Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Investor Presentation (December 2024)
31 slides from Sernova Biotherapeutics's investor presentation, December 2024
Slide 1: Our Mission: Create a Functional Cure for Type 1 Diabetes
OUR MISSION: ‘CREATE A FUNCTIONAL CURE FOR TYPE 1 DIABETES’ Corporate Overview
Slide 2: Disclaimers and Forward-Looking Statements
DISCLAIMERS AND FORWARD-LOOKING STATEMENTS This presentation is confidential and for your information only and is not intended to be distributed to or reviewed by anyone other than you. This presentation has been prepared by Sernova and is being supplied to you on a confidential basis for informatio
Slide 3: Current T1D Treatment
Hyperglycemia CURRENT T1D TREATMENT Normal Range Lacks full hormonal control - insulin only, no glucagon Hypoglycemia or somatostatin, highly complex and psychologically Glucagon (inhaled) Continuous Glucose burdensome: Monitor Insulin and syringe ▪ Strict blood glucose monitoring via continuous glu
Slide 4: Does Current Treatment Work? T1D Patients Suffer From & Prematurely Die of Comorbidities
Diabetic retinopathy Brain stroke DOES CURRENT TREATMENT Cerebrovascular Cataracts disease WORK? Glaucoma Cardiovascular T1D PATIENTS SUFFER FROM & disease Periodontal disease PREMATURELY DIE OF COMORBIDITIES Diabetic Peripheral vascular 1 IN 10 DIE OF SEVERE HYPOGLYCEMIA disease nephropathy Diabeti
Slide 5: Three Things Needed to Create a Functional Cure for Type 1 Diabetes
THREE THINGS NEEDED TO CREATE A FUNCTIONAL CURE FOR TYPE 1 DIABETES SERNOVA: CELL POUCH BIO-HYBRID ORGAN ▪ Retrievability of transplanted islet cells essential to decrease long-term regulatory and safety risks . ▪ Full vascularisation to provide oxygen and nutrients for long-term cell survival ▪ Cel
Slide 6: Value Creating Management Team: >$5B Exit
VALUE CREATING MANAGEMENT TEAM: >$5B EXIT …and type 1 diabetic
Slide 7: World-Class Clinical Advisory Board
WORLD-CLASS CLINICAL ADVISORY BOARD
Slide 8: Investment Highlights
INVESTMENT HIGHLIGHTS UNIQUE CELL POUCH BIO- POSITIVE PHASE 1 / 2 CLINICAL UPCOMING MILESTONES HYBRID ORGAN DATA ▪ Fully retrievable should the need ▪ On track to meet Primary and ▪ Q4 2025Initiate final Cohort C, arise to improve safety Secondary endpoints data readouts H1 2026 ▪ Fully vascularized
Slide 9: Cell Pouch Bio-hybrid Organ in T1D
Cell Pouch Bio-hybrid Organ in T1D Phase 1 / 2 Clinical Trial
Slide 10: Current Clinical Status, Data Summary and Next Steps
CURRENT CLINICAL STATUS, DATA SUMMARY AND NEXT STEPS ▪ Cohort A complete, Cohort B near complete. Data shows: ▪ Insulin independence ▪ Islet containment, engraftment, survival and functionality for up to 5 years ▪ No detrimental Cell Pouch fibrosis ▪ Highly favorable quality of life in 3 industry st
Slide 11: A New Functional Cure for T1D
A NEW FUNCTIONAL CURE FOR T1D CELL POUCH PRE-IMPLANT Our Cell Pouch Bio-hybrid Organ works to restore the body’s ▪ Porous surgical mesh ▪ Implanted below skin of abdomen and normal function and hormonal cycle control, so that patients with above muscle facia T1D can focus on what matters most: LIVIN
Slide 12: Abundant, Vascularized, Insulin-Producing Beta Cells After 5 Years
ABUNDANT, VASCULARIZED, INSULIN-PRODUCING BETA CELLS THROUGHOUT CELL POUCH AFTER 5-YEARS POST-TRANSPLANTATION 8 Channel Cell Pouch Tissue Chambers: 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8 INS vWF • Positive immunofluorescent staining for Insulin, and von Willebrand Factor (blood vessels) • Rich vascularizat
Slide 13: Abundant, Vascularized, Insulin-Producing Beta Cells After 5 Years (Islet Comparison)
ABUNDANT, VASCULARIZED, INSULIN-PRODUCING BETA CELLS THROUGHOUT CELL POUCH AFTER 5-YEARS POST-TRANSPLANTATION Insulin Glucagon Insulin Glucagon Somatostatin Somatostatin Islets in Cell Pouch >5 years Post-transplant Islets in Healthy Human Pancreas 13 Islets residing in Cell Pouch for >5 years have
Slide 14: Clinical Data
Clinical Data Phase 1 / 2 Clinical Study
Slide 15: All Patients Achieved an HbA1c of <7.0%
ALL 12 PATIENTS ACHIEVED AN HbA1c of <7.0% i.e., NORMAL GLYCEMIC CONTROL Epidemiologic analysis demonstrate each 1% reduction in A1C is associated with a 14% reduced risk of myocardial infarction HbA1c 14 ▪ Hemoglobin A1c or HbA1c, is a blood test that provides 13 a measure of a person's average blo
Slide 16: Insulin Independence Achieved Across Cohorts
