RAC - Race Oncology

[peter2]

April update: March 24 Qrtly news.

RC220 manufacturing completed on time to GMP standards enabling use in human clinical trials.
Early bonus option conversions and R&D tax refunds increase cash balance to $16M.

Chart perspective remains bullish as price hasn't sold off after the latest bullish swing up. Price is drifting lower with low volume but is still above the 50% pull-back level.

 

[JohnDe]

April update: March 24 Qrtly news.

RC220 manufacturing completed on time to GMP standards enabling use in human clinical trials.
Early bonus option conversions and R&D tax refunds increase cash balance to $16M.

Chart perspective remains bullish as price hasn't sold off after the latest bullish swing up. Price is drifting lower with low volume but is still above the 50% pull-back level.

I have had an exceptional ride with RAC for several years. A lot of people like to kick them, but they keep doing what they say.

 

[access]

Have my .75 cent Bonus Options ready to convert next month that are well within the money. Then receive 3 piggyback share options to convert at $1.25 by 29 May 2026. Will also be well within the money.

 

[JohnDe]

Investor Presentation is interesting -

https://cdn-api.markitdigital.com/apiman-gateway/CommSec/commsec-node-api/1.0/event/document/1410-02806072-7TFAG90S057VIJD18GDHDMCU92/pdf?access_token=0007UpNcltMuJEwog4WdSA2sl0iX

 

[JohnDe]

Good news has been taken well by the markets.

Combining Bisantrene with Decitabine Significantly Enhances Killing of Multiple Cancer Cell Types

● Bisantrene and decitabine used together offer significantly improved cancer cellkilling across a broad panel of 143 tumour cell lines than either drug used alone​

● These results support the use of decitabine in combination with bisantrene as a potential treatment for many cancers, including solid tumours such as lung, prostate, pancreas, breast and head and neck cancer​

● The Bisantrene/decitabine combination to be explored in a proposed Phase 1/2 investigator-initiated AML clinical trial​

 

[access]

After John De's article I don't need to add anything.

Next results for RC220 are due later this month.

I meant to enter RAC into the monthly comp but inadvertently put IMU instead. Them the breaks.

 

[JohnDe]

Bonus options results -

 

[JohnDe]

Some good news -

US FDA Orphan Drug Designation Awarded to RC220 Bisantrene for Acute Myeloid Leukemia

● The US FDA has extended Orphan Drug Designation (ODD) to Race’s re-formulated RC220 bisantrene drug product for the treatment of Acute Myeloid Leukemia​

● ODD confers a range of commercial advantages including US tax credits, fee waivers, grant eligibility, FDA regulatory assistance and 7-years market exclusivity in the US.​

 

[noirua]

13 June 2024 – Bisantrene Highly Active in a Mouse Model of Multiple Myeloma in Combination with Carfilzomib
● Bisantrene kills human multiple myeloma cells at clinically relevant drug concentrations in both cell culture and mice

Stockness Monster!

 

[JohnDe]

13 June 2024 – Bisantrene Highly Active in a Mouse Model of Multiple Myeloma in Combination with Carfilzomib
● Bisantrene kills human multiple myeloma cells at clinically relevant drug concentrations in both cell culture and mice

Stockness Monster!

More good news -

● US FDA Rare Paediatric Disease Designation (RPDD) has been extended to Race’s​

novel RC220 bisantrene drug product​

● RPDD provides eligibility for RC220 to receive a Priority Review Voucher (PRV) upon​

marketing approval that can be transferred/sold to other parties​

● Past sales of PRVs have averaged more than US$100 million.​

 

[JohnDe]

Cracked the $2 price point, hopefully this is the new low and July will be the month of more good news.

 

[JohnDe]

After John De's article I don't need to add anything.

Next results for RC220 are due later this month.

I meant to enter RAC into the monthly comp but inadvertently put IMU instead. Them the breaks.

New appointment to the RC220 development -

Dear Shareholder,

After a rigorous selection process, we are pleased to announce the appointment of George Clinical International as Race’s Contract Research Organisation (CRO) to support the clinical development of RC220 bisantrene.

George Clinical is a leading global CRO with over 20 years of operation, extensive trial experience globally and an impressive track record of success conducting oncology trials at all phases in the United States, Europe, China, South-East Asia, New Zealand and Australia. The company also brings access to an additional network of key opinion leading clinical oncologists with extensive expertise in the treatment of solid tumours with anthracyclines, who will assist us in the refinement and execution of our proposed Phase I study of RC220 bisantrene in combination with a standard-of-care in patients with advanced solid tumours.

