@Outlander2 you note “In saying that, it certainly doesn’t need...

@Outlander2 you note “In saying that, it certainly doesn’t need an approval to set the SP alight. Numerous quality posters have discussed what might provide the SP spark ... well before we have an FDA approval. That of course, is a different discussion, for another time”

Lets have that discussion now...

I’m not sure if you are referring to me as a quality poster, but I'll have a crack nonetheless, I've done some research and have an hour to spare…

Maybe we should start by assessing what these FDA Approvals are all about….

Back in August 2023 shares in the listed Australian biotech Mesoblast tanked by more than half their value in one day. Why? Because in essence the FDA rejected their cell therapy for children. Investors don’t like complications when it comes to either seeking or working toward FDA Approval for therapies. Putting that in perspective, many investors should feel somewhat secure in their choice of Imugene (IMU-ASX) as an investment. Not only has Imugene’s principals achieved extraordinary success in obtaining FDA Approval for the immunotherapy drugs they have assisted in developing, they are currently working with oncology drugs which meet a huge unmet need. Let’s take the latter point and explore Imugene’s cancer therapies a little further.

Patients who suffer from cancers mainly of abdominal origins such as gastric (stomach), ovarian, colorectal, appendix and pancreas cancers are at risk of developing peritoneal metastases. Some of the deadliest cancers are those that have spread behind the peritoneal cavity wall. Imugene’s CF33/Vaxinia oncolytic virus has illustrated success in treating many of these cancers both pre clinically (see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083877/) and now post clinically, in the current Vaxinia MAST Trial. As an example 7 patients with gastrointestinal cancers who received CF33-hNIS alone during dose escalation achieved a disease control rate (CR, PR or SD) of 86%. As a consequence of Imugene’s oncolytic viral therapy’s potential to treat these deadly cancers (i.e., bile duct cancer), they are much more likely to obtain FDA Approval if found to exhibit signs of efficacy in clinical trials. Why? Because the FDA fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

Does FDA Fast Track Designation usually result in FDA Approval?

It definitely does. As noted by centerwatch.com, historically speaking the success rates for Fast Track applications submitted to the FDA's Center for Drug Evaluation and Research (CDER) range between 70% and 80%. In November 2023 Imugene’s Vaxinia was granted FDA Fast track designation based on the promising data package from Imugene detailing Phase 1 efficacy and tolerability data in patients suffering with bile duct cancer. Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. Bile duct cancers are difficult to treat and typically respond poorly to immunotherapy drugs (see the 5 year survival rate in the my chart below):

Therefore one would assume, based on the statistics available, that Imugene’s Vaxinia has close to an 80% chance of obtaining an FDA Approval for use in patients with bile duct cancer.

What does this mean for the IMU share price, were a final FDA approval to eventuate?

The global bile duct cancer market is forecast to be worth close to $330 million USD. Even if Imugene’s Vaxinia were to only capture 50% or half of that market, with annual sales of around $210 million AUD the drug would be worth, at 4 times peak sales, $840 million AUD. $840 million AUD is the current market cap of all Imugene’s therapies put together, including not just Vaxinia, but CF33 (Check Vacc), PD1 Vaxx, Her Vaxx, Oncarlytics, Azer Cel and miscellaneous B cell therapies they have in development pre-clinically. Remember the Vaxinia Trial is designed to treat not only patients with bile duct cancer, but multiple cancer types. Strange isn’t it, when you look at the current market cap it would appear to the naked eye the market is suggesting Vaxinia is not going to receive any FDA Approvals for indications outside of bile duct cancer. That Imugene’s Azer cel, Oncarlytics, Check Vacc, Pd1 Vaxx and Her Vaxx are all going to fail, and be worth nothing.

If you discussed the aforementioned factors in depth with a sophisticated biotech investor they probably wouldn’t believe you when you said the current Imugene market cap was $841 million AUD, once you had shown them proof of the bile duct fast track designation. Once you had highlighted the track record of Imugene’s personnel in obtaining FDA Approval for over 14 drugs they have worked with to date ( at a variety of biotech company’s). They wouldn’t believe you when you showed them the fact that Imugene closed on Friday, February 22, 2024, with a market cap of $841 AUD, because when you pointed out that Imugene’s Vaxinia was treating several of the worlds deadliest cancers, to meet a huge unmet need, they would conclude multiple FDA Fast Track Designations may eventuate from the current MAST Trial. They would no doubt IMO reach the conclusion that some time in the future Imugene’s market cap could be in the tens of billions of dollars first, and $841 million AUD, or daylight second.

So that being the case, why if FDA approval is important, if FDA Fast Track designations are so successful in obtaining full FDA approval thereafter, is Imugene not valued accordingly?

In layman’s terms it could be explained away with phrases such as “It’s not over until the fat lady sings.” In other words not before Imugene has the FDA final approval for Vaxinia signed, sealed and delivered. The reason being markets aren’t in favour of risk. Unlike the TAB, sophisticated investors, institutions and fund managers, not to mention Big Pharma, would prefer to not simply rely on results, but on the final outcome. As an example when Neuren (NEU - ASX) had completed Phase 3 trials and was awaiting final FDA Approval they started 2023 at $8.70 per share. By the end of 2023, with FDA Approval in hand, they closed the year at $25.11, close to three times the figure they started the year at. Conversely Mesoblast (MSB - ASX), without final FDA Approval, fell to be less than a third of its value a year ago (i.e., by 68.82%).

As investors we are yet to determine the extent to which subsequent FDA Fast Track Designations for Vaxinia shall eventuate. This is due to the fact we are unaware of the indications in which the best results have occurred. Has most success been evident in gastrointestinal cancers? If so which types, colorectal? Or oesophageal, liver, stomach, gall bladder or pancreatic cancer? Once this information comes to hand throughout 2024 investors can assess the market size of the cancer indication in question and start to formulate valuations accordingly. But playing into Imugene’s hands is the fact that many, if not all the cancer indications Imugene’s Vaxinia is showing positive signals in, are ones in which there are low 5 year survival rates. These indications are ones, as outlined above, facing a huge unmet need. Therefore the chances of Imugene’s Vaxinia in obtaining FDA Fast Track designation status in these indications, and ultimately final FDA Approval, are relatively high.

What might provide the SP spark ... well before we have an FDA approval?

In conclusion, putting 2 and 2 together, the chances of the IMU share price appreciating accordingly throughout 2024 prior to an FDA Approval are relatively high, once the market fully digests the numbers surrounding Vaxinia’s current Fast Track Designation. It goes without saying the market size attributable to the majority of cancer indications being treated in the current Vaxinia (MAST) Trial, are much higher than that of the bile duct market.

Whilst as you correctly point out @Outlander2, with a registrational trial on the cards for their Azer Cel technology, the existing bile duct fast track coupled with the potential for additional FDA Fast Track designations in their Vaxinia Trial, may not be the only catalyst for upward movement in the IMU share price.

DYOR Seek investment advice as and when required Opinions only

P.s Thx @footie, @wasa, @t&p, @haripin, @valueadd and all those for yr comments on yesterday’s post. Though @agrisorb when you say It's results for SP nothing else, I think you’ve run over to the wrong thread mate. I do hope you read this post. Imugene’s about increasing the 5 year survival rate of people dying from the worlds deadliest cancers first. I’m kind of thinking that’s “something else” a little more important than the share price.