Stock Info (+) Info bourse (+)

TSX: SVA  |  OTCQB: SEOVF
Frankfurt Exchange, Xetra: PSH

Investors Investisseur

Sernova is a regenerative medicine company developing therapeutic technologies with multibillion-dollar market potential for each of its clinical indications. Sernova est une société de médecine régénérative développant des technologies thérapeutiques offrant un potentiel de marché de plusieurs milliards de dollars pour chacune de ses indications cliniques.

Read about Financial Reports, Events, Analyst Coverage and Stock Price. Consultez nos rapports financiers, nos événements, la couverture des analystes et le cours des actions.

 

Investor Presentation Présentation investisseurs

Les documents suivants ne sont présentement disponibles qu’en anglais

Sernova Corporate Presentation March 2024

March 15, 2024 15 Mars, 2024

Oppenheimer 34th Annual Healthcare MedTech & Services Conference

March 14, 2024 14 Mars, 2024
 

News Releases Communiqués de presse

Latest News Releases Derniers communiqués de presse

April 2, 2024 2 Avril, 2024

Sernova Provides Positive Clinical and Platform Portfolio Update

March 11, 2024 11 Mars, 2024

Sernova Announces Management Developments

January 29, 2024 29 Janvier, 2024

Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones

November 27, 2023 27 Novembre, 2023

Sernova Receives Orphan Drug and Rare Pediatric Disease Designations for its Hemophilia A Program from FDA

October 30, 2023 30 Octobre, 2023

Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress

October 27, 2023 27 Octobre, 2023

Sernova Announces Positive Ongoing Interim Phase 1/2 Clinical Data for the Cell Pouch System™ for Type 1 Diabetes Trial at the 2023 IPITA, IXA, and CTRMS Joint Congress

October 11, 2023 11 Octobre, 2023

Sernova to Provide Two Program Updates in Podium Presentations at 2023 IPITA Congress

September 29, 2023 29 Septembre, 2023

Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting

 

Latest Updates Dernières mises à jour

October 5, 2023 5 Octobre, 2023

Sernova Business Update

June 30, 2023 30 Juin, 2023

Marek Sutherland of CTV News London - Cure for type one diabetes getting closer, London company says

June 30, 2023 30 Juin, 2023

Noah Stansfield of CGT Live - Patients With T1D Achieve Insulin Independence Following Implantation of Cell Pouch System and Islet Transplant

June 28, 2023 28 Juin, 2023

Sean Whooley and Danielle Kirsh of Fast Five- Teleflex has a Class I recall, Boston Scientific appoints two new board directors (Sernova discussed in the podcast recording from 1:00-2:58 time marks)

June 26, 2023 26 Juin, 2023

Lei Lei Wu of EndPoints News - Sernova says five diabetes patients have now been taken off insulin after 'cell pouch' therapy

June 26, 2023 26 Juin, 2023

Shane Whooley of MassDevice - Sernova reports positive interim data for Cell Pouch System

June 26, 2023 26 Juin, 2023

Madeleine Armstrong of Evaluate Vantage talks about Sernova - ADA 2023 – Vertex raises hopes of type 1 diabetes cure But it still has a long way to go with its islet cell therapies.

June 26, 2023 26 Juin, 2023

Shane Whooley of Drug Delivery Business News: A MassDevice Resource - Sernova reports positive interim data for Cell Pouch System

May 5, 2023 5 Mai, 2023

Marisa Wexler of Hemophilia News Today - AstraZeneca, Sernova join forces on cell therapy research

May 4, 2023 4 Mai, 2023

Medical Device Network - Sernova and AstraZeneca team to study novel therapeutic cell applications

May 3, 2023 3 Mai, 2023

Manshi Mamtora of Seeking Alpha - Sernova joins hands with AstraZeneca for potential therapeutic cell applications

May 3, 2023 3 Mai, 2023

Shane Whooley of Drug Delivery Business - Sernova, AstraZeneca collaborate to deliver therapeutic cells with Sernova Cell Pouch

May 3, 2023 3 Mai, 2023

Noah Stansfield of CGTLive features Sernova in Around the Helix: Cell and Gene Therapy Company Updates – May 3, 2023

March 17, 2023 17 Mars, 2023

Dr. Philip Toleikis recently spoke with proto.life (formerly NEO.LIFE) on the advancements of our Cell Pouch System™ to develop a potential ‘functional cure’ to improve the quality of life for patients with T1D

February 8, 2023 8 Février, 2023

Dr. Philip Toleikis sat down with PharmaShots to discuss our global strategic partnership with Evotec and how it will contribute to the advancement of our Cell Pouch System as a "functional cure" for insulin-dependent diabetes

January 31, 2023 31 Janvier, 2023

Scrip Asks…What Does 2023 Hold For Biopharma? Part 5: Technological Advances

January 9, 2023 9 Janvier, 2023

Sernova Featured at PBA's Year in Review Event

December 20, 2022 20 Décembre, 2022

Jim Cornell of Labiotech.eu - Sernova's Cell Pouch System Tackles Diabetes

November 23, 2022 23 Novembre, 2022

The London Free Press - "London Company Working on Diabetes Cure Ramps Up Hiring as Trials Show Promise"

November 22, 2022 22 Novembre, 2022

Shane Whooley of Mass Device - "How Sernova seeks to treat insulin-dependent diabetes with its Cell Pouch System"

November 16, 2022 16 Novembre, 2022

Sernova's Fireside Chat from the 2022 Stifel Healthcare Conference

November 7, 2022 7 Novembre, 2022

Shane Whooley of Mass Device - "Sernova to enroll second cohort in trial of Cell Pouch System for type 1 diabetes"

October 12, 2022 12 Octobre, 2022

Collaborator, Dr. Alice Tomei from the University of Miami, discussed the advancements in conformal coating to overcome challenges associated with transplanting insulin-producing cells in the body.

