It's mainly because your questions highlight how behind the times you are, big man. If you are going to offer a contrarian view, you should probably spend a lot of time researching the company before you start.
AML: Every recent clinical investigation of Bisantrene in AML has been investigator run. Hematology clinicians are interested in Bisantrene because it achieved on average 50% CR rates in patients who were refractory to a huge list of other drugs, which investors now know is most likely because of a unique MoA. The upcoming AML trial is to be run by a leading hematology expert and is going to cost RAC $4M for quite a large trial using the drug in combination with Inqovi, owned by Otsuka pharmaceuticals who RAC have a supply agreement with. RAC have just released preclinical data highlighting that when used in combination, very low concentrations of the drug synergise to kill solid tumors. While I have my concerns about this translating to the clinic, it is significant grounds for a P1b basket trial using Bisantrene in combination with Inqovi for solid cancers.
505(b)(2) pathway: Clinical investigation of the drug bisantrene changed significantlly with the discovery of FTO inhibition in 2020. Anyone even remotely aware of RAC understands the implications of having the most potent inhibitor of the FTO protein in your inventory. The FTO protein has been demonstrated as a key driver in over 30 cancer types and there are no drugs on the market that target this mechanism. A careful review of historic clinical evidence shows clear signs of unusual activity that I think is due to the influence of m6A methylation rates in cancer, and if it is not that, then there is something else very exciting to concern myself with. I wouldn't be invested in the company if this was the pathway they were focusing on, but I suppose it is good to have a back up that is still worth a lot of money relative to our market cap.
$5-8 billion valuation: Actually this number is very conservative if you understand the implications of what Bisantrene is targeting. Simply put, Bisantrene has multiple mechanisms of action that protect the heart from cardiotoxic drugs while synergising with the same drug to kill cancer. Based on 1% total addressable market capture for anthracycline dosing globally (a 99% discount), yearly dollar value earnings are $3.4 billion dollars.
The really important thing to consider is that the mechanism of cardioprotection AND the mechanism of cytotoxic synergy appear to be universal, which opens the door to dosing Bisantrene with all effective but cardiotoxic agents in the treatment of cancer. The image below highlights the 10 drug classes that include chemotherapies that are both cardiotoxic AND synergise with FTO inhibition/knockdown to kill cancer. I apologise for the size of the image - it is difficult to fit all the opportunities into a single image. Bisantrene has been shown to provide cardioprotection in preclinical models consistently in 2 drug classes now, suggesting the mechanism is universal and therefore applicable to every cardiotoxic drug class.
There is clinical evidence investigating Bisantrene in combination with antimetabolites that are cardiotoxic where the combination achieved clinically meaningful responses in heavily pretreated patients refractory to the antimetabolites, while also preventing cardiotoxicity.
Bisantrene is aiming to be the first in class drug for cardiosynergy. It is proven that first to market drugs make the most money and are regularly followed by me-toos who even if they are better, fail to generate the same market capture. Since researchers have been trying for 40-years to develop a product that protects the heart while also synergises with therapy (bisantrene was created because of this exact reason), the potential value of this opportunity if successful is significantly greater than $5-8 billion while being conservative. Feel free to show us your analysis of what you think it is worth.
Pediatric AML: Yes, we are going for $150M pediatric opportunity over the above. Lol.
RC110: I should have been a smarter investor with regards to RC110. The patent life for that drug was 7-years. The work done by RAC to create RC220, which overcame a significant problem and now allows Bisantrene to be provided IV in patients. This provides a lot of value to RAC and investors, as it extends the patent life out to 20-years when they lodge the patent. With this in mind and also considering the discoveries of FTO inhibition and cardioprotection, RAC really only started around 2022. I should have been smarter here, but it's easy to look back. I suppose I won't be too hard on them, as it took roughly 40-50-years to find out what the drug actually does in patients.
Summary: I have to admit it is something quite special to watch a grown man be so upset by a person on the internet providing heavily researched contrarian views on an investment that adds to the discussion fall to bits on social media and attack a company he has no idea about. I don't know why you think the things RAC did 7-years ago have implications for today when there have been a number of significant discoveries about a drug with so much clinical history. I would be more concerned and I would not be invested if RAC did not act or investigate this potential. Bisantrene is a unique molecule with a massive amount of clinical data supporting its use in patients as well as providing circumstantial proof that these mechanisms are the reason Bisantrene was so successful clinically it achieved approval in France. I welcome your contrarian views, mate, but can we keep them up to date so you are actually adding some value to the discussion.
RAC Price at posting:
$1.55 Sentiment: Buy Disclosure: Held
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