$RLFTF
DD by Uncle Gee Gee (updated Oct 2, 2020)
Every RLF-100 Investor Should Read
EXECUTIVE SUMMARY
Relief Therapeutics is a small Swiss company with a patent for a drug called RLF-100 that treats Covid-19 patients. RLF-100 is a safe, synthetic version of a naturally-occurring peptide in the human body.
Relief Therapeutics has partnered with NeuroRX (led by CEO Dr. Javitt) for assistance with the U.S. FDA process, as well as manufacturing and distribution within the United States, Canada and Israel. Operations for the rest of the world will be handled separately by Relief Therapeutics.
RLF-100 has 4 clinical trials underway, and initial results look exceptionally promising. Highlights are provided below.
AVIPTADIL RLF-100 VIP
• VIP (vasoactive intestinal polypeptide) is a naturally occurring peptide in the human body.
• Aviptadil is a VIP for the treatment of erectile dysfunction, proven to be safe since 1970’s.
• Aviptadil is being repurposed as RLF-100 to treat Covid-19 patients.
• RLF-100 is a safe, patented, synthetic form of VIP, which increases surfactant production in the lungs to protect against Covid-19.
• RLF-100 is a trifecta treatment: 1) It blocks Covid-19 from attaching to host cells in the lungs; 2) it prevents the cytokine storm; and 3) it reduces inflammation.
• RLF-100 has 4 separate clinical trials for intravenous and inhaler versions of the drug.
• RLF-100 is inexpensive and easy to manufacture.
• RLF-100 shows promise for other lung applications beyond Covid, which also need to be studied and tested separately.
STOCK / COMPANY
• Relief Therapeutics is a small company in Switzerland that holds the patent on RLF-100.
• Relief is traded over the counter (OTC) on the Swiss SIX exchange.
• In August 2020, Relief up-listed from “OTC Pink” to the higher-tier “OTCQB” to allow a broader range of investors. Relief intends to seek a future presence on the NASDAQ or NYSE.
• Relief has CHF $48M cash on hand ($52M USD), enough to support planned trials and operations through 2022, without taking into account any RLF-100 revenue.
• NeuroRX is a private US-based partner and has connections at the highest levels of government and big pharma. They are guiding Relief Therapeutics through the FDA approval process and organizing manufacturing and distribution.
• Relief and NeuroRX will split profits from sales: 50/50 for U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.
Leadership Team: https://investorshub.advfn.com/boards/read_ms...=158200526
Partnership Agreement: https://relieftherapeutics.com/relief-and-neu...-partners/
Funding: https://relieftherapeutics.com/relief-announc...-with-gem/
OTCQB Uplisting: https://relieftherapeutics.com/relief-announc...-with-gem/
MANUFACTURING & DISTRIBUTION
• Robert Bestoff is the Chief of Operations and spent his career at Lilly & Pfizer. At Pfizer, he was head of the entire neuro science and pain division, responsible for $10B of drugs.
• Rich Siegel, former head of Johnson & Johnson’s drug portfolio, put together the manufacturing program.
• NeuroRX has signed 3 contracts in preparation to treat up to 1 million patients:
1) Bachem Americas has been contracted to manufacture drug substance for RLF-100.
2) Nephron Pharmaceuticals has been contracted to manufacture commercial supplies of RLF-100.
3) The largest supplier of inhaled sterile drugs in the United States, able to supply RLF-100 to any US hospital overnight, has been contracted as the pharmaceutical logistics partner.
M&D Contracts: https://relieftherapeutics.com/neurorx-and-re...iptadil-2/
CLINICAL TRIALS
Relief has the following 4 clinical trials underway:
1) Clinical Trial NCT04311697 – IV Trial
• This trial is for intravenous RLF-100 administered to patients in ICUs with respiratory failure.
• The trial seeks to enroll 144 patients.
• The trial is currently in “Phase 2b/3”, meaning it will evaluate both dosing and efficacy.
• A first interim review was held at 30 patients, which determined RLF-100 is safe for human use.
• A second interim review will be held at 102 patients with a determination to: 1) stop the trial because the drug is dangerous, 2) stop the trial because the drug shows no effect, 3) continue the trial because results look good, 4) stop the trial because the drug is proven.
• Patient #102 was enrolled on 9/30/2020; therefore once that patient completes their trial (28 days later), the Data Monitoring Committee (DMC) will review results and submit a recommendation to the FDA.
• Doctor (and Congressman) Andy Harris is 1 of 3 experts on the DMC.
First Interim Review: https://relieftherapeutics.com/neurorx-and-re...-covid-19/
2) Clinical Trial NCT04453839 – EAP Trial
• This EAP (Expanded Access Protocol) trial allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation (commonly referred to as "compassionate use"
.
• EAP is NOT the same as EUA (Emergency Use Authorization) – see clarification below
• Early EAP results were released in a “pre-print” document for patients considered to be “the sickest of the sick” (ICU, ventilator, ECMO patients).
• Results: For patients who received RLF-100, 19 out of 21 patients survived, where only about 6 were expected to survive.
