SON-081 / Sonnet BioTherap, New Life Therap - LARVOL DELTA

TARGETING NUCLEAR PROTEIN IMPROVES NAFLD ACTIVITY SCORE AND SHOWS ANTIFIBROTIC AND HEPATOPROTECTIVE EFFECTS SUPERIOR TO LANIFIBRANOR IN THE GAN DIET-INDUCED OBESE AND BIOPSY-CONFIRMED MOUSE MODEL OF MASH (AASLD 2025) - "NLT-101 treatment improved metabolic, biochemical and histopathological parameters of MASH, including hepatic transcriptomic profile, in the GAN DIO-MASH mouse model. Notably, NLT-101 treatment dose-dependently improved NAFLD Activity Score superior to late-stage clinical candidate lanifibranor, introducing NLT-101 as a promising first-in-class treatment for MASH."

Biopsy • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • COL1A1

Sonnet BioTherapeutics Completes Licensing Agreement with New Life Therapeutics (Sonnet BioTherapeutics Press Release) - "Sonnet BioTherapeutics...announced today that it has executed a definitive agreement with New Life Therapeutics Pte. Ltd. (NLT ) of Singapore for the license of low-dose Interleukin 6, or IL-6, for the treatment of Diabetic Peripheral Neuropathy (DPN)....Under the terms of the agreement, Sonnet is entitled to an upfront payment of $1.0 Million from NLT (including the $500,000 previously paid during 2020)."

Licensing / partnership • CNS Disorders • Diabetic Neuropathy • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides 2021 Business Update (Sonnet BioTherapeutics Press Release) - "SON-081 (Fully Human IL-6) - Diabetic Peripheral Neuropathy (DPN): Sonnet anticipates completing the partnership deal in South East Asia during April 2021 that Sonnet expects will position New Life Therapeutics (NLT) to fund and progress the asset forward into a Phase 1b/2a clinical trial...Sonnet anticipates that clinical trial initiation will occur during the second half of this year...and awaits final study completion and reports of product comparability, prior to IND filing."

Licensing / partnership • New P1/2 trial • CNS Disorders • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2021 First Quarter Business and Earnings Update (Yahoo Finance) - "In SON-080 (low-dose recombinant fully human Interleukin 6, or IL-6), the Company is planning to file an IND and initiate Phase 1b/2a pilot efficacy clinical trials during the second half of 2021 for Chemotherapy Induced Peripheral Neuropathy (CIPN), followed by a Phase 1b/2a pilot efficacy trial for Diabetic Peripheral Neuropathy (SON-081) in 2022."

IND • New P1/2 trial • CNS Disorders • Colorectal Cancer • Diabetic Neuropathy • Gastrointestinal Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

Sonnet BioTherapeutics Provides Fiscal Year 2020 Business and Earnings Update (Yahoo Finance) - "SON-080 and SON-081 (low-dose IL-6): On August 4th, Sonnet announced the execution of a letter of intent (LOI) to negotiate an agreement with New Life therapeutics to license both SON-080 and SON-081 in ten ASEAN countries....Sonnet continues to negotiate a definitive agreement, which it expects to reach in the first calendar quarter of 2021....The SON-080 development program in CIPN is progressing with an IND submission for the Phase Ib/IIa study expected in 2021."

IND • Licensing / partnership • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet Bio poised to ink neuropathy assets pact with New Life Therapeutics for ASEAN region (SeekingAlpha) - "Sonnet BioTherapeutics...+26% premarket in reaction to execution of letter of intent to license its SON-081 and SON-080...to New Life Therapeutics, in Singapore, Malaysia, Indonesia, Thailand, Philippines, Cambodia, Brunei, Vietnam, Myanmar and Lao PDR....Upon execution of a definitive agreement, New Life Therapeutics will conduct a Phase 1b/2a pilot scale efficacy study with SON-081 in DPN, which is expected to initiate in 1H of 2021, and a pilot scale efficacy study with SON-080 in CIPN by Sonnet, expected to be initiated in 1H of 2021."

Licensing / partnership • New P1/2 trial • New trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain