2023 Press Releases Communiqués de presse
Sernova Investor Conference Call Previously Scheduled for September 15 Now Rescheduled for September 22
Sernova to Host Investor Calls to Introduce Newly Appointed CEO and Provide Business Update
Sernova Provides Development Update on Proprietary Cellular Conformal Coating Technology in Combination with Cell Pouch Device
Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO
Sernova Expands Leadership Team with Appointment of Modestus Obochi, Ph.D., MBA, as Chief Business Officer
Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessi
Sernova to Present Updated Interim Phase 1/2 Clinical Data on Cell Pouch System™ During Oral Presentation at American Diabetes Association 83rd Scie
Sernova to Participate in Upcoming Truist Securities Cell Therapy Symposium
Sernova Announces Executive Alignment and Appoints New Board Chair
Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications
SERNOVA CORP. ANNOUNCES VOTING RESULTS OF THE 2023 ANNUAL GENERAL MEETING OF SHAREHOLDERS
Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA
Sernova Reminds Shareholders to Vote FOR the Eight Management Director Nominees Using ONLY the WHITE Management Proxy
Two Independent Proxy Advisory Firms, Including Glass Lewis & Co. LLC. Recommend Sernova's Shareholders Vote FOR all Management Nominees on Management
Institutional Shareholder Services Inc. Recommends Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy
Sernova to Present at 2023 Alliance for Regenerative Medicine Cell & Gene Meeting on the Med
Sernova Responds to Dissident Shareholders' Misleading Statements and Provides Corporate Updates
Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for
Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Su
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
Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences
Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy
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 Diab
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Press Release Communiqué de presse - September 14, 2023 14 September, 2023
Sernova Investor Conference Call Previously Scheduled for September 15 Now Rescheduled for September 22
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 14, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
it has rescheduled the investor and analyst conference call previously scheduled for September 15 at 10 a.m.
Eastern Time. The call will now occur on September 22 at 10 a.m. Eastern Time. The business strategy and
update call remains as scheduled for October 5, 2023.
This call will introduce the newly appointed CEO, Cynthia Pussinen, as well as the recently appointed Chief
Business Officer, Dr. Modestus Obochi, Ph.D., MBA, and will discuss the overall vision of both executives to
deliver novel medical therapies to patients.
CEO Introduction:
Date: Friday, September 22, 2023
Time: 10:00 a.m. Eastern Time
Dial-In: 1-877-704-4453
Conference ID: 13741199
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634340&tp_key=29a41cab17
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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.
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Press Release Communiqué de presse - September 13, 2023 13 September, 2023
Sernova to Host Investor Calls to Introduce Newly Appointed CEO and Provide Business Update
- Introduction of New CEO Cynthia Pussinen and Recently Appointed Chief Business Officer, Dr. Modestus
Obochi, on September 15, 2023 -
- Business Update, Strategy & Outlook Call on October 5, 2023 -
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 13, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
it will host two investor and analyst conference calls, with corresponding live webcasts.
The first of these two events will introduce the newly appointed CEO, Cynthia Pussinen, as well as the recently
appointed Chief Business Officer, Dr. Modestus Obochi, Ph.D., MBA, and will discuss the overall vision of both
executives to deliver novel medical therapies to patients. The second in this series of calls is intended to
provide an overall business update and discuss the strategy and operating plans going forward. Details of each
event are as follows:
CEO Introduction:
Date: Friday, September 15, 2023
Time: 10:00 a.m. Eastern Time.
Dial-In: 1-877-704-4453
Conference ID: 13741199
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634340&tp_key=29a41cab17
Business Update:
Date: Thursday, October 5, 2023
Time: 10:00 a.m. Eastern Time.
Dial-In: 1-877-704-4453
Conference ID: 13741177
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634043&tp_key=195a900d23
The October 5 event will conclude with a question-and-answer component, and investors can also email
questions in advance to info@sernova.com. The company will answer as many questions as allowable within
the given time constraints. Subsequently, replays of each event will be available on the events section of the
Company’s website at www.sernova.com.
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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.
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Press Release Communiqué de presse - September 07, 2023 7 September, 2023
Sernova Provides Development Update on Proprietary Cellular Conformal Coating Technology in Combination with Cell Pouch Device
Dr. Alice Tomei of the University of Miami, Miller School of Medicine, to present updates in podium
presentation at the 2023 IPITA-IXA-CTRMS Joint Congress being held in San Diego from October 26-29
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 7, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today provided a
development update on its exclusively licensed, proprietary conformal coating immune protection technology,
being advanced in combination with the Cell Pouch™ through a collaboration with Dr. Alice Tomei at the
University of Miami, Miller School of Medicine. The goal of the technology is to eliminate the need for long-
term use of conventional immunosuppressive medications currently required to prevent graft rejection with
Sernova’s flagship cell therapy program for treatment of type 1 diabetes (T1D).
“One of the biggest challenges in bringing a ‘functional cure’ to people living with T1D is preventing therapeutic
cell transplantation from eliciting an immune response without the need for conventional life-long
immunosuppressive agents,” said Dr. Philip Toleikis, Chief Technology Officer of Sernova Corp. “Our conformal
coating technology closely surrounds insulin-producing islets without altering the genetic makeup or function,
offering potential protection from the human immune system while maintaining normal cell function. We are
encouraged by both our ongoing preclinical results, and our continued progress with manufacturing scale-up of
conformally coated islets, which is a key hurdle prior to initiation of clinical studies.”
The conformal coating technology has been developed in partnership with Dr. Alice Tomei, Miami Engineering
Career Development Associate Professor of Biomedical Engineering at the University of Miami and director of
the Islet Immunoengineering Lab at the Miller School of Medicine Diabetes Research Institute. Dr. Tomei will
provide a detailed update of the technology in a podium presentation at the 2023 IPITA-IXA-CTRMS Joint
Congress being held in San Diego from October 26-29. Presentation details will be shared in October 2023.
Dr. Tomei added, “I am pleased with the technical advancements we have made in collaboration with the
Sernova scientific team. We have achieved success in pre-clinical safety and efficacy studies demonstrating the
optimal conditions for conformally coated islets within the Cell Pouch. We have also made significant progress
in developing release criteria which are essential for the clinical manufacturing process. Furthermore, along
with Sernova, we have optimized the manufacturing process and are currently scaling up the GMP production
of the conformally coated islets. These elements are critical to advancing the conformal coating technology
into the clinic for the potential treatment of all patients with T1D. I look forward to sharing more on our
progress at the 2023 IPITA-IXA-CTRMS Joint Congress in San Diego.”
Pre-clinical studies conducted at the University of Miami in collaboration with Sernova demonstrated that
conformally coated islets transplanted into the pre-vascularized Cell Pouch achieved normal blood glucose
control and reversed the effects of T1D in a syngeneic rat model of T1D. Conformally coated islets show
normal responsiveness to glucose and fully regulated insulin production when transplanted in the Cell Pouch.
Treated animals ultimately achieved full insulin independence (return to normal glucose levels).
In optimization studies in T1D animal models transplanted with conformally coated allogeneic islets in an
implanted Cell Pouch, subjects treated with a single selective immune response agent achieved sustained,
normalized blood glucose levels during the study period. These findings support our approach and the
potential to eliminate the need for the immunosuppressive cocktails that are typically used for islet transplant
patients and are frequently associated with toxic side effects.