October 6, 2022 6 Octobre, 2022

Dr. Philip Toleikis' Fireside Chat with LifeSci Partners at the Virtual HealthTech Symposium

August 18, 2022 18 Août, 2022

Dr. Philip Toleikis sat with Erin Harris, Cell & Gene Podcast to discuss the development of the Cell Pouch as a "functional cure" for chronic diseases such as T1D

July 28, 2022 28 Juillet, 2022

Dr. Philip Toleikis sat with Ayesha Rashid on the Xtalks Life Science Podcast to explain how our Cell Pouch System works and the clinical advances we are making to develop a "functional cure" for patients with diabetes

June 27, 2022 27 Juin, 2022

Dr. Philip Toleikis, shared his thoughts on the next treatment innovations being a "functional cure" for chronic diseases in a recent pharma's almanac roundtable

June 24, 2022 24 Juin, 2022

Miriam E. Tucker from Medscape highlights the recent presentation of our interim data at the 2022 ADA as well as how our innovative Cell Pouch differs from other developments in the diabetes space

June 21, 2022 21 Juin, 2022

Sernova featured in Evaluate Vantage: "Sernova gets under the skin"

June 16, 2022 16 Juin, 2022

Dr. Philip Toleikis joined Stacey Simms on Diabetes Cxns to discuss our Cell Pouch System, a potential "functional cure" for insulin-dependent diabetes.

June 14, 2022 14 Juin, 2022

Dr. Philip Toleikis was recently interviewed by Joachim Brunner of SmallCap Investor TV

June 9, 2022 9 Juin, 2022

Dr. Philip Toleikis spoke with Alex Keown from BioSpace about the updated positive interim data from the Phase 1/2 diabetes clinical trial of our Cell Pouch System, presented at the 2022 ADA by our collaborators at the University of Chicago

June 2, 2022 2 Juin, 2022

Loading... Chargement...

Sernova Opens the Market Thursday, June 2, 2022

February 25, 2022 25 Février, 2022

Loading... Chargement...

Sernova Made the 2022 TSX Venture 50 List!

November 18, 2021 18 Novembre, 2021

Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum

September 30, 2021 30 Septembre, 2021

Loading... Chargement...

Dr. Tomei Conformal Coating Immunoprotection Webinar with Sernova

April 28, 2021 28 Avril, 2021

Loading... Chargement...

Sernova KOL Event on Thyroid Disease with Dr. Sam Wiseman

June 29, 2020 29 Juin, 2020

Loading... Chargement...

Watch our latest commercial!

June 18, 2020 18 Juin, 2020

Loading... Chargement...

ADA Scientific Sesssions

December 4, 2019 4 Décembre, 2019

Loading... Chargement...

Whiteboard: Sernova's Cell Pouch for Type 1 Diabetes (T1D)

April 23, 2019 23 Avril, 2019

Loading... Chargement...

CTV London: Hope for diabetes cure

December 28, 2018 28 Décembre, 2018

Loading... Chargement...

New device from Ont. firm could revolutionize diabetes care

June 7, 2018 7 Juin, 2018

Loading... Chargement...

Watch Dr Philip Toleikis, Ph.D. on CTV News

 

Financial Report and Other Filings Rapport financier et autres dépôts

 

Events Événements

Upcoming Events Évènements à venir

There are no events at this time. Il n'y a pas d'événements pour le moment.


Aprilavril 2024

SundayMondayTuesdayWednesdayThursdayFridaySaturday
dimanchelundimardimercredijeudivendredisamedi
SMTWTFS
DLMMJVD

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

2024 Bloom Burton & Co. Healthcare Investor Conference2024 Bloom Burton & Co. Healthcare Investor Conference

18

19

20

21

22

23

24

25

26

27

28

29

30


Maymai 2024

SundayMondayTuesdayWednesdayThursdayFridaySaturday
dimanchelundimardimercredijeudivendredisamedi
SMTWTFS
DLMMJVD

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31


 

Analyst Coverage Couverture des analystes

Please Note Notez s'il vous plaît

Sernova and its securities are covered by the following investment firms. This list of investment firms is being provided solely for your information and convenience and does not constitute an endorsement of or concurrence with any information, opinions, estimates, forecasts or recommendations provided by any of the investment firms listed below by Sernova. Furthermore, Sernova does not distribute information or reports prepared by analysts. The following list includes analysts currently known by Sernova Corp. to follow the company but may not be complete or up to date and may change without notice. Sernova undertakes no obligation to update and maintain this list. Please refer to the Legal Notice on this website for further information. Sernova et ses titres font l’objet d’analyse de la part des sociétés d'investissement suivantes. Cette liste de sociétés d'investissement est fournie uniquement à titre informatif et pour votre commodité et ne constitue en aucun cas une approbation ou un accord par Sernova ou ses dirigeants avec les informations, opinions, estimations, prévisions ou recommandations fournies par les sociétés d'investissement énumérées ci-dessous. En outre, Sernova ne distribue pas d'informations ou de rapports préparés par des analystes. La liste suivante inclut les analystes actuellement connus pour suivre la société, mais elle peut ne pas être complete ou à jour et peut changer sans préavis. Sernova n’assume aucune obligation quant à la mise à jour et au maintien de cette liste. Veuillez-vous reporter à l'avis légal sur ce site pour plus d'informations.



