RLFTF DD (opinion) by J-Belfort "copy": BRPA/Neur
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(Total Views: 342)
Posted On: 02/25/2021 8:11:33 PM
RLFTF DD (opinion) by J-Belfort "copy": BRPA/NeuroRx & Relief Therapeutics (RLFTF) have demonstrated the 1st EFFECTIVE treatment for severe COVID 19 in today’s phase 3 results! There is MASSIVE Upside with CONFIRMED OWS stockpiling agreement and planned RLFTF NASDAQ uplisting, EUA/full FDA approval. This is the mother of all DD!
Until now, there have been NO effective COVID treatments. Although drugs like dexamethasone, Remdesivir and Monoclonal antibodies/convalescent plasma have been approved for fighting COVID, these drugs have minimal efficacy, are expensive to produce and difficult to transport. In fact, the World Health Organization doesn’t even recommend using Remdesivir because there is no proven mortality benefit. (https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients)
Relief Therapeutics, a penny stock trading under RLFTF is a small Swiss biotech that owns the rights to synthetic vasoactive intestinal peptide (VIP). The substance is also known by the trademarked names, aviptadil, RLF-100 and Zyesami. VIP is a peptide. Peptides are small molecules which are produced by the body and have systemic effects. In proof that good things come from small packages, consider the fact that the most famous peptide is insulin.
As of 2/23/21, Relief Therapeutics and their profit-sharing partner, NeuroRx have announced positive data related to their recent phase 3 trial. The results were STATISTICALLY SIGNIFICANT for patients high flow O2. These patients get out of the hospital faster BY 10 DAYS! This means we now have an effective COVID 19 therapy for patients in the ICU. It improves oxygenation, gets them out of the hospital fast and prevents progression to mechanical ventilation.
Based on the favorable results, one can reasonably conclude that:
Submission of phase 3 data has already occurred to the FDA in anticipation of possible EUA
OWS has received a copy of this favorable phase 3 data with the expectation that their pending contract (30k initial treatment purchase and purchase of 100k treatments quarterly) may rapidly be approved.
Rapid adoption in ICUs nationwide can be anticipated given the improvement in survival, oxygenation, days on mechanical ventilation and days in the ICU overall
Peer reviewed publication of results in The Lancet and other journals
WHY IS VIP/Aviptadil/RLF-100/Zyesami SO GREAT AT TREATING COVID?
Well, for one, VIP has five separate mechanisms of action.
It directly inhibits viral replication
It has broad anti-inflammatory effects with decrease in II 6, cytokines and TNF
It causes surfactant production
It has direct bronchodilator effects to improve pulmonary blood-flow and increase the V/Q ratio (level of oxygenation)
Blocks apoptosis (cell death)
Additionally, VIP is highly effective at treating COVID because it is not dependent on the protein spike that most current vaccines work on. To this end, VIP efficacy is not affected by the current coronavirus mutations (London strain, South African strain, etc) which are beginning to demonstrate increased mortality and vaccine resistance. (https://www.cbsnews.com/news/south-africa-covid-strain-resistance-antibodies-coronavirus-vaccine-latest-research/)
Contrary to the original theory of a cytokine storm (popularized by CYDY/Leronlimab without good scientific proof), more recent research has indicated that the SARS-CoV-2 infection triggers a dual mode of action with cell death pathways and inflammatory responses which may lead to severe lung damage in COVID-19 patients. (https://www.nature.com/articles/s41392-020-00334-0). The fact that Zyesami is both an inhibitor or apoptosis and a powerful anti-inflammatory medication makes this drug uniquely suited to treat COVID patients.
PHASE 3 RESULTS:
The recent phase 3 trial for VIP/Zyesami was based on the results of 196 patients. It was a randomized, placebo-controlled trial with identical drug and placebo infusion bags.
These patients received escalating doses of the IV medication in 3 separate doses. They were then followed for 28 days.
ClinicalTrials.org study information can be found here: https://clinicaltrials.gov/ct2/show/study/NCT...amp;rank=1
The results were STATISTICALLY SIGNIFICANT for 28 day hospital admission with 60 day results on respiratory failure and mortality pending (unblinded 2/22/21).