As prerequisites for clinical testing in humans, characterization assays have been identified to develop and
validate product release criteria for conformal coating. Long-term in vitro stability and durability studies have
been successfully completed and release testing is routinely conducted for the finished coated islet product to
ensure quality, safety, and efficacy potential, prior to the transplantation of conformally coated islets into Cell
Pouch. Sernova is also undertaking a standard array of biocompatibility studies and is completing an allogeneic
optimization study using conformally coated islets in the Cell Pouch with the addition of a selective immune
response agent which has proven effective in the ongoing Phase 1/2 clinical trial of the Cell Pouch System™ in
T1D at the University of Chicago. A single agent provided intermittently with the conformal coating technology
would be a significant advancement in the field of cellular immune protection.
Additionally, through a design and manufacturing partner, Sernova is developing a bench-top, scalable, fully
automated, and GMP-compatible cell coating system. The clinical-scaled system is designed for installation in
GMP cell manufacturing facilities that produce coated islets for clinical trials.
ABOUT THE CONFORMAL COATING TECHNOLOGY
The conformal coating technology is a proprietary, mechanically stable, thin, biocompatible, and cross-linked
polymer hydrogel that coats the outside of each individual islet housed within the Cell Pouch. The conformal
coating technology offers selective permeability, with immuno-protective capability, while not interfering with
the kinetics of insulin and glucose release. Importantly, the conformal coating configuration also allows for the
physiological transfer of oxygen and nutrients needed for islet survival and long-term function within the pre-
vascularized Cell Pouch.
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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.
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Press Release Communiqué de presse - September 05, 2023 5 September, 2023
Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO
Industry veteran with deep commercial experience joins to lead the next stage of growth and development
Dr. Philip Toleikis will serve as Chief Technology Officer
Sernova to host investor calls
LONDON, Ontario; Windham County, CT – September 5, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced that its Board of
Directors has appointed Cynthia Pussinen as Chief Executive Officer and a member of the Board of Directors.
Dr. Philip Toleikis, who has led the company since 2009 as President and CEO will serve as Chief Technology
Officer.
Ms. Pussinen’s expertise spans the drug development continuum from research through commercialization. She
has led the development, licensure, commercialization and/or subsequent delivery to patients, of more than
fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant),
Porcine Sequence), Eraxis® (anidulafungin), Zmax® (azithromycin extended-release) and LUXTURNA®
(voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European
Union.
Most recently, Ms. Pussinen was the Chief Technical Officer for Spark Therapeutics, Inc., a fully integrated,
commercial gene therapy company, and a member of the Roche Group. Prior to joining Spark in 2021, Ms.
Pussinen’s leadership roles include 6 years with Ipsen Biomeasure and Ipsen Biosciences, U.S. R&D focused
subsidiaries of Ipsen, where she served as President and CEO. She was instrumental in leading and executing
the divestiture of Obizur® and its associated manufacturing physical infrastructure to Baxter. Ms. Pussinen was
also the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium
Pharmaceuticals, Inc. and the Global Vice President and General Manager, Life Sciences and Specialty
Chemicals for Honeywell International. Early in her career Ms. Pussinen spent more than 18 years at Pfizer in a
variety of increasingly responsible leadership roles across various functional areas.
Ms. Pussinen also served on the Drexel University Solutions Advisory Board, as a Board Director for Spark
Therapeutics UK Ltd. and Spark Therapeutics Ireland Ltd. and is a member of an early-stage biotech
company’s scientific and technical advisory board.
Ms. Pussinen earned a Master of Science in R&D management from Rensselaer Polytechnic Institute and a
Bachelor of Science in chemistry, with a minor in engineering from the University of Connecticut. She is lean six
sigma certified, is recognized as a mentor through the Healthcare Businesswomen’s Association (HBA) and was
honored by WEST (Women in the Enterprise of Science and Technology) as a recipient of their Giving Back
award.
“Sernova has demonstrated tremendous growth over the past several years as it has transitioned from a
research company to one that is moving towards commercialization of a product for the treatment of multiple
chronic diseases including our flagship program for Type 1 Diabetes (T1D). As a united Board, we feel now is
the time to bring in an industry leader with extensive experience with large pharmaceutical companies as well
as entrepreneurial biotech and advanced therapeutics focused companies,” commented Brett Whalen, Chair of
the Board of Directors of Sernova. “The skills that Ms. Pussinen brings to our company include over 25 years
of global experience shepherding new therapies from development through commercialization across multiple
conditions with sales measured in the billions.”
Mr. Whalen continued, “the Board would like to thank Dr. Toleikis for his significant contributions to Sernova
and his passionate commitment to our mission, and for continuing in his new role as Chief Technology Officer.
Under his leadership, Sernova has solidified the strong scientific and technical foundations for future success
and created significant market value driven by the strong positive clinical data outcomes in T1D. The Board is
convinced that Ms. Pussinen and Dr. Toleikis bring the right combination of experience and talent to optimize
this unique opportunity for all stakeholders.”
Ms. Pussinen added, “It is an honor and a privilege to join Sernova at this pivotal stage in the company’s
evolution. Sernova has developed novel technology, and I am very excited by the positive pre-clinical and
clinical results thus far. The company is a pioneer in creating new ways to address some of the most
challenging chronic diseases, providing the possibility of a life-changing ‘functional cure’ for conditions
including Type 1 Diabetes. I am inspired by the mission to improve human health and look forward to working
with the passionate Sernova team to boldly advance the company’s mission for the benefit of all patients,
stakeholders and investors.”
Dr. Toleikis said, “I am grateful to have led Sernova’s dedicated team over the past years. I am proud of all that
we have accomplished together over the past years, including establishing a strong technology and scientific
foundation along with introducing new treatments options to patients with chronic conditions. I am very
pleased to welcome Ms. Pussinen to the Sernova team as the new CEO and look forward to working together. I
look forward to my continued involvement with the Company to see through the realization of Sernova’s
mission to bring a functional cure to patients around the world suffering from chronic diseases.
Sernova’s management will host investor calls, firstly to introduce Ms. Pussinen, and later, in approximately 30
days, to provide an overview of Sernova as well as a question-and-answer session. Investors will be informed
of the details once finalized.
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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 - July 26, 2023 26 July, 2023
Sernova Expands Leadership Team with Appointment of Modestus Obochi, Ph.D., MBA, as Chief Business Officer
LONDON, Ontario – July 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, today announced the appointment of Modestus Obochi, Ph.D.,
MBA, a veteran dealmaker and strategic leader with 25+ years of biotech and pharmaceutical industry
experience, as Chief Business Officer effective September 8, 2023.
“Dr. Obochi brings additional invaluable industry acumen to our expanding leadership team,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “His proven expertise in strategy, business
development, product lifecycle management, and operational excellence will be vital to our team as we
continue to strategically advance our proprietary therapeutic cell therapy technologies including our Cell Pouch
System™, both independently and with industry partners, as a potential ‘functional cure’ for multiple chronic
diseases.”
