We have obtained leaked documents of Relief Therapeutics (OTC:RLFTF) biotech presentation scheduled for January 11th to January 15th.
Overview of their Biotech Presentation
Available cash position of CHF 49.8M as of 11/13/20
Recent financing has brought in CHF 49.8M with/operational runway thru end of 2022
-Pricing subject to DRG pricing frameworks; possible 10K per patient
-“Existing plans to up-list near-term to the NASDAQ in the US.”
-0 warrants outstanding. 3.2billion shares outstanding and 24M options outstanding as of 12/9/20
Patent protection in the US until July 2029 with an extension opportunity for up to 5 years to 2034 per the Hatch-Waxman patent term restoration
Patent protection in the EU/ROW valid until 2026, including UK, Germany, Turkey, Spain, Switzerland, Netherlands, Denmark, Ireland, Austria, PRC, Mexico
-Potential for orphan drug designation in the US and EU for several indications:
-Severe COVID 19
-Sarcoidosis and berylliosis
-Pulmonary HTN and chronic thromboembolic pulmonary HTN
-NeuroRx partnering agreement for 50% profit splint in the US/Israel and 15% profit EU, 20% everywhere else
-Bachem agreement for them to act as a specialized manufacturing partner
– Nephron – fill/finish manufacturer
-“Multiple potential distribution partnerships (US and Ex-US) currently under discussion”
-“Manufacturing, distribution and logistic capacities expected to facilitate RLF-100 treatment of 150,000 patients/month by end of Q1 2021.
-“Relief to explore partnerships and distribution agreements to facilitate access to RLF-100 as broadly as possible in regions wherein it does not intend to establish its own commercial infrastructure (i.e emerging markets)
IV ZYSAMI/RLF100 CLINICAL TRIALS:
-NDA application planned pending Q1 2021 top line data release
-Possible EUA pending Q1 2021 top line data release
-“Approximately 230 patients currently enrolled in the EAP trial with a 72% survival rate seen in the first 90 patients.”
-Phase 3 RLF-100 phase 2b/3 study with multicentered (>20 sites across US), randomized, quadruple blinded and placebo controlled. Total enrollment 196.
INHALED ZYSAMI/RLF100 CLINICAL TRIALS:
-Primary endpoints: free of respiratory symptoms at 10 days and alive at 28 days.
-288 phase 3b/3 inhaled study on COVID Non acute lung infection without RDS. (144 hospitalized and 144 treated in an at home setting.
-Primary endpoint: progression to ARDS at 28 days
-Expansion of management team as company evolves 2020/2021
-Early Q1 2021 topline IV data for phase 2b/3
-Q2 2021 inhaled topline data
-Q3 2021 NDA
-Partnering activities for supply chain and commercialization well underway
-Sufficient funds to complete two ongoing US phase 2b/3 trials and the planned EU trial