We have commenced engagement of George Clinical under a Start-Up Agreement (SUA) at a cost of $1,071,067. Additional payments will be made to George Clinical under a Master Service Agreement (MSA) throughout the study after completion of key milestones, with the total dependent on the number of recruited patients and other cost variables of trial execution. The current estimated CRO cost of the Phase 1 trial is $6 million based on the recruitment of 34 patients, with additional costs for drug supply, pharmacokinetics and biomarker analysis.

Race Chief Medical Officer, Dr Michelle Rashford comments: “This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes. We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us. I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”

For further details, including an interview with our CMO Dr Michelle Rashford, please visit our Investor Hub here.

Best regards,

Dr Daniel Tillett

Chief Executive Officer

 

[access]

RC220 has now been proven safe to use and will now be prepared for trials.

 

[JohnDe]

RC220 has now been proven safe to use and will now be prepared for trials.

Chance for RAC to get some more investors on board.

ASX Announcement

Race to present at TechKnow Invest Roadshow in Sydney and Melbourne during July 2024

25 July 2024 – Race Oncology Limited (“Race”) is pleased to invite investors in Sydney and Melbourne to join us in person at the TechKnow Invest Roadshow on 30 July 2024 in Sydney and 31 July 2024 in Melbourne.

TechKnow Investor Roadshow will feature ASX-listed tech and medtech companies, showcasing investment opportunities within the sector and providing network space for all attendees. Race Executive Director, Dr Pete Smith and CEO, Dr Daniel Tillett will both be present at the two-day conference. Shareholders and investor attendees are invited to register for free to attend the event, as well as to meet and speak with Dr Smith and Dr Tillett at Race’s kiosk.

Race will also give investor presentations on both days of the conference, discussing Race’s bisantrene program and upcoming milestones, as well as cancer survivorship and the importance of cardioprotection in cancer treatment.

Conference details

Sydney

30 July 2024 at Swissôtel Sydney, NSW. | Race is presenting at 2.45pm.

Melbourne

31 July 2024 at Rydges Melbourne, VIC. | Race is presenting at 10.30am.

The full conference program can be found here. Investors who wish to join us can register for their free passes via this link.

The Race team looks forward to meeting attendees in person

 

[access]

Fully funded through until 2026 with options converted at $1.25 in that year extending the funding until about 2029 (if still around until then).
How many bio companies do you know that do not require additional funding for that period of time.

 

[access]

One more top-up and I am done.

 

[access]

Price has gone from .85 cents on 1/1/24 to current price of $1.78.

With more news on RC220 approval process due by year end I am expecting price at that time to be at least $2.50.

Probably the share that I am most positive about in the SMSF.

 

[access]

Got my final top-up.
Very hard commenting monthly on some of these stock when little will happen until trial results come out.

 

[JohnDe]

Got my final top-up.
Very hard commenting monthly on some of these stock when little will happen until trial results come out.

Trials are going well.

Race Oncology 2024 Chair’s Address and AGM Presentation

Preclinical work performed at Oncolines BV showed bisantrene’s potent cancer- killing activity in 113/143 human cancer cell lines that represented a broad cross-section of the most common haematological (blood/liquid) and solid organ cancers. When used in combination, bisantrene improved the cancer-killing activities of doxorubicin, an anthracycline chemotherapeutic and one of the most widely used anticancer drugs, with more than 20 million doses provided to patients around the world each year.

In a similar study, bisantrene, in combination with decitabine displayed enhanced cancer-killing activity across the same broad panel of 143 cancer cell lines. Another very promising result.

Furthermore, additional preclinical work showed that bisantrene, as a single agent treatment, was found to be effective against human multiple myeloma in a mouse model and which would support future evaluation of bisantrene and carfilzomib combination as a potentially more effective treatment for multiple myeloma.

We were pleased to announce that the RC110 bisantrene Phase 1b/2, the investigator-sponsored trial led by Professor Arnon Nagler at the Chaim Sheba Medical Centre in Israel, had concluded having met its endpoints. Results showed that 40% of the patients with relapsed or refractory acute myeloid leukaemia (AML) in the Phase 2 efficacy stage responded to RC110 bisantrene in combination with clofarabine and fludarabine. Although the study focused on the original RC110 formulation, the results have stimulated further clinician interest in taking the drug forward in new AML trials. We are still discussing future clinical trials with an Australian investigator in the AML field and will update our shareholders when we received a formal request for support.

 

[access]

Could not see my comment re December entry so here I go again.

Since posting my December selection I have read an item that may indicate the news I was expecting this month may not be ready for posting until possibly January. I still feel there will be a build up in December.

Following a recently completed 2 year investigation with Monash University it looks like RAC will be patenting the results of a range of other unique discoveries found in the investigation. There will probably not be time to bring these new discoveries to trials before the company or its principal product (Bisantrine) is sold in about 4 or 5 years time but they will add a lot of extra value to RAC.