2022 Press Releases Communiqués de presse
Sernova Receives Conditional Approval to Up-list to the Toronto Stock Exchange
Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a
Sernova Announces Abstract on Phase 1/2 Trial with Cell Pouch Selected for Oral Podium Presentation at American Diabetes Association 82nd Scientific
Sernova to Participate in Multiple U.S. Healthcare Investor Conferences
Sernova Announces 2022 Annual General Meeting Results
Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabete
Sernova Corp Ranks Among Top 50 Performing Companies on the 2022 TSX Venture List
Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therap
Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemo
The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Ind
Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference
Share the news Partagez les nouvelles
Press Release Communiqué de presse - May 24, 2022 24 May, 2022
Sernova Receives Conditional Approval to Up-list to the Toronto Stock Exchange
London, Ontario – May 24, 2022 – Sernova Corp. (TSX-V:SVA; OTCQB:SEOVF; FSE/XETRA:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that it has
received conditional approval to list its common shares on the Toronto Stock Exchange (the "TSX") and move
off of the TSX Venture Exchange ("TSXV").
Final approval of the listing is subject to the Company meeting certain customary conditions required by the
TSX. The company will issue a press release once the TSX confirms the date when trading of Sernova’s
common shares is expected to commence on the TSX. Upon completion of the final listing requirements,
Sernova’s common shares will be delisted from the TSXV.
Dr. Philip Toleikis, President and CEO of Sernova Corp commented, “Moving onto the Toronto Stock Exchange
represents a milestone achievement in our evolution as an emerging regenerative medicine company. Up-
listing will provide enhanced liquidity and bring new visibility and investors into the company as we advance
our therapeutic cell therapy platform with the goal to provide ‘functional cures’ for multiple diseases including
type one diabetes, hemophilia and thyroid disease.”
Shareholders are not required to exchange their share certificates or take any other action in connection with
the TSX listing, as there will be no change in the trading symbol or CUSIP for the common shares. The
Company will continue to trade its common shares on the OTCQB market in the United States under the
symbol "SEOVF", and the Frankfurt exchange under the symbol "PSH".
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY
Sernova Corp. is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., 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.
The Cell Pouch™ is a proprietary, scalable, implantable macro- encapsulation device solution designed for the
long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue,
forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells,
that release proteins and hormones as required to treat disease.
The Cell Pouch along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
For more information, please visit www.sernova.com
For further information contact:
Corporate and Investors:
Sernova Corp.
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, MD
LifeSci Communications
emiller@lifescicomms.com
Neither the TSXV nor the TSX accepts responsibility for the adequacy or accuracy of this news release.
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials, and the development of new technologies, cell therapy solutions and or products. The information
disclosed represents results from one patient and may not be representative of all study patients or of the final
study results. 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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - May 17, 2022 17 May, 2022
Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a ‘Functional Cure’ for Diabetes
• Partnership Leverages Sernova’s Proprietary Cell Pouch System™ with Evotec’s iPSC-Based Insulin-
Producing Beta Cells
• Partners to Develop and Commercialize an Off-The-Shelf Cell Replacement Therapy for Treatment of
Patients with Insulin-Dependent Diabetes
• Evotec to Make Strategic Equity Investment of CAD $27 M / €20 M in Sernova
• Sernova / Evotec Joint Conference Call and Webcast at 8:30 am EDT May 17, 2022
LONDON, ONTARIO – May 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a
clinical-stage company and leader in regenerative medicine cell therapeutics, and Evotec SE (FSE: EVT;
NASDAQ: EVO), a global pharmaceutical and life science company, and leading developer of iPSC cell
technologies for therapeutic applications, are pleased to announce an exclusive global strategic partnership to
develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two
Companies will combine and leverage their respective technologies and scientific expertise to develop an
implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited
insulin-producing cell source to treat patients with insulin-dependent diabetes.
The collaboration agreement is a transformative partnership that combines Sernova’s Cell Pouch System
technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with
Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within
Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people
suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.
With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably
produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary
process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like
clusters have now been proven to be functionally equivalent to primary human islets in their ability to
normalize blood glucose using in vivo models of type 1 diabetes (T1D).