Dr. Obochi added, “I am very excited by the significant commercial potential and the immense clinical potential
that Sernova’s proprietary cell therapy platform has shown in the ongoing Phase 1/2 study in people living with
type 1 diabetes. As an immunologist and someone whose family has been impacted by the devastating effects
of T1D, the Sernova opportunity is very personal to me. I look forward to working with Sernova’s management
and board of directors, its partners, and research collaborators as we aim to develop Sernova’s proprietary cell
therapy platform into a commercially viable ‘functional cure’ modality for multiple chronic diseases, including
insulin-dependent diabetes, hemophilia A, and hypothyroidism.”
Based in the Chicago, Illinois area, where he has resided for the last 16 years, Dr. Obochi joins Sernova from
Phlow Corp., where he served as Executive Vice President of Strategy and Business Development. In that role,
he led the design, development, and execution of corporate strategy and business development plans. He also
managed the due diligence, structuring, and negotiations of all transactions, including licensing deals, product
acquisitions, partnerships, M&A, and strategic investments. Prior to his role at Phlow Corp., Dr. Obochi held
several executive-level commercial and business development roles at leading pharmaceutical companies
including Pfizer, Hospira, and Baxter International, and has previously consulted for several biotechnology
companies. Most notably, in these roles, Dr. Obochi has helped corporations raise significant capital and has
successfully structured and closed multiple strategic transactions worth over $5 billion. Dr. Obochi holds a
Ph.D. in Immunology from the University of British Columbia, Vancouver, and an MBA from the Beedie School
of Business of Simon Fraser University, Vancouver. He has published over 30 manuscripts, including journal
articles and symposia abstracts, and is an inventor on several patents, including one on cell transplantation.
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 therapeutic cell technology 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
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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 - June 26, 2023 26 June, 2023
Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions
• In the first cohort of the ongoing Phase 1/2 clinical trial, the first 5 patients to complete protocol-defined
islet transplants achieved insulin-independence for ongoing periods of 6 to 38 months.
• Following islet transplants to the 8-channel Cell Pouches, patients in the first cohort required only modest
islet top-up via portal vein to achieve insulin independence, supporting the contribution to blood glucose
control from islet grafts in the Cell Pouch™.
• Five of the 7 planned patients have been enrolled in the second cohort and implanted with higher capacity
10-channel Cell Pouches. Three patients in the second cohort have received their first pancreatic islet
transplant to Cell Pouch.
• Persistent fasting and stimulated serum C-peptide confirms stable islet graft function in the first evaluable
patient to receive islet transplants to the higher capacity Cell Pouch.
LONDON, Ontario – June 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, today announced updated positive interim data from its ongoing
Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia
unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The
University of Chicago, were presented during an oral podium presentation at the American Diabetes
Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.
The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating
Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4
years following implant. During the trial, the function of the transplanted islets are measured by blood glucose
levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion.
To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet
transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin
independence for periods ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft
function.
In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch
with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting
the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell
Pouch. Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their
implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting
and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel
Cell Pouch.
KEY POINTS FROM THE INTERIM CLINICAL UPDATE
• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety
profile in patients receiving either 8 or 10-channel Cell Pouches.
• Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants
via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8-
channel Cell Pouch is supporting ongoing glucose control.
• Histological assessment of sentinel Cell Pouches excised at ≥90 days post-transplant revealed surviving
functional islets in 5 of 6 patients in the first cohort.
• The 5 patients in the first cohort that have achieved insulin independence have each remained free of
endogenous insulin therapy ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment.
• In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell
Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch.
• One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single
islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent
neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment.
Further data from the second cohort of the clinical trial is expected in the second half of 2023.
“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-
channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “These additional data continue to confirm our
understanding and provide verification of our estimates of islet dose thresholds and density required for
optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll
the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived
islet-like clusters in our upcoming clinical trial.”
Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and
principal investigator of the clinical trial added, “I continue to be encouraged by the results achieved in this
trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell
Pouch. I look forward to reporting further data later this year.”
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
To add to the ongoing Phase 1/2 clinical trial of the Cell Pouch System in T1D, Sernova also continues to
advance its global strategic partnership with Evotec SE (Evotec). Together the companies remain on track to
advance Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet-
like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune
protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the
need for immunosuppression agents.
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 novel 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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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 - June 22, 2023 22 June, 2023
Sernova to Present Updated Interim Phase 1/2 Clinical Data on Cell Pouch System™ During Oral Presentation at American Diabetes Association 83rd Scientific Sessions
Company to host in-person only analyst and investor event at an offsite location following the presentation on
Saturday, June 24 at the ADA Scientific Sessions
LONDON, Ontario – June 22, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, will be presenting updated interim data from its ongoing Phase
1/2 clinical trial of the Cell Pouch System™ in patients with type 1 diabetes (T1D) and hypoglycemia
unawareness at the American Diabetes Association (ADA) 83rd Scientific Sessions, to be held June 23-26, 2023,
in San Diego.
The abstract, which was submitted several months ago, written by Dr. Piotr Witkowski, M.D., Ph.D. and his
team at The University of Chicago Pritzker School of Medicine, was released by the ADA and shows that five of
the six patients receiving the Sernova Cell Pouch remain insulin independent (>2.5 years, >1 year, 10 months, 2
months, and 1 month). With the 6th patient awaiting a final protocol-mandated islet transplant. The oral
podium presentation will contain additional updated information and will take place on Saturday, June 24. In
alignment with the ADA embargo policy, the additional data updates will be shared by Sernova following the
completion of the presentation. The abstract for the oral presentation can be accessed here.
Presentation details:
• 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: Saturday, June 24, 2023
• Time: 5:15 PM PT
• Location: Room 30
• 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 host an in-person analyst and investor event following the presentation at ADA:
• Date: Saturday, June 24, 2023
• Time: 6:30 PM PT
• Location: The Hilton San Diego Bayfront
• Room: Aqua 310B
Register for the event here: https://events.r20.constantcontact.com/register/eventReg?
oeidk=a07ejsjhyfz2e580299&oseq=&c=&ch=
Abstracts for the ADA 83rd Scientific Sessions can be accessed here:
https://eppro02.ativ.me/src/EventPilot/php/express/web/planner.php?id=ADA23
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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 - June 16, 2023 16 June, 2023
Sernova to Participate in Upcoming Truist Securities Cell Therapy Symposium
LONDON, Ontario – June 16, 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
symposia-cel Truist Securities Cell Therapy Symposium being held June 27, 2023 in New York City. Company
management will also be participating in one-on-one investor meetings at the conference.
symposia-cel - A Truist Securities Cell Therapy Symposium
Format: Fireside Chat
Date: June 27, 2023, 2:15pm
Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp
Location: Lotte New York Palace
Please contact your representative at Truist to schedule a one-on-one meeting with the management team
during 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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
619-723-4326
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 31, 2023 31 May, 2023
Sernova Announces Executive Alignment and Appoints New Board Chair
LONDON, Ontario – May 31, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, today announced the outcomes from a strategic and executive
leadership review conducted by its Board of Directors (the “Board”).
