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Press Release Communiqué de presse - March 22, 2023 22 March, 2023
Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for Oral Podium Presentation at American Diabetes Association 83rd Scientific Sessions 2023
LONDON, Ontario – March 22, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, is pleased to announce that an abstract has been selected for
an oral podium presentation at the upcoming American Diabetes Association (ADA) 83rd Scientific Sessions, to
be held from June 23-26, 2023, in San Diego, CA. It will also be published on the journal Diabetes® website.
Abstract: #240-OR
Title: Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch—Early Results from the University of
Chicago
Abstract Session: Clinical Islet-Cell Transplantation
Date/Time: Saturday June 24, 2023 at 5:15 PM PT
Authors: Mateusz Ogledzinski, Sarah Gondek, William Lin, Kamila Milejczyk, Braden Juengel, Lisa Potter, Piotr
K. Bachul, Lindsay Basto, Laurencia Perea, Lingjia Wang, Martin Tibudan, Rolf Barth, John Fung, Piotr
Witkowski
Sernova will disclose additional information about the presentation at the time of the conference in alignment
with the American Diabetes Association’s abstract embargo policies, which lift at the conclusion of the
presentation on June 24, 2023. All abstracts are preliminary until the time of presentation.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - March 14, 2023 14 March, 2023
Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Summit
- First pre-clinical data presentation of Sernova’s Cell Pouch with Evotec’s iPSC derived islet-like cluster
technology for type 1 diabetes (T1D)
LONDON, Ontario – March 14, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, announced today that an abstract has been selected for an oral
presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell
Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, to be held from April 24-25, 2023 in
Cambridge, Massachusetts. The presentation will be given by Matthias Austen, PhD, SVP Cell Therapy at
Evotec SE (FSE:EVT; NASDAQ:EVO).
Abstract Title: Manufacturing of optimized human islet-like clusters (ILCs) from iPSCs and functional testing of
an ILC + Cell Pouch™ combination in vivo
Authors: Audrey Holtzinger, Simone Strauch, Thomas Reinbothe, Claudia Wrzos, Andreas Scheel, Cord
Dohrmann, Arash Memarnejadian, Pardis Pakshir, Philip M. Toleikis, Matthias Austen
Date / Time: Monday, April 24, 2023 from 2:45pm-4:25pm ET
Evotec has developed a scalable and comprehensive process for GMP manufacturing of ILCs from a human
GMP-grade induced pluripotent stem cell (iPSC) line for cell therapy treatment of insulin-dependent diabetes.
In 2022, Evotec entered into a collaboration with Sernova Corp., which has developed the proprietary Cell
Pouch System™. Following implantation, the Cell Pouch develops a vascularized environment to support
engraftment and long-term function of therapeutic cells.
Sernova will disclose additional information about the presentation at the time of the conference.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - March 08, 2023 8 March, 2023
Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes
- Third patient now implanted with higher capacity, 10-chamber Cell Pouch
- Company anticipates first interim data from second cohort in Q4 2023
LONDON, Ontario – March 8, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort
of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia
unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell
Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of
islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient
has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.
In November 2022, the Company announced the addition of a second cohort and protocol amendment for its
T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets
into Sernova’s higher-capacity Cell Pouch. Enrollment for the new second cohort has occurred rapidly with
approximately half of the patients already completed.
The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy
evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of
transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C-peptide
production, and insulin requirements. The higher capacity 10-channel Cell Pouch provides greater than 50%
more capacity relative to the Cell Pouches used for the T1D Study’s first cohort.
“I am excited to apply the learnings from the first patient cohort, including implementation of the higher
capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical
objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the
Pancreatic Islet Transplant Program at the University of Chicago. “I look forward to reporting the first interim
results of the second patient cohort.”
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, added, “With the first two patients
transplanted and a third patient now implanted with the higher capacity Cell Pouch, we are pleased to see the
successful results of our patient enrollment acceleration strategy and are driving to complete full enrollment as
expeditiously as possible. We look forward to presenting our next readout of interim results.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec SE entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for
hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - March 02, 2023 2 March, 2023
Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences
-Sernova provides warrant update
LONDON, Ontario – March 2, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced it will be participating in the upcoming 35th
Annual Roth Conference being held March 12-14, 2023 and the Oppenheimer 33rd Annual Healthcare
Conference, taking place March 13-15, 2023. Company management will also be participating in one-on-one
investor meetings at the conferences.