Secondary Endpoints were:
1.Improvement on NIAID Scale
2.Survival through day 28 and day 60
3.Time to ICU discharge
4.Time on ventilation (Time on mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen)
5.Time to extubation
6.Time to discharge alive
7.Multi-organ failure free days
Other Outcome Measures were:
1.Respiratory Distress while on mechanical ventilation (PaO2:FiO2 ratio)
2.Oxygenation index (Time Frame: Day 0 through day 28)
3. Improvement in chest x-ray (scored by RALES score)
4. Improvement in inflammatory markers (Improvement in IL-6, TNF alpha, and other inflammatory markers)
EAP CLINICAL TRIAL RESULTS:
Relief Therapeutics has enrolled more than 200 patients in their compassionate use (EAP) program. These patients were patients who were too sick for the Phase 3 trial. Patients who had multiple comorbidities such as: lung transplant patients, patients with lung cancer, patients who were immunocompromised or had evidence of severe, multisystem organ dysfunction.
Initial data from a 102 patient sample size showed a 72% rate of survival with aviptadil + SOC vs 27% SOC. Although full results of the EAP 200+ patients have not been reported to date, it is reasonable to assume that results will continue to show the same, favorable outcome.
Social media and traditional news media have been very beneficial in following along the stories of some of the EAP patients. A list of current EAP patients includes:
Dr. Jacobo Elgozy, a southern Florida doctor who contracted COVID in July 2020 was placed on ECMO being considered for a double lung transplant due to bilateral COVID pneumonia recovered rapidly after IV RLF-100 administration https://wsvn.com/news/local/miami-dade/miami-...-new-drug/
Mike Cardenas, a Nebraskan native, was treated with RLF100 after experiencing acute hypoxic respiratory failure secondary to COVID. Rapid recovery noted. https://nebraska.tv/news/local/exclusive-drug...ients-life
Phil Moreno contracted COVID and was placed on NIPPV for deteriorating hypoxia. Rapid improvement and removal from BIPAP was noted after VIP administration. https://northplattebulletin.com/north-platte-...ith-virus/
Roni Melton in Nebraska contracted COVID and was on mechanical ventilation for 10 days prior to rapid improvement and ventilator wean after aviptadil administration. https://nptelegraph.com/opinion/letters/lette...c5ed6.html
Brian DiDonato’s father was considered moribund after prolonged mechanical ventilation with hypoxia and multisystem organ failure. After VIP administration, he was able to be extubated and leave the hospital. https://twitter.com/BDiDonatoTDN/status/13523...25955?s=20
SO WHAT ARE THE CRITERIA FOR AN EUA FROM THE FDA?
The FDA states that to receive an EUA, companies must merely prove that their drug is safe and MAY be effective. You can read the exact wording here: https://www.fda.gov/regulatory-information/se...uthorities
Given that VIP is the FIRST AND ONLY therapeutic to demonstrate a rapid and statically significant resolution of respiratory failure in patients with severe COVID on high flow o2, it is reasonable to assume that the FDA will rapidly offer (within 0-30 days) an EUA to Relief Therapeutics. In fact, a recent interview with CEO Jonathan Javitt noted “We expect topline data at the end of the month (Jan 2021) and that may well trigger regulatory action if we have a positive readout.” (https://www.biospace.com/article/neurorx-on-the-move-an-interview-with-founder-and-ceo-jonathan-javitt/)
EUA approval means that VIP may be available for use in any hospital in the United States. Pharmacies can order and administer the drug without having to request compassionate use or go thru their hospital’s IRB process. Additionally, upon EUA approval, it can reasonably be anticipated that BARD/Operation Warp Speed stockpiling would occur (OWS contract pending for 30k treatments and 100k treatments quarterly!)
Full approval is also likely but anticipated to be Q2/Q3 due to submission requirements. The recent SEC document from 1/27/21 notes: “In order to file for New Drug Approval, NeuroRx must prove safety and efficacy in adequately controlled studies. FDA has already agreed that a single, adequately controlled trial of sufficient statistical significance would be adequate for acceptance of a New Drug Application (“NDA”) by FDA. In May 2020, NeuroRx proceeded at risk to launch RLF-100_001 trial under IND 149.152. This trial is nearing completion and will yield top line data in the first quarter of 2021. Should this trial demonstrate multidimensional efficacy, it will be sufficient for NDA. NeuroRx has conducted Pre IND meetings with FDA on the intravenous use versions of aviptadil and has an open IND with FDA for treatment of COVID-19. IND 149,152."
