2024 Press Releases Communiqués de presse
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 - Mai 01, 2024 1 Mai, 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 - Avril 25, 2024 25 Avril, 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 - Avril 22, 2024 22 Avril, 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 - Avril 02, 2024 2 Avril, 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 - Mars 11, 2024 11 Mars, 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 - Janvier 29, 2024 29 Janvier, 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.