A successful conclusion to the current B-CV19 huma

A successful conclusion to the current B-CV19 human Phase 2 trial IMO will trigger immediate Compassionate Use Approval demand. Emergency Use Authorization (EUA) could follow prior to an accelerated Phase 3 study. Gilead ran 2 concurrent SIMPLE Phase 3 studies from 2/26/20 to 4/29/20 (2 months) and on 5/1/20 was granted EUA by the FDA. The primary purpose of these studies were to compare 5 day and 10 day dosing and the result was that there was minimum efficacy improvements between the 5 and 10 day dosing. Gilead sold hundreds of millions of dollars under the EMU designation prior to being FDA approved 10/22/20. In that same Q4 Gilead sold $1.9B in Remdesivir revenue. This revenue was for a drug that does not kill the CV19 virus, has no mortality impact or benefit and needs to be given at the earliest onset of the virus to have any impact on viral replication. The primary end points on the Remdesivir FDA trials were initially designed to measure viral load impact and mortality rates and the goal posts were moved with the end points changed to average days hospitalized which was reduced from 15 to 11 days.

Remdesivir was FDA approved IMO because of a lack of any valid alternatives to treat CV19. As a repurposed drug, Remdesivir went through minimal lab testing specific to CV19. There are many country agencies in addition to the WHO that do not recognize Remdesivir as a valid Standard of Care (SOC) for CV19. The bar for effective CV19 therapeutics is very low IMO and I believe Brilacidin will be significantly differentiated by proving that it penetrates the viral wall (kills the virus) and decreases inflammation while modulating the human immune response. A cytokine storm where the human immune response goes wild is responsible for a significant percentage of CV19 deaths.

The U.S. may or may not be the first government agency to grant EUA for Brilacidin. Traditionally the European Medicines Agency (EMA) and the Eastern European Ministries have less stringent requirements for drug approval than the FDA does. If Gilead can do almost $2B in a single quarter with an inferior drug, what will the demand be for a drug that actually kills the virus?

If Brilacidin generated even 25% of what Remdesivir does in revenue and does $2B in a year vs what remdesivir did in a single quarter, it would explode IPIX share price (SP) upwards. IPIX’s current expense rate is less than $15M/year which is a rounding error on $2B/year revenue. If Leo for example priced an average 3 dose protocol of Brilacidin at half of remdesivir or $1,200/per patient protocol, that $2B would treat approximately 1.67M patients. A guesstimate COGS (manufacturing & distribution) might be $500M on $2B of revenue using the same cost guesstimate used in my sticky post #65303 from last July. That would bring $1.5B in bottom line earnings to little IPIX. If OS is rounded up to 500M shares (currently 428M) that would equate to $3 earnings per share. A PE ratio of 20 would equate to a $60 IPIX share price on B-CV19 alone.

This example is how a value investor would calculate the value of an investment. A CV19 killer would be looked at more as a growth stock and valuations are often trumped by future revenue potential and in Brilacidin’s case as a Broad Spectrum antiviral, multi instance and multiple use drug. Keep in mind that the above example has IPIX selling only 25% of Remdesivir revenue at half of the price per patient. Matching their revenue or competitively pricing Brilacidin more consistent with Remdesivir would multiply this example much higher.

The above is NOT a prediction of IPIX SP. It is however an example of the enormous opportunity for a direly needed effective CV19 treatment. Worldwide demand for an effective CV19 treatment could greatly exceed this example IMO. If you expand market demand beyond treating CV19 to uses as a Broad Spectrum antiviral, other Brilacidin instances like B-IBD UC and B-OM plus the potential of Kevetrin, the revenue potential and its impact on SP is enormous. We will know if we have a huge winner or not very shortly.