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September 25, 2024
Jonathan Rigby
President CEO
Dear Sernova Shareholders,
I am writing to introduce myself as the new President CEO of Sernova and to share some exciting updates from our incredibly talented and committed team on how we are working to Give Patients Their Lives Back, while creating value for our supportive shareholders.
Let me first share a little on my background. Foremost, I am the husband of Marylyn, a talented biotech senior executive, a wonderful wife and an incredible Mom. We are also devoted parents of our three children, Heather (28), Rex (10) and Juliette (8). A biologist by training, with an MBA, I have been in the pharmaceutical and biotech industry for over 30 years and really love it! As you know, it can be a rollercoaster, and I have experienced both lows and very gratifying highs! I started my career in large pharmaceutical companies and have founded, financed and grown several biotech companies through to IPOs and acquisitions and have been blessed to be a player on and leader of teams that have several drug approvals under their belts that have changed the lives of terribly sick patients. Having raised capital many times for the companies I have served, I have a great respect for shareholders and value the trust you place on management.
As a Type 1 diabetic (T1D) for most of my life, I am ebullient about Sernova?s Cell Pouch Transplant System T1D program and the promising data generated with multiple patients reaching insulin independence. I?m equally excited about the broad platform potential to treat other regenerative medicine indications. I am honored to have the opportunity to passionately drive our clinical programs forward so that we can Give Patients Their Lives Back!
We are off to a great start, having recently closed a non-brokered, oversubscribed bridge financing round. This strong support from our current and new investors and insiders highlights a confidence in our mission and the value of our innovative approach to providing functional cures for chronic diseases that have terrible impact on the lives of patients the world over.
In addition, we have recently filed new patent applications to protect and cover our key assets and data, potentially strengthening the longevity of our competitive position in the market. We are also pleased with recent discussions with the FDA regarding the filing of our upcoming Investigational New Drug (IND) application for the treatment of hypothyroidism, which we trust, subject to FDA approval of the IND will provide a pathway into the clinic in the new year.
I am particularly excited that we recently announced very positive news from our ongoing T1D clinical study. On September 12, Dr. Witkowski, our principal investigator, presented new data regarding our ongoing Cell Pouch Transplant System containing human donor islets at the European Association for the Study of Diabetes conference in Madrid. The data related to an analysis of Cell Pouches that were removed from a patient more than 5 years after they were transplanted. The key takeaways from this presentation, which we believe have never before been reported by other companies, sets Sernova apart and are as follows:
From one patient, our scientists found abundant, richly vascularized and functioning islets throughout all chambers of Sernova?s Cell Pouches more than 5 years after islet transplantation.
?§Histological analysis confirmed the presence of healthy beta, alpha and delta cells secreting insulin, glucagon, and somatostatin in all Cell Pouch chambers. These are the three cell types that create normal glucose control in non-diabetics and contributed to insulin independence for this patient for over 4,5 years.
?§We were delighted to find that Sernova?s Cell Pouch safely contains its therapeutic cells and provides full retrievability using conventional instruments and methods.
?§Lastly, pathology confirmed no evidence of detrimental fibrotic tissue associated with Cell Pouch more than 5 years after implantation.
We believe this first-in-world data is substantive for Sernova and is meaningful for the future of T1D patients. We also believe this is a significant step further in our mission of providing a functional cure for this terrible disease. I could not be more determined to drive our programs forward and ultimately onto the market.
We look forward to completing Cohort B of our ongoing T1D study in the near term and, based on positive data generated thus far, initiating Cohort C with an optimized immune suppression regimen. Lastly, we continue to work with our partner Evotec on the development of induced pluripotent stem cell (iPSC)-derived islet-like clusters, which will provide a scalable cell source so that one day we can Give Patients with T1D Their Lives Back and create value for our shareholders!
I want to sincerely thank each of you for your continued support and belief in our vision.
Giving Patients Their Lives Back
Jonathan
President CEO
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