With my brief review of the clinical history out of the way, I thought I might revisit the triangle report and state what should be obvious.
The Triangle Report effectively discounts future revenues for Bisantrene, projecting peak yearly revenues of $1.7B USD for breast cancer in the U.S. If you follow the yellow highlighting, you'll see the potential buyout value per share, which represents a significant improvement over the current share price. It's important to note that this figure is based on a discounted percentage from just one indication where Bisantrene has already demonstrated effectiveness. Although the improvement in Overall Survival wasn't statistically significant, Bisantrene outperformed Doxorubicin with a dosing regimen that wasn't optimized for its mechanisms of action.
There are many ways in which we can modify the numbers to be more suited to a world-first therapy that provides anti-cancer effects while protecting the heart from cardiotoxicity. In my view, Bisantrene has all the characteristics of a breakthrough therapy drug, which typically commands a significantly higher price per month than standard approved treatments. Research indicates a 73% increase in the average monthly cost for breakthrough drugs, reaching around $39k/month (1). If the upcoming P1a/b trial shows evidence of cardioprotection, I believe RAC will pursue breakthrough therapy designation, and I'm confident they will achieve it. No other anti-cancer agent has effectively killed cancer while also protecting the heart from a benchmark of cardiotoxicity.
Bisantrene offers immense potential as a CPACS drug when combined with Doxorubicin, though there's uncertainty among investors about how to best value it. However, the opportunity is undeniable. In my presentation, I emphasized that the ideal CPACS drug should be broadly active, synergistic, and cardioprotective. Cardioprotection aside, Bisantrenes unique mechanisms of action differentiate it from anything else on the market. Despite its past misuse, Bisantrene is now perfectly positioned to be leveraged correctly to maximize these distinct advantages in the clinic.
While this is all true, I want to focus specifically on breast cancer for simplicity.
The Triangle Report highlights that regardless of whether Bisantrene's anti-cancer efficacy is considered low or high, its uptake in combination with anthracyclines is projected between 93% and 99%. This shows a strong demand among oncologists for an agent that enhances anthracycline effects, even marginally, while protecting the heart. However, as a high achiever, I believe Bisantrene can surpass the threshold for high anti-cancer efficacy and cardioprotection. The requirement for this level of efficacy includes a 4-month improvement in progression-free survival, a 15% increase in pathologic complete response (pCR), and a 30% reduction in cardiac events.
The clinical history for Bisantrene in Breast cancer is captured below. The ORR averaged 14.17% across 411 patients from 9 clinical trials, with partial responses the clean majority. While the dosing regimen for Bisantrene varied, the total dose per month was maintained between 320 and 533 mg/m2, with an average of 389 mg/m2. This TD/mo is 4x lower than the average total dose per month achieved in all phase 2 AML trials (~1700 mg/m2).
The review I conducted shows a strong correlation between ORR and total dose per month, consistent across both AML (a hematological cancer) and EMD AML (a solid-tumor-like cancer). I used the regression equation from the ORR vs. total dose per month graph, adjusting it to align with baseline efficacy data from previous Bisantrene studies. This allowed me to generate potential dosing regimens for Bisantrene in combination with Doxorubicin for the upcoming P2 CPACS trial, which informed the total dose per month (TD/mo) and estimated ORR. While I acknowledge the assumptions involved, I advise investors to carefully consider the data. The analysis suggests that dosing regimens of 3-4 days every three weeks or 1-3 days each week should yield significant anti-cancer efficacy. Although there are limited methods to estimate cardioprotection with Bisantrene and Doxorubicin, a 200 mg/m² dose of Bisantrene should achieve the necessary concentrations observed in vitro and in vivo. Given Bisantrene’s comparability to Dexrazoxane, even with a 50% reduction in cardioprotection, it is likely to exceed the 30% threshold required. All the TD/mo examples provided are within safety margins already demonstrated in humans, with the 200 mg/m² dose below the maximally tolerated dose for both children and adults. The hypothetical ORR for Bisantrene was added to the ORR achieved by Doxorubicin in the P3 breast cancer trial.
Clearly, work like this is highly circumstantial and an appropriate amount of care needs to be taken when determining the likelihood chance that this plays out in humans. Personally, the access to the largest human dataset available for a small cap biotechnology company is of enormous significance, and influences the strength of this analysis more than most. All of this data comes together to suggest that if Bisantrene is only effective in breast cancer, it is an investment opportunity that people would dream of. The model that you use to determine value needs to consider that this is a world-first opportunity, there are no clinical and commercial competitors, and first-to-market drugs dominate their intended market.
Lastly, there are numerous factors that influence my target price for Bisantrene, so let me outline some of the key elements that would influence my projections:
- Assume the anti-cancer benefits of Bisantrene in any combination are excellent - Assume the cardioprotective effects are comparable to dexrazoxane in any combination - A successful CPACS Phase 1a/b with Doxorubicin could achieve breakthrough therapy designation, highlighting its potential across a wide range of cancers - This success would naturally flow into a Phase 2 trial aimed at accelerated approval - A successful Phase 1a/b would generate international interest in Bisantrene as the world’s first CPACS, leading to multiple investigator-led trials exploring its combination with major drug classes for CPACS opportunities - It would also likely lead to royalty or licensing deals across Asia for Anthracycline CPACS - The investigator-led Phase 1/2 AML trial could bolster Bisantrene’s profile - Conservatively, by 2028, Bisantrene will have broad interim results from these trials, affirming its potential as a platform drug - Additionally, RAC will have secured all IP rights, with patents that are airtight
In summary, while Breast cancer alone is an outstanding opportunity for Bisantrene and RAC, there is significant value outside of the US in Breast cancer as well as many other indications. If Bisantrene truly is the perfect CPACS drug, then the value of this drug becomes exponentially large. The key to all of this starts at the P1a/b - all we need is a signal of cardioprotection.
RAC Price at posting:
$1.57 Sentiment: Buy Disclosure: Held
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