on sarcoidosis (Prasse 2010), pulmonary hypertension (Leuchte 2008), pulmonary fibrosis and allergy/asthma show that THE VIP has no primary toxicities when inhaled at doses of 300 oz/day.
Relief Therapeutics is a company domiciled in Switzerland, with an incredibly smooth operating design and a large number of shares in circulation.
Normally, I look twice at a company with so many shares in circulation. However, the company’s progress in its COVID-19 drug has replaced its mind.
Other researchers will also note that Relief Therapeutics had only a few Swiss francs to rub at the end of 2019. It’s true. I hope this and the large number of actions will be a great challenge for skeptics. A counterpoint to doubt is science. What market capitalization does a company have with an effective drug that outperforms COVID-19? Is RLF-100 effective? Could you get the world out of its human and economic crisis?
On April 30, 2020, Relief Therapeutics announced the release of its 2019 annual report. The following monetary knowledge has been reported:
General and administrative expenses for the whole year 2019 decreased to 946,000 Swiss francs (approximately USD 1.03 million) from 1,050 Swiss francs (about USD 1,145 million) in 2018, mainly due to relief in the number of workers and their lower pay.
EBITDA in 2019 861,000 Swiss francs (US$938,000) compared to 483,000 Swiss francs (US$526490) last year.
Net loss for 2019 7.46 million Swiss francs (US$8.13 million) compared to 436,000 Swiss francs (US$475240) in 2018, is basically due to a deterioration rate of 11.2 million Swiss francs (US$12.21 million) in the price of e-books of intangible assets. . Triumphs.
Relief Therapeutics said it had obtained debt financing from its largest shareholder GEM Global Yield Fund LLC of 600,000 Swiss francs (US$654,000) to finance operations in 2019.Cash and cash equivalents were 137,000 Swiss francs (US$149,330) as of December 31, 2019.
In an interview with the Swiss publication The Market NZZ on August 7, 2020, Relief Therapeutics President Dr. Raghuram (Ram) Selvaraju said Relief Therapeutics currently has 3 million Swiss francs ($3.27 million) in cash. He estimates that the existing clinical trial program (including the COVID-19 critical exam and the next inhalation exam) will likely charge between $17 million and $23 million ($18.5 million to $25.1 million). Of that amount, he said they had already spent nearly $4 million ($4.36 million) on Swiss francs. Therefore, the remaining trial prices will charge between $13 million and $19 million ($14.7 million to $20.7 million).
As you know, you’re going to war with the army you have. This is the army you would like or would like to have later.
Rumsfeld visited U.S. troops heading to Iraq, and one soldier asked for more armor on his vehicles, which were continually destroyed by improvised explosive devices. Rumsfeld replied to the above.
Many others denounced Rumsfeld for this statement. He was callous, insensitive, and despised the sacrifices our American infantrymen were making. (That’s what I thought when I heard him say it.)
Now I sought to use this quote from Rumsfeld in the context of Relief Therapeutics and COVID-19 because of this little-known fact:
Donald Rumsfeld President of Gilead Sciences (GILD) from 1997 to 2001. In 1997, Gilead’s steady percentage was worth 0.77 cents according to the steady percentage and in 2001 it was $2.60 consistent with the constant percentage. Gilead, the manufacturer of Remdesivir, only 0.77 cents consistent with a percentage consisting of 1997. Today, Gilead is at around $70 consistent with a consistent percentage.
Sometimes the savior of the world economy does not meet all the requirements. Too many stocks in circulation. Bad purse. But you go to war with the army you have. We’re in the worst pandemic since the Spanish flu in 1918. Fortunately, we now have forward-looking responses that are shown as possible: placebo-controlled blind trials. We’ll soon know if the RLF-100 is up to the challenge.
