iTolerance, Inc. Closes $17.1 Million Convertible Note Financing to Advance Development of Innovative Regenerative Medicines for Transplantation Without the Need for Life-Long Immunosuppression

The Company’s proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel platform technology, iTOL-100, has demonstrated in animal models of Type 1 Diabetes the ability to induce local immune tolerance and allow long-term engraftment of insulin-producing allogenic pancreatic islet cells without the need for chronic life-long immunosuppression

Lead program, iTOL-101, being developed as a potential breakthrough in curing Type 1 Diabetes

Second lead program, iTOL-102, is also being developed as another potential breakthrough in curing Type 1 Diabetes leveraging stem cell derived pancreatic islet

MIAMI, FL / ACCESSWIRE / March 21, 2022 / iTolerance, Inc. (“iTolerance” or the “Company”), an early stage regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced the closing of its convertible note financing in which the Company raised a total of approximately $17.1 million in gross proceeds. The Company plans to use proceeds from the financing to translate the production of iTOL-100 from the academic labs to commercial manufacturing for use in its planned pre-clinical and clinical trials and for other general corporate purposes.

“As a start-up life sciences company, raising $17.1 million is a noteworthy endorsement from investors and bolsters our confidence in the potential of our proprietary platform technology. With this capital in hand, we are focused on executing next steps in de-risking our manufacturing processes and positioning ourselves to successfully advance into and through pre-clinical studies to support a Phase 1/2 clinical study for iTOL-101,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. “We believe our platform technology is a potential game changer for patients with Type 1 Diabetes and the physicians who treat them. Additionally, this technology can be applied to a number of cellular therapies for chronic conditions.”

The Company’s iTOL-100 platform technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. In pre-clinical studies, iTOL-100 has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells.

iTolerance’s lead program iTOL-101 is being developed as a potential cure for Type 1 Diabetes. Using the iTOL-100 platform technology, allogenic pancreatic islets are co-implanted and in pre-clinical studies have shown immune acceptance and long-term function of the graft with control of blood glucose levels and restoration of insulin secretion without the need for immunosuppression. The Company is moving forward with pre-clinical studies to support a Phase 1/2 study in Type 1 Diabetes.

The Company’s second lead program, iTOL-102, utilizes the iTOL-100 platform technology to induce local immune tolerance and leverages significant advancements in stem cell-derived pancreatic islets which allows an inexhaustible supply of insulin-producing cells as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression.

About iTolerance, Inc.

iTolerance is an early stage privately held regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company’s lead program, iTOL-101 is being developed for Type 1 Diabetes and in a pre-clinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. The Company’s second lead candidate, iTOL-102, is leveraging significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

SOURCE: iTolerance, Inc.

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