Analyst Analyste

Firm Société d’investissement

Phone Téléphone

Andre Uddin, Ph.D

Research Capital Corporation

416.860.8675

Doug Loe

Leede Jones Gable

416.365.9924

Joseph Pantginis, Ph.D

H.C. Wainwright Research

646.975.6968

Stefan Quenneville

Echelon Capital Markets

416.662.6134

 

Stock Price Prix de l'action

Please Note Notez s'il vous plaît

All information is provided "as is" for informational purposes only and is not intended for trading purposes or advice. Neither Sernova nor any independent providers are liable for any errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. Toutes les informations sont fournies "telles quelles" à des fins d'information uniquement, et ne sont pas destinées à des fins transactionnelles ou à titre de conseils ou recommandations. Ni Sernova ni aucun fournisseur indépendant ne peuvent être tenus responsables des erreurs d'information, des données incomplètes, des retards ou des actions prises en fonction des informations contenues dans les presentes.

 

Company Milestones Jalons de l'entreprise

2023

Septembre Septembre

Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting ... Read more



Septembre Septembre

Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO ... Read more



Juin Juin

Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions ... Read more



Mai Mai

Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications ... Read more



Avril Avril

Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit ... Read more



Mars Mars

Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for Oral Podium Presentation at American Diabetes Association 83rd Scientific Sessions 2023 ... Read more



Mars Mars

Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes ... Read more



Janvier Janvier

Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy ... Read more



Janvier Janvier

Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes ... Read more



2022

Novembre Novembre

Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes ... Read more



Novembre Novembre

Sernova Receives Authorization to Enroll Second Patient Cohort of Phase 1/2 Trial with Cell Pouch System™ for Type 1 Diabetes ... Read more



Septembre Septembre

Sernova Receives Second Tranche Equity Investment from Evotec of $6.8 Million at a Price of $2.50 Per Share ... Read more



Juin Juin

Sernova Announces Positive Updated Phase 1/2 Clinical Data on Cell Pouch System™ at American Diabetes Association 82nd Scientific Sessions 2022 ... Read more



Juin Juin

SERNOVA SHARES TO COMMENCE TRADING ON TSX ON JUNE 2, 2022 ... Read more



Mai Mai

Sernova Receives Conditional Approval to Up-list to the Toronto Stock Exchange ... Read more



Mai Mai

Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a 'Functional Cure' for Diabetes ... Read more



Mars Mars

Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabetes ... Read more



Février Février

Sernova Corp Ranks Among Top 50 Performing Companies on the 2022 TSX Venture List ... Read more



Janvier Janvier

Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therapeutic Approach for Treatment of Thyroid Disease ... Read more



Janvier Janvier

Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemophilia A ... Read more



Janvier Janvier

The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent ... Read more



Janvier Janvier

Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference ... Read more



2021

Octobre Octobre

Sernova: The Ultimate Combination of Two Proven Technologies as Potential Functional Cure for Type1 Diabetes and Other Chronic Diseases ... Read more



Septembre Septembre

Sernova Signs Collaboration Agreement to Advance Conformal Coated Immune Protected Therapeutic Cells for Diabetes with the University of Miami ... Read more



Juin Juin

Sernova's Principal Investigator Presents Positive New Data from Ongoing Type 1 Diabetes (T1D) Clinical Trial at ATC 2021 Virtual Connect Conference ... Read more



Avril Avril

Sernova KOL Event Highlights Novel Cell Therapy Approach for the Potential Treatment of Thyroid Disease ... Read more



Mars Mars

Sernova Provides Positive Outlook Regarding the Development of Its Innovative Therapeutics Platform Technology for Chronic Diseases ... Read more



Mars Mars

SERNOVA ANNOUNCES CLOSING OF C$23 MILLION BOUGHT DEAL FINANCING INCLUDING FULL EXERCISE OF OVER-ALLOTMENT OPTION ... Read more



Février Février

Sernova Corp. Selected for the TSX Venture Stock Exchange’s 2021 Venture 50 List of Top Performing Listed Companies ... Read more



Février Février

Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System™ Clinical Trial and Recommendation for Protocol Continuation ... Read more



2020

Août Août

Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies ... Read more



Juin Juin

Sernova Completes Acquisition of Cellular Local Immune Protection Technology ... Read more



Juin Juin

Sernova to Acquire Cellular Local Immune Protection Technology Accelerating Expansion of its Regenerative Medicine Therapeutics Platform ... Read more



Février Février

Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 Diabetes ... Read more



Février Février

Sernova Announces Positive DSMB Review and Recommendation for Continuation of Phase I/II Diabetes Clinical Trial of Cell Pouch ... Read more



2019

Octobre Octobre

Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes ... Read more



Juillet Juillet

Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes ... Read more



Avril Avril

Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes ... Read more



2018

Décembre Décembre

Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes ... Read more



Novembre Novembre

Sernova Highlights Achievements from the HemAcure Consortium in Developing a Novel Cell-Based Therapy for Hemophilia A ... Read more



Juillet Juillet

Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes ... Read more



Mai Mai

Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study ... Read more



Mai Mai

Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator ... Read more



Février Février

Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems ... Read more



2017

Décembre Décembre

Sernova Receives US FDA IND Allowance to Initiate a US Clinical Trial of its Cell Pouch for the Treatment of Type 1 Diabetes ... Read more



2016

Juillet Juillet

Sernova and JDRF Announce Funding of Joint Research Collaboration to Advance Human Clinical Trials for the Treatment of Hypoglycemic Unawareness Patients with Severe Type 1 Diabetes ... Read more



