The compound has never made it into a single US persons arm to date. Clearly stated by the company, the entire busines model for HER-Vaxx is to target jurisdictions that can't afford the standard of care HER2 options. This is why HER-Vaxx has never been used head-to-head with Herceptin: 1) because it would lose; and 2) because the US market is controlled by the big HER2 players.
I think this section of the report is unsubstantiated and no investor should ever consider seriously when making an investment decision. The entire oncology market for Eastern Europe and India are USD $1.84B and $2.21B (1.82% of the global market). It is therefore preposterous to assume peak revenues of $3b. Why have they used global HER2 gastric cancer incidence rates with US market values, and assumed that somehow HER-Vaxx will be approved by 2028?
Without a direct head-to-head phase 3 registrational trial, there is no way HER-Vaxx is taking market share off Herceptin or Enhertu. It is impossible. The only way that HER-Vaxx can gain market share is if they identify a sub-categorisation of responders and target them specifically or be sold in a country that can't afford Herceptin. The downside to sub-categorisation is that it can be difficult to find the patient populations required to fill the numbers, therefore the trials run slower. The downside to poor countries is you don't sell HER-Vaxx at USD $175,049. At AUD $232.38M and 18% of IMUs valuation, I think it is a joke. The nextHERIZON trial has stopped recruiting patients - it is dead.
PD1-Vaxx
Firstly, PD1-Vaxx has been used in 14 NSCLC patients, demonstrating 14% ORR and 43% DCR. One of the MAJOR things that no one has addressed is that a high dose of PD1-Vaxx has killed someone. PD1-Vaxx at 100 ug/dose produced 2 counts of Immune-mediated pneumonitis with one case severe enough the patient had to withdraw from trial and later died. PD1-Vaxx has not yet made it into the arm of a colorectal patient.
The immunotherapy market for NSCLC is extremely competitive with approvals stretching back to 2015. For 5 anti-PD(L)1 therapies, there are 22 different FDA approvals for NSCLC. The immunotherapy market for Colorectal cancer is not as competitive, as there are only three approvals, but this is because anti-PD(L)1 therapies typically don't respond well. Moreover, the PD1-Vaxx colorectal trial is not being conducted in the US (UK and AUS), so once again these numbers do not make any sense.
At $244.16M, PD1-Vaxx is 18.9% of IMUs valuation which is absurdity. The likelihood chance that PD1-Vaxx garners 0.5% of the NSCLC and Colorectal market is significantly more realistic. Once again, because there are a substantial number of approvals in NSCLC, PD1-Vaxx has to either compete against the big boys in a registrational P3 or carve out a highly specific niche. Once again, niche patient populations means slower trial execution.
There is substantial clinical and commercial risk for these programs because they are trying to take market share from long-standing effective competition, which encourages me to believe the combined value of AUD $476.5M misrepresents the opportunity.
Vaxinia
Then there is this suggesting that CF33 has had a 21% ORR from 31 patients. In the 14 patients that were treated intratumorally, CF33 has a 21% ORR, but one of those patients was treated with combination Keytruda. The actual ORR is 9.7% for the 31 patients. IMU shareholders have not received an update from the company for the open label Vaxinia trial since January 2024.
That is on the front page of the report, but located 4 pages down is the following (which is what I have been saying all along) - ORR 7.5%. No additional responses.
The report has made connections to prior acquisitions, but appears to follow Replimune Group closely. They have two separate compounds running through multiple clinical trials in multiple indications, with RP1 currently in a phase III registrational trial. By comparison, Vaxinia is completing a phase 1 trial via an expansion cohort for a very rare cancer type (Cholangiocarcinoma) with a substantially smaller patient population. They haven't even accurately calculated the average of the values, which equates to USD $587M, risked USD $154M, and a final AUD $229.5M.
The evidence for Vaxinia is not adding up, and the report should have followed the market cap for companies with phase 1 assets addressing rare cancer types and excluded the additional programs. Therefore, I think basing the valuation off Biovex and Replimune with phase 3 assets addresing larger patient pools is extremely misleading.
OnCARlytics
Once again, phase 2 and 3 are being used to estimate the value of onCARlytics, where the cytotoxic backbone is failing to show broad activity clinically and there are no reports of efficacy in humans yet.
I think IMU shareholders should be extremely careful when evaluating this report. Based on some basic adjustments to suit the data, I came up with some very different numbers, which I don't even necessarily believe.
1. HER-Vaxx figure adjusted by size of Eastern Europe + India compared to Global Oncology (1.82%) 2. PD1-Vaxx figure dropped to 10% of original to account for no Colorectal trial in US and substantial clinical/commercial competition in NSCLC 3. Vaxinia values altered by removing Biovex and Replimune Group and averages correctly calculated (I think this is still significantly overvalued) 4. OnCARlytics previously 80% of Vaxinia value, so this has been adjusted to be the same (I think this is still significanty overvalued) 5. Azer-cel has been kept the same
(20min delay)