Initial EAP Results Pre-print: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
Clarification: EAP and EUA
• EAP = Expanded Access Protocol – currently approved
• EUA = Emergency Use Authorization – submitted application to FDA
• EAP allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation.
• Qualifying for EAP is limited: the patient must be located at one of the few clinical trial hospitals, or transfer to a participating hospital, or have the hospital attempt to qualify for the drug.
• Due to EAP limitations, NeuroRX recently applied for EUA and is awaiting FDA approval.
• EUA allows experimental drug use during public health emergencies. Qualifications are that the drug must be safe and “may” be effective.
• If approved, EUA will allow RLF-100 to be used at all US hospitals, as a last resort when all other approved treatments have failed.
• EUA approval is not necessarily dependent upon trial completion or interim reviews, unless FDA subsequently requests more data.
• Currently there are only 2 other EUA approved therapeutics: Remdesivir and Convalescent Plasma.
EUA Submittal: https://relieftherapeutics.com/relief-partner...hausted-a/
Other Approved EUAs: https://www.fda.gov/media/136832/download
3) Clinical Trial NCT04360096 – Treatment Inhaler
• This trial is a study of 288 patients in the United States to test an inhaler-version of RLF-100, intended to ultimately be used for in-home nebulizer treatments.
• Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”
• Current estimated completion in 2020
4) Clinical Trial NCT04536350 – Preventative Inhaler
• This trial is a study of 80 patients in Switzerland to test an inhaler-version of RLF-100 as a “preventative treatment”.
• Current estimated completion in December 2021
Link to all 4 trials: https://clinicaltrials.gov/ct2/results?term=A...k=1#rowId0
OTHER EFFORTS
• Signed a cooperative agreement with NIH’s Institute of Arthritis and Infectious Diseases to test RLF-100 “against the flu virus and other viruses that kill people by attacking the lungs.”
• Israel has already granted Companionate Care Protocol across the country, and NeuroRX is in the process of determining how to serve it.
• When asked whether FDA approval would have an impact on other countries, Dr. Javitt responded with “the FDA determinations are highly influential around the globe”.
Yo Dr. Yo – Interview 1 on 8/12/2020: https://www.youtube.com/watch?v=KBG_BYfj-sY
Yo Dr. Yo – Interview 2 on 9/30/2020: https://www.youtube.com/watch?v=lrtsexJOxU8
Transcript: https://sonix.ai/r/CwLa15pid5GiS1N7dd9qyNa9/share
DD by Uncle Gee Gee (updated Oct 2, 2020)
Every RLF-100 Investor Should Read
EXECUTIVE SUMMARY
Relief Therapeutics is a small Swiss company with a patent for a drug called RLF-100 that treats Covid-19 patients. RLF-100 is a safe, synthetic version of a naturally-occurring peptide in the human body.
Relief Therapeutics has partnered with NeuroRX (led by CEO Dr. Javitt) for assistance with the U.S. FDA process, as well as manufacturing and distribution within the United States, Canada and Israel. Operations for the rest of the world will be handled separately by Relief Therapeutics.
RLF-100 has 4 clinical trials underway, and initial results look exceptionally promising. Highlights are provided below.
AVIPTADIL RLF-100 VIP
• VIP (vasoactive intestinal polypeptide) is a naturally occurring peptide in the human body.
• Aviptadil is a VIP for the treatment of erectile dysfunction, proven to be safe since 1970’s.
• Aviptadil is being repurposed as RLF-100 to treat Covid-19 patients.
• RLF-100 is a safe, patented, synthetic form of VIP, which increases surfactant production in the lungs to protect against Covid-19.
• RLF-100 is a trifecta treatment: 1) It blocks Covid-19 from attaching to host cells in the lungs; 2) it prevents the cytokine storm; and 3) it reduces inflammation.
• RLF-100 has 4 separate clinical trials for intravenous and inhaler versions of the drug.
• RLF-100 is inexpensive and easy to manufacture.
• RLF-100 shows promise for other lung applications beyond Covid, which also need to be studied and tested separately.
STOCK / COMPANY
• Relief Therapeutics is a small company in Switzerland that holds the patent on RLF-100.
• Relief is traded over the counter (OTC) on the Swiss SIX exchange.
• In August 2020, Relief up-listed from “OTC Pink” to the higher-tier “OTCQB” to allow a broader range of investors. Relief intends to seek a future presence on the NASDAQ or NYSE.
• Relief has CHF $48M cash on hand ($52M USD), enough to support planned trials and operations through 2022, without taking into account any RLF-100 revenue.
• NeuroRX is a private US-based partner and has connections at the highest levels of government and big pharma. They are guiding Relief Therapeutics through the FDA approval process and organizing manufacturing and distribution.
• Relief and NeuroRX will split profits from sales: 50/50 for U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.