Février Février

Sernova Honoured as Member of the “2016 TSX Venture 50” and Ranked #4 in Life Sciences and Clean Technologies ... Read more



Janvier Janvier

Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes ... Read more



 

Corporate Governance Gouvernance d'entreprise

Please read the related documents Les documents suivants ne sont présentement disponibles qu’en anglais

Insider Trading Compliance Policy Politique de conformité des opérations d'initiés

PDF file

Whistleblower Policy Politique de dénonciation

PDF file

Constating Documents and Articles Constatation des documents et articles

PDF file

Advance Notice By-law SEDAR filed 2014-04-03 Advance Notice By-law SEDAR filed 2014-04-03s

PDF file

Subscribe to our Newsletter Abonnez-vous à notre newsletter

*indicates required* requis

By subscribing to our Newsletter you will receive Sernova’s press releases and news as they develop by email. We do not send direct mail, customized online advertising, and we do not share your personal information. We respect your privacy. En vous abonnant à notre newsletter, vous recevrez par e-mail les communiqués de presse et les actualités de Sernova au fur et à mesure de leur développement. Nous n'envoyons pas de publipostage, de publicité en ligne personnalisée et nous ne partageons pas vos informations personnelles. Nous respectons votre vie privée.

Please read our Pour plus d’informations, veuillez lire notre Privacy policypolitique de confidentialité.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

  • Type 1 diabetes (T1D) Cohort 2 patient data demonstrates favorable islet engraftment and long-term survival of human donor islets in the Cell Pouch
  • First treated Cohort 1 patient in the T1D clinical trial to celebrate four years of insulin independence and normalized HbA1c
  • With recent positive findings in post-surgical hypothyroidism large animal study, Sernova anticipates filing an Investigational New Drug (IND) application in 2024
  • Additional chronic disease indications identified for further pipeline expansion with a focus on endocrine disorders


  • 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 e􀆯ects 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 O􀆯icer 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 di􀆯er 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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    Press Release Communiqué de presse - Novembre 27, 2023 27 Novembre, 2023

    Sernova Receives Orphan Drug and Rare Pediatric Disease Designations for its Hemophilia A Program from FDA


    Sernova announces research collaboration with Professor Antonia Follenzi, expert in hemophilia A at the University of Piemonte Orientale

    LONDON, Ontario; WINDHAM COUNTY, Connecticut – November 27, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for the company’s Hemophilia A program.

    The FDA grants orphan designation, also referred to as orphan status, to therapies intended for the treatment of rare diseases that affect fewer than 200,000 people in the US. This designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved. Separately, rare pediatric disease designations are granted for rare diseases that primarily affect children under 18 years old with recipients of this designation being awarded a priority review voucher, upon approval. The priority review voucher may be redeemed, transferred, or sold.

    “We are pleased with the FDA’s decision to grant these designations for our novel treatment for Hemophilia A, which uses the Cell Pouch™ in combination with cells corrected for the production of Factor VIII,” commented Cynthia Pussinen, Chief Executive Officer of Sernova. “Hemophilia A is a serious, life limiting condition and we are committed to advancing development of the program, with a hope to positively impact patients around the world who are waiting for improved treatments.”

    About Sernova’s Hemophilia A Cell Pouch System Program

    Sernova’s Hemophilia A program combines the Sernova Cell Pouch™ with a patient’s own cells and will not require the use of immunosuppression medications. This therapy is intended to replace Factor VIII (FVIII) - an essential blood-clotting protein that is deficient or absent in patients with hemophilia A; this is accomplished by correcting the patient’s own Blood Outgrowth Endothelial Cells (BOECs) and subsequently returning them to the patient via the Cell Pouch™. These modified cells function to release FVIII into the bloodstream, restoring the patient’s ability for clotting during periods of bleeding.

    Sernova and research partners, through a Horizon 2020 grant which is part of the EU's research and innovation funding program in proof-of-concept work, successfully corrected human blood cells from patients with hemophilia A to produce Factor VIII using a novel first-in-class gene and cell therapy approach where the corrected cells were transplanted into the pre-implanted, vascularized Cell Pouch in a preclinical model of Hemophilia A. The work demonstrated an improvement in blood clotting using the combined technologies (Efficient and safe correction of hemophilia A by lentiviral vector-transduced BOECs in an implantable device; Molecular Therapy: Methods & Clinical Development Vol.23, Dec 2021).

    Collaboration with the University of Piemonte Orientale

    The company is pleased to announce a collaboration with the University of Piemonte Orientale, Italy under the direction of Antonia Follenzi MD, Ph.D. Professor of Histology and Cell and Gene therapy. Dr. Follenzi is a pioneer of cell and gene therapy approaches to cure Hemophilia A. Her laboratory has expertise in the generation of BOECs from Hemophilic patients and correcting the FVIII gene using Lentiviral vectors.

    The purpose of the new collaboration is to optimize the technology using lentiviral vectors to drive the expression of FVIII transgene under the control of novel promoters into BOECs of hemophilia patients to achieve optimal sustained production of FVIII using an optimized cell dose within the Cell Pouch in an animal model of Hemophilia A. The overall goal of the collaboration is to develop a product combination along with pre-clinical results that support advancing into clinical trials in patients with Hemophilia A.