DISTRIBUTION & MARKETING:
Drug manufacturing is to be performed by Bacham. Bacham has manufacturing facilities in the US and Netherlands. Of note, recently (after Xmas), they posted jobs for more than 61 positions related to peptide manufacturing. (https://careers.bachem.com/search?locale=en_US)
Furthermore, “NeuroRx has arranged with the Nephron pharmaceutical group to initiate scaleup of aviptadil acetate 100µg/ml in saline. Pending review of the clinical data, NeuroRx is prepared to order the first 10,000 patient courses of treatment in the first quarter of 2021. At 1,500µg aviptadil per treatment kit, NeuroRx would have sufficient drug product in hand to supply 10,000 kits. NeuroRx has contracted with Bachem to supply 1 KG of Aviptadil during the first quarter of 2021, and glass syringes would be supplied by Nephron to support this order. NeuroRx has sufficient API on order to meet two years of supply at 100,000 patient doses per quarter. "
In their Biotech Investor Showcase, the CFO of Relief Therapeutics has indicated that distribution is to be handled by McKesson, Cardinal and AmerisourceBergen.
PIPELINE:
On 1/25/21, Relief Therapeutics announced that they had given Acer 1million and a 4million loan payment to obtain exclusivity for both companies working toward negotiation and execution of a definitive collaboration and license agreement by June 30, 2021. (https://relieftherapeutics.com/newsblog/relief-therapeutics-and-acer-therapeutics-sign-option-agreement-for-exclusivity-to-negotiate-a-collaboration-and-license-agreement-for-the-worldwide-development-and-commercialization-of-acer-001-for-the-treatment-of-urea-cycle-disorders-and-maple-syrup-urine-disease)
In their PR, the companies announced that they had signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
This is interesting on several fronts:
ACER market cap is 51million…almost the exact same amount as a share swap agreement between RLF and VC fund GEM announced last week.
ACER is in dire financial straits. They had bad clinical trial results last year and it tanked their SP into the $2s. The agreement between RLF and ACER indicates that if the 4million loan isn’t repaid within 1 year, all assets become forfeit to RLF.
RLF was previously a one trick pony with Zyesami. The addition of ACER-001 means they now have a 2-drug pipeline (just like NeuroRX has NRX-101) adding value to this pennystock company.
ACER is NASDAQ listed….guess who indicated in their Biotech Showcase a “near term plan for NASDAQ uplisting?” That’s right…the CFO of RLFTF.
ACER has a small outstanding float & RLF has a giant one. RLF has already indicated a plan for possible ACR share conversion vs 20:1 RS to downsize their float…merging/acquiring a small float stock would prevent further dilution upon uplisting.
Likewise, NeuroRx has NRX-101, an oral ketamine-based NMDA inhibitor which is expected to be a game changer in the world of PTSD and bipolar depression with suicidal features. Additionally, in their recent SEC filing, NeuroRx has indicated: "VIP is also known to be active in the brain and NeuroRx plans to explore its potential use in the treatment of Huntington’s Disease, Multiple Sclerosis, and other CNS diseases via our partnership with the nose to brain delivery system developed by Sipnose. "
MARKET CAP:
RLF and BRPA/NeuroRx are splitting all profits 50/50 from the United States and Israel.
RLF received 85% of all profits in Europe and 80% everywhere else in the world. (20/25% BRPA).
In their investor showcase, the CFO indicated that VIP is likely to be reimbursed similar to remdesivir at 3k/treatment. He also noted that in the US, reimbursement might be as high as 10k/dose. Of note, as of January 2021, 120k patients were hospitalized with COVID with up to 30k new hospitalizations weekly.
In a recent Lancet paper, Clark et al noted: “We estimated that 1.7 billion people, comprising 22% of the global population, have at least one underlying condition that puts them at increased risk of severe COVID-19 if infected (ranging from <5% of those younger than 20 years to >66% of those aged 70 years or older). We estimated that 349 million people (4% of the global population) are at high risk of severe COVID-19 and would require hospital admission if infected.” (https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(20)30264-3/fulltext)
Assuming that these numbers are accurate, we can estimate half of those patients hospitalized with severe COVID would meet criteria for acute respiratory failure and possible Zyesami treatment (i.e 125 million for the sake of simplified calculations). At $3000 per dose, that is an enormous amount of potential revenue to drive the share price up astronomically, especially since Relief Therapeutics explicitly indicated in the recent Biotech Investor Showcase a plan to uplist to the NASDAQ “near term.”
Furthermore, in addition to a COVID indication, VIP may also be used for RDS treatment if it is proven effective in COVID induced pneumonia. This would account for 500k additional patients per year.
Lastly, the NeuroRx SEC document noted: "in our many interactions with the U.S Department of Health and Human Services, Operation Warp Speed and the National Institutes of Health, no direct competitor has been identified."
Furthermore, the SEC document explicitly indicated that Operation Warp Speed is reviewing a contract contingent on phase 3 data for 30k initial treatments and 100k treatments quarterly. At an anticipated cost of 3k per dose, this will be an immense value driver for both NRX and RLFTF.
CAN VIP BE USED FOR TREATMENT OF OTHER CONDITIONS?
Yes! Zyesami is being investigated for use in Respiratory Distress Syndrome (RDS), Sarcoidosis, Immune Checkpoint Inhibitor Induced Pneumonitis and, possible, COPD.
If it is proven effective, VIP may have the potential to be as important to the treatment of pulmonary diseases as penicillin was to the treatment of bacterial infections.
Clinical trials are already underway for RDS: (https://clinicaltrials.gov/ct2/show/study/NCT04311697?term=zyesami&draw=2&rank=1) and moderate COVID with an inhaled form: (https://clinicaltrials.gov/ct2/show/NCT04360096?term=aviptadil&draw=2&rank=3.
Additional clinical trials are planned.
LOOKING FORWARD
In summary, this is a very interesting company with a very interesting drug with a very interesting share structure at a very interesting time period in the world.
The potential for this medication to treat indications other than COVID cannot be emphasized enough. Long after this pandemic has passed, the antiviral, immunomodulatory and anti-inflammatory effects of VIP stand to continue to offer clinical benefit.
Because the effects of IV VIP have been proven to be statistically significant for treating COVID induced respiratory failure. An inhaled version is very likely to have further positive effects with the benefit of at-home use in an inhaler form factor and institutional use as a nebulized medication.
Furthermore, NeuroRx and Relief therapeutics have already indicated that VIP will be investigated for other pulmonary conditions, including COPD, asthma, allergies, multiple sclerosis, Immune Checkpoint Inhibitor Pneumonitis and Pulmonary Sarcoidosis.
If even one of these indications can be added to VIP’s clinical indications for use, market cap will increase exponentially above where it is already headed. At risk of pumping, its reasonable to conclude that RLF/NeuroRx may be become the next Moderna, rising like a phoenix from the ashes to become the newest big pharma. GLTA.
CATALYSTS:
1 - Planned "near term uplisting" of RLFTF to NASDAQ (confirmed by CFO in the Biotech Investor Showcase)
2- EAP data on 300+ compassionate use patients
3 -Initiation of the inhalation trial – reported on 2/3/20 with top line results pending 1H2021
4 - I-SPY trial results for inhaled VIP vs remdesavir
5- Inclusion in NIH/TESICO/Active3b Trial (pg 18 of the NeuroRx investor presentation)
6 - BRPA merger completion
7 - Possible stockpiling agreements/OWS/Barda – described as pending phase 3 results with expected purchase of 100k treatments quarterly and 30k treatments up front
8 - Partnership announcements with McKesson, Cardinal and AmerisourceBergen (Reported by CFO orally in the biotech investor presentation)
9 - Mexico, India, Russia feedback/partnerships (reported by CFO in the biotech investor presentation)
REFERENCES:
NeuroRx 2/23/21 PR regarding Phase 3 results:
https://www.prnewswire.com/news-releases/neur...33805.html
Preprint Articles on RLF-100: (I’d suggest you check out the chest xrays in the first article) https://papers.ssrn.com/sol3/cf_dev/AbsByAuth...id=4173101
SEC 8k BRPA/NeuroRx Merger:
https://sec.report/Document/0001654954-20-013..._ex2-1.htm
SEC S4 Form from 1/27/21:
https://fintel.io/doc/sec-big-rock-partners-a...27-18654-7
FULL DISCLOSURE & DISCLAIMER:
I own shares of both BRPA and RLFTF and am a board certified intensivist. I am not a financial advisor and suggest you do your own DD.
===============================================
All above copied from:
https://www.reddit.com/r/SPACs/comments/lqx2m...lftf_have/
===============================================
His "daily job" is to provide care for critically ill patients, he IS the front lines and see's the current SOC and the promise Zyesami has to benefit those who desperately need something effective. I read everything he posts here and on other forums. In case some haven't read this particular one already I thought I'd repost it here.
