Empowering Peptide Self Administration with Needle-Free Smart Capsules

@

Next-Gen Peptide Formulation & Delivery Summit Boston

Sharat Singh, PhD

Head of Research, Biora Therapeutics

June 19, 2024

Innovating smart pill technologies to deliver the right dose to the right place, safely.

Treatment at the site of disease in the GI tract could improve outcomes for patients with inflammatory bowel disease

Needle-free, oral delivery of large molecules designed to replace injection for better management of chronic diseases

2 © 2024 Biora Therapeutics, Inc. All rights reserved.

UNMET NEED

Needles are associated with poor disease management

38%

42%

71%

of people with diabetes discontinue injectable medications due to injection concerns1,2

of patients fail to maintain diabetes treatment due to injection concerns when using an injectable GLP-1 agonist2

higher discontinuation rate for diabetes patients initiating treatment with an injectable GLP-1 agonist vs. those starting oral therapy2

  1. Palanca A, Ampudia-Blasco FJ, Calderón JM, et al. Real-World Evaluation of GLP-1 Receptor Agonist Therapy Persistence, Adherence and Therapeutic Inertia Among Obese Adults with Type 2 Diabetes. Diabetes Ther. 2023;14(4):723-736.doi:10.1007/s13300-023-01382-9
  2. Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes. Clin Ther. 2016;38(7):1653-1664.e1. doi:10.1016/j.clinthera.2016.05.009

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BIOJET SYSTEMIC ORAL DELIVERY PLATFORM

Needle-free, oral delivery to small intestine

ORAL CAPSULE

  • Convenient oral capsule the size of a multivitamin for ease of swallowing

PRECISE DELIVERY

  • Enteric trigger for precise timing of drug delivery to the small intestine

NEEDLE-FREE ADMINISTRATION

  • Liquid jet injection to the small intestine to maximize systemic uptake

Ionis

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Needle-free, liquid jet delivery of biomolecules

CATEGORY-LEADING

BIOAVAILABILITY

  • Liquid jet delivery to the small intestine designed to maximize systemic uptake
  • Enables liver-targeted delivery of large molecules

BROAD APPLICABILITY

  • Platform technology proven to deliver multiple molecule classes
  • Delivers large payload at multi-milligramdoses
  • Leverages liquid formulation without complex reformulation

NOVEL DRUG DELIVERY TECHNOLOGY

  • Possesses comprehensive patent protection
  • Provides opportunity to extend drug exclusivity

5 © 2024 Biora Therapeutics, Inc. All rights reserved.

PRECLINICAL MODELS

Canine model for oral administration; swine for bioavailability testing

  • Canine for autonomous oral administration, but GI tract anatomy is less ideal for testing bioavailability
    • Early autonomous versions tested in canine model to evaluate initial function and improvements
  • Ex vivo tissue testing confirmed porcine intestine more closely resembles humans and is more appropriate for evaluating bioavailability with liquid jet delivery1
    • However, porcine stomach anatomy requires endoscopic placement in small intestine
    • Data to date has demonstrated potential for technology (~30% average bioavailability) in swine

Canine jejunum

Swine jejunum

Human jejunum

Human ileum

Ex vivo tissue deposition of India ink

in intact bowel tissue

1.Lee SN, Stork C, Smith J, et al. Assessing the performance of an oral biotherapeutic delivery system (OBDS) usingintra-duodenalendoscopy delivery inYucatanminipigs. Poster presented at:Controlled Release Society Annual Meeting, July13-14,2022, Montreal, Canada.

6 © 2024 Biora Therapeutics, Inc. All rights reserved.

PRECLINICAL MODELS

Preclinical in vivo device performance and PK studies in porcine model

STUDY PROCEDURE

THE BIOJET DEVICE

  • Porcine model selected due to similar anatomical and

histological features to human

Jet injection

•

BioJet device designed for human oral delivery

•

Prolonged and variable gastric residence times in the

Trigger module

porcine model require that device be endoscopically

placed

  • BioJet device filled with ~1 mg semaglutide attached to

an endoscope and inserted orally into fasted animals

under anesthesia

Drug module

  • Device advanced past the pyloric sphincter and manually or autonomously triggered in the proximal

small intestine (ID dosing)

•

Blood PK sampling at 0-240 hours post-dose was

Jet injection

evaluated compared to IV administration

1.Lee SN, Stork C, Smith J, et al. Assessing the performance of an oral biotherapeutic delivery system (OBDS) usingintra-duodenalendoscopy delivery inYucatanminipigs. Poster presented at:Controlled Release Society Annual Meeting, July13-14,2022, Montreal, Canada.

7 © 2024 Biora Therapeutics, Inc. All rights reserved.

BioJet liquid jet pressure profile compared to needle-free injectors

NEEDLE-FREE INJECTOR PRESSURE PROFILE1

Stage 1

Stage 2

Stage 3

Time (seconds)

BIOJET PRESSURE PROFILE

550

450

(mN)

350

ForceJet

250

150

50 -50

Pressure profile in simulated injection of 0.5 mL fluid by needle-free injector

-0.3

9.7

19.7

29.7

device demonstrating Stage 1, peak pressure, Stage 2, delivery phase, and

Time (ms)

Stage 3, drop-off phase.

1.Chase CCL, Daniels CS, Garcia R, et al.Needle-freeinjection technology in swine: Progress toward vaccine efficacy and pork quality. J Swine Health Prod.2008;16(5):254-261.

8 © 2024 Biora Therapeutics, Inc. All rights reserved.

PRECLINICAL RESULTS

Demonstrated bioavailability across multiple molecules

Preclinical studies in swine model with endoscopically placed and autonomously triggered BioJet device

MOLECULE TYPE

DRUG

ORAL

BIOAVAILABILITY

adalimumab

ANTIBODY

(monoclonal

antibody)

~ 30%

semaglutide

mean oral bioavailability

PEPTIDE

(GLP-1 receptor

vs. IV control

agonist)

demonstrated across all

three biomolecule types1

undisclosed

OLIGONUCLEOTIDE

antisense

oligonucleotides

RESEARCH COLLABORATIONS

multiple undisclosed pharma collaborators

1. Biora Therapeutics data on file *undisclosed pharma collaborators

9 © 2024 Biora Therapeutics, Inc. All rights reserved.

SYSTEMIC EXPOSURE TO ADALIMUMAB

FOLLOWING AUTONOMOUS TRIGGERING OF

BIOJET DEVICE vs. IV CONTROLS

INTELLECTUAL PROPERTY

Comprehensive patent position for liquid jet delivery to the GI tract

  • Approximately 12 issued patents and 31 pending applications that broadly cover liquid jet delivery in the GI tract
  • Biora IP covers both the BioJet device and methods to treat a disease or condition using liquid jet delivery to the GI tract to achieve systemic uptake

BioJet Platform

7 patent families covering

  • Device designs, materials, components, and manufacturing
  • GI-specifictrigger compositions
  • Jet parameters
  • GI delivery by drug target, drug size, and molecule type
  • Dosing and PK/PD profiles

10 © 2024 Biora Therapeutics, Inc. All rights reserved.

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Biora Therapeutics Inc. published this content on 20 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 June 2024 23:20:08 UTC.