The partnership provides Sernova a global exclusive option to license Evotec’s iPSC-based beta cells for use in
treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has
made a strategic equity investment of €15M and will make a further investment of €5M. Specifically,
concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904
common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500. In addition,
pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further
2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the
securities issued to Evotec are subject to a four month hold period.
Further to the collaboration and Evotec’s strategic equity investment, Dr. Cord Dohrmann, Chief Scientific
Officer of Evotec will join Sernova’s Board of Directors.
Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, commented, “In tandem with our current
clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the
highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell
Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to
developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense,
both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr.
Dohrmann’s appointment to Sernova’s Board adds significant regenerative medicine depth and cell therapy
expertise. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our
diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired
conformal coating immune protection technology, this now establishes a total regenerative medicine cell
therapy solution for insulin-dependent diabetes.”
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “We searched long and hard for the right
partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits
perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta
cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-
dependent diabetic patients. The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to
become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic
interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on
the project as well as contributing to their Board of Directors.”
Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell
(iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective,
the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance.
Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will
contribute its cell manufacturing capabilities through research, development and product commercialization
and will decide in the future on the joint funding of clinical development. Upon commercialization, there will
be a profit-sharing arrangement between the two companies, with the split being dependent on Evotec’s
participation in funding the clinical development program.
Joint Sernova / Evotec Conference Call and Webcast Details:
Date: Tuesday, May 17, 2022
Time: 8:30 am EDT
US Toll Free: 1-877-704-4453
International: 1-201-389-0920
Conference ID: 13730121
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d
A simultaneous slide presentation will be available via the above webcast link.
ABOUT SERNOVA CORP AND THE CELL POUCH SYSTEM CELL THERAPY PLATFORM
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., 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.
The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation
device solution designed for the long-term survival and function of therapeutic cells. After implantation, the
device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation
and function of therapeutic cells, that release proteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
For more information, please visit www.sernova.com
ABOUT EVOTEC AND iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be
generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto,
Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could
convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John
Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem
cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well
as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they
represent a single source of cells that could be used to replace those lost to damage or disease.
Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated
iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to
industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the
highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s
proprietary EVOcells platform.
For further information contact:
Corporate and Investors:
Sernova Corp
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, MD
LifeSci Communications
emiller@lifescicomms.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees
of future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials, and the development of new technologies, cell therapy solutions and or products. The information
disclosed represents results from one patient and may not be representative of all study patients or of the final
study results. 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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - May 09, 2022 9 May, 2022
Sernova Announces Abstract on Phase 1/2 Trial with Cell Pouch Selected for Oral Podium Presentation at American Diabetes Association 82nd Scientific Sessions 2022
LONDON, ONTARIO – May 9, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage cell therapy therapeutics company focused on developing a potential ‘functional cure’ for type 1
diabetes (T1D) and other chronic diseases, is pleased to announce that that an abstract has been selected for
an oral podium presentation at the upcoming American Diabetes Association (ADA) 82nd Scientific Sessions, to
be held from June 3-7, 2022, at the Ernest N. Morial Convention Center in New Orleans, LA.
Abstract 306-OR: Modified Approach for Improved Islet Allotransplantation into Prevascularized Sernova Cell
PouchTM Device: Preliminary Results of the Phase I/II Clinical Trial at University of Chicago
Abstract Session: Islet Transplantation —Basic Science
Session Date/Time: Monday, June 6, 2022 at 2:15 PM – 4:15 PM CT
Presentation Time: 3:15-3:30 PM CT
Authors: Bachul PJ, Perez-Guetierrez A, Ling-jia Wang, Golab K, Basto L, Perea L, Tibudan M, Braden J,
Thomas C, Philipson L, Barth R, Fung JJ, Witkowski P
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.
