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$RAC.AX #asx #oncology #cancer
@RaceOncology could be a 2021 #asx 10+ bagger
Why follows in this thread. First watch the strategy video.
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@RaceOncology could be a 2021 #asx 10+ bagger
Why follows in this thread. First watch the strategy video.
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Bisantrene was shown decades ago to be safe and effective in both Acute Myeloid Leukaemia (AML) and Breast Cancer. It was then forgotten (more on this later).
Importantly -
Bisantrene works.
Bisantrene is safe.
Safety and efficacy are the two key tests for drug approval.
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Importantly -
Bisantrene works.
Bisantrene is safe.
Safety and efficacy are the two key tests for drug approval.
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Safe and effective oncology drugs are snapped up early.
That means mostly during or following Phase I or II trials or sometimes during the preclinical stage.
Phase II assets for USD $2.5B (average).
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That means mostly during or following Phase I or II trials or sometimes during the preclinical stage.
Phase II assets for USD $2.5B (average).
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This happened for Forty Seven $FTSV in March 2020 …
Also an Acute Myeloid Leukaemia asset.
Buyout for USD $4.9B ( AUD $6.4B ).
/4 https://www.fiercebiotech.com/biotech/how-do-you-get-acquired-by-gilead-forty-seven-explains
Also an Acute Myeloid Leukaemia asset.
Buyout for USD $4.9B ( AUD $6.4B ).
/4 https://www.fiercebiotech.com/biotech/how-do-you-get-acquired-by-gilead-forty-seven-explains
A buyout of the scale of the Forty Seven $FTSV transaction for $RAC.AX would result in an acquisition at over $30.00 per share.
That’s 10+ bagger territory.
(I’m expecting AML trial readouts by end 2021 so could be a possibility)
@RaceOncology #ASX
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That’s 10+ bagger territory.
(I’m expecting AML trial readouts by end 2021 so could be a possibility)
@RaceOncology #ASX
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Bisantrene was shown to be safe and effective in 80s/90s and was then forgotten.
(the acquirer of the original drug developer Cyanamid / Lederle Laboratories in 1994 seemed to be more focused on multi-vitamins and animal health products).
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(the acquirer of the original drug developer Cyanamid / Lederle Laboratories in 1994 seemed to be more focused on multi-vitamins and animal health products).
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In the 80s Bisantrene was developed to be a safer chemotherapeutic, much safer than the widely-used Doxorubicin (still a backbone of chemotherapy).
The main attention in pre-clinical studies was the lower cardio-toxicity.
This was one pre-clinical study in '82.
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The main attention in pre-clinical studies was the lower cardio-toxicity.
This was one pre-clinical study in '82.
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Bisantrene achieved an average 47% complete response in 6 Phase I and II trials in AML in the 80s/90s. A response rate that if repeated in modern US trials would easily pass the typical benchmarks needed for FDA approval.
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Bisantrene cured 2 French Girls of Leukaemia in the 80s/90s. After relapses following other treatments, treatment with Bisantrene and then bone marrow transplants cured them of AML.
They are both alive today.
They both have their own families.
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They are both alive today.
They both have their own families.
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Bisantrene was historically approved for Leukaemia in France in early 1990s. This is before the European Union took over registration of drugs.
A drug that was approved before has a strong chance to be approved again.
Here’s a record. Trade name Zantrene. 1990.
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A drug that was approved before has a strong chance to be approved again.
Here’s a record. Trade name Zantrene. 1990.
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Unfortunately Bisantrene was never marketed, however it was also trialled in Breast Cancer (trial in over 300 patients with over 100 patients in the Bisantrene arm).
It achieved similar cumulative survival to Doxorubicin, but with much better heart safety.
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It achieved similar cumulative survival to Doxorubicin, but with much better heart safety.
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American Home Products (who acquired Cyanamid / Lederle Laboratories) were distracted by a strategy focused away from Oncology and didn’t pursue Breast Cancer approval trials in the US.
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RACE Oncology picked up the drug in 2016.
Two of the RACE Oncology founders (Bill Garner and John Rothman) still hold a stake in the company (mix of shares and options).
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Two of the RACE Oncology founders (Bill Garner and John Rothman) still hold a stake in the company (mix of shares and options).
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4 patents have been secured.
13 new patents filed.
US Orphan Drug Designation secured (7 years commercial exclusivity post-approval).
US Rare Paediatric Disease Designation (potential for priority review voucher valued ~ USD $100M).
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13 new patents filed.
US Orphan Drug Designation secured (7 years commercial exclusivity post-approval).
US Rare Paediatric Disease Designation (potential for priority review voucher valued ~ USD $100M).
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New management with a background in cancer research saw the incredible potential in the drug.
(watch this segment at exactly 10 minutes into the 2019 AGM)
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(watch this segment at exactly 10 minutes into the 2019 AGM)
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The strategy has been turned around and the likely probability of success in clinical trials is the reason for the significant re-rate of the share price (better investor recognition of low clinical risk).
Bisantrene is a drug that should once again save lives.
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Bisantrene is a drug that should once again save lives.
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This is compelling ...
In a trial completed in Israel in 2020, Bisantrene achieved extraordinary tumour regression for a rare form of AML known as Extramedullary AML.
