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01/12/23

10:25

Post #: 71212951
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Originally posted by Davisite: ↑

The updated Three Pillar strategy is not “non conventional”, it is innovative. The endpoints and trials are all conventional and gold standard, it is the way they are put together that is innovative - even VO2Peak is completely conventional in cardiology. If you search on clinicaltrials.gov you will find hundreds of trials that use VO2Peak.

The updated Three Pillar strategy will provide gold standard, double-blinded, placebo-controlled data on cardioprotection and anticancer efficacy. This is what both the regulators and big pharma want to see. The major difference between the August strategy (we shouldn’t call it the DCB strategy) and the updated Three Pillar strategy is the later gets you to where big pharma want you to be much faster and cheap.

There are of course risks in all clinical activity, but the updated Three Pillar strategy allows us to get to proof-of-concept in cardioprotection with the cash resources we currently have and collected high quality clinical data on anticancer efficacy and m6A. With the modest support of our shareholders via the bonus option we can generate gold standard efficacy data in cardioprotection + anticancer activity, m6A and AML and be in a very strong position to negotiate with big pharma.

The August strategy proposed to use the available cash to run two Phase 1 trials in AML and had no funding available to run even the Phase 1a dose escalation trial. The plan in August was to raise non-dilutive funding to support the Phase 1a trial. The market appeared to not find this a credible plan and the rest everyone knows.

On the topic of non-dilutive funding every biotech tries to raise non-dilutive funding where ever and when ever they can, but if you look across the industry very few companies manage to run a clinical development program from non-dilutive funding alone. Even the conventional path of partnering with large pharma from an early stage to fund clinical development is very difficult to achieve as big pharma prefers to let biotechs investors take on the early risk and then pay more later for any programs that make it through Phase 2.

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Really thank you for your input here. I'm learning so much about the Biotech business through your presence on this site.

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