Leadership Team: https://investorshub.advfn.com/boards/read_ms...=158200526
Partnership Agreement: https://relieftherapeutics.com/relief-and-neu...-partners/
Funding: https://relieftherapeutics.com/relief-announc...-with-gem/
OTCQB Uplisting: https://relieftherapeutics.com/relief-announc...-with-gem/
MANUFACTURING & DISTRIBUTION
• Robert Bestoff is the Chief of Operations and spent his career at Lilly & Pfizer. At Pfizer, he was head of the entire neuro science and pain division, responsible for $10B of drugs.
• Rich Siegel, former head of Johnson & Johnson’s drug portfolio, put together the manufacturing program.
• NeuroRX has signed 3 contracts in preparation to treat up to 1 million patients:
1) Bachem Americas has been contracted to manufacture drug substance for RLF-100.
2) Nephron Pharmaceuticals has been contracted to manufacture commercial supplies of RLF-100.
3) The largest supplier of inhaled sterile drugs in the United States, able to supply RLF-100 to any US hospital overnight, has been contracted as the pharmaceutical logistics partner.
M&D Contracts: https://relieftherapeutics.com/neurorx-and-re...iptadil-2/
CLINICAL TRIALS
Relief has the following 4 clinical trials underway:
1) Clinical Trial NCT04311697 – IV Trial
• This trial is for intravenous RLF-100 administered to patients in ICUs with respiratory failure.
• The trial seeks to enroll 144 patients.
• The trial is currently in “Phase 2b/3”, meaning it will evaluate both dosing and efficacy.
• A first interim review was held at 30 patients, which determined RLF-100 is safe for human use.
• A second interim review will be held at 102 patients with a determination to: 1) stop the trial because the drug is dangerous, 2) stop the trial because the drug shows no effect, 3) continue the trial because results look good, 4) stop the trial because the drug is proven.
• Patient #102 was enrolled on 9/30/2020; therefore once that patient completes their trial (28 days later), the Data Monitoring Committee (DMC) will review results and submit a recommendation to the FDA.
• Doctor (and Congressman) Andy Harris is 1 of 3 experts on the DMC.
First Interim Review: https://relieftherapeutics.com/neurorx-and-re...-covid-19/
2) Clinical Trial NCT04453839 – EAP Trial
• This EAP (Expanded Access Protocol) trial allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation (commonly referred to as "compassionate use"
. • EAP is NOT the same as EUA (Emergency Use Authorization) – see clarification below
• Early EAP results were released in a “pre-print” document for patients considered to be “the sickest of the sick” (ICU, ventilator, ECMO patients).
• Results: For patients who received RLF-100, 19 out of 21 patients survived, where only about 6 were expected to survive.
Initial EAP Results Pre-print: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
Clarification: EAP and EUA
• EAP = Expanded Access Protocol – currently approved
• EUA = Emergency Use Authorization – submitted application to FDA
• EAP allows RLF-100 to be used as a last-resort for patients too sick for regular trial participation.
• Qualifying for EAP is limited: the patient must be located at one of the few clinical trial hospitals, or transfer to a participating hospital, or have the hospital attempt to qualify for the drug.
• Due to EAP limitations, NeuroRX recently applied for EUA and is awaiting FDA approval.
• EUA allows experimental drug use during public health emergencies. Qualifications are that the drug must be safe and “may” be effective.
• If approved, EUA will allow RLF-100 to be used at all US hospitals, as a last resort when all other approved treatments have failed.
• EUA approval is not necessarily dependent upon trial completion or interim reviews, unless FDA subsequently requests more data.
• Currently there are only 2 other EUA approved therapeutics: Remdesivir and Convalescent Plasma.
EUA Submittal: https://relieftherapeutics.com/relief-partner...hausted-a/
Other Approved EUAs: https://www.fda.gov/media/136832/download
3) Clinical Trial NCT04360096 – Treatment Inhaler
• This trial is a study of 288 patients in the United States to test an inhaler-version of RLF-100, intended to ultimately be used for in-home nebulizer treatments.
• Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”
• Current estimated completion in 2020
4) Clinical Trial NCT04536350 – Preventative Inhaler
• This trial is a study of 80 patients in Switzerland to test an inhaler-version of RLF-100 as a “preventative treatment”.
• Current estimated completion in December 2021
Link to all 4 trials: https://clinicaltrials.gov/ct2/results?term=A...k=1#rowId0
OTHER EFFORTS
• Signed a cooperative agreement with NIH’s Institute of Arthritis and Infectious Diseases to test RLF-100 “against the flu virus and other viruses that kill people by attacking the lungs.”
• Israel has already granted Companionate Care Protocol across the country, and NeuroRX is in the process of determining how to serve it.
• When asked whether FDA approval would have an impact on other countries, Dr. Javitt responded with “the FDA determinations are highly influential around the globe”.
Yo Dr. Yo – Interview 1 on 8/12/2020: https://www.youtube.com/watch?v=KBG_BYfj-sY
Yo Dr. Yo – Interview 2 on 9/30/2020: https://www.youtube.com/watch?v=lrtsexJOxU8
Transcript: https://sonix.ai/r/CwLa15pid5GiS1N7dd9qyNa9/share
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