Following the recent 2023 Annual General Meeting of Shareholders (the “AGM”), the Sernova Board welcomed
Mr. Brett Whalen, Dr. Steven Sangha and Mr. Bertram von Plettenberg as newly elected Directors. The newly
constituted Board has appointed Mr. Brett Whalen as its new Chair, Mr. Bertram von Plettenberg to serve on its
Audit and Compensation Committees, and Dr. Steven Sangha to serve on its Nomination and Corporate
Governance Committee. In addition, the new Board has determined that it is in the best interest of the
Company that Dr. Philip Toleikis remain as President and Chief Executive Officer and continue leading the
Company’s Management Team and executing Sernova’s vision.
“As newly appointed Chair, I would like to welcome Dr. Sangha and Mr. von Plettenberg,” said Mr. Whalen. “As
a long-standing shareholder and newly elected Board member, I am excited to take on the role as Chair. I look
forward to helping guide the company through its next critical phase of development.”
Sernova’s new Board and Management Team are fully aligned to position the Company in the biotech sector as
a leading player developing cell-based ‘functional cures’ for type one diabetes (“T1D”), hypothyroid disease
and rare diseases, such as hemophilia A, and are committed to unlocking the value inside of Sernova by
ensuring the market recognizes the full potential of the Company and its extendible cell therapy platform and
technologies.
The Board recognizes the contributions of the Concerned Shareholders Group that engaged in the democratic
process for the recent AGM, and therefore the Company intends, as an act of good faith, and in the interest of
fully aligning Sernova shareholders with Management and the Board, to reimburse the Concerned Shareholders
Group for their reasonable AGM related expenses. In addition, the Company has re-priced the recently issued
options granted to the Board members to $1.20 per share from $0.84, reflecting the unanimous belief from the
Board that the market is undervaluing the Company at this time. In a statement from the Concerned
Shareholders Group, “The newly constituted Board seems aligned with shareholder interests as evidenced by
the above actions. We are pleased to note a change in tone and energy resulting from the new Board
composition. We are confident they will bring about the necessary changes to unlock value for the short,
medium, and longer-term horizons.”
Dr. Toleikis added, “The most promising days for Sernova from a program and business development
perspective are ahead. We look forward to sharing the updated results from our ongoing T1D Phase 1/2 trial
with our Cell Pouch System™ at the upcoming American Diabetes Association 83rd Scientific Sessions meeting
on June 24th and advancing our second patient cohort towards full enrolment followed by anticipated initial
interim results by the end of 2023. Furthermore, we are thrilled to be advancing on schedule the first human
clinical studies with iPSC-based insulin-producing islet-like clusters in 2024 under our partnership with Evotec
SE that is catching the eye of the investment and pharmaceutical business communities.”
Lastly, Sernova Directors Ms. Deborah Brown and Dr. Mohammad Azab have retired from the Company’s
Board, effective May 30th. “The Board and Management wish to recognize and thank Ms. Brown and Dr. Azab
for their years of service and contributions in providing guidance to the Company, particularly relating to
corporate governance and clinical development, respectively, during their tenure,” said Mr. Whalen.
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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 03, 2023 3 May, 2023
Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications
LONDON, Ontario – May 3, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced it has entered into a preclinical research
collaboration with AstraZeneca (LSE/STO/Nasdaq:AZN) to evaluate the use of Sernova’s Cell Pouch System™ in
combination with AstraZeneca’s novel therapeutic cells.
“Sernova has developed a novel cell therapy approach for the potential treatment of insulin-dependent
diabetes, hypothyroidism and hemophilia A,” said Dr. Philip Toleikis, President and Chief Executive Officer of
Sernova. “By engrafting functional therapeutic cells within an implanted Cell Pouch, which naturally
vascularizes with surrounding tissues, we create an environment for the production and release of absent or
under-expressed hormones and proteins. We are pleased to be working with AstraZeneca in the preclinical
assessment of its various proprietary therapeutic cells in combination with our Cell Pouch.”
AstraZeneca is exploring the use of Sernova’s Cell Pouch System as a potential platform for integration with its
development of the next wave of innovative cell therapies for various indications. Under the terms of the
collaboration, AstraZeneca will lead and completely fund the development of the cell technologies and pre-
clinical activities in conjunction with Sernova. The discovery work is being funded and conducted at
AstraZeneca. The preclinical research outcomes will determine the feasibility of potential therapeutic
applications and subsequent product development activities between the two companies.
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 28, 2023 28 April, 2023
SERNOVA CORP. ANNOUNCES VOTING RESULTS OF THE 2023 ANNUAL GENERAL MEETING OF SHAREHOLDERS
LONDON, Ontario - April 28, 2023 - Sernova Corp. (“Sernova” or the “Corporation”) (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine company and leader in cell
therapeutics 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 27, 2023.
The following resolutions were proposed and approved at the AGM:
- Dr. Philip M. Toleikis, James T. Parsons, Deborah M. Brown, Dr. Mohammad Azab, Dr. Daniel Mahony, Brett
Whalen, Dr. Steven Sangha and Bertram von Plettenberg were elected as directors of the Corporation for the
ensuing year.
- Appointment of KPMG 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.
The resolution to ratify and confirm amendments to the Option Plan and DSU Plan and to increase the
maximum number of Common Shares reserved for issuance was not tabled at the AGM and as such the current
incentive plan without the amendments continues in effect.
“As they transition out of their director roles, I would like to acknowledge Frank Holler and Jeffrey Bacha’s
many years of contributions to Sernova’s Board of Directors,” said Dr. Philip Toleikis, President & CEO of
Sernova Corp. “With today’s results, I would also like to welcome our two new directors, Dr. Steven Sangha and
Bertram von Plettenberg to the company. We look forward to working with them as we strive to advance the
Cell Pouch™ and work to create other therapeutic options for patients with chronic diseases.
“We are honored to be given the opportunity to represent the voice of all shareholders. As directors on the
Board of Sernova, we will work hard to ensure the best interests of the company, shareholders and all other
stakeholders are addressed in a timely manner,” said Dr. Steven Sangha and Bertram von Plettenberg.
ABOUT SERNOVA CORP.
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders
including 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. The Cell Pouch on implantation forms a natural vascularized tissue
environment in the body for long-term survival and function of therapeutic cells that release necessary proteins
or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it
can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase I/II clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the
need for chronic immunosuppressives. 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) beta cell
replacement therapy. This partnership provides Sernova an unlimited supply of insulin-producing cells to treat
millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the
clinic in two additional 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 8 gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 24, 2023 24 April, 2023
Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit
- Evotec’s scalable GMP manufacturing process has been designed to produce induced pluripotent stem cell
(iPSC)-derived islet-like clusters (ILCs) with high insulin-producing beta cell content as well as glucagon and
somatostatin (produced by alpha cells and delta cells, respectively), similar to human islets
- The ILCs are cryopreserved during manufacturing, enabling storage of mass volumes and cost efficient on-
demand worldwide delivery as required
- Results from a type 1 diabetes (T1D) preclinical model with Evotec’s ILCs implanted into Sernova’s Cell
Pouch™ demonstrated robust and durable insulin independence with blood C-peptide levels and glucose
tolerance test results equivalent to a test group with human islets
- An additional T1D study with Evotec’s ILCs demonstrated sustained normalization of blood sugar levels in
diabetic mice throughout the 320 day term of the study
- IND filing and Phase 1/2 clinical program with Sernova’s Cell Pouch and Evotec’s iPSC ILCs on track for 2024
LONDON, Ontario – April 24, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced the presentation of preclinical data supporting
the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s (FSE: EVT; NASDAQ:
EVO) iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of
patients with T1D. The objective of the partnership is to produce an off-the-shelf, commercially scalable cell
therapy treatment, with human testing anticipated to begin in 2024.
