Not Totally Blind…INmune Provides A Clue

This week I’m starting the newsletter with a discussion on INmune Bio (INMB). There are two reasons for this. Firstly, the company put out a Press Release on Thursday that I deem to be highly significant. We’ll discuss that more in a minute…

The second reason I’m leading off with INmune is to also discuss a major change to the TW Research platform. Starting on July 1, I’ll be consulting to INmune in the role of head of investor relations. As such, I’ll not be able to comment about the company in this format. So, this is my last chance to blog about INmune for the foreseeable future.

~ Please note that all comments on INmune Bio (INMB) in this blog, and in all prior newsletters and blogs, represent my opinion only and are neither endorsed by nor approved by the company ~

But, back to the more important point about the news story INmune released last week. That PR discussed the results of an independently run interim analysis of the ongoing Phase 2 Alzheimer’s Trial. In the words of INmune Bio, “The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality.”

This is highly significant for many reasons, some of which are not so obvious. The fact that the trial is being professionally run certainly increases the significance of the upcoming results. When they are released, investors will be able to gain great comfort in the data presented. This speaks volumes to the company’s continual efforts to perform more like a large pharma company than a fledgling startup; that is the attitude they have always brought to the table.

Even more important from an investor standpoint, the analysis provides insight into the upcoming results. Yes, it’s blinded and there’s a placebo group, so we all need to await the results before ringing the bell. However, my confidence level is greatly increased post this PR. Here’s why.

The fact that the trial design (which was quite short and not a large “N”) has been endorsed by the interim analysis means that the data is showing statistically significant variance from what would be expected if the patients were not on drug. Basically, we are seeing an effect in a short time and enough variance that it’s meaningful. This is good news.

Just as importantly, the variance (ie the distribution of the results) was spot on with what the company had predicted and upon which they had based the trial design and picked their primary endpoint of EMACC. In the words of Dr. Judith Yeager PhD, “this interim analysis confirmed once again its [EMACC] excellent suitability for this population as indicated by normally distributed data, paucity of outliers and absence of floor and ceiling effects.”

If you combine enough variance to achieve statistical significance without exceeding a normal distribution of data and with a lack of outliers, you can see that the trial appears to be working exactly as designed. This is confirmed by CJ Barnum’s comment, “the results presented to the Company from this blinded analysis were extremely encouraging.”

Does this mean the trial is going to be successful? Of course not…this is only a portion of the patients in the trial and we still need to see the actual individual data. However, it does greatly increase the likelihood of success. Knowing that all the metrics one should expect from a pool of data have been hit certainly buoys the bullish thesis. At this time, it would take an incredibly strong placebo effect to skew the data such that the trial doesn’t come through.

Shares of INMB rallied nicely on the back of this news but are still down 22% for the year. With the AD data coming in early 2025 and data out of the prostate trial later this year, I believe shares of INmune are crazy cheap and not at all representing all the positives going on at the company. I feel so strongly about this that I’m joining the company. [mic drop]

Now that we’ve closed out June, the Russell rebalance is behind us. Perhaps that was responsible for a good chunk of the 25% gain in INMB late in the week. The other stocks in TW’s universe going into the Russell 2000 also had nice jumps with Perma-Fix (PESI) and Quest Resource Holding (QRHC) each up around 10% from early in the week.

With big blocks of stock trading in all the names on Friday’s close, the indexers have loaded up. Amazingly, they did so at prices well below where things stood when the first look at the index changes was published. Someone certainly lost money playing the reconstitution. I’m personally very surprised the stocks didn’t perform better but the annual R2K event is always a tough one to play.

At the time of my most recent newsletter, my son was single and IN8bio (INAB) was well over a dollar. Both situations changed dramatically over the last two weeks, but only one for the better.

What happened to iNAB that it gave up almost 50% in two weeks on the back of good data? I believe its price action demonstrates just how tough it is in early stage biotech. The space continues to be crowded, especially in oncology, and money burning companies are suffering.

I’ll also say that INAB has a combo therapy with no control group which does take some of the luster off the results. But, still, they were good. It’s just tough out there.

enVVeno (NVNO) put out some good data last week and that stock actually traded up and stayed up. Imagine that, a catalyst that wasn’t a selling opportunity. (Actually, it was at first as it traded down but then reversed on very large volume)

All signs point towards NVNO being very successful with their product, which should be approved at some time in 2025. The street doesn’t like pre-revenue med tech. Once it is approved, they will start generating revenues and the street will suddenly like it; we are ahead of the curve.