Relief Therapeutics has a US patent (US8,178.489B2) and an EU policy for its artificial aviptadil formulas to improve stability, among other benefits. Because VIP is an herbal peptide, I think some other company should propose some other formula approach and produce VIP. However: 1.) Relief Therapeutics (with NeuroRx) conducts FDA-registered trials, meaning that, if approved, only Relief Therapeutics would be entitled to market aviptadil rather than place in the United States for a given condition; 2.) RLF-100 has the designation of orphan drug in the United States and Europe. This means that even if the RLF-100 was not patented (which is), by reversing the testing procedure and passing the drug through the FDA, if approved, Relief Therapeutics will have exclusive rights to place the RLF-100 on the market. United States for an era of 7 years. If, for some reason, the RLF-100 does not enjoy a 7-year exclusivity, there are also exclusive eras of 5 and 3 years based on other considerations. [source: FDA]
NeuroRx is based on over a hundred years of collective delight in drug progression and is led by former senior executives from Johnson-Johnson, BMS, Eli Lilly, Pfizer and Sunovion. In addition to his paintings on RLF-hundred, NeuroRx has earned the designation of revolutionary cure and a special protocol agreement to expand NRX-101 for the remedy of suicidal bipolar depression and lately is in Phase 3. Your board of administrators and advisors come with Hon. . Sherry Glied, former undersecretary of the U.S. Department of Health and Human Services; Mr. Chaim Hurvitz, former president of Teva International Group, Lt. Gen. HR McMaster, 23rd National Security Adviser, Wayne Pines, former associate commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former senior U.S. food adviser. and Drug Administration. [source: press releases]
Dr. Javitt has played a leading role in seven successful IT and biopharmaceutical start-ups in the fitness sector with public outings. He has also led drug progression commitments for Merck, Allergan, Pharmacia, Novartis and Pfizer. He appointed senior health care positions under Reagan Presidents George H.W. Bush, Clinton and George W. Bush. In the latter role, he was guilty of leading the White House’s policy for the universal adoption of physical computing and the creation of the Office of the National Coordinator. He graduated from Princeton University, Cornell University School of Medicine, Harvard School of Public Health, Wills Eye Hospital and Johns Hopkins School of Medicine. Dr. Javitt has published more than two hundred clinical articles in the fitness and pharmacoeconomic outcome spaces that have been cited through more than 16,000 people.
Dr. Javitt is also president of the examination of the 3 ongoing clinical trials for RLF-100, and is the author of another preprinted paper entitled “Perspective: The Potential Role of Vasoactive Intestinal Peptide in the Treatment of COVID-19”, which I strongly advised to obtain a detailed overview of the science of using RLF-100 in COVID-19.
Speaking of government contacts, for the first time in their press on August 3, 2020, Relief and NeuroRx revealed that RLF-100:
… It has been developed as a medical countermeasure that opposes threats in cooperation with the National Institutes of Health and other federal agencies. “
It seems that NeuroRx members with government delight can now help Relief Therapeutics obtain secure government funds.
I do not mean the main points of dating between Relief Therapeutics and NeuroRx, nor the payment structure; However, in my evaluation analysis below, I assumed that a large portion of sales would pass to manufacturing, distribution and marketing partners.
In dr. Javitt’s pre-impression summary, “Vasoactive intestinal peptide treats respiratory failure in COVID-19 by saving the type II alveolar cell”, one is very convincing when it comes to evaluation:
Due to its lack of toxicity and low production load compared to patented biological products, VIP can be especially horny for those who oppose global countermeasures to COVID-19.
Making an evaluation is complicated because there are many unknown variables, “known unknowns” so to speak, to quote Gilead’s former president, Rumsfeld. In my evaluation estimates, I will make a far-fetched assumption from the outset: that the RLF-100 succeeds in receiving international approval for the COVID-19 remedy in critical and mild to moderate patients (avoiding its progression to critical).
Relief Therapeutics, as I know, has not set the value of a dose of RLF-hundred. In critical patients, the process is intravenous management from 50 to 150 pmol/ kg/h for 12 hours. In the mild to moderate test, patients will get misted RLF: one hundred, one hundred micrograms 3 times a day.
