2024 Press Releases Communiqués de presse
Sernova Announces Key New Executive Appointments
Sernova to Present at the 2024 Cell & Gene Meeting on the Mesa
Sernova Appoints David Paterson Ph.D. to its Board of Directors
Sernova Announces New Positive Data from Phase I/II Trial Regarding Islet Survival and Function
Sernova to Participate in Upcoming H.C. Wainwright Investor Conference
Sernova Closes $5.2 Million Over-subscribed Non-brokered, Private Placement
Sernova Announces Oversubscribed Non-brokered Private Placement
Sernova Announces Up to $4 Million Private Placement Priced at a Premium
Lead Investigator for Sernova's Clinical Trial with Cell Pouch for Type 1 Diabetes to Deliver Oral Presentation at the 2024 EASD Annual Meeting
Sernova Corp. Announces Appointment of New Chief Executive Officer
Jonathan Rigby Appointed as Executive Chairman for Sernova
Sernova Announces Additional Patient Insulin Independent and Cohort 2 Enrollment Complete in Ongoing Phase I/II Clinical Trial for Treatment of Type 1
Sernova Announces Marketed Public Offering of Units
Sernova Appoints Jonathan Rigby to its Board of Directors
Sernova Announces AGM Voting Results
Sernova Provides Organizational Update
Sernova Welcomes Dr. Bernd Muehlenweg as Evotec’s Nominee for its Board of Directors
Sernova Provides Positive Clinical and Platform Portfolio Update
Sernova Announces Management Developments
Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones
Press Release Communiqué de presse - October 11, 2024 11 October, 2024
Sernova Announces Key New Executive Appointments
Experienced leadership team positions company to advance Cell Pouch™ bio-hybrid organ programs.
LONDON, Ontario; BOSTON, Massachusetts - October 11, 2024 – Sernova Corp. (TSX: SVA) (OTCQB:
SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company currently executing a phase 1/2
clinical study with its’ Cell Pouch™ bio-hybrid organ in type 1 diabetes is pleased to announce key new
appointments to its executive leadership team. This strategic move reflects Sernova's commitment to
enhancing communication with stakeholders and corporate governance, as the company drives its’
innovative research and ongoing clinical development programs.
James Parsons has been named Chief Financial Officer (CFO), bringing over 20 years of financial
management experience to the team. With a comprehensive track record in biotech corporate finance,
governance and strategic planning, Mr. Parsons will lead Sernova's finance team and ensure the company’s
financial strength to support expanding objectives.
Joining as Chief Communications Officer (CCO) is Marylyn Rigby, an accomplished professional with a rich
history in branding, corporate communications and biotech and health tech marketing. Ms. Rigby will direct
Sernova’s comprehensive communication strategies, enhancing marketing initiatives, expanding media
relationships, and elevating investor and stakeholder engagement, pivotal for bolstering Sernova's brand
identity and outreach.
David Burke assumes the role of Vice President of Investor Relations, tasked with fortifying connections with
the investment community. Bringing extensive experience in investor communications and financial markets,
Mr. Burke will ensure transparent, timely, and effective dialogue with current and prospective investors,
building trust and fostering long-term support for Sernova’s visionary projects.
Jonathan Rigby, CEO of Sernova Corp., expressed his enthusiasm for the appointments, stating, "We are
thrilled to welcome James, Marylyn, and David to our leadership team. Each brings a unique set of skills
and deep industry knowledge that will be vital as we continue to advance our pipeline and expand our
corporate presence. Their expertise aligns perfectly with our mission to Give Patients Their Lives Back
through our groundbreaking therapies."
These key appointments exemplify a step change in Sernova’s unwavering commitment to excellence and
innovation as it continues to drive forward novel treatments that aim to transform how chronic conditions are
treated in order to improve the lives of patients, their families, and their caregivers.
ABOUT SERNOVA CORP
Sernova Corp. is a clinical-stage company developing regenerative medicine therapeutics combining its Cell
Pouch™ with human donor cells or stem cells to create a bio-hybrid organ. A bio-hybrid organ refers to a
medical device designed to be implanted into the human body, where it integrates with existing living tissue
to replicate or enhance the function of a natural organ, essentially aiming to restore normal organ function
by combining living cells with non-living materials to mimic the properties of the original organ and
seamlessly interact with surrounding tissues. This innovative approach aims to deliver a potentially
revolutionary treatment for patients with chronic diseases, initially focusing on type 1 diabetes and thyroid
disorders.
FOR FURTHER INFORMATION, PLEASE CONTACT:
David Burke
VP, Investor Relations
(917) 618-2651
Email: David.Burke@sernova.com
Website: Sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy
of this news release.
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities
laws. Forward-looking statements in this press release include our expectations of the positive impact our
management changes will have on our operations.
With respect to the forward-looking statements contained in this press release, Sernova has made numerous
assumptions regarding, among other things: the company’s ability to secure additional financing on
reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the
company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the
risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended
October 31, 2023 filed with Canadian securities authorities and available at www.sedarplus.ca, as updated
by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking
statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any
obligation to revise or update any such forward-looking statements or to publicly announce the result of any
revisions to any of the forward-looking statements contained herein to reflect future results, events or
developments, except as required by law.
Press Release Communiqué de presse - October 03, 2024 3 October, 2024
Sernova to Present at the 2024 Cell & Gene Meeting on the Mesa
LONDON, Ontario; BOSTON, Massachusetts – October 3, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative
medicine cell therapies for treatment of chronic diseases, announced that its CEO, Jonathan Rigby, will be
presenting at the 2024 Cell & Gene Meeting on the Mesa being held October 7-9, 2024, at the Arizona Biltmore
Hotel in Phoenix, Arizona. The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference
bringing together senior executives and top decision-makers in the industry to advance cutting-edge research
into cell therapy cures.
Mr. Rigby’s presentation is scheduled to begin at 10:00 A.M. MT (12:00 P.M. ET) on Monday, October 7, 2024.
The presentation will include updates on Sernova’s type 1 diabetes phase 1/2 clinical trial at the University of
Chicago, and its pre-clinical work with Evotec to advance a potential iPSC-based (induced pluripotent stem cell)
islet replacement therapy with Sernova’s Cell Pouch™ Transplant System.
ABOUT SERNOVA AND ITS CELL POUCH™ TRANSLPLANT 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 technology, the Cell Pouch Transplant 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 allowing long-term
survival and function of therapeutic cells that release essential factors that are absent or deficient in patients with
certain chronic diseases. Sernova’s Cell Pouch Transplant System has demonstrated its potential to be a
‘functional cure’ for people with T1D in an ongoing Phase I/II clinical study at the University of Chicago.
Sernova partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch Transplant System also includes: 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:
David Burke
VP, Investor Relations
Sernova Corp.
Tel: +1 917-618-2651
Email: david.burke@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of
this news release.
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.sedarplus.ca for additional information on risks and uncertainties relating to the
forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - September 19, 2024 19 September, 2024
Sernova Appoints David Paterson Ph.D. to its Board of Directors
Sernova Appoints David Paterson Ph.D. to its Board of Directors
LONDON, Ontario; BOSTON, Massachusetts – September 19, 2024 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of
regenerative medicine cell therapies for treatment of chronic diseases, announces today that David Paterson
Ph.D. will join Sernova’s Board of Directors effective immediately.
“I am pleased to have been able to attract David’s Paterson’s significant talent to Sernova’s Board of Directors,”
said Jonathan Rigby, President and Chief Executive Officer of Sernova. “Mr. Paterson brings more than 30 years
of biotech experience with substantial contributions as both a senior executive, Board member and founder of
numerous companies with a focus on corporate and business development, intellectual property generation
and prosecution and alliance management.”