35th Annual Roth Conference – March 12-14, 2023
Format: Fireside Chat
Date: 4:00PM PT, March 13, 2023
Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp
Location: The Ritz Carlton, Laguna Niguel in Dana Point, California
Webcast Link: https://wsw.com/webcast/roth46/sva/1689510
Oppenheimer Virtual 33rd Annual Healthcare Conference – March 13-15, 2023
Format: Corporate Presentation
Date & Time: 2:00PM ET, March 14, 2023
Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp
Location: Virtual
Webcast Link: https://wsw.com/webcast/oppenheimer27/sva/2565906*
*A replay will be available on the Investors section of Sernova’s website for 90 days.
Please contact your representative at either Roth or Oppenheimer to schedule a one-on-one meeting with the
management team during the conference.
Sernova also announced that 20,136,918 warrants, issued at the time of its previous financing in March 2021,
expired unexercised on March 1, 2023. Total shares outstanding in the Company stands at 303,332,686. There
are no outstanding warrants remaining in Sernova’s capital structure.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII
gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - January 30, 2023 30 January, 2023
Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy
- Preclinical proof of concept study demonstrates that thyroid auto-transplantation into the Cell Pouch can
restore thyroid hormone production following removal of the thyroid gland
- Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective
therapy for hypothyroidism
LONDON, Ontario – January 30, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, today announced advancements in its thyroid cell
therapy program – one of three cell therapy development programs utilizing the Company’s proprietary Cell
Pouch System™. In a preclinical proof of concept study, the Company demonstrated that auto-transplantation
of thyroid tissue into the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy),
restoring normal thyroid hormone levels in an animal model.
The thyroid is a vital hormone-producing gland that is critical for metabolism and regulation of body
functions.1 Loss of thyroid function occurs following surgical removal of the gland and is associated with
memory impairment, depression, intolerance to cold, chronic fatigue, constipation, weight gain and lethargy.2
It is estimated that more than 150,000 patients in the US undergo thyroidectomies annually3, and subsequently
require lifelong thyroid hormone replacement therapy.
Despite some benefits, patients on thyroid replacement medications often experience significant impairment in
psychological well-being.4 The primary goal of Sernova’s thyroid program is to restore normal thyroid function
without life-long medication, and avoid the burden of repeated laboratory testing in patients who have
undergone thyroid surgery.
Data from Sernova’s preclinical program demonstrates that total thyroidectomy with auto-transplantation into
the Cell Pouch allows for reestablishment of production of triiodothyronine (T3) and thyroxine (T4).
The study was conducted in a pre-clinical animal model whereby the Cell Pouch was pre-implanted for several
weeks prior to each subject undergoing total thyroidectomy. The thyroid gland of each Treatment Group
subject was removed, prepared with minimal manipulation, and transplanted into the pre-implanted Cell
Pouch. Thyroid hormones were monitored over several months with weekly measurements of circulating
thyroid hormones (T3, T4). Following thyroidectomy in the Treatment Group, the T3 and T4 levels fell initially
but subsequently recovered to normal or near-normal levels following thyroid transplant into the Cell Pouch.
Control Group subjects received the Cell Pouch implant and underwent total thyroidectomy but did not receive
a thyroid transplant. In the Control Group, post-thyroidectomy T3 and T4 rapidly decreased and remained
below baseline concentrations throughout the experiment.
“Along with previously published preclinical data that reported survival and function of human thyroid tissue
transplanted into the Cell Pouch5, this preclinical study also supports the viability of Sernova’s Cell Pouch
System approach and represents an important step towards establishing an entirely new treatment option for
post-thyroidectomy hypothyroidism,” commented Dr. Sam Wiseman, BSc, MD, FRCSC, FACS.
“These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “In addition to type 1 diabetes [and hemophilia],
this study shows the potential to treat the significant number of patients undergoing removal of their thyroid
glands each year. We have already begun to interact with regulatory authorities towards initiating clinical trials
with this novel therapy.”
Sernova intends to present data from the Company’s thyroid development program at a scientific conference
later this year.
References
1. InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care; How does the
thyroid gland work? 2010 Nov 17 [Updated 2018 Apr 19]. https://www.ncbi.nlm.nih.gov/books/NBK279388/
2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017; 390: 1550–1562.
https://doi.org/10.1016/S0140-6736(17)30703-1 PMID: 28336049
3. Al-Qurayshi Z, Robins R, Hauch A, Randolph GW, Kandil E. Association of Surgeon Volume With
Outcomes and Cost Savings Following Thyroidectomy: A National Forecast. JAMA Otolaryngol Head Neck
Surg. 2016;142(1):32–39. doi:10.1001/jamaoto.2015.2503
4. Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in
patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire
study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x. PMID:
12390330.
