All,Please see the below from Ken.Guys,I see nothing but a...

All,

Please see the below from Ken.

Guys,

I see nothing but a really bright future for IMU in mid-term: the next 9 to 12 months. Given the trial successes to date, and their clinical impacts, I have very little doubt about the ultimate commercial viability of both the B-cell platform and Vaxinia. In both cases I believe a pharma deal will be predicated on clinical trial data.

The B-cell factor:

The NextHorizon Her-Vaxx combo (with Keytruda) trial has had slow enrollment rates, to date. I'm guesstimating they will have a trial readout sometime Q4 2023 or Q1 2024. And a possible pharma deal in Q2/Q3. With the doubling of the dosage and the combination with Keytruda, I'm expecting pretty impressive results from this trial. Remember, we still have several terminalpatients from the earlier, less powered P2 trial that are still alive!

The PD1-Vaxx combo (with Tecentriq) trial has just started so I have no clear idea how enrollment will go. But based on the first PD1-Vaxx trial, and the patient demographics, I expect it will go much faster than NextHorizon. I expect a trial readout sometime Q4 2023 or Q1 2024. Likewise, a pharma deal for PD1-Vaxx in Q2/Q3. The first PD1-VAXX trial resulted in a terminal patients that is still alive and cancer free. I expect the combo trial to exceed greatly exceed the first.

However, for these reasons I think these 2 ongoing B-cell trials will have minimal impact in the short-term SP. The only wild card: if they publish interim results from the PD1-Vaxx trial, like they did last time. Remember, it was the publishing of the complete responses from the PD1-Vaxx trial (and fomo) that drove the SP to 40 cents and beyond.

The Vaxinia factor:

Vaxinia is a whole other question entirely. On the one hand, the CheckVacc trial is moving at a snail's pace; but this was a legacy trial that was funded by the NIH, designed by COH, and run at a single site (it's clearly bottlenecked). However, the Vaxinia trial is moving at warp speed. It was a trial designed by Leslie's team and currently being run at 12 sites across the USA and Australia. While it's only a phase 1 trial, the potential upside is enormous. It's not out-of-line to suggest that it may be a game-changing therapeutic, much like chemo was in the 60s.

To date, all indications from the Vaxinia trial suggest that patients are doing very well. So, there's a good chance that IMU will pivot into a FDA registrational phase 2 trial for Vaxinia. Ideally with a breakthrough therapy designation from the FDA.

Planning-wise I think it will be a question of how well the current Vaxinia cohort 4 does. They should have those results sometime in September. A trial pivot or breakthrough therapy designation would represent a very significant inflection point for IMU's SP. To top it off, they may decide to partner with a tier-1 pharma.

IMO, partnering for the phase 2 Vaxinia trial makes the most business sense. I'd say the smart money's on Roche as the eventual IMU partner. They sell Herceptin, which is out of patent and plagued with biosimilars. IMU's Her-Vaxx is a superior--in terms of safety, cost and efficacy--alternative to Herceptin. They also market Tecentriq, a PD-L1 drug that is currently being trialed in combination with IMU's PD1-Vaxx. So along with acquiring a game changing oncolytic virus, they would significantly bolster 2 of their existing products: growing their addressable market and margins.

Short-term risks:

The real short-term challenge for IMU is the current dismal SP. Without a relief in SP the board is likely to face a serious backlash at the next AGM in November. Leslie has already said they plan to wait until they can publish the Vaxina/CheckVacc results in a suitable scientific journal or conference. There's no way for me to gauge the lead time to get something published; but the next suitable conference is SITC which convenes the first week in November.

If they publish Vaxinia results at the SITC conference they'll be able to placate shareholders at the AGM with the (hopefully) fantastic Vaxinia results. The best outcome, however, would be for Vaxinia to get the breakthrough therapy designation and announce plans to start a registrational trial early 2024. The crowd would go wild on this news.

The OnCARLytics factor:

The real dark horse is OnCARlytics. They've gotten the IND, so they're cleared to start the first-in-patient clinical trial. I've been assuming this trial won't start until late Q4. So it's possible it could launch before the November AGM. Who knows, maybe they will announce the trial start next month (a fella can dream, can't he). Given all the excitement around OnCARlytics this trial could also turn around shareholder sentiment, and very likely boost the SP.

Anyway these are just a few of my speculations. Over the next few months it will be important for shareholders to stay on top of things and always DYOR.