Mr. Paterson is currently employed at Colorado State University as Assistant Vice President for Research
Translation and Commercialization where he manages strategic industry relationships. In addition, he brings
broad biopharma industry knowledge having worked for Impax Laboratories (IPXL: NASDAQ) in both Europe
and North America where he provided leadership and Board support to the business development team for ten
years until its acquisition by Amneal Pharmaceuticals (AMRX: NASDAQ). Prior to Impax, Mr. Paterson held
senior roles with Sepracor (Sunovion), GlaxoSmithKline and Skyepharma. Mr. Paterson is also a co-founder of
Neurogastrx, Inc helping to bring in early-stage capital. Mr. Paterson has a Batchelor of Science from the
University of Glasgow, a Ph.D. from the University of Illinois and was a Post-Doctoral Fellow in Molecular
Genetics and Cellular Biology at the University of Chicago.
“I am very excited to be joining the Board of Sernova and offer up my scope of expertise to help the company
grow and prosper within the type 1 diabetes space and to help open doors to new collaborations and further
establish the Cell Pouch Transplantation System as a top tier technology within the Regenerative Medicine Cell
Therapy sector,” said David Paterson.
ABOUT SERNOVA AND ITS 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 technology, 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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of
this news release.
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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - September 12, 2024 12 September, 2024
Sernova Announces New Positive Data from Phase I/II Trial Regarding Islet Survival and Function
Sernova Announces New Positive Data from Phase I/II Trial Regarding Islet Survival and Function
- Abundant, richly vascularized and functioning islets observed throughout all chambers of Sernova’s Cell Pouch
more than 5 years after islet transplantation
- Histological data confirmation of healthy beta, alpha and delta cells secreting insulin, glucagon, and
somatostatin in all Cell Pouch Chambers
- Sernova’s Cell Pouch safely contains its therapeutic cells and provides full retrievability using conventional
instruments and methods
- Pathology confirmed no evidence of detrimental fibrotic tissue associated with Cell Pouch more than 5 years
after implantation
LONDON, Ontario; BOSTON, Massachusetts – September 12, 2024 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of
regenerative medicine cell therapies for treatment of chronic diseases today announced the presentation of new
positive interim data from the ongoing Phase I/II clinical trial evaluating the safety, tolerability, and efficacy of
the Sernova Cell Pouch Transplant System containing donor islets in people living with type 1 diabetes (T1D).
The data was presented by Piotr Witkowski, M.D., Ph.D., Professor of Surgery and Director of the Pancreatic
and Islet Transplant Program at University of Chicago Medicine, who is the Lead Investigator for the study,
during an oral session at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting in
Madrid, Spain.
All 6 of the patients enrolled in Cohort A of Sernova’s Phase I/II clinical trial with Cell Pouch and donor islets
achieved sustained insulin independence after combined islet transplantation into Cell Pouch and intraportally.
The first patient to be treated in the trial experienced sustained insulin independence for more than 4 years
accompanied by blood sugar levels in the non-diabetic range (HbA1c ≤6.5%). More than 5 years after the first
islet transplant, the patient’s Cell Pouches containing the transplanted islets were removed because immune
suppression had to be stopped when that patient developed other, nondiabetic health issues not related to Cell
Pouch or transplanted islets.
The new histological data from those explanted Cell Pouches confirmed abundant, well-vascularized,
functioning islets consisting of cells producing insulin, glucagon and somatostatin, throughout all chambers,
more than 5 years after being transplanted to Cell Pouch. Additionally, after being in the body for more than 5
years, a pathology examination confirmed there was no evidence of detrimental fibrotic tissue, material
degradation or changes in the architecture of the Sernova Cell Pouch.
“I am excited to see this evidence of well-vascularized and healthy islets 5 years after transplant to Sernova’s
Cell Pouch; these interim findings are very promising,” commented Piotr Witkowski M.D., Ph.D. “This is a major
step forward in the development of a contained and retrievable cell therapy for the treatment of T1D. This is
the first evidence that I am aware of that demonstrates this level of healthy islet survival and function in an
implantable and retrievable system for such a long duration.”
“We believe this first-in-world data is significant for Sernova and, more specifically, provides tangible hope for
T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible
disease; as a Type 1 diabetic myself I could not be more determined to drive our program forward and
ultimately onto the market,” said Jonathan Rigby, President and CEO of Sernova. “We look forward to
completing Cohort B in the near term and, based on positive data generated thus far, initiating Cohort C of our
ongoing trial later this year with an optimized immune suppression regimen. Lastly, we continue to work with
our partner Evotec on the development of induced pluripotent stem cell (iPSC)-derived islet-like clusters, which
will provide a scalable cell source so that one day we can give patients with T1D their lives back”
ABOUT THE PHASE I/II TRIAL
The Phase I/II trial (NCT03513939) is a U.S. prospective, single-arm, multi-cohort study evaluating the safety,
tolerability, and efficacy of Sernova’s Cell Pouch in combination with transplanted human-donor islets in people
living with type 1 diabetes (T1D). The trial includes participants aged 18-65 with T1D who experience
hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet
transplantation. The trial is currently divided into two cohorts. Cohort A involved six patients who received the
first-generation 8-channel Cell Pouch. Cohort B is evaluating seven patients transplanted with an optimized 10-
channel Cell Pouch, which has a 50% greater islet capacity than the Cell Pouch used in Cohort A. As part of the
process, patients are implanted with the Cell Pouch subcutaneously. Approximately six weeks later - allowing
time to establish a stable immunosuppression therapy for the patient - islets are transplanted into the
prevascularized tissue chambers formed by the Cell Pouch. Safety and efficacy are assessed throughout the 12
months following the last islet transplant. Patients still dependent on insulin 6 months after the second islet
transplant may qualify for a third transplant via the portal vein. Those who retain implants will be followed for
at least three years. The secondary objectives of the trial include the following efficacy endpoints: continuous
glucose monitoring, production of C-peptide, insulin use, HbA1c levels, and the frequency of severe
hypoglycemic episodes.
ABOUT SERNOVA AND ITS CELL POUCH™ TRANSPLANT 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 technology, the Cell Pouch Transplant 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 allowing long-
term survival and function of therapeutic cells that release essential factors that are absent or deficient in
patients with certain chronic diseases. Sernova’s Cell Pouch Transplant System has demonstrated its potential
to be a ‘functional cure’ for people with T1D in an ongoing Phase I/II clinical study at the University of Chicago.
Sernova partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch Transplant System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or
adequacy of this news release.
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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - September 05, 2024 5 September, 2024
Sernova to Participate in Upcoming H.C. Wainwright Investor Conference
Sernova to Participate in Upcoming H.C. Wainwright Investor Conference
LONDON, Ontario – September 5, 2024 – 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 H.C. Wainwright 26th Annual Global Investment Conference being held September 9 to 11, 2024
in New York City at the Lotte New York Palace. Company management will also be participating in one-on-
one investor meetings at the conference.
Sernova’s presentation will be webcast, details as follows:
Sernova Corporate Presentation Date & Time: 11:00AM ET, September 11, 2024 presented by Jonathan
Rigby, President & Chief Executive Officer, Sernova Corp Location:
https://journey.ct.events/view/c4b9e5c3-766e-4c11-a345-bedcacb42ce8
Please contact your representative at H.C. Wainwright to schedule a one-on-one meeting with the
management team during the conference.
ABOUT SERNOVA AND ITS 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 and thyroid disease. Sernova is currently focused on
developing a ‘functional cure’ for insulindependent diabetes with its lead technology, 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 allowing long- term survival and
function of therapeutic cells that release essential factors that are absent or deficient in 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 collaborating
with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership is expected to provide Sernova a potentially unlimited supply of
insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2).
