This is a posting published by the user bcgk on the German board. I used google translator for translating:
So what is one speculating at a biotech company that does not yet have an approved drug? What needs to be considered?
a) How big is the market for Leronlimab?
First of all, it is important to weigh up the indications for which the medication is suitable. In our case, the effectiveness for HIV has already been proven. All study results of the FDA trials exist for this. Leronlimab was tested in all studies with more than 830 patients over a period of more than 5 years. The result is an outstanding response rate (> 85%) and 0 (!), In words - ZERO - SAEs. SAEs are "serious adverse events", in other words "serious side effects". Zero! With 830 patients! An approval in 2020 for an HIV combo should therefore become a self-advocate. For HIV Mono, a P3 is required, for which the protocol has already been submitted. One can expect an off-label use here according to Combo Approval. The HIV market is approximately $ 6-9 billion. How much of it will get the best product on the market by far? Then there is oncology. Leronlimab has filed BTD for mTNBC based on excellent results in 2 patients. Admittedly, in a hurry, but the data situation is overwhelming. CTCs (circulating tumor cells) after 14 weeks = ZERO. No metastases and the tumor has shrunk by more than 20% within 2 weeks. Unheard of. 2 other patients have already been enrolled. Another 50-60 are apparently lining up to be accepted into the trials. Since Leronlimab obviously jumps to all types of CCR5 and CCL5 cancer, we're talking about more than 20 types of cancer. A cancer basket is in the works for around 10 of them to facilitate approval. Market size cancer? More than $ 100 billion. I don't even talk about NASH, GvHD, MS etc.
b) what is the chance of approval?
With HIV 95%, there is really nothing to be said against it. In the field of oncology, the probability is very high, you can see the rest.
c) how much is further dilution?
The current cash balance extends until the end of February. Warrants are currently being converted, so money is constantly flowing in. If the announced 40-50m non-dilutive still come, there will be no large features and no watering will have occurred. Now you have to decide for yourself whether a company with $ 400m is fairly valued, which stands before HIV approval and with the previous results has good chances to enter a multi-billion dollar market. Incidentally, in the case of a Nasdaq listing, the price will multiply by itself if the above Market participants are suddenly allowed to invest. The comparison to Nasdaq companies with significantly worse fundamentals is devastating. Such companies cost not $ 400m but $ 4 billion. If you have any questions about the mode of action of Leronlimab and what the CCR5 receptors are all about, please refer to the links given above. I would like the discussion to return to a reasonable level now.
He imo absolutely nailed it. Meanwhile, he has 100 followers and does an excellent job on that board (as far as I can judge) and spreads the news and potential of this stock.
So what is one speculating at a biotech company that does not yet have an approved drug? What needs to be considered?
a) How big is the market for Leronlimab?
First of all, it is important to weigh up the indications for which the medication is suitable. In our case, the effectiveness for HIV has already been proven. All study results of the FDA trials exist for this. Leronlimab was tested in all studies with more than 830 patients over a period of more than 5 years. The result is an outstanding response rate (> 85%) and 0 (!), In words - ZERO - SAEs. SAEs are "serious adverse events", in other words "serious side effects". Zero! With 830 patients! An approval in 2020 for an HIV combo should therefore become a self-advocate. For HIV Mono, a P3 is required, for which the protocol has already been submitted. One can expect an off-label use here according to Combo Approval. The HIV market is approximately $ 6-9 billion. How much of it will get the best product on the market by far? Then there is oncology. Leronlimab has filed BTD for mTNBC based on excellent results in 2 patients. Admittedly, in a hurry, but the data situation is overwhelming. CTCs (circulating tumor cells) after 14 weeks = ZERO. No metastases and the tumor has shrunk by more than 20% within 2 weeks. Unheard of. 2 other patients have already been enrolled. Another 50-60 are apparently lining up to be accepted into the trials. Since Leronlimab obviously jumps to all types of CCR5 and CCL5 cancer, we're talking about more than 20 types of cancer. A cancer basket is in the works for around 10 of them to facilitate approval. Market size cancer? More than $ 100 billion. I don't even talk about NASH, GvHD, MS etc.
b) what is the chance of approval?
With HIV 95%, there is really nothing to be said against it. In the field of oncology, the probability is very high, you can see the rest.
c) how much is further dilution?
The current cash balance extends until the end of February. Warrants are currently being converted, so money is constantly flowing in. If the announced 40-50m non-dilutive still come, there will be no large features and no watering will have occurred. Now you have to decide for yourself whether a company with $ 400m is fairly valued, which stands before HIV approval and with the previous results has good chances to enter a multi-billion dollar market. Incidentally, in the case of a Nasdaq listing, the price will multiply by itself if the above Market participants are suddenly allowed to invest. The comparison to Nasdaq companies with significantly worse fundamentals is devastating. Such companies cost not $ 400m but $ 4 billion. If you have any questions about the mode of action of Leronlimab and what the CCR5 receptors are all about, please refer to the links given above. I would like the discussion to return to a reasonable level now.
He imo absolutely nailed it. Meanwhile, he has 100 followers and does an excellent job on that board (as far as I can judge) and spreads the news and potential of this stock.
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