ABOUT SERNOVA
Sernova is developing regenerative medicine cell therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
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
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - May 05, 2022 5 May, 2022
Sernova to Participate in Multiple U.S. Healthcare Investor Conferences
Sernova Engages Leading U.S.-Based Healthcare Communications Firm to Broaden Awareness of Potential
‘Functional Cure’ Technology for Type 1 Diabetes
LONDON, ONTARIO – May 5, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical stage regenerative medicine company focused on developing a potential ‘functional cure’ for type 1
diabetes (T1D) and other chronic diseases including hemophilia A and thyroid disease, today announced that
the company will be participating in several upcoming U.S. healthcare industry and investor conferences.
Conference details are provided below.
The Company is also pleased to announce it has engaged New York-based LifeSci Communications, a global
life science and medical technologies-focused communications and marketing agency. LifeSci Communications
will assist Sernova to expand and elevate its profile through strategic communications and public relations.
Sernova is also working with affiliate LifeSci Advisors LLC, a leading investor relations consultancy firm serving
life science companies, providing institutional investor communications and capital markets outreach services
in support of the Company’s U.S. capital markets objectives.
“With multiple collaborations advancing across our pipeline and growing interest in our best-in-class cell
therapy therapeutic solution platform - consisting of immune protected therapeutic cells and our proprietary
Cell Pouch™ medical device - as a potential ‘functional cure’ for multiple patient populations, the timing is right
to drive awareness of our unique cell therapy proposition and unprecedented clinical results including the
demonstration of continuous insulin independence for over two years now in our most advanced Phase 1/2
T1D study patient, in contrast to the clinical setbacks of several of our peer companies,” commented Dr.
Philip Toleikis, President & CEO of Sernova.
UPCOMING U.S. HEALTHCARE INDUSTRY AND INSTITUTIONAL INVESTOR PRESENTATIONS
Event: Roth Capital’s Canada Corporate Access Day
Date: May 17, 2022
Format: Corporate presentation and 1x1 meetings with institutional investors
Location: New York, NY
Event: H.C. Wainwright Global Life Sciences Conference
Date: May 24-25, 2022
Format: Corporate presentation and 1x1 meetings with institutional investors
Location: Miami Beach, FL
Event: Truist Securities Cell Therapy Symposium
Date: June 28, 2022
Format: Panel expert and discussions
Location: New York, NY
ABOUT SERNOVA
Sernova is developing regenerative medicine cell therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investors and Analysts
Christopher Barnes Corey Davis, Ph.D.
VP, Investor Relations Managing Director
Sernova Corp. LifeSci Advisors, LLC
christopher.barnes@sernova.com cdavis@lifesciadvisors.com
Tel: 519-902-7923 Tel: 212-915-2577
www.sernova.com
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
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 complete collaboration activities; ability to secure collaboration arrangements from its
collaboration activities; 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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 29, 2022 29 April, 2022
Sernova Announces 2022 Annual General Meeting Results
LONDON, ONTARIO – April 29, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical stage
regenerative medicine company focused on developing a potential ‘functional cure’ for type 1 diabetes (T1D)
and other chronic diseases, is pleased to announce results from its Annual General Meeting of Shareholders
(the “AGM”) held virtually via live audio webcast, on April 28, 2022. Shareholders voted overwhelmingly in
favour of all management resolutions proposed in the Company’s Information Circular.
The following resolutions were proposed and approved at the AGM:
• The re-election of the following directors for the ensuing year: Frank Holler, James Parsons, Jeffrey
Bacha, Deborah Brown, Dr. Mohammad Azab and Dr. Philip Toleikis.
• The appointment of Davidson & Company LLP, as auditors of the Company until the next annual meeting
and the authorization of the directors of the Company to fix the remuneration to be paid to the auditors.
“I sincerely appreciate our shareholders ongoing support for Sernova. The Board and management are very
excited about the immediate and long-term prospects of the Company as we expand our therapeutic
applications, broaden our capital markets following and execute on a number of strategic initiatives,” said Dr.
Philip Toleikis, President & CEO of Sernova Corp.
Management’s corporate update to shareholders will be available on Sernova’s website next week at
www.sernova.com.