The data were presented by Matthias Austen, PhD, SVP Cell Therapy at Evotec SE (Evotec), as an oral podium
presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell
Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge,
Massachusetts. The presentation included an introduction to Evotec’s proprietary GMP process for
manufacturing iPSC-derived ILCs for use in Sernova’s Cell Pouch, as well as encouraging results from multiple
studies using a standard mouse model of T1D.
Key findings:
- Evotec has developed a scalable GMP manufacturing workflow, starting from GMP-grade iPSCs to the final
product of ILCs, yielding a high beta cell fraction with no post-implantation variability of cell composition.
- Evotec ILCs are cryopreserved at a late-intermediate stage of differentiation allowing for a cost-effective
large-scale manufacturing process to optimize both pre- and post-implantation durability, offering a major
advantage over competing cell therapies in development.
- ILCs implanted to mouse kidney capsule demonstrated complete and durable normalization of glucose levels
in a standard diabetic mouse model out to the pre-planned termination date at 320 days.
- ILCs implanted into Sernova’s Cell Pouch demonstrated rapid normalization of glycemic control in the
streptozotocin (STZ)-induced diabetic NSG (NOD.SCID.IL-2Rgammanull) mouse model.
- Circulating C-peptide levels (a biomarker for insulin production) in mice implanted with the Cell Pouch and
ILCs were equivalent after 6 weeks to those in mice that received 4000 IEQ human islets under the kidney
capsule.
- Efficient glucose clearance and no hypoglycemia was demonstrated in an oral glucose tolerance test
administered at 8 weeks post-implantation. Animals implanted with Cell Pouch and ILCs showed an identical
glucose clearance time course compared to animals transplanted with 4000 IEQ human islets.
- Upon explantation of the Cell Pouch with ILCs after the 32-week survival period, histological graft analyses
showed the presence of all relevant islet cell types including insulin-producing beta cells, glucagon-producing
alpha cells, and somatostatin-producing delta cells, indicating a favorable cell composition of the implanted
ILCs.
- Histological graft analyses also revealed extensive intra-graft vascularization, likely contributing to the
excellent endocrine cell survival with a high beta cell fraction, and consistent with the observed functional
outcomes.
“Our ongoing productive partnership with Evotec continues to progress towards human clinical trials in 2024
with an impressive cell therapy paired with our Cell Pouch to create a potential ‘functional cure’ for T1D,” said
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These results demonstrate that Evotec’s
ILCs in the Cell Pouch can become fully functional endocrine islets following implantation, with potency
equivalent to human islets. Our goal is to advance beyond decades-old insulin injections to provide a potential
one-time treatment to restore normal pancreatic glycemic control for individuals with T1D. We look forward to
providing an update at the American Diabetes Association conference in June on our ongoing Phase 1/2 study
in T1D patients with our Cell Pouch containing human donor islet cells and to progressing our next generation
product utilizing Evotec cells into the clinic in 2024.”
Dr. Cord Dohrmann, Chief Scientific Officer of Evotec commented, “We are thrilled to show these results with
Evotec’s ILCs that we have spent years perfecting with a scalable cost-effective GMP workflow to create a
cryopreserved product with excellent survival under standard shipping conditions and optimized for
implantation into Sernova’s Cell Pouch. These new data demonstrating rapid, complete, and durable
normalization of glucose control that is equi-potent comparable in potency to human islets is one of the final
steps prior to our anticipated human testing in 2024.”
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 has secured an exclusive option for an
exclusive global license for Evotec’s ethically derived iPSC insulin producing islet clusters for use with Sernova’s
Cell Pouch System or alone with other technologies. 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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 21, 2023 21 April, 2023
Sernova Reminds Shareholders to Vote FOR the Eight Management Director Nominees Using ONLY the WHITE Management Proxy
- Protect your investment in Sernova by voting FOR all of Sernova Management’s director nominees.
- ISS and Glass Lewis, independent third-party proxy advisory firms, both recommend that shareholders vote
FOR Sernova’s eight management nominees and not to vote for the dissident nominees.
- The deadline to submit WHITE management proxies is Tuesday April 25, 2023 at 10:00 a.m. (Pacific time)
- Shareholders who have questions or need assistance with voting their shares voting should contact Sernova
Corp.’s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452-
7184 or by email at assistance@laurelhill.com.
LONDON, Ontario – April 21, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB:
SEOVF) (FSE/XETRA: PSH), reminds shareholders to vote the WHITE management proxy in advance of the
proxy voting deadline on Tuesday April 25, 2023 at 10:00 a.m. (Pacific Time) FOR all of the Sernova
management director nominees. We thank the many shareholders who have already voted FOR Sernova’s
management nominees using the WHITE proxy and urge those who have not voted yet to cast their vote using
the WHITE proxy —every shareholder and every share counts.
Shareholders are encouraged to read Sernova’s management information circular, the letter to shareholders
the Corporation recently mailed to all shareholders and press releases by visiting Sernova - AGM Annual
General Meeting, for details about how a group of dissident shareholders is trying to impose two unqualified
nominees on Sernova’s board of directors.
Sernova’s Board Nominees – The Right Team with the Right Experience
Sernova’s nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr. Daniel Mahony,
James Parsons, Dr. Philip Toleikis and Brett Whalen possess the skills Sernova needs to continue the
successful execution the Corporation’s plan to progress Sernova to its next stage of development:
- Significant expertise and experience in leading biotech companies. Sernova’s nominees all have significant
breadth and depth of expertise and experience in directing public biotech, pharmaceutical, and healthcare
sector companies in Canada and elsewhere.
- Director Qualifications. Sernova’s nominees each have deep biotechnology industry experience
encompassing relevant capabilities in finance, product and corporate development. The board has been
developed and refreshed over time against a specific skills matrix with currently 50% of the board having
served for less than 4 years.
- Strong Financial and Cash Position. Sernova ended Q1 2023 with a strong balance sheet including cash
resources of $45.6 million. Since the April 2022 annual meeting of shareholders, proceeds of $8 million were
raised from the full exercise of the remaining outstanding 2019 and 2020 private placement common share
purchase warrants. Additionally, the Company completed a private placement with strategic partner Evotec
resulting in a total equity investment of $27 million.
In addition, within the last year, Sernova’s Board and management team have made significant progress with a
‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System (“CPS”), a novel
implantable medical device with immune protected therapeutic cells. With a strong management and Board of
Directors in the last 12 months the Company has:
- In May, 2022 - Entered into a global strategic partnership with Evotec SE (“Evotec”) 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 islet clusters to treat millions
of patients with insulin-dependent diabetes (both type 1 and type 2).
- In June, 2022 - Transitioned the Company from the TSX Venture Exchange to the TSX as part of the
Company’s capital markets strategy to access a broader base of investors and position the Company more
favourably for institutional investment.