Sernova’s Cell Pouch System development pipeline also includes 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:
Christopher Barnes
VP Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the
accuracy or adequacy of this news release.
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 forwardlooking statements contained in this news release. Such factors
could include, but are not limited to, the company’s ability to secure additional financing and/or licensing
arrangements on reasonable terms, or at all; 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;
obtain all necessary regulatory approvals, or on a timely basis; in-license additional complementary
technologies; 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.sedarplus.ca for
additional information on risks and uncertainties relating to the forward-looking statements. Sernova
expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
Press Release Communiqué de presse - September 04, 2024 4 September, 2024
Sernova Closes $5.2 Million Over-subscribed Non-brokered, Private Placement
SERNOVA CLOSES $5.2 MILLION OVER-SUBSCRIBED NON-BROKERED, PRIVATE PLACEMENT
LONDON, ONTARIO – September 4, 2024 - Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE: PSH) is
pleased to announce that it has closed its non-brokered, private placement in the amount over $5.2 million,
which includes over-subscriptions of more than $1.2 million.
All securities issued pursuant to the private placement are subject to a hold period of four months under
applicable provincial securities laws in Canada. The private placement was announced on August 20, 2024,
and closed on September 3, 2024.
On Thursday September 12 at the 2024 EASD Annual Meeting in Madrid, Spain, Sernova’s principal clinical
study investigator will provide an update on recent data generated from its phase I/II clinical study of Cell
Pouch™ containing human donor islets for the treatment of type 1 diabetes.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities
in the United States. The securities have not been and will not be registered under the United States
Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be
offered or sold within the United States unless registered under the U.S. Securities Act and applicable state
securities laws or an exemption from such registration is available.
ABOUT SERNOVA AND ITS 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 and thyroid disease. Sernova is currently focused on
developing a ‘functional cure’ for insulindependent diabetes with its lead technology, 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 allowing long-
term survival and function of therapeutic cells that release essential factors that are absent or deficient in
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 collaborating with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem
cells) based islet replacement therapy. This partnership is expected to provide Sernova a potentially
unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type
1 and type 2). Sernova’s Cell Pouch System development pipeline also includes 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:
Christopher Barnes
VP Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy
of this news release.
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 forwardlooking statements contained in this news release. Such factors
could include, but are not limited to, the company’s ability to secure additional financing and/or licensing
arrangements on reasonable terms, or at all; 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;
obtain all necessary regulatory approvals, or on a timely basis; in-license additional complementary
technologies; 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.sedarplus.ca for
additional information on risks and uncertainties relating to the forward-looking statements. Sernova
expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
Press Release Communiqué de presse - August 29, 2024 29 August, 2024
Sernova Announces Oversubscribed Non-brokered Private Placement
SERNOVA ANNOUNCES OVERSUBSCRIBED NON-BROKERED PRIVATE PLACEMENT
THIS NEWS RELEASE IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR
DISSEMINATION IN THE UNITED STATES.
LONDON, ONTARIO - August 29, 2024 - Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE: PSH) is pleased to
announce that its non-brokered, private placement offering of $4M is oversubscribed with $4.7M of binding
agreements received. The closing will occur on Tuesday September 3, 2024, subject to TSX approval.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in
the United States. The securities have not been and will not be registered under the United States Securities Act
of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold
within the United States unless registered under the U.S. Securities Act and applicable state securities laws or
an exemption from such registration is available.
ABOUT SERNOVA AND ITS 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 and thyroid disease. Sernova is currently focused on
developing a ‘functional cure’ for insulindependent diabetes with its lead technology, 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 allowing long- term survival and
function of therapeutic cells that release essential factors that are absent or deficient in 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 partnered with
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 cells to treat
millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that
uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or
adequacy of this news release.
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
forwardlooking statements contained in this news release. Such factors could include, but are not limited to, the
company’s ability to complete the Offering, in part or at all; secure additional financing and/or licensing
arrangements on reasonable terms, or at all; 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;
obtain all necessary regulatory approvals, or on a timely basis; in-license additional complementary
technologies; 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.sedarplus.ca for
additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly
disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Press Release Communiqué de presse - August 20, 2024 20 August, 2024
Sernova Announces Up to $4 Million Private Placement Priced at a Premium
Sernova Announces Up to $4 Million Private Placement Priced at a Premium
THIS NEWS RELEASE IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR
DISSEMINATION IN THE UNITED STATES.
LONDON, ONTARIO - August 20, 2024 - Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE: PSH) is pleased to
announce that the Company has secured over $2 million in lead orders in connection with a non-brokered
private placement offering (the “Offering”) for up to $4 million units priced at a premium to the market.
Each unit is priced at $0.25, and consists of one common share and one warrant. Each warrant is priced at
$0.30 per share and is exercisable for a period of 18 months, subject to Sernova’s option to shorten the exercise
period if the 20-day volume-weighted average price of the Company’s shares exceeds $0.50.
The net proceeds from the private placement will be used to continue enrolment in the Company's US-based
Phase I/II Type 1 diabetes clinical trial, to advance an IND filing for its post-operative hypothyroidism program
and for general corporate purposes.
Newly appointed Sernova CEO Jonathan Rigby stated, “We are pleased to announce a financing round led by
legacy investors with insider participation. Our goal is to secure sufficient capital to maintain ongoing clinical
initiatives. The company recently announced that data from its ongoing clinical trial of its Cell Pouch™
technology containing donor Islet cells to treat Type 1 diabetes will be presented at the European Association
for the Study of Diabetes (EASD), 9-13 September in Madrid, Spain.”
All securities issued in connection with the private placement will be subject to a statutory hold period of four
months. Completion of the private placement is subject to customary closing conditions, including acceptance
of the TSX. The private placement is expected to close prior to August 28, 2024.
The Company expects insider participation in the Offering, which may be considered a related party transaction
within the meaning of Multilateral Instrument 61-101 (“MI 61-101”). Sernova intends to rely on the exemptions
from the valuation and minority shareholder approval requirements of MI 61-101 contained in Sections 5.5(a)
and 5.7(1)(a) of MI 61-101 in respect of any insider participation.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in
the United States. The securities have not been and will not be registered under the United States Securities Act
of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold
within the United States unless registered under the U.S. Securities Act and applicable state securities laws or
an exemption from such registration is available.
ABOUT SERNOVA AND ITS 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 and thyroid disease. Sernova is currently focused on
developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, 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 allowing long-
term survival and function of therapeutic cells that release essential factors that are absent or deficient in
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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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 complete the Offering, in part or at all; secure additional financing and/or licensing
arrangements on reasonable terms, or at all; 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;
obtain all necessary regulatory approvals, or on a timely basis; in-license additional complementary
technologies; 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.sedarplus.ca for
additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly
disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Press Release Communiqué de presse - August 15, 2024 15 August, 2024
Lead Investigator for Sernova's Clinical Trial with Cell Pouch for Type 1 Diabetes to Deliver Oral Presentation at the 2024 EASD Annual Meeting
Lead Investigator for Sernova’s Clinical Trial with Cell Pouch for Type 1 Diabetes to Deliver Oral Presentation at
the 2024 EASD Annual Meeting
- Dr. Piotr Witkowski MD PhD, Professor of Surgery and Director of the Pancreatic and Islet Transplant Program,
and his islet transplant team at University of Chicago Medicine authored an abstract that will be presented,
including new data from the ongoing Phase I/II clinical trial of the Cell Pouch System™ in patients with type 1
diabetes (T1D).