    Professor Follenzi stated, “I am pleased to be working with the Sernova team on these advanced technologies for a new and safe treatment of patients with Hemophilia A using a gene and cell therapy approach within the Cell Pouch. Our goal is to advance these new technologies to further maximize the release of FVIII into the bloodstream and to extend the duration of that release for a sufficient duration of time to eliminate the need for weekly infusions of FVIII and to significantly improve the lives of people with Hemophilia A.”

    BENEFITS OF ODD AND RPDD

    Combined benefits of these designations include exclusive marketing rights for a seven-year period, after marketing approval, a 25% federal tax credit for clinical research expenses incurred in the US which is applicable for up to 20 years, waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs (currently worth >US$3 million), ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for the orphan indication, and eligibility to receive regulatory assistance and guidance from FDA to design the development plan.

    Furthermore, once the therapy is approved for marketing, it cannot be copied and sold in the US for 7 years regardless of patent life and the sponsor will be granted a Priority Voucher which can be used to receive approximately 4 months reduction time of the standard FDA review period or sold.

    ABOUT HEMOPHILIA A

    Hemophilia encompasses a group of inherited disorders that alter blood coagulation. Classical hemophilia, also known as hemophilia A, is a hereditary hemorrhagic disorder resulting from a congenital deficit of FVIII that manifests as protracted and excessive bleeding either spontaneously or secondary to trauma. 1 Hemophilia A is the most common form of Hemophilia and is a genetic disorder caused by missing or defective FVIII, a blood clotting protein. Severe Hemophilia A occurs in about 60% of cases where the deficiency of FVIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene.

    According to the US Centers for Disease Control and Prevention, Hemophilia A occurs in about 1 in 5,000 births. Prolonged bleeding, in areas such as the brain, of a person with Hemophilia A, can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States, 2,500 in Canada and 10,000 in Europe have moderate to severe forms of Hemophilia A. Though there is no cure for the disease, Hemophilia A can be controlled with regular infusions of recombinant clotting FVIII. Treatment costs per patient are as high as US $200,000 or more each year, with an aggregate therapeutic cost of over US$ 10 billion per year.

    ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

    Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

    Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

    Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326 FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    Press Release Communiqué de presse - Octobre 30, 2023 30 Octobre, 2023

    Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress


    LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 30, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced an update on its conformal coating immune protection technology program, that is used in combination with the Cell Pouch™.

    The goal of the program is to eliminate the need for chronic immunosuppression medications, currently used in islet cell transplantation for type 1 diabetes (T1D) treatment.

    The update was presented by Dr. Alice Tomei, of the University of Miami, at the International Pancreas and Islet Transplant Association (IPITA)-International Xenotransplantation Association (IXA)-Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress, taking place from October 26-29 in San Diego, California.

    The presentation showcased positive advancement in the refinement of the coating composition and process, outcomes of preclinical studies with the Cell Pouch as well as rationale and historical development of the technology.

    The following summarizes key advancements presented: • The final conformal coating composition exhibits significantly improved cell compatibility and overall biocompatibility, representing evolution across years of process development work and preclinical testing. • Coating process enhancements resulted in a 500% increase in conformal coating production capacity (number of starting islets to be coated) and an 89% overall islet encapsulation yield (ratio of conformal coated islets to initial islets). These enhancements have a direct positive impact on the in vitro and in vivo efficacy of the coated islets. • The final conformal coated product was purified using a process to contain 98% conformal coated islets and only 2% empty capsules. This enables an increase in the number of functional coated islets that are transplanted within the Cell Pouch chambers and minimization of graft volume. • Using these composition and process development improvements, the coated islets were tested, in combination with the Cell Pouch, in a syngeneic gold standard animal model of T1D to assess the safety and efficacy of the combined product. o Biocompatibility of the coated islets within the Cell Pouch was confirmed histologically demonstrating healthy islets within the vascularized tissue matrix; o Importantly, normal physiological transfer of glucose-stimulated insulin from the conformal coated islets within the Cell Pouch was confirmed; o Diabetic animals that received conformal coated islets within the Cell Pouch exhibited controlled blood glucose to non-diabetic levels - which reversed upon removal of the Cell Pouch - proving function of the conformal coated islets. • A series of pilot studies using conformal coated islets, in combination with the Cell Pouch, in an allogeneic rat model of T1D established the optimal conditions to achieve diabetes reversal. These conditions, which are being used in confirmatory allogeneic studies in additional upcoming preclinical work, included: o Drug kinetic studies which identified the optimal dose and frequency of a single selective immune response agent to be used in combination with conformal coated islets; o Islet dose-dependent glucose control was demonstrated using conformal coated islets in the Cell Pouch with the selective immune response agent.

    • The release criteria essential for clinical manufacturing have been developed, including coating conformality, completeness, stiffness, thickness, and selective permeability. Using these criteria, the conformal coating material showed long term mechanical stability, durability and selective permeability to insulin and glucose molecules but not to antibodies or inflammatory cells. These are key requirements for long-term function of the conformal coating technology in vivo.

    • Significant progress was achieved in manufacturing of the coating scale up equipment. Prototype devices are manufactured, and testing is in progress. Final system design will provide fully automated, GMP- compliant coating applied to transplantable coated islets. The system function will involve conformal coating, washing, counting and production monitoring.

    “We have made significant advancements in the evolution of the conformal coating technology in our collaboration with Sernova and are confident we have the final formulation. I look forward to our continuing studies and presenting more results,” said Dr. Alice Tomei, Miami Engineering Career Development Associate Professor of Biomedical Engineering at the University of Miami and director of the Islet Immunoengineering Lab at the Miller School of Medicine Diabetes Research Institute.

