Uitstekende samenvatting van alles dat speelt van investorshangout. Opvallend is ook toezegging dat geen nieuwe aandelenuitgifte nodig is voor inhaler-onderzoek volgens CEO door voorfinanciering GEM.
For potential new investors, or for longs who who need reassurance, the insiderfinancial article is a good summary. For an even better bullet point summary, this is a repost from investorshangout (https://investorshangout.com/post/view?id=5870444):
Summary of known facts about RLFTF: Aviptadil RLF-100 VIP
• Aviptadil is a repurposed erectile dysfunction drug, proven to be safe since 1970’s.
• Aviptadil blocks Covid from attaching to host cells in the lungs, prevents the cytokine storm, and reduces inflammation. This is a targeted trifecta for treating Covid.
• An inhaler version of Aviptadil will undergo clinical trials, with the intent to ultimately be used for in-home treatment of Covid cases. This study is expected to complete around Nov 31, with results being published sometime afterwards.
• Aviptadil is inexpensive and easy to manufacture.
• Aviptadil shows promise for other lung applications beyond Covid, which also needs to be studied and tested.
Stock/Company
• Relief Therapeutics holds the patent on Aviptadil. It is a small company in Switzerland, traded over the counter (OTC). Dit klopt niet meer: het OTC QB, er is een uplisting geweest.
• NeuroRX is a private US-based partner with leadership that is well-connected at the highest levels of government and big pharma. They are guiding Relief Therapeutics through the FDA approval process.
• Company has $3M cash, but will need approx. another $20M to complete all 3 trials, including inhaler version.
• Unconfirmed: Most of the outstanding shares are owned by insiders.
• Chairman Raghuram (Ram) Selvaraju says there is no real need to raise capital via additional shares at this point, due to liquidity option provided by GEM.
• Speculation: Company may have recently raised enough additional capital to complete trials through Princeton Angels.
Manufacturing and Distribution
• Robert Bestoff, Chief of Operations, spent his career at Lilly & Pfizer. At Pfizer, he was head of entire neuro science and pain division and was responsible for $10b of drugs.
• Manufacturing program put together by Rich Siegel, former head of Johnson & Johnson’s drug portfolio.
• 2 Partnership arrangements are expected to be announced soon.
• “We are about to announce a partnership with the largest supplier of inhaled sterile drugs in the United States.” NeuroRX CEO Dr. Javitt
• “We are about to announce a partnership with a very large well-known public company that can get any drug to any hospital overnight” NeuroRX CEO Dr. Javitt
• “By October, we should be manufacturing enough drug for 100,000 people each month.” NeuroRX CEO Dr. Javitt
Clinical Trials
• Clinical Trial NCT04311697 – The initial clinical trial underway to test intravenously administered drug. Approximately 86 out of 122 patients have been recruited as of Aug 12, and the company’s data committee will begin reviewing the cases once they reach 102 patients. From there, they will present findings to the FDA. Speculation: Review could begin this week of 8/24; however, official publication of results could take several more weeks, but likely before October, due to Javitt’s comments about being able to ramp up production by October.
• Clinical Trial NCT04453839 – The FDA-approved Expanded Access program for treating patients who are too sick for clinical trials.
• Expanded Access results were released in a “pre-print” document, showing 19 of 21 patients have survived. These are the sickest of the sick (ICU, ventilators, ECMO patients). The pre-print is under peer review & expected to be officially released in the coming weeks.
• Clinical Trial NCT04360096 – A study of 288 patients to test an inhaler-version of RLF-100, intended to ultimately be used for in-home treatments. Estimated completion of trial is November 30th. According to Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”