Best,
JB
Disclaimer
All of my posts are just my own opinion and not advice to buy, sell or trade any stock, security or anything else for that matter. I post my own personal thoughts and information that I have found regarding positions that I am invested in
Until now, there have been NO effective COVID treatments. Although drugs like dexamethasone, Remdesivir and Monoclonal antibodies/convalescent plasma have been approved for fighting COVID, these drugs have minimal efficacy, are expensive to produce and difficult to transport. In fact, the World Health Organization doesn’t even recommend using Remdesivir because there is no proven mortality benefit. (https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients)
Relief Therapeutics, a penny stock trading under RLFTF is a small Swiss biotech that owns the rights to synthetic vasoactive intestinal peptide (VIP). The substance is also known by the trademarked names, aviptadil, RLF-100 and Zyesami. VIP is a peptide. Peptides are small molecules which are produced by the body and have systemic effects. In proof that good things come from small packages, consider the fact that the most famous peptide is insulin.
As of 2/23/21, Relief Therapeutics and their profit-sharing partner, NeuroRx have announced positive data related to their recent phase 3 trial. The results were STATISTICALLY SIGNIFICANT for patients high flow O2. These patients get out of the hospital faster BY 10 DAYS! This means we now have an effective COVID 19 therapy for patients in the ICU. It improves oxygenation, gets them out of the hospital fast and prevents progression to mechanical ventilation.
Based on the favorable results, one can reasonably conclude that:
Submission of phase 3 data has already occurred to the FDA in anticipation of possible EUA
OWS has received a copy of this favorable phase 3 data with the expectation that their pending contract (30k initial treatment purchase and purchase of 100k treatments quarterly) may rapidly be approved.
Rapid adoption in ICUs nationwide can be anticipated given the improvement in survival, oxygenation, days on mechanical ventilation and days in the ICU overall
Peer reviewed publication of results in The Lancet and other journals
WHY IS VIP/Aviptadil/RLF-100/Zyesami SO GREAT AT TREATING COVID?
Well, for one, VIP has five separate mechanisms of action.
It directly inhibits viral replication
It has broad anti-inflammatory effects with decrease in II 6, cytokines and TNF
It causes surfactant production
It has direct bronchodilator effects to improve pulmonary blood-flow and increase the V/Q ratio (level of oxygenation)
Blocks apoptosis (cell death)
Additionally, VIP is highly effective at treating COVID because it is not dependent on the protein spike that most current vaccines work on. To this end, VIP efficacy is not affected by the current coronavirus mutations (London strain, South African strain, etc) which are beginning to demonstrate increased mortality and vaccine resistance. (https://www.cbsnews.com/news/south-africa-covid-strain-resistance-antibodies-coronavirus-vaccine-latest-research/)
Contrary to the original theory of a cytokine storm (popularized by CYDY/Leronlimab without good scientific proof), more recent research has indicated that the SARS-CoV-2 infection triggers a dual mode of action with cell death pathways and inflammatory responses which may lead to severe lung damage in COVID-19 patients. (https://www.nature.com/articles/s41392-020-00334-0). The fact that Zyesami is both an inhibitor or apoptosis and a powerful anti-inflammatory medication makes this drug uniquely suited to treat COVID patients.
PHASE 3 RESULTS:
The recent phase 3 trial for VIP/Zyesami was based on the results of 196 patients. It was a randomized, placebo-controlled trial with identical drug and placebo infusion bags.
These patients received escalating doses of the IV medication in 3 separate doses. They were then followed for 28 days.
ClinicalTrials.org study information can be found here: https://clinicaltrials.gov/ct2/show/study/NCT...amp;rank=1
The results were STATISTICALLY SIGNIFICANT for 28 day hospital admission with 60 day results on respiratory failure and mortality pending (unblinded 2/22/21).
Secondary Endpoints were:
1.Improvement on NIAID Scale
2.Survival through day 28 and day 60
3.Time to ICU discharge
4.Time on ventilation (Time on mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen)
5.Time to extubation
6.Time to discharge alive
7.Multi-organ failure free days
Other Outcome Measures were:
1.Respiratory Distress while on mechanical ventilation (PaO2:FiO2 ratio)
2.Oxygenation index (Time Frame: Day 0 through day 28)
3. Improvement in chest x-ray (scored by RALES score)
4. Improvement in inflammatory markers (Improvement in IL-6, TNF alpha, and other inflammatory markers)
EAP CLINICAL TRIAL RESULTS:
Relief Therapeutics has enrolled more than 200 patients in their compassionate use (EAP) program. These patients were patients who were too sick for the Phase 3 trial. Patients who had multiple comorbidities such as: lung transplant patients, patients with lung cancer, patients who were immunocompromised or had evidence of severe, multisystem organ dysfunction.