    “We understand that eliminating the standard immune suppression regimen is key to Sernova delivering a ‘functional cure’ for all T1D patients,” said Cynthia Pussinen, Chief Executive Officer at Sernova. “Our goal is to continue to drive this technology ahead and ultimately bring a local immune-protected cell product into the clinic combined with the Sernova Cell Pouch and iPSC islet-like clusters.”

    RELEVANT PRESENTATION DETAILS

    Title: Transplantation of Conformal Coated Islets in a Pre-Vascularized Cell Pouch™ Device for Beta Cell Replacement in Diabetic Rats Session: Islet Transplantation: Engineering the Islet Site Session Date: Friday, October 27, 2023

    ABOUT THE CONFORMAL COATING TECHNOLOGY

    The conformal coating technology is a proprietary, mechanically stable, thin, biocompatible, and cross-linked polymer hydrogel that coats the outside of each individual islet housed within the Cell Pouch. The conformal coating technology offers selective permeability, with immuno-protective capability, while not interfering with the kinetics of insulin and glucose release. Importantly, the conformal coating configuration also allows for the physiological transfer of oxygen and nutrients needed for islet survival and long-term function within the pre- vascularized Cell Pouch. ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

    Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT:

    Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

    Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

    Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326 FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.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.



    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    Press Release Communiqué de presse - Octobre 27, 2023 27 Octobre, 2023

    Sernova Announces Positive Ongoing Interim Phase 1/2 Clinical Data for the Cell Pouch System™ for Type 1 Diabetes Trial at the 2023 IPITA, IXA, and CTRMS Joint Congress


    • All six patients in the first cohort (Cohort A) were successfully implanted with the 8-channel Cell Pouch System with post-transplant follow-up periods ranging from 6 months to 3.5 years; • 5 of 6 patients in Cohort A discontinued insulin therapy (insulin independent) following islet transplantation into the Cell Pouch and modest islet top-up via portal vein. All 6 patients achieved HbA1c values in the non-diabetic range (<6.5%); • In Cohort B, the first 6 of 7 planned patients have received the higher capacity 10-channel Cell Pouch and 5 patients have 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 B patient who subsequently achieved insulin independence with a modest portal vein top up.

    LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 27, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today presented interim positive results from its ongoing Phase 1/2 clinical trial investigating islet allotransplantation into pre- vascularized Sernova Cell Pouch™ during an oral presentation at the 2023 IPITA, IXA, and CTRMS Joint Congress in San Diego, California.

    Enrollment in Cohort A, which utilizes the 8-channel Cell Pouch, is complete with post-transplant data available for periods of follow-up ranging from 6 months to 3.5 years. Enrollment in Cohort B, which utilizes the higher capacity Cell Pouch and a revised and better-tolerated immunosuppressive regimen, began in November 2022 and 6 of the 7 planned patients have now been successfully implanted.

    The primary objective of the study is to investigate the safety and tolerability of islet transplantation into Cell Pouch in patients with T1D, impaired hypoglycemia awareness, and a history of severe hypoglycemic episodes. Secondary study objectives include establishment of islet release criteria predictive of outcomes from islet transplant into the Cell Pouch and optimal dose and concentration ranges for purified islets transplanted into the Cell Pouch.

    Interim results from Cohort A demonstrated successful implantations of the 8-channel Cell Pouch in the 6 treated patients that were well tolerated with no seromas and no unexpected AEs (adverse events), chronic pain or discomfort. Data showed histological evidence of surviving and functional islets and positive fasting and stimulated serum C-peptide (a measure of islet insulin secretion) in patients who maintained optimal immunosuppression. All 6 patients eventually received supplemental, marginal-dose islet infusions via the portal vein with the first 5 having achieved sustained insulin independence. All 6 Cohort A patients achieved HbA1c values in the non-diabetic range (<6.5%) with persistent serum fasting and stimulated C-peptide levels for current durations out to 3.5 years.

    In Cohort B, 6 of the planned 7 patients have been implanted with the higher capacity 10-channel Cell Pouch, without complications. Among the 6 patients that have been implanted, 5 have completed at least one of the two protocol-defined islet transplants to Cell Pouch.

    The first assessable patient in Cohort B following the first Cell Pouch islet transplant showed persistent fasting and stimulated serum C-peptide, with stable BETA-2 scores (a measure of islet graft function) that continued at Day 180 following their first islet transplant to Cell Pouch. The same patient showed modest but favorable improvements in HbA1c from 7.5% at baseline to 6.9% also at Day 180.

    The day following the second islet transplant to Cell Pouch, results from a sample of the islets taken from the donor pancreas on the day of transplant came back positive for the yeast, Candida albicans. Out of an abundance of caution, Cell Pouches containing the contaminated islets were immediately removed. The Cell Pouches that were previously transplanted with the first dose of uncontaminated, healthy islets were not removed and remained in place, continuing to function. Explantation of the Cell Pouches containing contaminated islets was completed without complications and the patient fully recovered without any wound or systemic blood infection, demonstrating the designed retrievability of the transplanted Cell Pouch. Following recovery, this patient received a modest intraportal islet transplant and remains insulin independent. The revised immunosuppression protocol, used in Cohort B, continues to demonstrate favorable protection for the islet grafts with no donor islet rejection or donor specific antibodies observed under the new regimen.

    “I am pleased with the overall patient outcomes and learnings from the first trial cohort. We have applied those learnings to the second patient cohort along with the introduction of the higher capacity 10-channel Cell Pouch.” commented Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and principal investigator for the Sernova trial. “I am encouraged by the positive safety profile observed with Cell Pouch implants longer than 4 years, and early patient outcomes with the enhanced 10-channel device that we are using in the second cohort. Enrollment of the second cohort is nearly complete, and I look forward to reporting further results.”