- In January 2023 - The Company announced the confirmation of its hypothyroid program proof-of concept,
demonstrating that thyroid auto-transplantation in the Cell Pouch can compensate for removal of the thyroid
gland and restore normal thyroid hormone production – potentially a lifechanging treatment for patients who
have gone through the thyroid gland removal procedure.
Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy
Voting is easy. We encourage you to vote online or by telephone using the information on your WHITE proxy.
Shareholders who have voted using the dissident’s GOLD proxy and wish to support Sernova’s management
nominees still have the right to change their vote by simply voting FOR Sernova’s management nominees using
the WHITE proxy. A later dated WHITE proxy will replace a previously submitted vote.
YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT
NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN
Shareholders are encouraged to vote your shares as soon as possible. The deadline for voting your shares is at
10:00 a.m. (Pacific Time) on Tuesday April 25, 2023.
Sernova’s board of directors recommends that shareholders vote FOR all of the management director
nominees and meeting resolutions using only the WHITE proxy.
Shareholder Questions
Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation
agent and shareholder communications advisor:
Laurel Hill Advisory Group
Toll Free: 1-877-452-7184 (for shareholders in North America)
International: +1 416-304-0211 (for shareholders outside Canada and the US)
By Email: assistance@laurelhill.com
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 18, 2023 18 April, 2023
Two Independent Proxy Advisory Firms, Including Glass Lewis & Co. LLC. Recommend Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy
- Following Institutional Shareholder Services’ positive recommendations, Glass Lewis is the second
independent, third-party proxy advisory firm to recommend Sernova’s shareholders vote FOR all
management’s director nominees using ONLY management’s WHITE proxy.
- Glass Lewis does not believe Sernova’s dissident shareholders have compiled a sufficiently compelling case
to warrant investor support and refers to their arguments as “incomplete”.
- Shareholders who have questions or need assistance with voting their shares should contact Sernova Corp.’s
strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452-7184 or by
email at assistance@laurelhill.com.
LONDON, Ontario – April 18, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB:
SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce
that a second independent, third-party proxy advisory firm, Glass Lewis & Co. LLC (“Glass Lewis”), has
recommended Sernova’s shareholders vote FOR all of Sernova’s management nominees using only
management’s WHITE proxy.
Glass Lewis also recommended that shareholders vote FOR the appointment of KPMG LLP as Sernova’s
auditors and FOR the resolution to amend the Corporation’s stock option plan and DSU Plan.
Glass Lewis is a leading independent, third-party proxy advisory firm which provides proxy voting
recommendations to pension funds, investment managers, mutual funds, and other institutional shareholders.
Reasons for Glass Lewis’ Support of Sernova’s Management Nominees
Glass Lewis’ recommendation that shareholders vote FOR all of Sernova’s management nominees using only
management’s WHITE proxy, is based on a number of factors. Glass Lewis’ report states:
“In this case… we do not believe the Dissidents have compiled a sufficiently compelling case to warrant investor
support at this time. Our view in this regard hinges on three principal factors: (i) the Dissidents overall case
against incumbent management and the board is fairly broad and arguably incomplete, with core analyses (e.g.
share price performance) lacking context and certain strategic commentary failing to offer much depth relative
to the board's much more copious rebuttal; (ii) the need to pursue the Dissidents' promulgated alternatives for
the Company (i.e. positioning Sernova to secure additional financing within the next 18 months, investing in a
go-to-market strategy, solidifying succession planning) is not especially well established, in our view,
particularly given the Company's stable capital position and relationship with Evotec; and (iii) the Dissident
nominees — which include a dentist with unspecified experience investing in early stage companies and a
business consultant with a prior relationship with Sernova — do not appear to represent a clear, incremental
improvement over the incumbent board members.
We also consider the board has, with due reference to Sernova's development stage and size, offered a
reasonably well-rounded corporate update, touching both on the Company's prior milestones and anticipated
near-term developments. The board also draws attention to Sernova's currently adequate capital position,
which, though certainly not intended to serve as an indefinite bulwark against future funding requirements,
appears to offer Sernova sufficient near-term liquidity and structural flexibility.
Under these conditions, we do not see that the Dissidents have provided Sernova investors with sufficient cause
to support their agenda at this time.”
Glass Lewis Recommends Support of Sernova’s Proposed Securities Authorized for Issuance Under its Equity
Compensation Plans
Glass Lewis recommended that shareholders vote FOR the resolution to amend the Corporation’s stock option
plan and DSU Plan, as the proxy advisory firm believes the terms of the plan are in line with the majority of
similar equity-based plans of TSX issuers. Glass Lewis’ view is that the plan will serve to strengthen the
alignment of company and shareholder interests. The Corporation believes that encouraging its executive
officers, senior management and employees to become shareholders is the best way of aligning their interests
with those of its long-term shareholders. As a result, executive officers management and employees are
provided with the opportunity to participate in the appreciation of the Corporation’s share price, through
Sernova’s equity compensation incentive plan.
Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy
It is up to you to protect the value of your investment in Sernova by voting FOR the eight management
nominees. We encourage you to read Sernova’s management information circular and visit our website at
www.sernova.com for more information. It is important that you ACT TODAY to protect your investment by
voting FOR Sernova’s management nominees.
Sernova’s management nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr.
Daniel Mahony, James Parsons, Dr. Philip Toleikis and Brett Whalen are committed to creating value for the
Company’s shareholders through delivering results from clinical trials, expanding the Sernova’s Cell Pouch
System™ technology platform for additional indications, and building on the relationships with the
Corporation’s business partners to create long term shareholder value.
YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT
NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN
Shareholders are encouraged to read Sernova’s management information circular and vote your shares as soon
as possible. The deadline for voting your shares is at 10:00 a.m. (Pacific Time) on Tuesday, April 25, 2023.
Sernova’s board of directors recommends that shareholders vote FOR all of the management director
nominees and meeting resolutions using only the WHITE proxy.
Shareholder Questions
Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation
agent and shareholder communications advisor:
Laurel Hill Advisory Group
Toll Free: 1-877-452-7184 (for shareholders in North America)
International: +1 416-304-0211 (for shareholders outside Canada and the US)
By Email: assistance@laurelhill.com
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 14, 2023 14 April, 2023
Institutional Shareholder Services Inc. Recommends Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy
- ISS, an independent, third-party proxy advisory firm, recommends Sernova’s shareholders vote FOR all
management’s director nominees using ONLY management’s WHITE proxy.
- ISS notes the dissidents failed to present a detailed explanation of their case and there does not seem to be a
compelling case that change at Sernova is warranted at this time.
- Shareholders who have questions or need assistance with voting their shares voting should contact Sernova
Corp.’s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452-
7184 or by email at assistance@laurelhill.com.
LONDON, Ontario – April 14, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB:
SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce
that Institutional Shareholders Services Inc. (“ISS”) has recommended Sernova’s shareholders vote FOR all of
Sernova’s management nominees using only management’s WHITE proxy.
ISS is a leading independent, third-party proxy advisory firm which provides proxy voting recommendations to
pension funds, investment managers, mutual funds, and other institutional shareholders.