INSULIN INDEPENDENCE ACHIEVED IN 8 OF 12 PATIENTS SO FAR ACROSS COHORTS (2 ONGOING) 1. Islet dose required to achieve insulin independence has been determined 2. The more islets administered via the Cell Pouch, the fewer required in the portal vein 3. **Cell Pouch alone has capacity to reach insulin
Slide 17: Successful Islet Engraftment
SUCCESSFUL ISLET ENGRAFTMENT C-peptide is a biomarker that measures the amount of insulin produced by the transplanted islets in Cell Pouch. ▪ For successful islet transplantation, a C-peptide level of 0.3 ng/mL is generally considered a threshold for graft function. ▪ 7 of 12 patients, with Cell Po
Slide 18: BETA & BETA-2 Scores Show Positive Islet Engraftment and Function
BETA & BETA-2 SCORES SHOW POSITIVE ISLET ENGRAFTMENT AND ISLET FUNCTION IN CELL POUCH Patient # -3 -7 -8 -9 -10 -11 -15 -16 -19 -20 -21 -23 3.5 5 5 BETA BETA- 2 5 3 5 4 4 4 4 4 2.5 4 4 4 4 4 3 3 2 3 3 3 3 1.5 1 41 Patients did not start with a FASTING C- Peptide that is 1 0.5 required for Beta 2 sco
Slide 19: 1 in 10 T1Ds Die of Severe Hypoglycemia Unawareness
Cell Pouch Islets and Portal Vein Islets 1 2 3 4 5. 6. 7. 8. 9 10. 11. 12 1 IN 10 T1Ds DIE OF SEVERE HYPOGLYCEMIA UNAWARENESS! 19
Slide 20: Patients Reported Improved Diabetes Distress Scores
PATIENTS REPORTED AN IMPROVED DIABETES DISTRESS SCORES Cell Pouch Islets Alone DDS Total Scores 6 ▪ The Diabetes Distress Scale (DDS) is a tool used to assess the emotional distress associated with living with diabetes 5 ▪ The DDS helps individuals with diabetes self- 4 report their emotional experi
Slide 21: Patients Reported a Reduction in Fear of Hypoglycemia
PATIENTS REPORTED A REDUCTION IN FEAR OF HYPOGLYCEMIA Total Score 160 ▪ The Hypoglycemia Fear Survey (HFS) is a well-validated 140 measure of fear of hypoglycemia in people with type 1 120 diabetes. ▪ The HFS-II consists of two subscales: the Worry scale (HFS-W) and the Behavior scale (HFS-B). 100 8
Slide 22: Patient Willingness to Adopt Cell-Based Therapies for T1D is Overwhelming
Patient Willingness to Adopt Cell-Based Therapies for T1D is Overwhelming ▪ 2019 study found ~75% expressed interest in an artificial pancreas or cell-based therapy as a future treatment option (Journal of Diabetes Science and Technology, 2019). ▪ 2018 survey ~65% were interested in undergoing stem
Slide 23: Cell Pouch Bio-hybrid Organ Compared to Vertex
CELL POUCH BIO-HYBRID ORGAN COMPARED TO VERTEX Most Advanced, Vascularized, Implantable, Retrievable, T1D Cell Therapy in US Trials Trial Stopped 23
Slide 24: Collaborating for the Future
COLLABORATING FOR THE FUTURE
Slide 25: Collaborating To Achieve Our Mission
Collaborating To Achieve Our Mission
Slide 26: Sernova and Evotec Collaboration to Commercialize a Functional Cure for T1D
SERNOVA AND EVOTEC COLLABORATION TO COMMERCIALIZE A FUNCTIONAL CURE FOR T1D Evotec GMP manufacturing site near Modena/Italy • Scalable, GMP-compatible process for ILC manufacturing from a GMP iPSC line • Drug product with completed endocrine differentiation and optimized beta cell fraction The Goal
Slide 27: Strong Anti-Diabetic Activity of ILCs in the Cell Pouch
Strong Anti-Diabetic Activity of ILCs in the Cell Pouch Selected Clinical Dose Equivalent Provides Rapid Normalization of Glucose Preclinical Control with Human Islet-like Potency + ILCs Robust circulating hC-peptide Efficient normalization of random fed glucose levels comparable to human islets + I
Slide 28: Tacrolimus – Current Standard of Care Immune Suppression is Sub-Standard
TACROLIMUS – CURRENT STANDRD OF CARE IMMUNE SUPPRESSIOIN, IS SUB-STANDARD ▪ Impaired Insulin Secretion: Directly interferes with islet cells insulin production ▪ Insulin Resistance: Contributes to the body's cells becoming less responsive to insulin ▪ Beta-Cell Dysfunction: Causes dysfunction of the
Slide 29: Tegoprubart Offers Advantages Over Tacrolimus
CLINICAL TRIALS DEMONSTRATE THAT TEGOPRUBART OFFERS ADVANTAGES OVER TACROLIMUS IN SAFETY AND EFFICACY AND PREVENTION OF ISLET CELL REJECTION Demonstrated a better safety profile than tacrolimus, with fewer side effects like new- onset diabetes, hyperglycemia, and tremors Data showing more effective
Slide 30: Islet Cell Transplant
ISLET CELL TRANSPLANT CLINICAL RESULTS DEMONSTRATED POSITIVE OUTCOMES IN ISLET TRANSPLANT RECIPIENTS, WITH REDUCED INSULIN REQUIREMENTS AND IMPROVED BLOOD GLUCOSE CONTROL. ▪ All 3 subjects achieved stable graft function, blood glucose control in normal range and insulin independence ▪ No signs of ce
Slide 31: Thank You!
Thank You!
Sernova Biotherapeutics — Investor Presentation (December 2024) on 6ix