LONDON, Ontario; BOSTON, Massachusetts – August 15, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative
medicine cell therapies for treatment of chronic diseases such as Type 1 Diabetes, today announced a short
oral presentation at the upcoming European Association for the Study of Diabetes (EASD) taking place
September 9-13, 2024 in Madrid, Spain.
Additional details, including accepted abstracts, are available on the EASD website at www.easd.org In
alignment with the embargo policy, Sernova plans to share details from Dr. Witkowski’s talk, following the
presentation.
Presentation details:
European Association for the Study of Diabetes - 2024 Annual Meeting – Madrid, Spain Oral Event F: Improving
Islet Transplantation - Thursday September 12, 2024 2:00pm to 3:00pm Central European Time
Abstract # 447: Islet allotransplantation into pre-vascularized Sernova Cell Pouch™: Interim Results: P.
Witkowski, N. Wojcik, S. Gondek, J. Tomecki, K. Milejczyk, B. Juengel, L. Wang, J. J. Fung, R. Barth, USA.
Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions to
expand the scope and impact of its technology. The company anticipates further advancements as it progresses
through additional cohorts and trials, with the ultimate goal of offering a scalable solution for insulin-dependent
diabetes plus other chronic diseases.
ABOUT SERNOVA AND ITS 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 technology, 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 allowing long-
term survival and function of therapeutic cells that release essential factors that are absent or deficient in
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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - August 12, 2024 12 August, 2024
Sernova Corp. Announces Appointment of New Chief Executive Officer
SERNOVA CORP. ANNOUNCES APPOINTMENT OF NEW CHIEF EXECUTIVE OFFICER
LONDON, Ontario; BOSTON, Massachusetts – August 12, 2024. Sernova Corp. (“Sernova” or the
“Company”) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused
on the development of regenerative medicine cell therapies for treatment of chronic diseases, led by an
ongoing phase 1/2a clinical trial in type 1 diabetes, is pleased to announce Mr. Jonathan Rigby as the
Company’s new Chief Executive Officer.
James Parsons, on behalf of the Board of Directors of Sernova, stated, “The Board believes that Sernova is
now positioned to achieve its strategic milestones under Jonathan’s leadership. Jonathan brings a track
record of success raising equity capital for biotech companies. Jonathan has led multiple biotech companies
through listings onto Nasdaq, and the achievement of key operational and clinical developments, leading to
strategic acquisitions that have generated significant value for shareholders.”
On his appointment, Mr. Rigby commented, “As a type 1 diabetic myself, I am honored to serve the company
and its shareholders as Sernova’s new CEO. I am passionate about Sernova’s mission and determined to lead
the Company to realize its full potential. I have financed and grown multiple companies through to exits and
my goal is clear; I will work tirelessly with the team to do the same for Sernova and its shareholders.”
Mr. Rigby has held several CEO roles and currently serves on the board of directors of cancer therapy
company, Oncolytics Biotech Inc. (Nasdaq: ONCY), and IM Therapeutics, working in the diabetes field. He
was formerly a board member of Xeris Pharmaceuticals (Nasdaq: XERS), which developed and
commercialized a product to treat type 1 diabetes severe hypoglycemia. Mr. Rigby holds a degree in
biological sciences from the University of Sheffield, U.K., and has a master of business administration degree
from the University of Portsmouth, U.K.
The Board thanks Ms. Cynthia Pussinen, the Company’s former CEO, for her dedication and service to the
Company and wishes her the very best in her future endeavors.
ABOUT SERNOVA CORP.
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies that
are implanted in patients inside its Cell PouchTM System for chronic diseases, including an ongoing phase
1/2a trial in insulin-dependent diabetes and plans to enter the clinic in 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. In May 2022, Sernova and Evotec entered
into a global strategic partnership to develop an implantable iPSC (induced pluripotent stem cells) based
Cell Pouch 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 evaluate the potential for 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
519-902-7923
www.sernova.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.sedarplus.ca for additional information on risks and uncertainties relating to the forward-
looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-
looking statements, whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - July 15, 2024 15 July, 2024
Jonathan Rigby Appointed as Executive Chairman for Sernova
LONDON, Ontario; BOSTON, Massachusetts – July 15, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative
medicine cell therapies for treatment of chronic diseases such as Type 1 Diabetes, today announced that the
Board of Directors has appointed Jonathan Rigby, who previously joined as a Director in May, as Executive
Chairman effective immediately. Brett Whalen, who was previously Chairman, has resigned from the Board.
These changes continue carefully curated management and Board transitions aimed at positioning Sernova to
enter the next phase of the Company’s growth and evolution.
As Executive Chairman Mr. Rigby will focus on partnering with company leadership on capital markets efforts
for Sernova as well as leadership of the Board. Cynthia Pussinen, the Company’s Chief Executive Officer, will
continue in her role as originally defined managing Sernova’s day to day business strategy and operations; she
will continue to report to the Board.
“We welcome Jonathan to his expanded role as Executive Chairman to increase our focus on capital markets
where he has a demonstrated track record of success through multiple capital raises, Nasdaq listings and
successful exits of several biotech companies,” said James Parsons, Director of Sernova. “The Board fully
supports the leadership team and Jonathan will further augment our overall Company strength. We are grateful
to Brett for his Chairmanship.”
“I am delighted to serve the Company and its shareholders as Executive Chairman with passion and
enthusiasm. As a sufferer myself, I will do all I can to help the Company give lives back to patients suffering
from diseases such as Type 1 Diabetes” said Jonathan Rigby, Executive Chairman. “I have financed and grown
multiple companies through to exits and my goal is quite clear, I will work tirelessly with the team to do the
same for Sernova and its shareholders.
Mr. Rigby has held several CEO roles and currently serves on the Board of Directors of cancer therapy company
Oncolytics Biotech Inc. (NASDAQ: ONCY) and IM Therapeutics and was formerly on the board of Xeris
Pharmaceuticals (NASDAQ: XERS). Mr. Rigby holds a degree in Biological Sciences from the University of
Sheffield, UK, and has a Master of Business Administration degree from the University of Portsmouth, UK.
Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions to
expand the scope and impact of its technology. The company anticipates further advancements as it progresses
through additional cohorts and trials, with the ultimate goal of offering a scalable solution for insulin-dependent
diabetes plus other chronic diseases.
ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - June 25, 2024 25 June, 2024
Sernova Announces Additional Patient Insulin Independent and Cohort 2 Enrollment Complete in Ongoing Phase I/II Clinical Trial for Treatment of Type 1 Diabetes
Sernova Announces Additional Patient Insulin Independent and Cohort 2 Enrollment Complete in Ongoing
Phase I/II Clinical Trial for Treatment of Type 1 Diabetes
- To date Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin
injections and demonstrate blood sugar control in the non-diabetic range (HbA1c <6.5%);
- 6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from
severe hypoglycemic episodes;
- Completion of enrollment in Cohort 2
LONDON, Ontario; BOSTON, Massachusetts – June 25, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company, today announces developments in its Phase I/II
clinical trial investigating a novel treatment for Type 1 Diabetes (T1D). To date a total of 7 patients across
Cohorts 1 and 2 have achieved insulin independence following transplants of human donor islets via Sernova’s
proprietary Cell Pouch System™ and a marginal portal vein top up. Additionally, the study, which is being
conducted at the University of Chicago, completed full enrollment of the second cohort of patients with the last
patient being enrolled June 24, 2024.