For further information contact:
Sernova Corp
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e., 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. For more information, please visit www.sernova.com
ABOUT SERNOVA’S CELL POUCH
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming
highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then
release proteins and hormones as required to treat disease. The device along with therapeutic cells has been
shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been
proven to provide a biologically compatible environment for insulin-producing cells in humans.
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees
of future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials. The information disclosed represents results from one patient and may not be representative of all
study patients or of the final study results. 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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - March 17, 2022 17 March, 2022
Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabetes
Confirms Ongoing Safety and Tolerability of Sernova’s Cell Pouch
March 17, 2022 10:00 a.m. EDT
LONDON, ONTARIO – March 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that the Data
Safety Monitoring Board ("DSMB") has completed the third annual review of Sernova’s ongoing Phase 1/2
clinical study “Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch for Clinical Islet Transplantation”
in patients with Type-1 Diabetes (T1D) who suffer from hypoglycemia unawareness and severe hypoglycemic
events.
In their assessment, the DSMB recommended that the clinical study should continue according to the study
plan.
The DSMB is an independent committee of clinical experts who review the accumulated trial data to evaluate
patient safety and ensure the integrity of the study data.
“This recommendation from the DSMB affirms our understanding of the safety of Cell Pouch in this patient
population transplanted with human donor islets. We look forward to sharing updates from the study through
upcoming conference presentations by Dr. Piotr Witkowski, the trial Principal Investigator.” said Dr. Philip
Toleikis, President & CEO of Sernova Corp.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they
become severe enough to be incapacitating or even fatal, which may occur when blood glucose levels are
below 3.0 mmol/L. It is estimated that approximately 15% of people with T1D, or approximately 240,000
people, are affected by hypoglycemia unawareness in the US alone.
Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and
personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care
and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure,
coma, or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA
Sernova is developing regenerative medicine cell therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - February 24, 2022 24 February, 2022
Sernova Corp Ranks Among Top 50 Performing Companies on the 2022 TSX Venture List
Sernova awarded top performer status for two years standing
February 24, 2022 7:30 a.m. EST
LONDON, ONTARIO – February 24, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company focused on developing a potential
‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce that that it has
been named as one of the top 50 performers on the TSX Venture Exchange.
The 2022 TSX Venture Top 50 is a ranking of top performers on the TSX Venture Exchange over the last year
based on three equally weighted criteria: share price appreciation, average trading volume and market
capitalization growth.
“We are honored by the TSX Venture Exchange recognition of Sernova as a 2022 Top 50 recipient company.
Being awarded this title two years in a row is strong validation of our persistent dedication to increasing
shareholder value as we continue to deliver on our strategic plan to build a leadership position in the
regenerative medicine cell therapy therapeutics field. In 2022, we look forward to driving continued success
through, evolving our clinical programs, further developing our pharmaceutical partnerships and by advancing
our capital market initiatives,” said Dr. Philip Toleikis, Chief Executive Officer of Sernova.
As part of the award, the TSX Venture Exchange sponsored a Q&A highlight interview with Dr. Toleikis. To view
the video, please https://share.vidyard.com/watch/dsfSgoQyYi87x8pj8oUEz6
and for the complete list of 2022 TSX Venture 50 companies.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
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
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - January 27, 2022 27 January, 2022
Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therapeutic Approach for Treatment of Thyroid Disease
Sernova prepares for clinical trial of new treatment for post-operative hypothyroidism
LONDON, ONTARIO – January 27, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for chronic diseases including type 1 diabetes (T1D) is pleased to announce publication of a peer
reviewed preclinical study demonstrating positive results of a novel Cell Pouch System™ cell therapy approach
to treat hypothyroidism and potentially avoid lifelong dependence on thyroid medication following surgical
removal of the thyroid gland.
The journal article entitled “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,” by
lead author, Dr. Sam M. Wiseman was published in the prestigious scientific journal, PLOS ONE, January 20,
2022. In this study, thyroid tissue from patients undergoing surgery for treatment of benign disease was
transplanted into Sernova Cell Pouches that had been previously implanted into laboratory mice. The aim of
the study was to investigate the long-term survival of human thyroid tissue in the Cell Pouch and evaluate the
ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that
the human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the
bloodstream, with no adverse effects for the three-months duration of the study. Thyroglobulin was used as a
biomarker efficacy measure in this study as it is the precursor of thyroid hormones.