    “We are very encouraged by the results and our learnings from our trial to date.” said Cynthia Pussinen, Chief Executive Officer at Sernova. “Having recently advanced the trial into Cohort B, using our higher capacity 10- channel Cell Pouch, we are already seeing positive signals for both safety and efficacy. We look forward to sharing the next trial update, in the coming months.”

    These results were presented by Piotr Witkowski, Professor of Surgery at the University of Chicago at the International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress, taking place from October 26 – 29 in San Diego, CA as an oral presentation entitled “Islet allotransplantation into pre- vascularized Sernova Cell Pouch - Lessons learned from the first patient cohort” (Abstract #105, Session: “Islet Transplantation: Engineering the Islet Site Session,” Thursday, October 26, 2023 2:45 p.m. to 3:45 p.m. PT)

    For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).

    ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

    Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

    FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

    Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

    Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326

    FORWARD-LOOKING INFORMATION

    This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    Press Release Communiqué de presse - Octobre 11, 2023 11 Octobre, 2023

    Sernova to Provide Two Program Updates in Podium Presentations at 2023 IPITA Congress


    Dr. Piotr Witkowski presenting new data from ongoing Phase 1/2 clinical trial of the Cell Pouch System™ in patients with type 1 diabetes (T1D)



    Dr. Alice Tomei presenting preclinical data on transplantation of conformal coated islet cells in pre- vascularized Cell Pouch



    LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced two oral presentations at the upcoming International Pancreas and Islet Transplant Association (IPITA), International Xenotransplantation Association (IXA) Cell Transplant & Regenerative Medicine Association (CTRMA) joint congress taking October 26-29, 2023 in San Diego, CA.

    More details about the conference, including accepted abstracts, are available on the IPITA website HERE. In alignment with the embargo policy, Sernova plans to share details from both speakers lectures following completion of their presentations.

    Presenation details:

    Abstract #: 105.1 Title: Islet allotransplantation into pre-vascularized Sernova Cell Pouch™ - Lessons learned from the first patient cohort Presenter: Piotr Witkowski, United States, Associate Professor of Surgery, University of Chicago Session: Islet Transplantation: Engineering the Islet Site Session Date and Time: Thursday, October 26, 2023 from 2:45 p.m. to 3:45 p.m. PT

    Abstract #: 205.1 Title: Transplantation of conformal coated islets in a pre-vascularized Cell Pouch™ device for beta cell replacement in diabetic rats Presenter: Alice Tomei, United States, Associate Professor - Biomedical Engineering and Diabetes Research Institute, University of Miami Session: Engineering the site (Joint) Session Date and Time: Friday, October 27, 2023 from 8:30 a.m. to 9:30 a.m. PT

    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 insulindependent 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, with Cell Pouches implanted for periods of more than four years and counting.

    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 insulinproducing 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

    Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

    Media: Hannah Holmquist LifeSci Communica􀆟ons hholmquist@lifescicomms.com Tel: 619-723-4326

    FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.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.

    Share the news     Partagez les nouvelles

    Email Facebook LinkedIn Twitter See direct link

    Press Release Communiqué de presse - Septembre 29, 2023 29 Septembre, 2023

    Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting


    Proof-of-concept data supports the clinical evaluation of the Cell Pouch System as a potential treatment for post-operative hypothyroidism

    LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 29, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced new preclinical data for its novel cell therapy platform, the Cell Pouch System, as a potential treatment for post-operative hypothyroidism at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, D.C., from September 27 to October 1, 2023.

    Key insights from the poster:

    • After total thyroidectomy, re-implantation of thyroid tissue into the pre-vascularized Cell Pouch™ resulted in the restoration of the two main thyroid hormones, i.e., free thyroxine (FT4) and triiodothyronine (T3), to the baseline levels.

    • Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a gradual decline observed starting five weeks after the re-implantation of thyroid glands. This pattern underscores the re-establishment of the intrinsic thyroid feedback loop's impact.

    • Newly reported radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch six months following re-implantation.

    “Currently, thyroidectomy patients are bound to life-long thyroid hormone replacement therapy. A significant subset of those patients grapple with persistent symptoms of thyroid dysfunction including weight gain, fatigue, depression, memory and cognitive impairment, negatively impacting their quality of life,” said Cynthia Pussinen, Chief Executive Officer at Sernova. “With Sernova’s Cell Pouch System, we aim to improve quality of life with a treatment for post-operative hypothyroidism. These new data replicate a human clinical scenario in which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal thyroid function. Sernova is assessing the commercial opportunity and pathways for accelerated development of the thyroid program.”

    Approximately 150,000 thyroidectomies are performed annually in the U.S. alone, representing a significant market opportunity*. Sernova’s potential first-generation product would utilize healthy tissue from the patient’s own gland removed during thyroidectomy for benign disease. This therapeutic approach would negate the need for immune suppression medication. A second-generation stem cell-derived technology could potentially be used to treat the broader population with hypothyroid disease.

    (*Sun, G. H., DeMonner, S., & Davis, M. M. (2013). Epidemiological and economic trends in inpatient and outpatient thyroidectomy in the United States, 1996–2006. Thyroid, 23(6), 727-733.)

    Poster details:

    Title: Auto-Transplantation of Rat Thyroid into a Pre-Vascularized Retrievable Cell Pouch™ Device for the Treatment of Post-Operative Hypothyroidism Presenter: Dr. Arash Memarnejadian, Senior Research Scientist, Sernova Corp. Date and Time: September 29 from 9:50 a.m. to 12:40 p.m. Eastern Time Poster #: 323

    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, with Cell Pouches implanted for periods of more than four years and counting.

    Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

    FOR FURTHER INFORMATION, PLEASE CONTACT:

    Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

    Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

    Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326

    FORWARD-LOOKING INFORMATION

    This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.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.

    Disclaimer Avis de non-responsabilite

    Sernova maintains the investor relations section of this internet site as an informational service and for the readers. Sernova maintient la section des relations investisseurs de ce site Internet en tant que service afin d’informer les lecteurs.

    This site is not intended to supplement or substitute for the legal disclosure for the Corporation or the prospectus disclosure related to the public offering of any of its securities. Please read the legal notice on the site before you proceed. Ce site n'a pas pour objet de compléter ou de remplacer la divulgation légale de la Société ou les informations du prospectus relatives à l’offre au public de ses titres. Veuillez lire l'avis juridique sur le site avant de poursuivre.


    Privacy PolicyPolitique de confidentialité

    Updated July 6, 2018

    Please read this Policy carefully along with our Legal Notice that describes our Terms of Use for the Website.

    By accessing www.sernova.com (the “Website”) you hereby agree with the practices described in this Privacy Policy (the “Policy”)

    This Policy applies to all information gathered through the Website and/or any related marketing technique or events.



    Information Collection

    The information collected is limited to the information that you decide to share with us through the News Dispatch Service, when participating at event or activities or in the general course of business by expressing an interest in obtaining information about Sernova Corp. and our products, such as name, email, phone number, and similar contact information. This information is stored through MailChimp (please refer to MailChimp Privacy Policy at https://mailchimp.com/legal/privacy/).



    Information Sharing

    Sernova Corp. is the sole owner of any information collected on the Website. We do not sell, share or rent this information to others.



    Traffic and Automatic Information Collection

    Sernova Corp. maintains log files of the traffic on www.sernova.com. This information is not linked to any personal information that you have provided us. Logs are used to manage traffic, identify content accessed, and IT requirements. Information logged and automatically collected includes without being limited to IP addresses and browser types. This information does not reveal your specific identity.



    Cookies

    Cookies can be used to provide you with a more personalized experience. The Website may use cookies to make that experience more companionable when you return to the Website. You have the option at all time to decline the use of cookies. If you choose to do so, you may not be able to fully use all features of the Website. You can also delete cookie files at all time from your computer. Those cookies may include first-party cookies (such as the Google Analytics cookies).



    Updates

    This Policy is a living document and may be amended or updated from time to time without further notice. We encourage you to review the Policy periodically.



    Contact

    If you have any questions or comments about our policy, you can email us at info@sernova.com or by phone at 1(877) 299-4603 or by mail at

    Sernova Corp.
    700 Collip Circle, Suite 114
    London, ON Canada N6G 4X8

    Mis à jour le 6 juillet 2018

    Veuillez lire attentivement cette politique ainsi que notre avis juridique qui décrit nos conditions d'utilisation du site Web.

    En accédant à www.sernova.com (le «site Web»), vous acceptez les pratiques décrites dans la présente politique de confidentialité (la «politique»).

    Cette politique s'applique à toutes les informations collectées via le site Web et / ou toute technique ou événement marketing associé.



    Collecte d'informations

    Les informations collectées se limitent aux informations que vous décidez de partager avec nous par le biais du service d’expédition de nouvelles, lorsque vous participez à un événement ou à des activités ou que vous vous intéressez à obtenir des informations sur Sernova Corp. comme nom, email, numéro de téléphone et informations de contact similaires. Ces informations sont stockées via MailChimp (veuillez vous reporter aux règles de confidentialité de MailChimp sur https://mailchimp.com/legal/privacy/).



    Partage d'information

    Sernova Corp. est l'unique propriétaire de toute information collectée sur le site Web. Nous ne vendons pas, ne partageons pas ou ne louons pas ces informations à des tiers.



    Collecte d'informations routières et automatiques

    Sernova Corp. gère les fichiers journaux du trafic sur www.sernova.com. Ces informations ne sont liées à aucune information personnelle que vous nous avez fournie. Les journaux sont utilisés pour gérer le trafic, identifier le contenu accédé et les besoins informatiques. Les informations consignées et collectées automatiquement ne sont pas limitées aux adresses IP et aux types de navigateur. Cette information ne révèle pas votre identité spécifique.



    Cookies

    Les cookies peuvent être utilisés pour vous offrir une expérience plus personnalisée. Le site Web peut utiliser des cookies pour rendre cette expérience plus conviviale lorsque vous revenez sur le site Web. Vous avez la possibilité à tout moment de refuser l'utilisation de cookies. Si vous choisissez de le faire, vous ne pourrez peut-être pas utiliser toutes les fonctionnalités du site Web. Vous pouvez également supprimer des fichiers de cookies à tout moment depuis votre ordinateur. Ces cookies peuvent inclure des cookies de première partie (tels que les cookies de Google Analytics).



    Mises à jour

    Cette politique est un document évolutif et peut être modifié ou mis à jour de temps à autre sans préavis. Nous vous encourageons à consulter la politique périodiquement.



    Contact

    Si vous avez des questions ou des commentaires sur notre politique, vous pouvez nous envoyer un courriel à info@sernova.com ou par téléphone au 1 (877) 299-4603 ou par courrier à

    Sernova Corp.
    700 Collip Circle, Suite 114
    London, ON Canada N6G 4X8