This was after a single course of treatment
(normal dosing is two courses).
Significantly de-risks RAC.
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In a trial completed in Israel in 2020, Bisantrene achieved extraordinary tumour regression for a rare form of AML known as Extramedullary AML.
This was after a single course of treatment
(normal dosing is two courses).
Significantly de-risks RAC.
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EM AML has become a compelling niche for Bisantrene.
It provides an opportunity for rapid approval via the FDA 505(b)(2) pathway ( this will be very attractive to big Pharma ).
It also provides an opportunity to secure a valuable Priority Review Voucher ( ~ USD $100M ).
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It provides an opportunity for rapid approval via the FDA 505(b)(2) pathway ( this will be very attractive to big Pharma ).
It also provides an opportunity to secure a valuable Priority Review Voucher ( ~ USD $100M ).
/18
First readouts from modern Australian or US trials should attract Big Pharma Interest. Big Pharma could swoop with buyout or partnership interest before a trial completes.
Remember that we already know that Bisantrene works very well for both EM AML and R/R AML.
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Remember that we already know that Bisantrene works very well for both EM AML and R/R AML.
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RACE are planning to start a small EM AML trial in Australia in 2021 and then plan to the US in 2022
We could have first readouts by end of 2021
In parallel FDA Pre-IND and IND activities to allow an R/R AML trial will also be underway
2 sets of FDA Pre-IND & IND in 2021
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We could have first readouts by end of 2021
In parallel FDA Pre-IND and IND activities to allow an R/R AML trial will also be underway
2 sets of FDA Pre-IND & IND in 2021
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So what’s happening with Breast Cancer?
Well, preclinical study in 2020 reconfirmed Bisantrene still works very well against Breast Cancer - both as a single-agent and in combination with other drugs.
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Well, preclinical study in 2020 reconfirmed Bisantrene still works very well against Breast Cancer - both as a single-agent and in combination with other drugs.
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Modern chemotherapy is combination with other drugs.
RACE are positioning Bisantrene as a safer chemotherapeutic (safer for the heart
) with application to many types of Breast Cancer.
It’s a very large revenue opportunity for a Big Pharma. Much bigger than AML.
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RACE are positioning Bisantrene as a safer chemotherapeutic (safer for the heart
) with application to many types of Breast Cancer.It’s a very large revenue opportunity for a Big Pharma. Much bigger than AML.
/22
Breast Cancer is a blockbuster opportunity.
A buyout for a large solid tumour indication could be as much as USD $21B taking the Immunomedics $IMMU buyout as a benchmark.
A similar buyout for $RAC.AX would be 50-bagger territory.
https://endpts.com/news-briefing-gilead-completes-21b-buyout-of-immunomedics-innate-receives-50m-milestone-payment-from-astrazeneca/
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A buyout for a large solid tumour indication could be as much as USD $21B taking the Immunomedics $IMMU buyout as a benchmark.
A similar buyout for $RAC.AX would be 50-bagger territory.
https://endpts.com/news-briefing-gilead-completes-21b-buyout-of-immunomedics-innate-receives-50m-milestone-payment-from-astrazeneca/
/23
I expect a Breast Cancer clinical trial to start in H1 2021.
We are currently waiting for planning to be completed. More information in February. This should allow recruitment to start by the end of June.
We could have first readouts from a trial by the end of 2021.
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We are currently waiting for planning to be completed. More information in February. This should allow recruitment to start by the end of June.
We could have first readouts from a trial by the end of 2021.
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I estimate trials in Australia for Breast and R/R AML in 2021 at 30 patients per trial would total AUD $2-3M (without discounting for R&D tax offsets) with some of the spend in 2020 and the remainder in 2021.
( note $2.1M in options revenue pending in 2021 )
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( note $2.1M in options revenue pending in 2021 )
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Biggest opportunity for Bisantrene is as a cancer inhibitor like blockbuster PD-1 cancer inhibitors such as #Keytruda.
An FTO inhibitor would be a blockbuster revenue carrot for Big-pharma.
#mRNA @RaceOncology #ASX
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An FTO inhibitor would be a blockbuster revenue carrot for Big-pharma.
#mRNA @RaceOncology #ASX
/26
This is the reason RACE have pivoted their strategy with FTO and the #precisiononcology opportunity being a key priority.
FTO preclinical study is planned in 2021 with a trial to start in 2022.
#mRNA @RaceOncology #ASX
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FTO preclinical study is planned in 2021 with a trial to start in 2022.
#mRNA @RaceOncology #ASX
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Expected share price catalysts - H1 2021
- Plans for Breast Cancer and AML trials
- Start of Breast Cancer trial in Australia
- Start of EM AML trial in Australia
- Start of FTO preclinical activities
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- Plans for Breast Cancer and AML trials
- Start of Breast Cancer trial in Australia
- Start of EM AML trial in Australia
- Start of FTO preclinical activities
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Expected share price catalysts - H2 2021
- Pre-IND and IND for 2 x US AML trials
- first readout Breast Cancer
- first readout for EM AML
- preclinical results for FTO
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- Pre-IND and IND for 2 x US AML trials
- first readout Breast Cancer
- first readout for EM AML
- preclinical results for FTO
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