“I’m very excited about this study because it represents a critical first step towards a future where we can offer
our patients a treatment option that allows for preservation of their thyroid function with avoidance of
postoperative hypothyroidism, its many associated morbidities and life-long dependence on thyroid
medication,” commented Sam M. Wiseman BSc, MD, FRCSC, FACS.
Dr. Philip Toleikis, President and CEO Sernova Corp stated, “For hypothyroid disease, these data support the
potential of our Cell Pouch to allow for a recovery of the natural thyroid hormone feedback system following
thyroidectomy, restoring thyroid hormone levels without the risks and side effects associated with hormone
replacement drugs. This could provide life-changing options for the more than 150,000 patients who undergo
a thyroidectomy in the US, alone, each year. These preclinical data are consistent with our findings utilizing the
Cell Pouch in the treatment of T1D and Hemophilia A. We believe the Sernova Cell Pouch System therapeutic
approach could provide a ‘functional cure’ for millions of patients who suffer from afflictions caused by the
absence of systemic proteins or hormones.”
Sernova Corp., with Dr. Wiseman as clinical investigator, is preparing regulatory documents to proceed with a
Phase 1/2 human clinical trial in subjects undergoing thyroid surgery. In this study, the subjects will be
implanted with the Cell Pouch to create the vascularized tissue environment several weeks prior to transplant
of their healthy thyroid tissue. The objective of the study is to assess the safety and efficacy of the Cell Pouch
transplanted tissue, with efficacy measured as recovery of thyroid hormone in the bloodstream. The Company
expects to submit a clinical trial application within 2022.
The thyroid gland produces hormones that regulate metabolism within a narrow functional range. Thyroid
hormone replacement drugs are frequently used to treat insufficient or absent thyroid activity. Optimization of
thyroid hormone replacement medications can be difficult with dose adjustments requiring frequent lab tests
to reach appropriate levels. Thyroid hormone replacement therapy is associated with several side-effects
including impaired cognition, lethargy, and weight gain, leading to diminished quality of life, and incurring
significant ongoing costs to the patient and healthcare system.
ABOUT THYROID DISEASE
Surgical removal of the thyroid gland, or thyroidectomy, is commonly performed for management of thyroid
cancers, and for treatment of benign (non-cancerous) diseases that include nodules, goitre, and
hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the U.S. annually, with
most individuals undergoing thyroid surgery eventually being diagnosed with benign conditions. Some patients
undergoing partial thyroidectomy and all patients undergoing total thyroidectomy require life-long oral
postoperative thyroid hormone replacement treatment.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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, thyroid disease and other diseases treated
through cellular production of proteins or hormones missing or in short supply within the body. For more
information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans. Sernova is currently conducting a Phase 1/2 study at the University of
Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - January 20, 2022 20 January, 2022
Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemophilia A
LONDON, ONTARIO – January 20, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for chronic diseases is pleased to announce a peer reviewed published scientific journal article
highlighting successful development of a novel cell therapy approach for treatment of severe hemophilia A , a
serious genetic bleeding disorder caused by missing factor VIII (FVIII) activity in the blood stream.
The journal article entitled “Efficient and Safe Correction of Hemophilia A by Lentiviral Vector-Transduced
BOECs in an Implantable device (Sernova’s Cell Pouch™),” was published in the prestigious scientific journal,
Molecular Therapy: Methods & Clinical Development, Volume 23, December 2021.
The therapeutic approach includes use of the patient’s own cells obtained from a blood sample, which are then
modified using a lentiviral vector-mediated gene transfer procedure using the B-domain deleted form of FVIII
under the control of an endothelial-specific promoter and subsequently transplanted within Sernova’s
vascularized Cell Pouch into a mouse model of hemophilia A. These cells then provide a continuous therapeutic
release of factor VIII into the bloodstream. The publication highlights that the HemAcure Consortium has now
successfully demonstrated safety and long-term improvement in blood clotting in a hemophilia A mouse
model.