Reasons for ISS’ Support of Sernova’s Management Nominees
In reaching its conclusion to recommend that Sernova’s shareholders vote FOR the Corporation’s management
nominees and reject the attempt of a group of dissident shareholders to impose their director nominees on
Sernova, ISS provided a number of reasons including the following:
“As the dissident has failed to present a detailed explanation of its case, there does not seem to be a
compelling case that change is warranted at this time. The case for change is further impaired by the fact that
the dissident has targeted two of the more tenured and experienced board members…. As such, the election of
the dissidents to the board carries risk to cause an additional near-term impact at the management level which
diverges from a status quo that does not seem unreasonable. Shareholders are therefore recommended to vote
on the management proxy card for the eight management nominees.”
ISS’ review of dissident shareholders reasons for proposing change on Sernova’s board shows that a number of
claims the dissidents made in their communications with Sernova’s shareholders are unsubstantiated:
“The dissident's arguments do not provide context in support of its claims, and the proposed solution does not
include a reasoned basis for how it could lead to a superior outcome. As the dissident has not made a
compelling case that board change is necessary at this time, votes on the management proxy card for the eight
management nominees are warranted…. Moreover, the company's ability to secure relevant industry
partnerships, as evidenced by its agreement secured with Evotec during 2022, seems difficult to call into
question. The board has overseen the successful up-listing of the company to the TSX and there are members
of the incumbent board which have sat on NASDAQ-listed biotech boards. In addition, the company seems to
communicate interim data or study progress updates to shareholders multiple times annually and continues to
provide this information at investor conferences, making broad-based allegations with respect to company
communication look dubious.”
Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy
It is up to you to protect the value of your investment in Sernova by voting FOR the eight management
nominees. We encourage you to read Sernova’s management information circular and visit our website at
www.sernova.com for more information. It is important that you ACT TODAY to protect your investment by
voting FOR Sernova’s management nominees.
Sernova’s management nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr.
Daniel Mahony, James Parsons, Dr. Philip Toleikis and Brett Whalen have reputational credibility in capital
markets to finance the growth of the Company. Sernova’s board and management team are committed to
creating value for the Corporation’s shareholders through delivering results from clinical trials, driving
preclinical programs, expanding the application of Sernova’s Cell Pouch System technology.
YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT
NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN
Shareholders are encouraged to read Sernova’s management information circular and vote your shares as soon
as possible. The deadline for voting your shares is at 10:00 a.m. (Pacific Time) on Tuesday April 25, 2023.
Sernova’s board of directors recommends that shareholders vote FOR all of the management director nominees
and meeting resolutions using only the WHITE proxy.
Shareholder Questions
Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation
agent and shareholder communications advisor:
Laurel Hill Advisory Group
Toll Free: 1-877-452-7184 (for shareholders in North America)
International: +1 416-304-0211 (for shareholders outside Canada and the US)
By Email: assistance@laurelhill.com
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
Investor
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.
Share the news Partagez les nouvelles
Press Release Communiqué de presse - April 10, 2023 10 April, 2023
Sernova to Present at 2023 Alliance for Regenerative Medicine Cell & Gene Meeting on the Med
LONDON, Ontario – April 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced that President and Chief Executive Officer, Dr.
Philip Toleikis, will present at the upcoming annual Cell & Gene Meeting on the Med to be held April 12-14,
2023 at the Hotel Arts Barcelona in Barcelona, Spain and livestreamed globally.
Panel: Navigating CGTx Development in 2023
Date: Wednesday, April 12, 2023
Time: 4:45 – 5:30 PM CET
Location: BioCentriq Ballroom | Hotel Arts Barcelona, Spain
Virtual attendance is available which includes a livestream of Sernova’s presentation and the ability to view all
conference sessions on-demand. Please visit https://meetingonthemed.com/ for full information including
registration.
Complimentary attendance at this event is available for credentialed investors. Investors should contact Laura
Stringham at lstringham@alliancerm.org.
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
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 - April 06, 2023 6 April, 2023
Sernova Responds to Dissident Shareholders' Misleading Statements and Provides Corporate Updates
- The dissident director nominees declined to follow proper protocol to participate in Sernova’s board renewal
process and instead are imposing themselves on the Company through a costly and disruptive proxy battle
- Management and the Board have placed Sernova in a position to bring value to shareholders and in a
challenging time for companies in the biotech sector, Sernova’s share price is up 17% year-to-date compared to
an 8% decline in the benchmark Nasdaq XBI biotech index over the same period
- Shareholders who have questions or need assistance with voting their shares should contact Sernova’s proxy
solicitation agent, Laurel Hill Advisory Group by telephone at 1-877-452-7184 or by email at
assistance@laurelhill.com
LONDON, Ontario – April 6, 2023 – Sernova Corp. (“Sernova” or the “Company”) (TSX:SVA) (OTCQB: SEOVF)
(FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today responds to misleading
statements made in a press release from a group of dissident shareholders. Additionally, Sernova is pleased to
highlight select upcoming milestones for the remainder of 2023 and into 2024 and provides an update on key
achievements and events since the Company’s last annual general meeting (AGM) in 2022.
BACKGROUND TO DISSIDENT ACTIONS AND BOARD RENEWAL PROCESS
Leading up to the Company’s 2023 annual meeting of shareholders and pursuant to Sernova’s Advance Notice
By-law, the Company received two nominations for the position of director to Sernova’s board of directors (the
“Board”) from the dissident shareholders. A third candidate also expressed interest in joining Sernova’s board
of directors. With three candidates to consider for a single board seat, the board’s Nominating and Governance
Committee (the “NGC”) invited all three candidates to participate in a formal review and rigorous evaluation
process, including presentation of their respective credentials and expertise to the board. Following good
corporate governance practices, Sernova’s NGC evaluates candidates against formalized criteria and a skills
matrix that align with the Company’s current, and more importantly, future needs to ensure the best candidates
are selected as nominees for election to the board.
The Dissident Shareholders’ claim that the board did not meaningfully engage is simply untrue
- Only one candidate, Mr. Brett Whalen, chose to participate in the formal process. After rigorous evaluation,
vetting and determination that his background and experience would be beneficial to the future direction of the
Company, Mr. Brett Whalen was selected for nomination for election to the board at Sernova’s 2023 annual
meeting of shareholders.
- The two individuals nominated by the dissident shareholder group elected not to participate in the interview
process nor did they meet with Sernova’s board. Instead, they have chosen to go the route of a costly and
distracting proxy battle.
The Dissident Shareholders are opposing the revised / amended compensation plan based on their claim that
management unilaterally decreased their price from $1.30 to $0.91, which is simply untrue
- No outstanding stock options have been repriced by the Company nor is there any intention.
- The pricing of any future stock options granted by the Company would be in compliance with the policies of
the TSX.
The current board members are well positioned to build on the progress the Company has made to date and
take Sernova to its next stage of development as outlined under the Corporate Updates below.
CORPORATE UPDATES
Sernova’s board and management team are committed to creating value for the Company’s shareholders
through delivering results from clinical trials, driving preclinical programs, expanding the Company’s Cell Pouch
System technology platform to additional indications, and evolving industry relationships for potential future
partnership opportunities to create long term shareholder value. The Company is providing the following
updates to keep shareholders abreast of developments and work that will create value for shareholders.