At baseline, all patients in the study were dependent on multiple daily insulin injections with average HbA1c
levels (a measure of glucose control over the prior 2 to 3 months) greater than 6.5% across the study
population. In addition, prior to enrollment in the study, patients had a history of severe hypoglycemic events (a
potentially life-threatening drop in blood sugar leading to impaired cognition and consciousness) and
undetectable plasma levels of C-peptide (a marker of natural insulin production). Insulin independence in these
first 7 patients has been accompanied by freedom from severe hypoglycemic events, sustained HbA1c levels in
the non-diabetic range (HbA1c <6.5%), and persistent transplant-mediated insulin production measured by
plasma C-peptide.
The trial, which focuses on Sernova’s Cell Pouch technology, demonstrates that insulin independence and
additional clinically meaningful patient outcomes were achieved with lower than traditional islet masses infused
intra-portally, indicating an important contribution of the islet grafts in Cell Pouch to the observed favorable
blood glucose control. Sernova continues to be the first and only company to announce positive patient
outcomes in a clinical trial for T1D that combines donor islets transplanted via an implantable delivery vehicle
that also has full payload containment and retrievability capabilities should it be required, as evidenced by the
first patient in Cohort 2. Interim data from this study indicates that Cell Pouch is generally safe and well
tolerated and, when transplanted with donor islets, contributes to the reversal of T1D, potentially minimizing
the long-term comorbidities that include heart and kidney disease, blindness and amputation. The Company
anticipates announcing additional trial results for the remaining 5 patients in Cohort 2, later in the year.
Cynthia Pussinen, CEO of Sernova, expressed "we are excited with and encouraged by the impressive progress
of our ongoing Phase I/II clinical trial with donor islets and Cell Pouch. The ability to achieve sustained insulin
independence, HbA1c levels in the non-diabetic range and reductions in severe hypoglycemic events in
patients, using a retrievable payload device, signifies a transformative step forward in the treatment – and
essentially functional cure - of Type 1 Diabetes. Sernova remains committed to advancing the potential of our
Cell Pouch technology to significantly improve the lives of patients and their families worldwide.”
Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions
to expand the scope and impact of its technology. The company anticipates further advancements as it
progresses through additional cohorts and trials, with the goal of offering a scalable solution for insulin-
dependent diabetes plus other chronic diseases.
About Sernova
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 technology, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells.
Sernova partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2).
Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
About Sernova’s Cell Pouch for use with Cell Therapeutics
On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing
longterm 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. The Cell Pouch technology integrates with the body's natural biological processes, creating a
biocompatible environment for the delivery of therapeutic cells previously missing from the body including
cells, hormones, blood factors and tissues. This innovative approach aims to provide a durable and sustainable
treatment option for Sernova’s lighthouse program to treat individuals living with T1D, with additional future
therapeutic programs to follow for hypothyroidism and hemophilia A.
For further information, please contact:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - June 11, 2024 11 June, 2024
Sernova Announces Marketed Public Offering of Units
NEWS RELEASE
Sernova Announces Marketed Public Offering of Units
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE
UNITED STATES
LONDON, Ontario; BOSTON, Massachusetts – June 6, 2024, Sernova Corp. (“Sernova” or the “Company”)
(TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH) is pleased to announce that it has filed a preliminary short
form prospectus in connection with a best efforts marketed public offering (the “Offering”) of units of the
Company (the “Units”). The Offering is being led by Stifel Nicolaus Canada Inc., as lead agent (the “Lead
Agent”) and joint bookrunner with Leede Jones Gable Inc., on behalf of a syndicate of agents that includes
Ventum Financial Corp., Raymond James, Research Capital Corporation and Roth Canada, Inc. (together
with the Lead Agent, the “Agents”) and is for minimum gross proceeds of $6,500,000 and up to maximum
gross proceeds of $10,000,000. Each Unit will be offered at a price of $0.33 per Unit (the “Offering Price”),
and shall consist of one (1) common share of the Company (each, a “Common Share”) and one (1) Common
Share purchase warrant (a “Warrant”). Each Warrant will entitle the holder to purchase one Common Share
(each, a “Warrant Share”) at an exercise price of $0.40 per Warrant Share for 36 months. It is expected that
a definitive agency agreement will be entered into between the Company and the Agents following the
successful marketing of the Offering.
The Company has agreed to grant the Agents an option (the “Over-Allotment Option”) to sell up to an
additional number of Units at the Offering Price as is equal to 15% of the number of Units issued pursuant to
the Offering, exercisable in whole or in part, at any time and from time to time on or prior to the date that is
30 days following the Closing Date (as defined below) to cover over-allotments, if any, and for market
stabilization purposes. The Over-Allotment Option shall be exercisable for any number of Units, Common
Shares, Warrants, or any combination thereof at a price equal to the Offering Price for a Unit and a price to
be agreed upon for the Common Shares and Warrants.
The Company plans to use the net proceeds from the offering to expand enrollment in the Company’s phase
I/II Human Donor Islet clinical study, to support the Company’s R&D activities and for general corporate
purposes. In addition Sernova would like to announce that Evotec SE, its largest shareholder and
collaboration partner, will participate in the offering.
The Offering is scheduled to close on or about June 20, 2024 (the “Closing Date”), and is subject to certain
conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the
Toronto Stock Exchange (the “Exchange”).
A preliminary short form prospectus containing important information relating to the Offering has been filed
with the securities regulatory authorities in each of the provinces in Canada, other than the Province of
Québec, and is still subject to completion or amendment. The preliminary short form prospectus is available
via SEDAR+ at www.sedarplus.ca. Alternatively, the Company, any Agent or any dealer participating in the
Offering will arrange to send you the preliminary short form prospectus upon request from the Lead Agent at
ecmcanada@stifel.com.
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities
in the United States. The securities have not been and will not be registered under the United States
Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities laws and may not
be offered or sold to or for the account or benefit of persons in the “United States” or “U.S. persons” (as
such terms are defined in Regulation S under the U.S. Securities Act) unless registered under the U.S.
Securities Act and applicable state securities laws or an exemption from such registration is available.
ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations Sernova Corp.
christopher.barnes@sernova.com
519-902-7923 www.sernova.com
Press Release Communiqué de presse - May 28, 2024 28 May, 2024
Sernova Appoints Jonathan Rigby to its Board of Directors
Sernova Appoints Jonathan Rigby to its Board of Directors
LONDON, Ontario; BOSTON, Massachusetts – May 28, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative
medicine cell therapies for treatment of chronic diseases, announces today that Jonathan Rigby will join
Sernova’s Board of Directors effective immediately.
“We are excited to welcome Jonathan to Sernova’s Board of Directors. With more than 30 years of diverse
experience across the biopharmaceutical landscape, Jonathan brings a track record of substantial
contributions across our sector as a biotech CEO and Board member. He will both complement and
augment the expertise and composition of our current Board,” said Cynthia Pussinen, Chief Executive
Officer of Sernova. “We welcome Jonathan’s passion for improving the lives of patients and his guidance on
accelerating delivery of our development programs.”
Mr. Rigby has a breadth of industry knowledge and productive experience having served as President and
CEO of Revolo Biotherapeutics where he took the company through multiple financings and two Phase 2
clinical trials, as well as serving as Chairman and Chief Business Officer of BIOS Acquisition Corporation
(NASDAQ: BIOS), with an oversold IPO. Mr. Rigby served as the CEO for SteadyMed Therapeutics (NASDAQ:
STDY), which he listed on Nasdaq prior to its acquisition by United Therapeutics (NASDAQ: UTHR), and was
co-founder of Zogenix (NASDAQ:ZGNX), which was also acquired by UCB (Euronext: UCB) after completing
a NASDAQ listing.
In addition, Mr. Rigby currently serves on the Board of Directors of cancer therapy company Oncolytics
Biotech Inc. (NASDAQ: ONCY) and IM Therapeutics which is developing therapies for Type 1 diabetes (T1D).