It is estimated that 115,000 people live with hemophilia A in North America and Europe with a significant
proportion who rely on regular infusions of FVIII. Treatment costs per patient are as high as US $200,000 each
year, with an aggregate therapeutic cost of over US$ 10 billion per year.
“This novel ex vivo gene therapy approach is the first demonstration showing the safety and feasibility of
transplantation of lentiviral-corrected blood outgrowth endothelial cells (BOECs) within an implantable
medical device using GMP-like procedures for the long-term treatment of hemophilia A,” said the lead author
Dr. Antonia Follenzi, MD, PhD, Professor, Department of Health Sciences, School of Medicine, Università del
Piemonte Orientale. “If this therapy is successful in future clinical trials, it could become an important new
therapeutic approach to improve the quality of life for people suffering with severe hemophilia A.”
Dr. Philip Toleikis, President and CEO Sernova Corp stated, “This publication represents approximately four
years of dedicated work by the HemAcure consortium, from conceptualizing this novel treatment approach,
through to validating its potential as a safe and long-term treatment option for people with hemophilia A. The
Sernova Cell Pouch provides the required environment for transplanted cells to survive and function in the
body, as demonstrated by the production of FVIII to improve blood clotting as reported by Dr. Follenzi and
colleagues.” He continued, “We recognizes ex vivo gene therapy as a potential therapeutic option for people
suffering from multiple rare diseases and we are proud that our technologies may contribute to the
development and future delivery of functional cures for these ailments.”
The HemAcure consortium research was supported by funding from the European Commission’s Horizon 2020.
ABOUT HEMOPHILIA A
Hemophilia A is the most common form of hemophilia and is a genetic disorder caused by the reduced or
absence of FVIII, a blood clotting protein. People with hemophilia A have prolonged abnormal bleeding as a
result of trauma or surgery. While it is passed down from parents to children, about 1/3 of cases are caused by
a spontaneous change in the gene responsible for FVIII production. According to the US Centers for Disease
Control and Prevention, hemophilia A occurs in about 1 in 5,000 male births. Prolonged bleeding in high-risk
areas such as the brain can be catastrophic, while persistent bleeding in joints results in permanent damage
making joint replacement surgery common and risky procedures among these patients. Approximately 115,000
people in North America and Europe have hemophilia A. Although there is no cure for the disease, hemophilia
A can be controlled with medications to supplement or replace the missing FVIII. Annual worldwide costs for
the treatment of the disease for each patient may range from $60,000 to $260,000 US for an aggregate
therapeutic cost of approximately $15B per year.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
ABOUT HORIZON 2020 PROGRAM AND HEMACURE
Horizon 2020 was the biggest EU Research and Innovation program ever with nearly €80 billion of funding
available over seven years (2014 to 2020). It promised more breakthroughs, discoveries and world-firsts by
taking great ideas from the lab to the market. The project was funded as part of societal challenges
“personalizing health and care” in a specific call about innovative treatments and technologies. The overall
objective of the HemAcure project was to develop and refine the tools and technologies for a novel ex vivo
prepared cell-based therapy to treat the bleeding disease, hemophilia A (caused by a genetic deficiency in
clotting Factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The European
Union's Horizon 2020 research and innovation program awarded approximately €5.5 million (CDN$8.5) to
support the project. International consortium members included the University Hospital Würzburg
(Coordinating Institute), Germany; IMS - Integrierte Management, Heppenheim, Germany; Università del
Piemonte Orientale “Amedeo Avogadro,” Novara, Italy; Loughborough University, Loughborough, United
Kingdom; ARTTIC International Management Services, Munich, Germany and Sernova Corp., London, Ontario,
Canada. This project received funding from the European Union’s Horizon 2020 Research and Innovation
Programme under grant agreement No 667421. The Consortium worked together to provide sets of design and
manufacturing protocols, based on current European GMP regulations to prepare an Investigational Medicinal
Product Dossier (IMPD) for an Investigational Medicinal Product (IMP), composed of therapeutic cells and an
implantable medical device (Sernova’s Cell Pouch).
