As we approach the end of 2021, I’m pleased for the opportunity to offer our best wishes for the coming Holiday Season and share with you our latest Investor Newsletter.
Having just completed the American Thanksgiving Holiday, where it is traditional to be thoughtful about those things we are thankful for, I feel there is much that I personally, and Imagion, have to be thankful for. We are privileged to be working on a technology that could change people’s lives and significantly improve health outcomes. We have collaborators and patients participating to help us, and, not insignificantly, we have investor support and enthusiasm for what we are doing.
That investor support was most evident in the recent completion of the exercise of IBXO options. Throughout this year the options had been exercised in bits and pieces, but by the November 26th exercise date, all but just under $100,000 had been exercised by the option holders, the remainder having been taken up by Mercer Capital, a US institutional investor that had committed to underwrite any unexercised options. As a result, the Company’s balance sheet was strengthened by approximately $3.8m.
This month we will be moving into our new facility, something we have been working towards for almost a full year. It is not a big move in terms of distance (only a few kilometers from our existing facility) but it is a big move in terms of capabilities and capacity. The new location will give us the ability to grow and expand our research and development capabilities, and most importantly, develop the manufacturing processes necessary to support our clinical programs and commercial relationships. To date, we have been making our nanoparticles at a relatively small scale, but the new facility will allow us to more easily increase our production capacity as our business develops. I’d like to acknowledge all the Imagioneers that have managed to work on making the move possible while not dropping the ball on our daily work and projects.
Lastly, a brief word about our MagSense® HER2 Breast Cancer study. As reported previously, we have four sites across VIC, NSW, and QLD recruiting with multiple patients having been enrolled and completing the study. We are pleased with the recent progress of the study and know that cancer doesn’t take holiday breaks, so we and our investigators will remain vigilant throughout the coming weeks to be sure to keep the study moving forward.
Wishing all of you safe and happy holidays,
A Word From One of Our Clinical Sites
As noted in our 3rd Quarter Activity Report, the Lake Macquarie Private Hospital was added as a fourth study site for our MagSense® HER2 Breast Cancer study. Lake Macquarie has a stellar history of participating in clinical research and we are pleased to have them join our efforts to investigate the clinical potential of our MagSense® technology. Here are a few words from the principal investigator at Lake Macquarie about why they wanted to participate.
"The discovery of the HER2 protein has revolutionized breast cancer research, positively impacting the outcome of many breast cancer patients. So, it is indeed an exciting opportunity to participate in research utilizing the HER2 protein in a novel manner, further expanding the ability to provide targeted precision therapy.”
- Dr Shanta Velaiutham, General Breast Surgeon Lake Macquarie Private Hospital
VBIC Annual Meeting Recap
As part of our continued efforts to be an active participant in and educate the sector on Imagion’s innovative technology, we recently participated as a sponsor and presented at the 2021 Annual Victorian Biomedical Imaging Capability (VBIC) Network Meeting.
Held virtually on Friday 26th November, the event brought together Australia’s leading bioimaging experts, scientists, and Victorian decision-makers.
As a sponsor of the event, our President and CEO, Bob Proulx, gave a presentation on magnetic nanoparticles as imaging agents, showcasing our MagSense® technology and its revolutionary potential to transform today’s medical imaging practice.
Our Clinical Study Manager, Leanne Daly, also participated in an interesting panel discussion on the biomedical imaging industry and commercialisation.
We were also proud to sponsor the 2021 VBIC Emerging Leader Award - presented to Dr. Talitha Ford. A big congratulations to Dr. Ford!
We often get inquiries regarding our announcements, usually around when and how we communicate to the markets. We'd like to take the opportunity here to remind investors of our communication strategy and policies.
As a listed entity, Imagion Biosystems is governed by the Listing Rules of the Australian Securities Exchange (ASX). Therefore, we are committed to complying with the ASX’s disclosure requirements, along with corporate regulations and guidelines for clinical trials.
We understand and appreciate shareholder interest in and enthusiasm for information about what is happening, and the company has several processes in place to ensure we appropriately inform and apprise IBX investors of relevant events. The Board and Executive teams are committed to meeting our continuous disclosure obligations, including providing timely, and informative announcements to the market, but we don’t’ put out announcements prematurely or just for the sake of news flow.
This is particularly true for our MagSense® HER2 Breast Cancer study. Imagion Biosystems will continue to maintain its commitment to disclosure, updating shareholders and the market through announcements on material events - in line with ASX listing rules - but not risking the integrity of the study.
We would also like to note that the ANZCTR site is a registry and while we update the registry as necessary, the site is not designed to provide a source of real-time information on the progression of the study.
Imagion invites all investors to stay connected through our newsletters and social media to remain up to date on the latest company developments.
Get to Know Us
We sat down with Carmen Soikowski, who joined us as our Director of Operations in November 2021, to talk about her experience prior to joining Imagion Biosystems, her goals in her role, and what is motivating her work.
Carmen brings with her more than 25 years of cGMP (Current Good Manufacturing Practice) operation-focused experience which includes areas in manufacturing, quality control, pilot plant tech transfer, supply chain, and warehousing.
Originally drawn to Imagion Biosystems due to personal interest, having her mother currently go through Breast Cancer, Carmen wanted to help other women like her avoid painful diagnostic surgeries. She’s also interested in superparamagnetic nanoparticles and is motivated to see how we can expand on the use of magnetic particles in diagnostic applications.
Her initial goal in this new role is to help design and set up a cGMP manufacturing environment to allow us to manufacture our nanoparticles, which are at the core of our business. Having this new cGMP operations support will allow us to increase our R&D efforts and expand production.
Carmen adds, “The team at Imagion is really terrific to work with. They are focused on their projects while still maintaining a ‘How can we partner to get this done?’ attitude. Each team member I have encountered has been welcoming, helpful, and very knowledgeable.”
As previously announced,our San Diego-based operations will be moving to a new location this month. The new facility will provide upgraded research laboratory capabilities and increased capacity for manufacturing of our nanoparticle technology. The latter being important as we move towards our next phase of clinical development and cultivate 3rd party commercial opportunities.
New Patent Issued
The US Patent and Trademark Office (USPTO) has issued Imagion a new patent related to the MagSense magnetic relaxometry technology.
The patent expands the issued claims related to the instrumentation design and use.
.png?width=1200&upscale=true&name=Investor%20Update%20Email%20Header_3%20(2).png)
.png?width=1120&upscale=true&name=Bob%20Signature%20600px%20(2).png)
.png?width=1120&upscale=true&name=Employee%20Spotlight_Carmen_email%20(600%20x%20150%20px).png)
.png?width=450&upscale=true&name=office%20photo%20(2).png)