Initial data from a 102 patient sample size showed a 72% rate of survival with aviptadil + SOC vs 27% SOC. Although full results of the EAP 200+ patients have not been reported to date, it is reasonable to assume that results will continue to show the same, favorable outcome.
Social media and traditional news media have been very beneficial in following along the stories of some of the EAP patients. A list of current EAP patients includes:
Dr. Jacobo Elgozy, a southern Florida doctor who contracted COVID in July 2020 was placed on ECMO being considered for a double lung transplant due to bilateral COVID pneumonia recovered rapidly after IV RLF-100 administration https://wsvn.com/news/local/miami-dade/miami-...-new-drug/
Mike Cardenas, a Nebraskan native, was treated with RLF100 after experiencing acute hypoxic respiratory failure secondary to COVID. Rapid recovery noted. https://nebraska.tv/news/local/exclusive-drug...ients-life
Phil Moreno contracted COVID and was placed on NIPPV for deteriorating hypoxia. Rapid improvement and removal from BIPAP was noted after VIP administration. https://northplattebulletin.com/north-platte-...ith-virus/
Roni Melton in Nebraska contracted COVID and was on mechanical ventilation for 10 days prior to rapid improvement and ventilator wean after aviptadil administration. https://nptelegraph.com/opinion/letters/lette...c5ed6.html
Brian DiDonato’s father was considered moribund after prolonged mechanical ventilation with hypoxia and multisystem organ failure. After VIP administration, he was able to be extubated and leave the hospital. https://twitter.com/BDiDonatoTDN/status/13523...25955?s=20
SO WHAT ARE THE CRITERIA FOR AN EUA FROM THE FDA?
The FDA states that to receive an EUA, companies must merely prove that their drug is safe and MAY be effective. You can read the exact wording here: https://www.fda.gov/regulatory-information/se...uthorities
Given that VIP is the FIRST AND ONLY therapeutic to demonstrate a rapid and statically significant resolution of respiratory failure in patients with severe COVID on high flow o2, it is reasonable to assume that the FDA will rapidly offer (within 0-30 days) an EUA to Relief Therapeutics. In fact, a recent interview with CEO Jonathan Javitt noted “We expect topline data at the end of the month (Jan 2021) and that may well trigger regulatory action if we have a positive readout.” (https://www.biospace.com/article/neurorx-on-the-move-an-interview-with-founder-and-ceo-jonathan-javitt/)
EUA approval means that VIP may be available for use in any hospital in the United States. Pharmacies can order and administer the drug without having to request compassionate use or go thru their hospital’s IRB process. Additionally, upon EUA approval, it can reasonably be anticipated that BARD/Operation Warp Speed stockpiling would occur (OWS contract pending for 30k treatments and 100k treatments quarterly!)
Full approval is also likely but anticipated to be Q2/Q3 due to submission requirements. The recent SEC document from 1/27/21 notes: “In order to file for New Drug Approval, NeuroRx must prove safety and efficacy in adequately controlled studies. FDA has already agreed that a single, adequately controlled trial of sufficient statistical significance would be adequate for acceptance of a New Drug Application (“NDA”) by FDA. In May 2020, NeuroRx proceeded at risk to launch RLF-100_001 trial under IND 149.152. This trial is nearing completion and will yield top line data in the first quarter of 2021. Should this trial demonstrate multidimensional efficacy, it will be sufficient for NDA. NeuroRx has conducted Pre IND meetings with FDA on the intravenous use versions of aviptadil and has an open IND with FDA for treatment of COVID-19. IND 149,152."
