We had a very nice trading day, with the SP closing at 25 cents, with the intraday high of 25.5 cents. We had 32 million shares trading hands worth nearly AUD$10 million. We finally--at least for today--got over the dreaded 24.5 cents resistance level. Talk about a hard hump up a hill. Phew! But the important question is: can we remain above 24.5 cents, turning resistance into an equally strong support level. Tomorrow's close will provide a strong hint. If we can we'll have a nice runway that could bring us back into 30-cents land (and hopefully beyond). However, we shouldn't be surprised or too disappointed if it does dip below 24.5 for a bit, as the momentum is clear and convincing.
For me the important macro factor was yesterday's response to the reported inflation number. Once again, it was much higher than predicted. But unlike the previous inflation report
the market did not freak out. I believe the market is slowly pricing-in the inflation story and likely fallout from Fed actions. This will definitely provide some breathing room for more speculative biotech stocks.
On the macro side things have been improving in this sector, lately. You only have to look at the various biotech indices. The NASDAQ biotech index chart has shown a healthy improvement since mid-June, correlating quite nicely with IMU's recent positive price-action. Market analysts are also starting to reflect positively on this market segment. Who knows, with this encouragement, we may see sector rotation into biotech stocks as smart-money investors gain more confidence, on the prowl, looking for promising undervalued assets.
It has been a slow, steady and exhausting march through mud and rain for us but these are the conditions of the global economy. Everyone is caught in its immense gravitational pull. So there's no choice for any investor--holding shares in a solid company-- but to tough it out. As painful as it is, these kinds of cycles are necessary. It's like a forest fire that clears out all the dead and diseased wood, paving the way for a more healthy forest. We're lucky. We've got a strong healthy company that will do quite well once the smoke clears.
On the CF33 front:
We're somewhat handicapped by the FDA restrictions placed on our CF33 programs. The first cohort group can only be dosed one patient at a time. And the FDA has put a tight gag on what can be publicly disclosed about the ongoing trial. However, I expect this latter restriction to be lifted once a few cohorts have been cleared. In my opinion we should be extra cautious about the CF33 program. The old adage is especially relevant here: you only get one chance to make a first impression. CF33 represents a potential breakthrough cancer therapy. So we want there to be no questions about the program. If the cost is an extra few months of waiting I'm OK with that, as I'm confident of the results.
Given that (up to) 8 dosing cohorts have been specified for the CheckVacc trial I expect that the first, and possibly the second, cohort were given very small doses--possibly sub-clinical. Having 8 dosing levels offers investigators fine-grained control over a dosing schedule. Again, why not be extra careful with the first human patient ever; to make sure there's no safety concerns and to reassure the FDA.
Will these first CheckVacc dosing levels produce some results? I would think so, given the preclinical data; but I wouldn't expect anything exceptional, as human beings rarely respond as well as rats. I would place my bet on the 3rd cohort--which should be starting soon--when we're going to see substantial clinical results. I'm a shareholder so I'd love to be wrong about this. Hopefully we'll get readouts from the 3rd cohort by October. And I believe it will be well worth the wait.
But make no mistake: by now IMU has a clear understanding of the safety profile and pharmacokinetics of CheckVacc. Using PET scans they can see the dynamic flow of viral particles as they move through the body. They can determine the level of viral infectivity; whether only tumors are infected. And by now I expect they know this for Vaxinia as well. In other words: they know, right now, whether it works. All that's left is to discover the optimum dosage and overall efficacy. IMO, this is behind the excitement from Leslie and company. They're clearly expecting big things from CF33. So should we.
Our 2 dark horses:
It goes without saying that our OnCARlyticsprogram is the darkest of our horses as it has the potential to utterly upend cancer therapy completely. By analogy OnCARlytics could turn any cancer into a very treatable disease, like AZT did for AIDS. With cancer patients able to live decades with a good quality of life. We can expect news of the preclinical results with Celuarity and Eureka at any time. The OnCARlytics preclinical trial results are already known to IMU. They're just awaiting publication in a suitable medical journal before the results are publicly announced. Clearly we can expect good news on this front.
But my favorite dark horse is PD1-Vaxx. Once the PD1-Vaxx phase 1 trial is complete IMU will have the option of pivoting PD1-Vaxx into a FDA registrational trial. OnCARlytics won't even start its phase 1 trial until sometime in 2023. Imagine, in 3-4 years time, FDA approval for a clearly superior checkpoint inhibitor that addresses a USD$25 billion market, growing at a healthy clip. Can you imagine the impact the start of a registrational trial for PD1-Vaxx would have on IMU's SP?
The key, of course, will be the results from combining PD1-Vaxx with Roche's PD-L1 drug Tecentriq. Remember, PD1-Vaxx's stand-alone results were impressive as hell. So if there's just marginal improvement over the stand-alone results we can expect a licensing deal with Roche. However, clinical trials combining a PD-1 with a PD-L1 have shown impressive results. The biggest problem with this combination is its additive toxicity. PD1-Vaxx completely eliminates this problem. So I have very high hopes for this combo. And given that the PD1-Vaxx/Tecentriq combo trial is open label, exposing early results, I would not be surprised to see a Roche licensing deal announced by year's end (knock on wood).
It wouldn't be far-fetched if the PD1-Vaxx/Tecentriq combo becomes the standard of care for lung cancer. And with Roche's backing this combo could be trialed against other cancer indications--across the spectrum. What I'm saying is this: PD1-Vaxx alone is a company-maker. The revenue opportunity--partnering with Roche--could easily turn IMU into a USD$10 billion market cap company over the next 3-5 years. A tasty 10X from its current valuation.
And finally, an emerging dark horse: our very own PD-L1 vaccine. Professor Kaumaya has turned his B-cell platform into a veritable vaccine factory. He's able to turn out vaccines for most cancer targets within 6 months. I expect we could see a PD-L1 vaccine come out of his lab sometime in Q1 2023. Whether it gets an early trial will depend on the commercial goals of our eventual PD1-Vaxx pharma partner. I'm just reflecting on the difference a safe and tolerable PD1-Vaxx/PDL1-Vaxx combo would make for cancer sufferers.
Enough for now. I'm crossing my fingers for a nice Friday close.
(20min delay)