He is a past Board Member of Thermalin Inc., which engineered new forms of insulin to improve patient lives
and outcomes for the treatment of T1D and was formerly on the board of Xeris Pharmaceuticals (NASDAQ:
XERS) which developed and commercialised a therapy to treat T1D severe hypoglycemia. Mr. Rigby holds a
degree in Biological Sciences from the University of Sheffield, UK, and has a Master of Business
Administration degree from the University of Portsmouth, UK.
“As an individual with T1D, I am acutely aware of the challenges of living with this life changing condition and
the need to effectively cure the disease. Given Sernova’s vision of a future where chronic conditions are no
longer insurmountable obstacles, and their foundational work on delivering a ‘functional cure’ for T1D, I am
especially excited to join the Board and work hard to progress the company forward. Sernova represents a
new era of development for cell therapy treatments and I look forward to working with the Board and the
leadership team in advancing Sernova’s groundbreaking technology and therapies,” said Mr. Rigby.
ABOUT SERNOVA AND ITS 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 technology, 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 partnered with 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 cells to treat millions of
patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its
Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on risks and uncertainties relating to the forward-
looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-
looking statements, whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - May 01, 2024 1 May, 2024
Sernova Announces AGM Voting Results
SERNOVA ANNOUNCES AGM VOTING RESULTS
LONDON, Ontario; BOSTON, Massachusetts – May 1, 2024, Sernova Corp. (“Sernova” or the “Corporation”)
(TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH) a clinical-stage biotechnology company focused on the
development of regenerative medicine cell therapies for treatment of chronic diseases, is pleased to announce
results from its Annual General Meeting of Shareholders (the “AGM”) held virtually via live audio webcast, on
April 30, 2024. At the Meeting, a total of 88,316,160 common shares were voted, representing 29.11% of the
votes attached to all outstanding common shares as of the record date. The voting results were as follows:
Director | % of Votes For | % of Votes Against |
Cynthia Pussinen | 95.62% | 4.38% |
James T. Parsons | 98.63% | 1.37% |
Dr. Steven Sangha | 96.43% | 3.57% |
Brett A. Whalen | 73.91% | 26.09% |
Accordingly, Cynthia Pussinen, James T. Parsons, Dr. Steven Sangha and Brett A. Whalen were elected to the
board of directors for the ensuing year. In addition, Bernd Muehlenweg was appointed to the board of directors
following the AGM. Bertram von Plettenberg resigned from the board of directors prior to the AGM and did not
stand for election at the AGM.
Shareholders also approved (with 99.79% of the votes approving) the re-appointment of KPMG LLP, Chartered
Professional Accountants as the Company’s auditor for the ensuing year, and approved (with 82.57% of the
votes approving) the amendments to the Option Plan and DSU Plan and the increase in the maximum number of
Common Shares reserved for issuance.
ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with Evotec to develop an implantable o-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’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
519-902-7923
www.sernova.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 dier 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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - April 25, 2024 25 April, 2024
Sernova Provides Organizational Update
Sernova Provides Organizational Update
• Dr. Philip Toleikis to retire as of April 30, 2024
• Cost savings from restructuring and strategic transformation anticipated to extend runway
• Board rebuild underway
LONDON, Ontario; BOSTON, Massachusetts – April 25, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative
medicine cell therapies for treatment of chronic diseases, today announced the retirement of Chief Technology
Officer (CTO), Dr. Philip Toleikis along with progress on strategic transformation efforts including a
restructuring of operations and a workforce reduction of approximately 35%.
Commenting on his retirement, Dr. Toleikis said, “It has been a tremendous honor and privilege to serve
Sernova since 2009, initially as the President, CEO and director, and more recently as its CTO. Significant
progress has been made and there is exciting work ahead that I am confident will be realized by the team,
under the guidance of our CEO, Ms. Pussinen.” Dr. Toleikis further states, “I am pleased to provide continued
support to Sernova as a consultant. I am proud of the Company’s advancements towards redefining the way
chronic diseases will be treated using a cell therapy-based approach while importantly contributing to
improving the lives of those living with chronic diseases.”
“Philip’s contributions to Sernova’s research and development, and fund-raising efforts have been foundational
to the Company’s evolution into a next-generation regenerative medicine company,” said Brett Whalen,
Chairman of the Sernova Board. “He will leave a company which is well-positioned to foster the next wave of
innovations in stem cell therapies. On behalf of the Board of Directors and the entire company, I would like to
thank Dr. Philip Toleikis for his contributions and unwavering dedication to the Company. We wish him all the
best for his future.”
As communicated in early April, following a review of the company’s therapeutic pipeline and emerging
opportunities for its Cell Pouch system platform technologies, Sernova confirmed key priorities including its
lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post-
operative hypothyroidism program. “The pipeline and platform review and associated strategy refresh
highlighted several ways by which to optimize financial resources, extending the Company’s cash runway. We
continue to seek ways to raise additional capital to strengthen our financial foundation,” said Cynthia Pussinen,
Chief Executive Officer of Sernova. “In connection with the strategic transformation, we will pause on any new
investments into the conformal coating program to reallocate funds. In parallel, we continue to evaluate
alternative approaches to obviate the need for immunosuppressive regimens for our allogeneic therapies.”
Sernova has implemented a plan to fortify the balance sheet and cash position, including a workforce
restructuring, representing a key step towards streamlining the organization while ensuring the ability to secure
core competencies needed to drive further progress in key clinical and pre-clinical assets. “Decisions to scale
back or to rebalance headcount are extremely difficult. I want to express my heartfelt appreciation and
gratitude to those impacted for their invaluable contributions, dedication to helping patients and impact to
furthering the Company’s vision of a future where chronic conditions are no longer insurmountable obstacles”,
said Ms. Pussinen.
The Company confirms the completion and closure of all internal investigation efforts, previously announced
with respect to its former CFO and potentially a second employee of the Company. No new findings were
revealed and there will be no further action on the matter. The investigation confirmed that there have been no
securities violations and that findings bore no material impact to financial statements and operations.
Lastly, Sernova Director Mr. Bertram von Plettenberg has retired from the Company’s Board, effective April
23rd. “The Board and Management sincerely thank Mr. von Plettenberg for his past year of service to the
Company, and wish him well in future endeavors,” said Ms. Pussinen. “The evolution and composition of the
Board will continue, as we look to enhance our life sciences industry specific strength, to better serve our
patients and shareholders.”
ABOUT SERNOVA’S ANNUAL GENERAL MEETING
Sernova’s Annual General Meeting will be held on Tuesday April 30, 2024 starting at 1:00 PM ET. The meeting
will be conducted virtually, via live webcast and accessible online at https://virtualmeetings.tsxtrust.com/1571.
Please note that this site may not be fully accessible on all internet browsers, and it is advisable to use a
browser other than Internet Explorer for optimal experience. If you are unable to join the meeting through your
usual web browser, we suggest trying an alternate browser.
For investors who wish to submit questions via the TSX Trust portal voting control numbers will be needed. For
attendees who would simply like to listen to the meeting conduct, you can register as a guest.
ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s
development pipeline that uses its Cell Pouch System also includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - April 22, 2024 22 April, 2024
Sernova Welcomes Dr. Bernd Muehlenweg as Evotec’s Nominee for its Board of Directors
Dr. Daniel Mahony to step down to pursue new commitment
LONDON, Ontario; BOSTON, Massachusetts – April 22, 2024 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the
development of regenerative medicine cell therapies for treatment of chronic diseases, announces
today that Dr. Bernd Muehlenweg, Senior Vice President of Global Business Development at Evotec
SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO), has been
appointed to its Board of Directors. Evotec recently shared that due to the impending departure of Dr. Daniel
Mahony, its current Sernova Board delegate, who is leaving to pursue a new professional
undertaking, they would be nominating a new Board representative. With heartfelt gratitude, we
wish Dan all the very best in his future endeavors.
