I put some concerns I had to the company, some of which arose from questions being raised here. I really appreciate the response and am sure others may find the responses informative. I asked these questions around the time that the quarterly came out. Here are the replies:
Q: Is it a concern that we are in phase 2 cardio protection and pre-clinical work is still being undertaken?
DCB:
The preclinical work that was discussed in the quarterly report released last week is important to informing the setup and design of our clinical studies in cardioprotection and breast cancer.
Within drug development, we are constantly looking to characterise and define the profile of the product. So while we have moved into the clinic, there is always ongoing preclinical work that helps to validate the features and benefits of the product. In fact, with other drugs I’ve been involved with, preclinical work continued to be conducted even as late as phase 3. This is often used to support the regulatory pathway and commercial success of a product.
Q: Why are the updates for preclinicals only in the quarterly? Why no in-depth reports with scientific data?
DCB:
In the quarterly report, we specifically tried to provide at least a top line brief of the preclinical work that is part of our overall development strategy. Some of the data is being held in commercial confidence as it is part of ongoing validation work for the program. In addition, our goal is to start publishing some of the excellent work that our Race team has completed and this data will be utilised within future publications and then shared publicly. If we release this data prematurely, it can have an adverse impact on our ability to get it into scientific channels which are important to us as we focus on a more commercial phase of the business.
We acknowledge that we have evolved the structure of the quarterly report, which previously had been a recap, but to make sure we were transparent, we decided to provide you with a snapshot of the ongoing work program.
Q: Is reformulation delayed? With CSO to possibly come later than June, will this hold up P2?
DCB:
Changes to our senior executive leadership haven’t had any impact on the progress of our strategy. As you are aware, Dr Ajay Duggal, CMO and Dr Tim Hammond, CSO have been extensively involved with Race since December 2022 and have an intimate knowledge of the program.
As for the RC220 formulation, this development is ongoing. Best case scenario is that there will be no hold ups for RC220 to move into the clinic. We are actively progressing toward a cGMP batch now.
Q: What are the "strategic goals for 2023"? Will you be addressing shareholders with an investor update or Q&A?
DCB:
In my CEO’s commentary in the quarterly, it was discussed that we are engaging with key opinion leaders and the Race team to further define what the target product profiles look like for Zantrene (ie. safety and efficacy related characteristics for our target populations.) We have a range of activities lined up to take us out to July / August at which time we will understand what our enhanced clinical development plans look like.
I am very keen to both meet shareholders formally and to also have a Q+A, but will hold off until I am in a position to answer all your questions on strategic goals. I appreciate this timeframe might be longer than preferred, but it’s important we get this right.
(20min delay)