15:39:52 EDT Fri 03 Jul 2020
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Sernova Corp
Symbol SVA
Shares Issued 195,945,114
Close 2020-03-24 C$ 0.115
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Sernova provides 2020 outlook

2020-03-24 09:59 ET - News Release

Mr. Dominic Gray reports

SERNOVA PROVIDES CORPORATE UPDATE AND OUTLOOK FOR 2020

Sernova Corp. has provided a corporate update and outlook for 2020.

Dr. Philip Toleikis, president and chief executive officer of Sernova, remarked: "The past year has been one of significant advancement and success for Sernova's clinical and preclinical programs. We are pleased with the progress, including increased patient enrolment and early observations from our U.S. phase I/II clinical trial for people with type 1 diabetes and severe hypoglycemia unawareness. Advancements have also been made with preclinical initiatives for our Cell Pouch System platform relating to the development of stem-cell-derived islets toward the ultimate goal of developing an unlimited source of therapeutic cells for diabetes, factor VIII producing cells for hemophilia A and a novel treatment for people with hypothyroid disease. We also continue to evolve and make progress with our pharma and academic collaborations. Despite the current COVID-19 environment, we are encouraged with the path ahead for Sernova and what we expect to achieve in 2020 to enhance long-term shareholder value."

Recent progress and achievements for Sernova's pipeline by therapeutic indication and area of interest

Diabetes

The company is currently conducting a United States phase I/II clinical trial in type 1 diabetic patients with severe hypoglycemia unawareness -- entitled Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch(TM) for Clinical Islet Transplantation -- at the University of Chicago.

Key requirements for a successful diabetes regenerative medicine approach have been the company's focus; more specifically, these include first ensuring robust survival of insulin-producing cells within the company's Cell Pouch and proof of insulin release into the bloodstream in subjects with no ability to produce insulin prior to Cell Pouch transplant.

The following represents significant achievements for the U.S. phase I/II Cell Pouch clinical trial:

  • The company increased the number of patients enrolled and transplanted in its clinical trial. In the most advanced patient treated with the Cell Pouch and insulin-producing islets, abundant and surviving vascularized insulin-producing islets were confirmed in the sentinel Cell Pouch by independent pathologist assessment following 90 days transplant.
    • Why is this important? This early efficacy end point within the sentinel Cell Pouch is an indicator of transplanted islet health in the therapeutic Cell Pouches remaining in the patient, including the islets ability to read blood sugar and produce insulin into the bloodstream.
  • Enduring bloodstream levels of insulin from the Cell Pouch transplanted islet cells in the fasting patient was shown through detection of C-peptide, a biomarker of insulin produced by the islet cells.
    • Why is this important? This finding, combined with glucose-stimulated C-peptide and other early efficacy indicators observed, is an indication of a normalizing response by the Cell Pouch therapeutic cells to the body's varied need for insulin production, that is an indicator and evidence of continuing islet survival within the vascularized environment of the Cell Pouch.
  • The independent Data Safety Monitoring Board (DSMB) completed its first review of the company's U.S. phase I/II Cell Pouch clinical trial. No safety concerns were raised and continuation of the clinical study was recommended.
    • Why is this important? Independent DSMB review of the trial on a yearly basis is in compliance with Food and Drug Administration guidelines, and confirmation of favourable safety profile of the Cell Pouch and islets.

Hemophilia A:

  • The HemAcure consortium, a collaboration including Sernova and a team of European academic investigators that received 5.6 million euros financing from the EU Horizon 2020 program, successfully completed its objective to research and develop a therapeutic approach that would provide constant delivery of factor VIII to normalize blood levels in an effort to significantly improve the quality of life of patients suffering from hemophilia A.
  • A series of breakthroughs were achieved demonstrating success in correcting cells from the blood of patients with hemophilia A to produce the required factor VIII protein within the implanted Cell Pouch resulting in improvement in blood clotting in an animal model of hemophilia A in preparation for future completion of formal preclinical studies and potential advancement to human clinical trials.

Hypothyroid disease:

  • Sernova has established a collaboration with Dr. Sam Wiseman of the University of British Columbia for development of a novel Cell Pouch cell therapy approach with the goal to reverse the serious effects of hypothyroidism, which occurs following removal of the thyroid gland in over 150,000 patients each year in the U.S.
  • This collaboration, supported by Sernova and a Transplant Research Foundation (TRF) of British Columbia transplant venture grant award, has made important advancements and study results are anticipated for release in 2020.

Local immune protection technologies:

  • Local immune protection of therapeutic cells within the Cell Pouch would represent a major advance in cell therapy as it would reduce or eliminate the need for immunosuppression drugs and reduce both the potential of side effects and risk profile for cell therapy patients.
  • The company is continuing to evaluate local immune protection approaches with the objective of providing locally immune protected therapeutic cells within the company's Cell Pouch to improve current cell therapy treatment options.

Collaborations:

  • Sernova's current collaborations with leading pharmaceutical, medical technology and academic researchers are progressing according to plan. The company continues to field collaboration inquiries from other international and large regional pharma companies.
  • Current collaborations include the assessment of safety and efficacy of combined technologies in preclinical studies, which could lead to strategic development or commercial partnership opportunities for diabetes and the company's other platform technologies.

Outlook 2020

Some of the company's key initiatives for 2020 include:

  • Focusing on patient enrolment completion, which includes Cell Pouch implantation and the continued advancement of its U.S. phase I/II Cell Pouch clinical trial;
  • Evolving stem-cell-derived islet technologies, with the end goal to provide an unlimited supply of stem-cell-derived islet cells for the anticipated treatment of any person inflicted with insulin-dependent diabetes;
  • Continuing the evaluation of alternative novel local immune protection technologies for therapeutic cells to be used in conjunction with the company's Cell Pouch technologies for potential in-licensing or acquisition;
  • Advancing further investigational new drug-enabling preclinical proof-of-concept studies for the treatment of postoperative hypothyroid disease;
  • Developing additional collaborations with pharma companies;
  • Releasing results of the company's research through publications in peer-reviewed scientific journals and conferences.

"While COVID-19 has introduced uncertainties for all people and businesses worldwide, we are pro-actively evolving how we operate, and are adopting alternative methods and approaches to enable us to carry on our business and the U.S. phase I/II Cell Pouch clinical trial with the goal of mitigating potential impact. We are also continuing to advance our scientific, clinical and business activities within the context of the COVID-19 situation, and are committed to following the evolving guidelines recommended by WHO, CDC, and the federal and provincial governments of Canada to protect the safety of our employees and families, collaborators, and business partners," said Dr. Philip Toleikis. He continued, "Despite the current environment, we are focused and committed to build upon our recent clinical and preclinical program achievements towards further important advancements in 2020 to deliver long-term value to our shareholders."

About Sernova Corp.

Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells, that is human donor cells, corrected human cells and stem-cell-derived cells, to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

We seek Safe Harbor.

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