Dr. Muehlenweg will join Sernova’s Board of Directors effective immediately. Sernova expects the
brief period of overlap with Dr. Daniel Mahony will assist in the transition bringing Dr. Muehlenweg
rapidly up to speed on Sernova’s operational and strategic matters.
Bernd Muehlenweg's work experience includes various senior leadership positions in the biotech
and pharmaceutical industry with a concentration on business development and alliance
management roles. At Evotec, he leads the company's partnering and out-licensing efforts in their
focus areas including iPSC-based Cell Therapy, Panomics-driven drug discovery, Oncology,
Immunology & Inflammation, Infectious Diseases, Predictive Safety and Enabling Technologies.
Prior to joining Evotec, he held the position of Chief Business Officer and served on the Executive
Board of Nanobiotix, a French clinical stage oncology company. Bernd co-founded Panoptes
Pharma GmbH, an Austrian biotech company focused on developing therapies for eye diseases,
which was later acquired by Eyegate Pharmaceuticals. Additionally, at Wilex AG, he played a key role
in the company's growth and expansion. He began his career as a Group Leader at the Technical
University of Munich, Germany.
Bernd Muehlenweg graduated with a Ph.D. from the oncology research group at the Department of
Gynecology at the Technical University of Munich in 2000. He further attended management classes
at the Switzerland based St. Galler Business School in 2006.
“Sernova’s Cell Pouch and Evotec’s iPSC derived islet like clusters are a powerful combination,
offering a potential functional cure for type 1 diabetes (T1D) in the not-too-distant future. My
personal goal is to foster sustainable, fruitful and durable partnerships to advance scientific
innovations into approved treatments. I have tremendous confidence that the strategic
collaboration between Evotec and Sernova will provide a strong foundation to potentially achieve
this objective” said Bernd Muehlenweg, Sernova’s new Board Director.
“At Sernova, we will continue to pursue opportunities to improve the lives of patients with unmet
needs while building long-term value for shareholders in multiple ways. I cannot stress enough the
importance of the Cell Pouch System as the anchor for our ongoing T1D trial. In addition to its longterm
payload survival, containment and retrievability characteristics, we believe that the Cell Pouch
is a key differentiator in delivering clinically meaningful outcomes, including insulin independence
and normalized HbA1c counts amongst others, to several patients in our ongoing Phase 1/2 trial. We
are pleased to welcome Bernd as he joins us on our mission to build a future where chronic
conditions are no longer insurmountable obstacles.” said Cynthia Pussinen, CEO of Sernova.
ABOUT SERNOVA AND ITS 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 technology, 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 partnered with 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 cells to treat millions of patients with insulin-dependent
diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also
includes: 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca for additional information on
risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any
intention or obligation to update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Press Release Communiqué de presse - April 02, 2024 2 April, 2024
Sernova Provides Positive Clinical and Platform Portfolio Update
Sernova Provides Positive Clinical and Platform Portfolio Update
LONDON, Ontario; BOSTON, Massachusetts – April 2, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, today provided a business update. Following a review of the company’s therapeutic pipeline and emerging opportunities for its Cell Pouch system platform technologies, Sernova confirms key priorities including its lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post-operative hypothyroidism program.
Data from a patient in Cohort 2 of the company’s lead clinical program for insulin dependent Type 1 diabetes (T1D) confirms histologic evidence of long-term (one year) robust survival of abundant human donor islets throughout the Cell Pouch. Additional Cohort 2 findings are specific to an advanced immunosuppression regimen planned for use in its upcoming Phase I/II trial with stem cell-derived islets under co-development with Evotec.
Cohort 2 patients treated with an advanced immunosuppression protocol avoided graft rejection and experienced minimal side eects in comparison to those patients observed in Cohort 1. None of the six patients in Cohort 2 treated with the advanced regimen have tested positive for donor specific antibodies (DSAs), a marker of graft rejection, in comparison to three of six patients who developed DSAs under the conventional immunosuppression regimen in Cohort 1. Ancillary medication, used in some Cohort 2 patients, demonstrated highly favorable graft survival and function for islets transplanted to the Cell Pouch and has been integrated into the updated regimen and implemented for all subsequent patient trial enrollments. The company anticipates reporting additional data from Cohort 2 of its ongoing Phase 1/2 clinical trial of its expanded 10-channel Cell Pouch during the second half of the year at major medical conferences. Sernova is pleased to report that this month marks the four-year anniversary of the first patient in Cohort 1 of this Phase 1/2 study who will celebrate insulin independence and normalized blood sugar levels, based on two transplants of human donor islets to the Cell Pouch plus a marginal portal vein top up.
“Based on the favorable results we are observing in ongoing pre-clinical studies, we have concluded that our hypothyroidism program represents another compelling opportunity by which to improve patients’ lives. We look forward to completing our pre-clinical work, engaging with regulatory agencies, and preparing for an IND filing later this year, with the goal of advancing a second indication into the clinic, further demonstrating the Cell Pouch as a drug delivery vehicle platform technology. Also of note, in addition to allowing for long term payload survival, our Cell Pouch has powerful containment and retrievability capabilities that we expect will have tremendous value for pharmaceutical companies looking to treat patients with cell therapies,” said Cynthia Pussinen, Chief Executive Oicer of Sernova.
“In parallel with these activities, and our ongoing hemophilia A work, we have identified several high value indications with unmet medical needs that could potentially benefit from our platform Cell Pouch technology, with an initial focus on endocrine disorders. In the coming months, we will be conducting commercial assessments to prioritize those areas where we can best extend our reach to more patients while creating enduring value for our shareholders. I am excited for what we are poised to achieve this year and look forward to providing further updates in the future,” Ms. Pussinen concluded.
ABOUT SERNOVA AND ITS 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 technology, 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 partnered with 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 cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: 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:
- Christopher Barnes
- VP, Investor Relations
- Sernova Corp.
- Tel: +1 519-902-7923
- Email: christopher.barnes@sernova.com
- Website: www.sernova.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 dier 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.sedarplus.ca for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - March 11, 2024 11 March, 2024
Sernova Announces Management Developments
LONDON, Ontario; BOSTON, Massachusetts – March 11, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage company focused on providing regenerative medicine therapeutics to
patients with chronic conditions, today announced that Nicholas J. Rossettos, CPA has joined Sernova on a
consulting basis as interim Chief Financial Officer (CFO).
With a wealth of experience in financial leadership within the biotech industry, Nick brings a fresh perspective
and a strong track record of success to the Sernova team during this transition period. The company has
initiated a formal search for a permanent CFO and is also actively recruiting additional talent to fill key
leadership roles and strengthen its senior executive team, which started with the additions of Cynthia Pussinen
as the Chief Executive Officer and Modestus Obochi as Chief Business Officer. The goal is to ensure that
Sernova has the expertise to execute its strategic vision and drive the company forward by delivering life-
changing therapies to patients worldwide.
David Swetlow, Chief Financial Officer, is no longer with the company. Mr. Swetlow’s employment was
terminated for cause after the Board received and considered findings made by independent legal counsel in
connection with an ongoing investigation into alleged misconduct. Another senior officer of the company has
been placed on administrative leave pending the final outcome of the investigation. None of the allegations, if
substantiated, are expected to materially change or impact the Company's financial statements or its reporting
obligations. The Sernova mission remains unchanged: to improve the lives of patients through groundbreaking
innovation and compassionate care. The board and the senior leadership team are deeply grateful for the
dedication and hard work of the Company’s employees, partners, and stakeholders, and remains steadfast in
its commitment to maintaining the highest standards of integrity, transparency, and accountability in all aspects
of our operations.