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - January 10, 2022 10 January, 2022
The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent
LONDON, ONTARIO – January 10, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE / XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to provide a progress update on its Phase
1/2 T1D clinical trial in conjunction with Dr. Piotr Witkowski, the clinical trial’s Principal Investigator at the
University of Chicago. Dr. Witkowski was originally scheduled to provide a clinical trial update at the 2022
American Society of Transplant Surgeons (ASTS) Winter Symposium; however, the conference is now
postponed until August 2022 as a result of the ongoing COVID-19 pandemic.
The objective of Sernova’s Phase 1/2 clinical trial is to assess the safety, tolerability and efficacy of its
proprietary Cell Pouch™ transplanted with insulin-producing islets in patients with T1D complicated by
hypoglycemia unawareness and a history of severe hypoglycemic events. Study patients must meet stringent
eligibility criteria including, but not limited to, long-standing T1D, recent episodes of hypoglycemic
unawareness and an absence of glucose-stimulated C-peptide detectable in their bloodstream. Study patients
are eligible to receive up to three islet cell transplants throughout the study, including two marginal dose
transplants into the Cell Pouch and a single, marginal islet supplement transplanted via the portal vein.
Sernova would like to highlight some updated study findings and key points from the ongoing trial:
• the ongoing safety and tolerability of Cell Pouch has been maintained in all study patients;
• Islet transplantation to the Cell Pouch resulted in the establishment of new, measurable islet function
documented by detectable levels of stimulated C-peptide in the first three patients, who completed the
protocol-defined course of transplants.
• a supplemental, single intraportal islet transplant was sufficient for the first two patients to achieve and
maintain sustained ongoing insulin independence and freedom from severe hypoglycemic events for over
21 and 2 months, respectively.
• the third transplanted patient recently completed their course of Cell Pouch transplants and a
supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normal
levels of C-peptide, an absence of severe hypoglycemic events and reductions in daily insulin use;
• the other three enrolled study patients are progressing through the study protocol, as planned. All have
received Cell Pouch implants and are at various stages of protocol-defined islet transplants and follow-up;
and
• a 7th study patient has been identified.
“We are very encouraged by finding detectable serum C-peptide levels after islet transplantation into the
Sernova Cell Pouch in the three most advanced study patients. Additionally, we are very excited about the first
two patients becoming insulin independent and free from severe hypoglycemic events after a single
supplemental intraportal islet infusion,” said Dr. Witkowski. “I look forward to continuing this trial with
Sernova as we further optimize our use of the Cell Pouch System and validate its therapeutic potential.”
Dr. Philip Toleikis, President & CEO of Sernova Corp further remarked, “We believe Sernova is the first
company to report that its first two transplanted T1D cell therapy study patients achieved sustained insulin
independence. We are further reassured that our Cell Pouch System is performing as expected by creating a
safe, vascularized, and natural tissue environment inside the human body, allowing the islet cells to thrive and
function efficiently following transplantation. As we progress through the trial, under the expert guidance of Dr.
Witkowski, we have had several scientific breakthroughs and advancements related to insulin producing cell
dynamics and efficacy related to our Cell Pouch technologies. These findings have led to several technical
optimizations, including the upcoming introduction of a higher capacity Cell Pouch configuration designed to
accommodate the total quantity and distribution of islets that are achieving insulin independence for patients
in our clinical trial. This configuration of Cell Pouch has already received regulatory authorization to be used
for the remaining trial implants. Sernova is grateful to Dr. Witkowski’s leadership in this trial as we further
enhance our therapeutic cell transplantation approach with our goal to achieve a ‘functional cure’ for the
patients with complicated T1D.”
Sernova has developed its cell therapy platform, the Cell Pouch System, with the vision of treating the millions
of patients with T1D and other chronic diseases using immune-protected therapeutic cells, including stem cell-
derived technologies. Sernova’s approach is to provide a minimally invasive, retrievable, safe, organ like
environment for rapid engraftment and long-term survival of therapeutic cells as well as to avoid blood
mediated inflammatory reactions and permit cell retrievability that cannot be achieved with the traditional
portal vein transplantation.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939.