5. Wiseman SM, Memarnejadian A, Boyce GK, Nguyen A, Walker BA, Holmes DT, Welch ID, Mazzuca DM,
Toleikis PM. Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device
in a Mus musculus model: Evidence of viability and function for thyroid transplantation. PLoS One. 2022;
17(1): e0262345. https://doi.org/10.1371/journal.pone.0262345
ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM
Sernova is utilizing its Cell Pouch System platform as a potential treatment for hypothyroid disease. Our
approach is to transplant a patient’s own healthy thyroid tissue following thyroidectomy into the pre-implanted
vascularized Cell Pouch to preserve the normal thyroid function and reduce or eliminate the need for lifelong
daily thyroid replacement therapy. Sernova plans to conduct clinical assessments of the Cell Pouch with
transplanted thyroid tissue in patients suffering from post-surgical hypothyroidism with the aim of preserving
thyroid function and improving patient quality of life.
Thyroidectomy is commonly performed for cancer diagnosis or treatment and for treatment of benign (non-
cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000
thyroidectomies are performed in the US yearly. Patients undergoing total thyroidectomy, and many patients
undergoing partial thyroidectomy, require life-long thyroid hormone medication. Post-surgical thyroid hormone
replacement therapy, if monitored carefully, can be effective; however, patients often suffer from deleterious
side-effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative
impact on quality of life, and significant costs to the healthcare system. The development of new therapeutic
strategies to overcome hypothyroidism remains an important unmet medical need.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII
gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - January 10, 2023 10 January, 2023
Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes
- First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards
regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D)
and severe hypoglycemia
- iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation
for first human clinical evaluation
- T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now
demonstrated consistent long-term insulin independence de-risking the combined technologies for both
companies
LONDON, Ontario – January 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, announced today that significant progress has been
achieved in its collaboration with Evotec SE (FSE: EVT; NASDAQ: EVO). This progress includes advancement
of Evotec’s iPSC derived islet-like clusters in combination with Sernova’s implantable Cell Pouch™ device
toward a first-in-human Phase 1/2 clinical trial for the treatment of patients with T1D and severe
hypoglycemia slated for regulatory filing in 2024. The objective of the collaboration is to produce an off the-
shelf, commercially viable, ethically derived cell therapy treatment for people suffering from T1D. The
treatment would include Sernova’s Cell Pouch System™ incorporating Evotec’s iPSC-derived islet-like
clusters. The combination product is anticipated to be the first treatment of its kind to reach clinical testing
for T1D.
The Evotec and Sernova collaboration has to date resulted in the following significant achievements:
- Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the
ability to cryopreserve and store batches of differentiated islet-cell clusters
- Demonstration of excellent islet-like cluster survival under standard shipping conditions and following
transplantation
- Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent
safety profiles in a gold standard T1D preclinical model with Evotec’s iPSC-derived islet-like clusters
transplanted in Sernova’s Cell Pouch
- iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec’s iPSC GMP facility
are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply
- Interactions with experts in support of design of the first Phase 1/2 clinical trial
Based on these achievements the following activities will be continuing throughout 2023 in preparation for
regulatory filings anticipated in 2024:
- Completion of standard formal safety/toxicology studies and other required preclinical studies
- Identification and securing of potential clinical study sites to enable efficient patient enrollment following
initiation of the Phase 1/2 clinical study
- Preparation of regulatory submissions for planned trial geographies, combining both the established library
of regulatory documentation for Sernova’s Cell Pouch and that developed by Evotec for their iPSC islet-like
clusters
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, commented, “Together Sernova and
Evotec maintain a shared, singular focus on developing the first combination product involving ethically
sourced iPSC-derived islet-like clusters within Sernova’s Cell Pouch for a type 1 diabetes functional cure
that could, conceivably, eliminate the need for daily insulin injections in patients with diabetes and
significantly reduce the burden on healthcare systems worldwide. Furthermore, we believe that Evotec’s
strategic design of its islet-like clusters to closely match human islets and the cost-efficient manufacturing
process combined with our collective approach to efficiently deliver the islet-like clusters to patients for
transplant into our Cell Pouch represents a disruptive and commercially attractive treatment, that could
one day treat people with insulin-dependent diabetes worldwide.”
Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “Evotec’s iPSC-derived human beta
cells in combination with Sernova’s implantable Cell Pouch device represent a unique cell therapy product
opportunity aiming to provide a potential functional cure to insulin-dependent diabetic patients. The
combination product is highly differentiated through the quality of the cells and the device but also the
scalability of the manufacturing process of the iPSC-derived cells and therefore clearly positioned to
become the best-in-class cell therapy in the field.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative therapeutic cell
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood
disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for
insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable
medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural
vascularized tissue environment in the body for long-term survival and function of therapeutic cells that
release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases.
Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D
in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary
technology in collaboration with the University of Miami to shield therapeutic cells from immune system
attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022,
Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf
iPSC-based (induced pluripotent stem cells) islet replacement therapy. This partnership provides Sernova
a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent
diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize
its Cell Pouch System: an implantable cell therapy for benign thyroid disease resulting from thyroid gland
removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate Investors Media
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may
constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions,
including, without limitation, statements regarding the prospects, plans, and objectives of the company.
Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends",
"estimates", "projects", "potential for" and similar expressions, or that events or conditions "will",
"would", "may", "could" or "should" occur are used to identify forward-looking statements. These
statements reflect management’s beliefs with respect to future events and are based on information
currently available to management on the date such statements were made. Many factors could cause
Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended
or to differ materially from those expressed or implied by the forward-looking statements contained in
this news release. Such factors could include, but are not limited to, the company’s ability to secure
additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all
required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies,
including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on
a timely basis; ability to in-license additional complementary technologies; ability to execute its business
strategy and successfully compete in the market; and the inherent risks associated with the development
of biotechnology combination products generally. Many of the factors are beyond our control, including
those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the
company’s quarterly and annual filings available on www.sedar.com for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention
or obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - December 06, 2022 6 December, 2022
Sernova Corp. Announces CEO Succession Plan and Expanded Management Team
The Company is recruiting a new CEO for its next stage of growth - Dr. Toleikis, President and CEO, to
transition to Chief Technology Officer upon new appointment
LONDON, Ontario -- December 6, 2022 -- Sernova Corp. (Sernova) (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that, as part of
a planned leadership succession process, and after a successful 13-year tenure leading the Company through
the development of its pioneering Cell Pouch SystemTM and ensuing growth, Dr. Philip Toleikis, President and
Chief Executive Officer will be appointed Sernova’s Chief Technology Officer (CTO). To achieve a seamless
transition and continue progress on all Company activities, Dr. Toleikis will remain in the CEO role during the
search period and continue to work closely with Executive Chair, Frank Holler. Mr. Holler will, in particular,
take a leadership role and work closely with Dr. Toleikis in advancing Sernova’s business development and
corporate finance activities during the search period.
“On behalf of the board, I am very grateful for the substantial contributions made by Dr. Toleikis to the
Company’s growth and success over the years,” said Frank Holler, Executive Chair. “Philip has played a pivotal
role in strategically advancing Sernova’s CPS platform to become one of the world’s most prominent cell
therapy platforms and a leader in the development of cell therapy treatments for insulin- dependent diabetes.
With the Company’s anticipated next phase of growth in US capital markets, it is a natural time to recruit a
new CEO. Dr. Toleikis has endorsed this transition plan as it will enable him to focus on accelerating the
further development of the Cell Pouch System.”
Dr. Philip Toleikis joined Sernova in 2009. Under his leadership, the Company has achieved remarkable interim
results in its ongoing Phase 1/2 type 1 diabetes (T1D) clinical trial, expanded the capabilities of its CPS
platform via technology acquisitions, and significantly bolstered its balance sheet.
“It has been an absolute privilege to lead Sernova from the initial concept of cell therapy as a means of
achieving a potential functional cure for chronic diseases, to the development and refinement of our Cell
Pouch System, and now the reality of long-term diabetic patients achieving insulin independence in our current
US Phase 1/2 clinical study,” said, Dr. Toleikis “Furthermore, our recent global strategic partnership with
Evotec is transformative because it provides the potential for Sernova to treat millions of insulin-dependent
diabetic patients with scalable, best-in-class, iPSC-derived islet cells. I am very proud of the Company’s
achievements to date, and I look forward to working closely with the new CEO. I am delighted to continue
working with our extraordinary team, and the best-in-class leadership within, to advance Sernova to the next
level of growth as well as the continued development of Sernova’s cell therapy platform on the world stage.”
The Company has engaged Slone Partners, an executive search firm with offices in Boston, San Francisco and
Washington, D.C., to assist the Board of Directors in the hiring of the new CEO.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing its Cell Pouch System, a novel
implantable and scalable medical device with immune protected therapeutic cells, for the treatment of chronic
diseases such as insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A.