DISTRIBUTION & MARKETING:
Drug manufacturing is to be performed by Bacham. Bacham has manufacturing facilities in the US and Netherlands. Of note, recently (after Xmas), they posted jobs for more than 61 positions related to peptide manufacturing. (https://careers.bachem.com/search?locale=en_US)
Furthermore, “NeuroRx has arranged with the Nephron pharmaceutical group to initiate scaleup of aviptadil acetate 100µg/ml in saline. Pending review of the clinical data, NeuroRx is prepared to order the first 10,000 patient courses of treatment in the first quarter of 2021. At 1,500µg aviptadil per treatment kit, NeuroRx would have sufficient drug product in hand to supply 10,000 kits. NeuroRx has contracted with Bachem to supply 1 KG of Aviptadil during the first quarter of 2021, and glass syringes would be supplied by Nephron to support this order. NeuroRx has sufficient API on order to meet two years of supply at 100,000 patient doses per quarter. "
In their Biotech Investor Showcase, the CFO of Relief Therapeutics has indicated that distribution is to be handled by McKesson, Cardinal and AmerisourceBergen.
PIPELINE:
On 1/25/21, Relief Therapeutics announced that they had given Acer 1million and a 4million loan payment to obtain exclusivity for both companies working toward negotiation and execution of a definitive collaboration and license agreement by June 30, 2021. (https://relieftherapeutics.com/newsblog/relief-therapeutics-and-acer-therapeutics-sign-option-agreement-for-exclusivity-to-negotiate-a-collaboration-and-license-agreement-for-the-worldwide-development-and-commercialization-of-acer-001-for-the-treatment-of-urea-cycle-disorders-and-maple-syrup-urine-disease)
In their PR, the companies announced that they had signed an Option Agreement providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. ACER-001 (sodium phenylbutyrate) powder is a taste-masked, immediate release proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
This is interesting on several fronts:
ACER market cap is 51million…almost the exact same amount as a share swap agreement between RLF and VC fund GEM announced last week.
ACER is in dire financial straits. They had bad clinical trial results last year and it tanked their SP into the $2s. The agreement between RLF and ACER indicates that if the 4million loan isn’t repaid within 1 year, all assets become forfeit to RLF.
RLF was previously a one trick pony with Zyesami. The addition of ACER-001 means they now have a 2-drug pipeline (just like NeuroRX has NRX-101) adding value to this pennystock company.
ACER is NASDAQ listed….guess who indicated in their Biotech Showcase a “near term plan for NASDAQ uplisting?” That’s right…the CFO of RLFTF.
ACER has a small outstanding float & RLF has a giant one. RLF has already indicated a plan for possible ACR share conversion vs 20:1 RS to downsize their float…merging/acquiring a small float stock would prevent further dilution upon uplisting.
Likewise, NeuroRx has NRX-101, an oral ketamine-based NMDA inhibitor which is expected to be a game changer in the world of PTSD and bipolar depression with suicidal features. Additionally, in their recent SEC filing, NeuroRx has indicated: "VIP is also known to be active in the brain and NeuroRx plans to explore its potential use in the treatment of Huntington’s Disease, Multiple Sclerosis, and other CNS diseases via our partnership with the nose to brain delivery system developed by Sipnose. "
MARKET CAP:
RLF and BRPA/NeuroRx are splitting all profits 50/50 from the United States and Israel.
RLF received 85% of all profits in Europe and 80% everywhere else in the world. (20/25% BRPA).
In their investor showcase, the CFO indicated that VIP is likely to be reimbursed similar to remdesivir at 3k/treatment. He also noted that in the US, reimbursement might be as high as 10k/dose. Of note, as of January 2021, 120k patients were hospitalized with COVID with up to 30k new hospitalizations weekly.
In a recent Lancet paper, Clark et al noted: “We estimated that 1.7 billion people, comprising 22% of the global population, have at least one underlying condition that puts them at increased risk of severe COVID-19 if infected (ranging from <5% of those younger than 20 years to >66% of those aged 70 years or older). We estimated that 349 million people (4% of the global population) are at high risk of severe COVID-19 and would require hospital admission if infected.” (https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(20)30264-3/fulltext)
Assuming that these numbers are accurate, we can estimate half of those patients hospitalized with severe COVID would meet criteria for acute respiratory failure and possible Zyesami treatment (i.e 125 million for the sake of simplified calculations). At $3000 per dose, that is an enormous amount of potential revenue to drive the share price up astronomically, especially since Relief Therapeutics explicitly indicated in the recent Biotech Investor Showcase a plan to uplist to the NASDAQ “near term.”
Furthermore, in addition to a COVID indication, VIP may also be used for RDS treatment if it is proven effective in COVID induced pneumonia. This would account for 500k additional patients per year.
Lastly, the NeuroRx SEC document noted: "in our many interactions with the U.S Department of Health and Human Services, Operation Warp Speed and the National Institutes of Health, no direct competitor has been identified."