However, according to Relief and NeuroRx, the production load is low and, of course, the dosage amounts discussed above are incredibly low. This can result in a higher margin for Relief Therapeutics, even after the conclusion of production, filling/finishing and distribution agreements.
How many doses will be needed in the world? If the pandemic (estimated at five years), only 1% of the world’s population (76 million people) will need a dose of RLF-100, either to prevent their condition from getting worse or to recover from a critical, or even prophylactic, condition, this would equal 228 million doses (at an average patient-related 3 dose rate). If each remedy dose yields only $50 for net Relief Therapeutics, that equates to $11.4 billion in a net source of revenue over five years, or $2.28 billion on annual average. Assuming a dilution of six hundred million more consistent with the percentages and applying a value-to-earnings ratio of 18 to that, it has a consistent percentage value of approximately $18 consistent with the consistent percentage.
Of course, this can be very wrong, basically due to the lack of aforementioned inputs, such as the production load and the value of the dosage. I think only 1% of the world’s population for five years is a conservative estimate of usage needs.
Company
Capitalization
Modern (ARNM)
$29 billion
Novavax (NVAX)
$8.7 billion
Inovio (INO)
$3.2 billion
Biotechnology vir (VIR)
$6.53 billion
Remdesivir’s FDA emergency use approval added $10 billion to Gilead’s market capitalization overnight when it was first announced. And as we all know, Remdesivir has only been effective in cutting hospital debris for about four days. It also has side effects, contraindications and an average value of $2730 consistent with the remedy if you average the insured and uninsured value.
The addition of a $10 billion market capitalization to Relief Therapeutics provides us with a consistent percentage value of approximately $5 consistent with a consistent percentage and overall market capitalization of approximately $12 billion.
In the interview discussed earlier with a Zurich-based publication, The Market NZZ, Relief’s president, Dr. Selvaraju, made a valuable comment that reflects his perspectives on the evaluation:
Q: Ram, at the beginning of the year, Relief’s market capitalization only CHF 2 million [millions]. Last week, the price rose to more than a billion francs. This increase was motivated in the hope that Relief would have a drug candidate, RLF-100 (Aviptadil), which showed in the first clinical trials an immediate cure for respiratory failure in patients at peak critical condition with Covid-19. In addition, independent researchers have reported that Aviptadil blocks the replication of Sars-CoV-2 in human lung cells and monocytes. How are you feeling?
A: I think the attention we’re getting right now is due to the gravity and global nature of the Covid-19 pandemic. And it is an advantage that we had the possibility to move a clinical program very quickly: now we have started to see evidence that the drug is working. Many other people have tried things in Covid-19 and haven’t gone very far. This reflects how complicated it is to treat this disease and how rare it is to identify a remedy that can actually have an impact. This now draws attention to our stock.
Q: To justify an existing market price well above one billion francs, Relief will have to have a prospective profit of more than one hundred million francs. [millions] in line with the year achievable for at least 10 consecutive years. Is that realistic?
A: It’s very realistic. Covid-19’s pandemic officially ignited 19 Mio. [millions] of other people around the world. However, this is a blatant underestimation of the actual figure. The official figures only reflect the number of tests carried out. The number of other people who are sick and have difficulty breathing is between one and five, consistent with one hundred. This might not seem like an impressive statistic. But given the number of tens of millions of other people inflamed, this is a giant population, especially if you look at the relative advantages of our drug: if it saves lives, how do you characterize the price?
Q: What are your expectations?
A: If the drug is approved, there are 3 situations: Let’s say it’s approved in an environment where Covid-19 disappears very quickly. I think we can almost completely rule out that situation. It turns out the challenge is getting worse and worse. The current situation is the approval of the drug while the disease persists for several years, but eventually disappears. In this context, we believe that the maximum annual sales of RLF-hundred are likely to exceed one hundred million Swiss francs. [million] annual figure discussed in your question. The price depends on the competitive landscape and whether effective vaccines are available, etc. In this critical situation and with effective vaccines available, it will take several years to implement them. Our drug would have 4 to six years of prospective deployment for critically ill patients, and can generate millions of dollars a year during that time.