I posted about this company a couple weeks ago, so I won’t go into a long explanation again here - see my previous post if you want details.
I am only posting this message to inform folks that TMDX is expected to publish the results from their latest trial (Liver PROTECT trial) sometime in the next couple weeks. They have hinted in the last ER call that the results are extremely good. The description that the CEO gave for the results was:
“Related to the liver PMA, the trial results are known to us, and they are extremely, extremely exciting to us, and we cannot wait to publicly announce the results……We’re hoping that given the strength of the results that we’re going directly toward a major submission of manuscript to a major publication. And we hope that that will happen over the next several weeks. The results are very, very strong. They’re the first of its kind type results.”
“…the results, when they become public, they will speak for themselves. We have already initiated the continued access protocol (CAP) for it. We expect that the review process within the FDA will be within the targets we’ve set. Our PMA filing will be according to our original plan in Q2, which is six months ahead of our original plan. So we’re not expecting any reduction or pullback on the liver. The opposite is true. Once these (trial) results become public, we expect that the CAP will be rapidly rolling, and we’re probably going to extend the CAP. And we will leverage the results to encourage the FDA to hopefully accelerate the review process.”
TMDX had previously stated that they were going to share the results of this Liver trial at the American Transplant Congress - which starts next Saturday. If the results are as good as they say, it could lead to a boost in the stock. Right now, the stock is below it’s IPO price.
A second catalyst coming in the next few months is the expected approval of their Heart OCS device from the first heart trial.
A final catalyst is the continued roll-out of their service organization - “Perfusion Services” which is a completely new type of organization in the organ transplant field. I go into detail on this in the research summary I posted a couple weeks ago.
If anyone is remotely interested in this company, you might want to do some research and consider getting in prior to the release of the upcoming data report.
FYI - the stock suffered greatly during COVID because many transplant hospitals had to stop doing transplants - both in the US and internationally. COVID also delayed the FDA review of their heart OCS trial results - they were supposed to have the review and approval in Q2, but it is now expected in Q3. COVID also delayed the start of their latest trial for OCS Liver specifically for DCD organs (Donated after Circulatory Death). So, results suffered a little, and the stock was knocked way down, but IMO it was temporary due to COVID. 2021 should be a huge year for the following reasons:
- Heart OCS will be fully approved and commercial
- Perfusion Services will be fully operational in most zones of the US
- Liver OCS should get fully approved in Q1 or Q2
- International expansion will resume (it was paused this year due to COVID)
- Heart and Liver for DCD donated organs will complete their trials and possibly publish results.
- It is not officially announced, but it is expected that they will kick off Kidney OCS trials in 2021.
Final Note - it is likely they are going to have a secondary offering. They recently filed a shelf registration. Their cash position is pretty good, but with COVID unknowns I think they are planning to raise some more cash “just in case”. It’s hard to predict what a secondary offering will do to the stock price - I personally think it is priced in, but I just want to make sure people are aware that it is probably coming and could have a short term negative impact.