BIOTECH INDUSTRY PERFORMANCE AND SERNOVA SHARE PRICE
After a record-breaking year in 2021, 2022 was one of the most challenging years for the general healthcare
and biotech industries in capital markets history. Similar to that experienced by peer companies and healthcare
related industries as a whole, Sernova’s share price was negatively impacted with investors reallocating capital
to other market sectors. Despite the ongoing difficult markets, Sernova has made encouraging progress in 2023
as reflected in its share performance being up 17% year-to-date (as of April 3, 2023) compared to an 8%
decline in the Nasdaq XBI biotech index over the same period. The 25% relative advance of Sernova’s share
price compared to this benchmark index recognizes the sound fundamentals and progress as the Company
continues to deliver results from the clinic and evolve preclinical programs and key technologies to create long
term shareholder value.
UPCOMING EVENTS AND PROGRAM MILESTONES
- On April 24, 2023, the Company’s global iPSC strategic partner, Evotec SE (Evotec), will showcase the first
data on the use of its iPSC pancreatic islet-like clusters in Sernova’s Cell Pouch™ in a podium presentation at
the IPITA / HSCI / JDRF Summit. The peer reviewed abstract is entitled: “Manufacturing of Optimized Human
Islet-like Clusters (ILCs) from iPSCs and Functional Testing of an ILC + Cell Pouch Combination In Vivo.”
- On June 24, 2023, the research team of Dr. Piotr Witkowski, primary investigator for the Company’s ongoing
Phase 1/2 clinical trial for type-1 diabetes (T1D), will deliver an oral presentation at the American Diabetes
Association (ADA) 83rd Scientific Sessions, providing an update on interim results from patients enrolled and
treated in the ongoing study. The peer reviewed abstract is entitled: “Islet Allotransplantation into
Prevascularized Sernova Cell Pouch – Early Results from the University of Chicago.”
- During 2023 H2, Sernova anticipates providing the first interim data for the recently initiated second cohort
of patients for its ongoing Phase 1/2 T1D clinical trial using the dose-optimized higher capacity 10-channel Cell
Pouch.
- In 2024, Sernova plans to initiate a Phase 1/2 clinical trial for T1D with Evotec’s iPSC islet-like cluster
technology in Sernova’s Cell Pouch.
- In 2024, Sernova plans on initiating a Phase 1/2 clinical trial for treatment of hypothyroid disease following
complete thyroidectomy and transplanting a patient’s own healthy thyroid tissue into the Sernova Cell Pouch.
SELECT HIGHLIGHTS SINCE SERNOVA’S 2022 AGM
Advances in Sernova’s U.S. Phase 1/2 clinical trial for the treatment of T1D and hypoglycemia unawareness (the
“Phase 1/2 T1D Study”)
- November 2022 – Completion of enrollment for the first cohort of patients.
- November 2022 – Regulatory clearance received to proceed to enroll a second patient cohort (of up to seven
patients) with the dose optimized higher capacity 10-channel Cell Pouch.
- January 2023 – The first two patients in the second cohort were enrolled and implanted with the dose
optimized 10-channel Cell Pouch.
- March 2023 – The second cohort’s third patient was enrolled and implanted with the dose optimized 10-
channel Cell Pouch and initial islet transplantation completed for the first two patients.
May 2022 – Sernova signed a landmark iPSC stem cell technology deal with Evotec
- Sernova and Evotec entered an exclusive global strategic partnership to develop a best-in-class iPSC stem
cell-derived technology to provide a commercially viable supply of islet clusters for patients living with insulin-
dependent diabetes.
- Sernova has option exercise rights for an exclusive global license up to and upon filing of an IND.
- Evotec will contribute its cell manufacturing capabilities through research, development and product
commercialization and may also jointly fund future clinical development. Upon commercialization, royalties will
be payable by Sernova to Evotec with the royalty rate dependent on Evotec’s participation in funding of the
clinical development program.
- Evotec made a strategic investment into Sernova with an initial 6% equity stake.
June 2022 - Sernova common shares up-listed to the Toronto Stock Exchange (TSX)
- Transition from the TSX Venture Exchange to the TSX was part of the Company’s capital markets strategy to
pursue more senior exchange listings, at the appropriate time, to access a broader base of investors and
position the Company more favourably for institutional investment.
- This transition also further favourably readies the Company to leverage the unique advantages of the
Multijurisdictional Disclosure System (“MJDS”) available to qualifying Canadian companies for a potential
future senior U.S. exchange listing. A senior U.S. exchange listing would be contingent on further improvement
to the challenging capital markets for healthcare companies.
June 2022 – Dr. Piotr Witkowski presented positive interim Phase 1/2 clinical data in an oral podium
presentation at the American Diabetes Association 82nd Scientific Sessions
- The first three transplanted patients presented positive serum C-peptide values confirming active insulin
production after islet transplantation into the Cell Pouch System.
- All patients who had favorable immunosuppression achieved complete insulin independence with normal
HbA1c measurements of 5.0, 5.2 and 5.2%.
January 2023 – Hypothyroid program proof-of-concept confirmed and advancements announced
- A pre-clinical study confirmed proof-of-concept for the thyroid indication – the third indication for the
Company’s Cell Pouch System™ - demonstrating that thyroid auto-transplantation in the Cell Pouch can
compensate for removal of the thyroid gland (total thyroidectomy), restoring normal thyroid hormone
production.
- Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective
therapy for hypothyroidism.
FINANCIAL AND CASH RESOURCES UPDATE
- Sernova ended Q1 2023 with a strong balance sheet including cash resources of $45.6 million.
- Since the April 2022 AGM:
- Proceeds of $8 million were raised from the full exercise of the remaining outstanding 2019 and 2020
private placement common share purchase warrants.
- The Company completed a private placement with strategic partner Evotec resulting in a total equity
investment of $27 million.
VOTE TODAY USING ONLY MANAGEMENT’S PROXY
Shareholders are encouraged to read Sernova’s 2023 AGM Management Information Circular available on the
Company’s website at www.sernova.com/investor/agm. The best path forward is for shareholders to vote for
management’s slate of directors and the resolutions contained within.
YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S NOMINEES
USING ONLY MANAGEMENT’S PROXY AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES
YOU OWN
The deadline for voting your shares is at 10:00 a.m. Pacific Time on Tuesday April 25, 2023.
SHAREHOLDER QUESTIONS
Sernova shareholders who have any questions or require assistance with voting may contact Sernova’s proxy
solicitation agent and shareholder communications advisor:
Laurel Hill Advisory Group
Toll Free: 1-877-452-7184 (for shareholders in North America)
International: +1 416-304-0211 (for shareholders outside Canada and the US)
By email: assistance@laurelhill.com
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Contact Us Contactez-nous
Investor Relations Relations avec les investisseurs
Christopher Barnes
VP Investor Relations, Sernova
519.902.7923
christopher.barnes@sernova.com
Corey Davis, PH.D.
LifeSci Advisors, LLC
212.915.2577
cdavis@lifesciadvisors.com
Communications & Media Communications & Médias
Hannah Holmquist
LifeSci Communications
619.723.4326
hholmquist@lifescicomms.com
General Inquires Renseignements généraux
Toll free: 1.877.299.4603
Local: 519.858.5184
Fax: 519.858.5099
info@sernova.com
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address
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de la société
Sernova Corp.
700 Collip Circle, Ste 114
London, ON, Canada N6G 4X8
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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.
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