Furthermore, the SEC document explicitly indicated that Operation Warp Speed is reviewing a contract contingent on phase 3 data for 30k initial treatments and 100k treatments quarterly. At an anticipated cost of 3k per dose, this will be an immense value driver for both NRX and RLFTF.
CAN VIP BE USED FOR TREATMENT OF OTHER CONDITIONS?
Yes! Zyesami is being investigated for use in Respiratory Distress Syndrome (RDS), Sarcoidosis, Immune Checkpoint Inhibitor Induced Pneumonitis and, possible, COPD.
If it is proven effective, VIP may have the potential to be as important to the treatment of pulmonary diseases as penicillin was to the treatment of bacterial infections.
Clinical trials are already underway for RDS: (https://clinicaltrials.gov/ct2/show/study/NCT04311697?term=zyesami&draw=2&rank=1) and moderate COVID with an inhaled form: (https://clinicaltrials.gov/ct2/show/NCT04360096?term=aviptadil&draw=2&rank=3.
Additional clinical trials are planned.
LOOKING FORWARD
In summary, this is a very interesting company with a very interesting drug with a very interesting share structure at a very interesting time period in the world.
The potential for this medication to treat indications other than COVID cannot be emphasized enough. Long after this pandemic has passed, the antiviral, immunomodulatory and anti-inflammatory effects of VIP stand to continue to offer clinical benefit.
Because the effects of IV VIP have been proven to be statistically significant for treating COVID induced respiratory failure. An inhaled version is very likely to have further positive effects with the benefit of at-home use in an inhaler form factor and institutional use as a nebulized medication.
Furthermore, NeuroRx and Relief therapeutics have already indicated that VIP will be investigated for other pulmonary conditions, including COPD, asthma, allergies, multiple sclerosis, Immune Checkpoint Inhibitor Pneumonitis and Pulmonary Sarcoidosis.
If even one of these indications can be added to VIP’s clinical indications for use, market cap will increase exponentially above where it is already headed. At risk of pumping, its reasonable to conclude that RLF/NeuroRx may be become the next Moderna, rising like a phoenix from the ashes to become the newest big pharma. GLTA.
CATALYSTS:
1 - Planned "near term uplisting" of RLFTF to NASDAQ (confirmed by CFO in the Biotech Investor Showcase)
2- EAP data on 300+ compassionate use patients
3 -Initiation of the inhalation trial – reported on 2/3/20 with top line results pending 1H2021
4 - I-SPY trial results for inhaled VIP vs remdesavir
5- Inclusion in NIH/TESICO/Active3b Trial (pg 18 of the NeuroRx investor presentation)
6 - BRPA merger completion
7 - Possible stockpiling agreements/OWS/Barda – described as pending phase 3 results with expected purchase of 100k treatments quarterly and 30k treatments up front
8 - Partnership announcements with McKesson, Cardinal and AmerisourceBergen (Reported by CFO orally in the biotech investor presentation)
9 - Mexico, India, Russia feedback/partnerships (reported by CFO in the biotech investor presentation)
REFERENCES:
NeuroRx 2/23/21 PR regarding Phase 3 results:
https://www.prnewswire.com/news-releases/neur...33805.html
Preprint Articles on RLF-100: (I’d suggest you check out the chest xrays in the first article) https://papers.ssrn.com/sol3/cf_dev/AbsByAuth...id=4173101
SEC 8k BRPA/NeuroRx Merger:
https://sec.report/Document/0001654954-20-013..._ex2-1.htm
SEC S4 Form from 1/27/21:
https://fintel.io/doc/sec-big-rock-partners-a...27-18654-7
FULL DISCLOSURE & DISCLAIMER:
I own shares of both BRPA and RLFTF and am a board certified intensivist. I am not a financial advisor and suggest you do your own DD.
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All above copied from:
https://www.reddit.com/r/SPACs/comments/lqx2m...lftf_have/
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His "daily job" is to provide care for critically ill patients, he IS the front lines and see's the current SOC and the promise Zyesami has to benefit those who desperately need something effective. I read everything he posts here and on other forums. In case some haven't read this particular one already I thought I'd repost it here.
Best,
JB
Disclaimer
All of my posts are just my own opinion and not advice to buy, sell or trade any stock, security or anything else for that matter. I post my own personal thoughts and information that I have found regarding positions that I am invested in
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