On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for the long-term
survival and function of therapeutic cells that release essential factors absent or deficient in patients with
certain chronic diseases. Sernova is also advancing a proprietary technology to shield therapeutic cells from
immune system attacks with the goal to eliminate the need for chronic, systemic immunosuppression. In May
2022, the Company announced a global strategic partnership with Evotec, providing Sernova with a potentially
unlimited supply of insulin-producing islet cells to treat patients with insulin-dependent diabetes (type 1 and
type 2). Sernova continues to progress additional development programs utilizing its Cell Pouch System: a cell
therapy for hypothyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene
therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - November 17, 2022 17 November, 2022
Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes
- Company’s recent recruitment strategy change has resulted in an unprecedented level of inquiries
regarding potential study participation
- Transplantation of islets into the enhanced 10-channel Cell Pouch is anticipated in early 2023
- Company continues to anticipate first interim safety/efficacy data from second cohort in 2023
LONDON, Ontario – November 17, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the
second cohort of its active U.S. Phase 1/2 type 1 diabetes (T1D) clinical trial have been implanted with its 10-
channel Cell Pouch, which provides >50% more capacity relative to the Cell Pouches used for the first cohort.
The transition to this new 10-channel Cell Pouch under the revised protocol enables optimized dosing and
shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints
include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, changes in HbA1c,
increased C-peptide production, and reduction in insulin requirements.
Sernova has engaged a clinical trial recruitment partner with extensive experience and success in accelerating
T1D clinical trial patient enrollment. The second cohort of the study is intended to enroll up to seven patients
with insulin dependent T1D who also suffer from severe hypoglycemic episodes and hypoglycemia
unawareness. The Company anticipates reporting interim data in 2023. Results from the combined cohorts
will inform the design of Sernova’s anticipated Phase 3 T1D pivotal study.
“Our drive to liberate individuals suffering with type 1 diabetes from the burden of daily insulin injections has
been strengthened by the safety and efficacy observations in the first cohort of patients in our Phase 1/2 study,
and we are pleased to have commenced the treatment phase for the second cohort,” said Dr. Philip Toleikis,
President and Chief Executive Officer of Sernova. “We believe the new 10-channel Cell Pouch configuration
provides for optimal dosing of islets towards achievement of a potential ‘functional cure’. We look forward to
reporting interim data from the second cohort in 2023. Planning and preparations are underway for the pivotal
trial program, while we advance our iPSC-derived islet program into the clinic in collaboration with Evotec.”
ABOUT THE US PHASE 1/2 SECOND STUDY COHORT
The US Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and
efficacy of Sernova’s Cell Pouch System™ for clinical transplantation of human donor islets in patients with
T1D. Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim
data have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the
second cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and
includes those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe
hypoglycemic episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at
least one episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide
(a marker of insulin production by the body) in response to a mixed meal tolerance test.
Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow
development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen.
At 90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of
islets. At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints
are evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second
islet transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.
Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant into
the Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3
years and none have elected to have their Cell Pouch implants removed.
The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the
following efficacy endpoints: production of C-peptide, insulin use, HbA1c and frequency of hypoglycemic
events.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are
absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for
hypothyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Privacy PolicyPolitique de confidentialité
Updated July 6, 2018
Please read this Policy carefully along with our Legal Notice that describes our Terms of Use for the Website.
By accessing www.sernova.com (the “Website”) you hereby agree with the practices described in this Privacy Policy (the “Policy”)
This Policy applies to all information gathered through the Website and/or any related marketing technique or events.
Information Collection
The information collected is limited to the information that you decide to share with us through the News Dispatch Service, when participating at event or activities or in the general course of business by expressing an interest in obtaining information about Sernova Corp. and our products, such as name, email, phone number, and similar contact information. This information is stored through MailChimp (please refer to MailChimp Privacy Policy at https://mailchimp.com/legal/privacy/).
Information Sharing
Sernova Corp. is the sole owner of any information collected on the Website. We do not sell, share or rent this information to others.
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Sernova Corp. maintains log files of the traffic on www.sernova.com. This information is not linked to any personal information that you have provided us. Logs are used to manage traffic, identify content accessed, and IT requirements. Information logged and automatically collected includes without being limited to IP addresses and browser types. This information does not reveal your specific identity.
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Updates
This Policy is a living document and may be amended or updated from time to time without further notice. We encourage you to review the Policy periodically.
Contact
If you have any questions or comments about our policy, you can email us at info@sernova.com or by phone at 1(877) 299-4603 or by mail at
Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8
Mis à jour le 6 juillet 2018
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