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. 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.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.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - January 29, 2024 29 January, 2024
Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones
- Recently completed recruitment of all 7 patients in Cohort 2
- Anticipates additional data from Cohort 2 of Phase 1/2 clinical trial evaluating its enhanced 10-channel
Cell Pouch in patients with type 1 diabetes (T1D) in Q1/24
- Expects to report preclinical data supporting an IND application to evaluate the use of therapeutic cells in
combination with Cell Pouch in patients with post-operative hypothyroidism
LONDON, Ontario; Boston, Massachusetts – January 29, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today provided a business
update, including a recap of 2023 accomplishments and a preview of certain milestones anticipated in 2024.
“In 2023, we added to the compelling and expanding set of data demonstrating the safety and efficacy of our
novel cell therapy platform for chronic diseases, including our higher capacity 10-channel Cell Pouch that is
being evaluated in our ongoing Phase 1/2 human donor islet clinical trial in T1D,” said Cynthia Pussinen, Chief
Executive Officer of Sernova. “We also made significant progress with our hemophilia A program, including
receipt of both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug
Administration (FDA). Lastly, we announced an exciting preclinical research collaboration with AstraZeneca
that has the potential to significantly expand the use of the Cell Pouch in additional high-value indications.”
“Looking ahead to 2024, we anticipate additional patient data from Cohort 2 of our T1D human donor islet
trial, as well as important data from our thyroid disease program as we work to further our preclinical pipeline.
We continue to advance plans for our next T1D Phase 1/2 clinical study utilizing Evotec’s iPSC-derived islet
like clusters (ILCs) in our Cell Pouch. Use of iPSCs provides significant advantages over human donor islets,
including the ability to scale this promising treatment to commercially viable levels enabling the treatment of
millions of patients. Throughout 2024 our strategic partner, Evotec, will continue to optimize and advance the
development of iPSC derived ILCs for use in additional IND enabling studies and clinical trials. Given the
complexity around scaling-up of iPSCs and therapeutic cell manufacturing, as well as the relative nascency of
the entire advanced therapeutics field, timelines have extended, and we now anticipate initiating a clinical trial
evaluating our Cell Pouch with iPSC-derived ILCs in the fourth quarter of 2025.” Ms. Pussinen added.
“I am encouraged with our progress and believe we have built a solid foundation consisting of a portfolio of
fundamentally transformational medical treatments for patients living with chronic conditions that will result in
multiple potentially value-creating milestones this year and next,” Ms. Pussinen concluded.
2023 Achievements:
• Announced senior leadership additions, including Cynthia Pussinen as new Chief Executive Officer, and
Dr. Modestus Obochi, Ph.D., MBA, as Chief Business Officer
• Received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the
U.S. FDA for the Company’s hemophilia A program
• Announced positive interim data from Cohorts 1 and 2 of the ongoing Phase 1/2 human donor islet
clinical trial of its Cell Pouch System™ in patients with T1D at the 2023 IPITA-IXA-CTRMS Joint Congress.
Notably, five of the six patients in Cohort 1 were able to discontinue insulin therapy following islet
transplantation, and all six patients achieved HbA1c values in the non-diabetic range (<6.5%). In Cohort
2, the first six of seven planned patients received the higher capacity 10-channel Cell Pouch and five
patients received a first islet transplant. Stable fasting and stimulated serum C-peptide levels were
observed following a single islet transplant into the 10-channel Cell Pouch in the first assessable Cohort 2
patient who subsequently achieved insulin independence with a modest portal vein top-up.
• Announced positive results from its conformal coating immune protection technology program that is
used in combination with the Cell Pouch System™ and is intended to eliminate the need for chronic
immunosuppression medications.
• Presented preclinical data supporting the planned Phase 1/2 clinical trial of Evotec’s “off-the-shelf” iPSC-
derived ILCs in combination with Sernova’s Cell Pouch System for the treatment of patients with T1D.
Specifically, data demonstrated that Evotec’s iPSC-derived ILCs generated robust and durable insulin
independence with blood C-peptide levels and glucose tolerance test results equivalent to a test group
with human islets. A separate study showed sustained normalization of blood sugar levels in diabetic mice
throughout the 320-day term of the study. Human testing is anticipated to begin in late 2025.
• Announced a research collaboration with AstraZeneca to evaluate the use of Sernova’s Cell Pouch System
in combination with AstraZeneca’s novel therapeutic cells for various indications. The discovery work is
being funded and conducted by AstraZeneca.
• Completed recruitment of all 7 patients in Cohort 2 of the ongoing Phase 1/2 trial using the 10-channel
Cell Pouch.
Anticipated Select 2024 Milestones:
• Additional data from Cohort 2 of the ongoing U.S. Phase 1/2 clinical trial, which is evaluating its enhanced
10-channel Cell Pouch in patients with T1D, are expected beginning in Q1.
• Additional preclinical data to support an IND application to evaluate the Company’s autograft thyroid
cells in patients suffering from thyroid disease, with no immunosuppressive regimen required.
• Completion of thyroid disease market study validating the current market size and detailing the unmet
medical need.
• Potential engagement with additional life sciences focused companies, academic institutions and external
parties through partnership and collaboration opportunities, which could be announced over the course
of 2024.
• Additional funding to support growth through strategic alliances, credit facilities and/or institutional
equity financings with the goal of maximizing shareholder value.
Fiscal Year 2023 Financials
Today, Sernova filed its financial results on SEDAR for the fiscal year 2023.
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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.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. Forward looking statements in this news
release include, without limitation, statements relating to the timing of clinical trials, the timing with respect to
the receipt of data from on-going clinical trials, timing with respect to preclinical data, the completion of
thyroid disease market study, statements with respect to the potential future engagement with additional
universities, life sciences focus companies and external parties and the timing thereof.
These statements reflect the current expectations, assumptions and beliefs of management currently available
to it on the date such statements were made, including Sernova’s ability to secure additional financing and
licensing arrangements; the timing with respect to the engineering and scaling-up of Sernova’s technologies;
the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies; the timing and results of preclinical and clinical trials; the ability to obtain all necessary
regulatory approvals on a timely basis; the ability to in-license additional complementary technologies; and
the ability of Sernova to execute its business strategy, attract additional partners and successfully compete in
the market.
Although the Company believes that the assumptions inherent in these forward-looking statements are
reasonable, forward-looking statements are not a guarantee of future performance and accordingly undue
reliance should not be placed on such statements. Forward-looking statements are subject to a number of
risks and uncertainties, some that are similar to biotechnology companies and some that are unique to
Sernova. The actual results may differ materially from those expressed or implied by the forward-looking
information, and even if such actual results are realized or substantially realized, there can be no assurance
that they will have the expected consequences to, or effects on, Sernova. Sernova’s annual information form
dated January 29, 2024, its annual management's discussion and analysis for the year ended October 31,
2023, and other documents it files from time to time with securities regulatory authorities describe the risks,
uncertainties, material assumptions and other factors that could influence actual results and such factors are
incorporated herein by reference. Copies of these documents are available without charge by referring to the
company's profile on SEDAR+ at www.sedarplus.ca. All forward-looking statements speak only as of the date
on which they were made and, except as may be required by applicable securities laws, the Company
disclaims any intent or obligation to update any forward-looking statements, whether as a result of new
information, future events or results or otherwise.