Author: iTolerance, Inc.

Watch the next video segment here

MIAMI, FL / ACCESS Newswire / December 3, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the release of the next segment in its Patient Journey video series featuring Kristen and Raul, parent and grandparent, respectively, of a child with Type 1 Diabetes.

As part of the segment, Kristen shares about her daughter’s Type 1 Diabetes diagnosis, the impact it has on daily living as a family, and how her daughter currently navigates living with the disease. Additionally, Raul gives a physician’s perspective, and how a new treatment option would impact his granddaughter and the broader Type 1 Diabetes community.

Watch the video segment featuring Kristen and Raul here, and access future segments on the Patient Journey page of the Company’s website, www.itolerance.com.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
iTolerance@jtcir.com

Media Contact
Susan Roberts
T:202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.

View the original press release on ACCESS Newswire

MIAMI, FL / ACCESS Newswire / November 12, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced that Anthony Japour, Chief Executive Officer and President of iTolerance, received the Research & Developer of the Year Award at the recently held BioFlorida Innovation Conference in Miami, FL.

“We are honored that BioFlorida has recognized our team’s work and the potential of our technology to transform the Type 1 diabetes treatment landscape. Receiving the Research & Developer of the Year Award from BioFlorida is a humbling recognition of the dedication of the entire iTolerance team and our collaborators. At iTolerance, we are driven by a singular purpose; to advance therapies that enable life-changing therapies without the need for life-long immunosuppression. This award reinforces our conviction that innovation backed by science can bring real hope to patients who currently face limited options. We look forward to building on this momentum and accelerating our journey forward,” commented Anthony Japour, CEO of iTolerance.

This accolade underscores iTolerance’s commitment to innovation, patient focused development and driving its pipeline forward to clinical translation. Looking ahead, the Company remains focused on advancing its lead programs toward first-in-human clinical studies and broader applications of its immune tolerance platform.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
iTolerance@jtcir.com

Media Contact
Susan Roberts
T:202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.

View the original press release on ACCESS Newswire

Watch the first video segment here

MIAMI, FL / ACCESS Newswire / October 9, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the launch of its Patient Journey video series, with the release of the first segment featuring Sandra Cohen Kalter, recently appointed member to the Company’s Strategic Advisory Group and parent of a child with Type 1 Diabetes.

This video series is designed to shed light on the daily realities of patients, caregivers and family members of those living with Type 1 Diabetes. Through these real-life experiences, the series aims to increase awareness and highlight the urgent need for better treatment options for Type 1 Diabetes.

“We believe it’s critical to put a human face to the disease. The Patient Journey series gives a voice to those navigating the challenges of Type 1 Diabetes every single day. Their stories are not only deeply moving but they are also a driving force behind our mission to develop innovative, life-changing therapies for those living with Type 1 Diabetes,” commented Anthony Japour, Chief Executive Officer of iTolerance.

Each episode will spotlight a different perspective, from patients managing the daily burden of insulin therapy, to caregivers balancing support and advocacy, and families adjusting different aspects of their lives around the disease.

As part of the first segment, Mrs. Cohen Kalter shares about her son’s Type 1 Diabetes diagnosis, the impact it has on daily living, and how their family has come to engage with the Type 1 Diabetes community. Additionally, she shares about how she connected with iTolerance, why she believes in the Company’s potential cure for Type 1 Diabetes, and how a new treatment option would impact her son and the broader Type 1 Diabetes community.

Watch the first video segment featuring Mrs. Cohen Kalter here, and access future segments on the Patient Journey page of the Company’s website, www.itolerance.com.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
iTolerance@jtcir.com

Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.

View the original press release on ACCESS Newswire

Legal & regulatory executive with extensive expertise in FDA law and regulatory leadership for one of the world’s leading medical device companies

MIAMI, FL / ACCESS Newswire / September 22, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the appointment of Sandra Cohen Kalter to its Strategic Advisory Group.

“This appointment represents another step toward bolstering our ability to navigate complex regulatory pathways, potentially accelerate clinical translation and unlock the full potential of our pipeline. Our Strategic Advisory Group was formed to provide strategic guidance from individuals with a diverse background of expertise to support our initiatives, and Sandra is a wonderful addition that provides valuable insight and expertise. Over the course of her career, Sandra has navigated a number of regulatory pathways, inspections and integrations which have provided her with a depth and breadth of expertise that we believe will be instrumental as we move our development plans forward,” commented Anthony Japour, Chief Executive Officer of iTolerance.

Mrs. Kalter added, “I am pleased to serve in this capacity for iTolerance and leverage my knowledge and experience from my career to help advance this important technology forward. iTolerance’s platform technology, which has the potential to eliminate the need for life-long immunosuppression, continues to demonstrate promise, and I look forward to bolstering the Company’s efforts to provide patients with a treatment option where there remains significant unmet need.”

Sandra Cohen Kalter is a seasoned senior legal executive most recently serving as Vice President & Chief Regulatory Counsel at Medtronic plc (“Medtronic”), overseeing global strategies in regulatory compliance, quality, clinical affairs and medical safety for a world-renowned medical-device leader. She has led transformative enterprise-wide initiatives, including a patient safety and quality program that delivered major reductions in FDA findings and field corrective actions.

Additional career highlights include:

• Built and managed an in-house FDA legal team that navigated 17 regulatory inspections in a single year, ensuring product continuity

• Guided due diligence and integration efforts for more than 27 acquisitions, led regulatory responses to FDA violations and high-profile media scrutiny, and helped steer approval strategies for groundbreaking devices like the Evolut TAVR system and Micra leadless pacemaker

• Previously served as FDA/Health Care Counsel at King & Spalding LLP, where she advised on complex regulatory filings and FDA panel proceedings

• Received several awards including: Service to FDLI Award, Food and Drug Law Institute, 2023; Rapaport Lifetime Achievement Award, Juvenile Diabetes Research Foundation, 2019; Medtronic Wallin Leadership Award, June 2010; Marketing Campaign Team Award, Spinal & Biologics “Just the Facts,” 2010; Medtronic Star of Excellence Award, 2009

• Member of AdvaMed (Advanced Medical Technology Association) Legal Committee and Business Case for Quality Working Group

• Co-Chair of AdvaMed Advertising and Promotion Working Group , Off-Label Working Group, and Business Case for Quality Working Group

• Board of Directors of Food and Drug Law Institute (FDLI)

• Board of Directors of Juvenile Diabetes Research Foundation (JDRF) and Corporate Recruitment Chair of JDFR One Walk

• Member of Food and Drug Law Institute Medical Devices Advisory Committee

Mrs. Kalter attended George Washington University, The National Law Center and received a Juris Doctor Degree and a Bachelor of Science in Journalism from Northwestern University.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
iTolerance@jtcir.com

Media Contact
Susan Roberts
T:202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.

View the original press release on ACCESS Newswire