For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they
become severe or even fatal. It typically occurs when blood glucose levels are below 3.0 mmol/L and is
estimated to affect approximately 15% of people with T1D.
Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and
personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care
and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure,
coma or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - January 05, 2022 5 January, 2022
Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference
LONDON, ONTARIO – January 5, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company focused on developing a potential
‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce that new interim
results from the ongoing safety, tolerability and efficacy Phase I/II clinical trial of Sernova’s Cell Pouch™ will be
released on January 10, 2022.
Originally, it was planned that Dr. Piotr Witkowski, principal investigator of Sernova’s Phase I/II clinical trial
would present an update in a poster session at the American Society of Transplant Surgeons (ASTS) 22nd
Annual “State of the Art” Winter Symposium on January 13, 2022, but the conference was postponed
yesterday until the end of July 2022 because of the ongoing COVID-19 pandemic.
“We are pleased to be announcing these new interim data earlier than anticipated in conjunction with the J.P.
Morgan conference which is one of the premier international healthcare conferences,” said Dr. Philip Toleikis,
President & CEO of Sernova.
ABOUT THE J.P. MORGAN HEALTHCARE CONFERENCE
The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment
symposium in the industry which connects global industry leaders, emerging fast growth companies, innovative
technology creators and members of the investment community. The J.P. Morgan 40th Annual Healthcare
Conference (JPM 2022) will take place virtually, January 10-13, 2022.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. 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 cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
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.
Contact Us Contactez-nous
Business
Development
Développement des affaires
Dr. Philip Toleikis
Sernova Corp.
1.519.858.5184
info@sernova.com
Corporate Communications, Investor Relations and Media Relations Communications d'entreprise, relations avec les investisseurs et relations avec les médias
Sernova, Corp.
1.519.858.5184
info@sernova.com
About UsL'entreprise
Company OverviewPrésentation de l'entreprise
ManagementLa gestion
Board of DirectorsConseil d'administration
PartnersLes partenaires
Company MilestonesJalons de l'entreprise
TechnologyTechnologie
Regenerative MedicineMédecine régénérative
Cell Pouch System™Cell Pouch System™
Immune Protection TechnologyImmuno-Protection
IndicationsLes Indications
Therapeutic PipelinePipeline Thérapeutique
Clinical StudiesEtudes cliniques
InvestorInvestisseur
Investor PresentationsPrésentation investisseurs
News ReleasesCommuniqués de presse
Latest Updates/Videos/FeaturesDernières mises à jour / vidéos / fonctionnalités
Financial Report and Other FilingsRapport financier et autres dépôts
EventsÉvénements
Analyst CoverageCouverture des analystes
Stock InfoInformations sur le stock
Company MilestonesJalons de l'entreprise
Corporate GovernanceGouvernance d'entreprise
About Sernova.com A propos de Sernova.com
Sernova Corp (TSX-V: SVA) is a clinical stage (US FDA; Health Canada) company, developing disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-dependent (TI) diabetes, hemophilia A and thyroid disease. Sernova Corp (TSX-V: SVA) est une société en phase clinique (US FDA; Santé Canada) développant des applications thérapeutiques afin de traiter les maladies chroniques grâce à une approche régénérative. L’objectif principal de Sernova est de développer des technologies pour le traitement des patients atteints de diabète insulino-dépendant (T1), d’hémophilie A et de maladie de la glande thyroïde.
Please read our Legal Notice and Privacy Policy which includes information about Disclaimers and Terms of Use. Veuillez lire notre notice légale et notre politique de confidentialité, qui comprennent des informations sur les clauses de non-responsabilité et les conditions d'utilisation.
Career OpportunitiesOpportunités de carrière
See our latest job posting and long-term career opportunities: Voir nos dernières offres d'emploi et opportunités de carrière à long terme:
Career Opportunities pagePage web Opportunités de carrière
Follow us Suivez nous
All content is copyright
Tout le contenu est copyright
© 2001 - 2022 Sernova, Corp.
All content is copyright Tout le contenu est copyright © 2001 - 2022 Sernova, Corp.