atexakin alfa (recombinant interleukin-6) / Sonnet BioTherap, New Life Therap, Alkem Labs - LARVOL DELTA

Sonnet BioTherapeutics Provides Fiscal Year 2025 First Quarter Business and Earnings Update (GlobeNewswire) - "Alkem will conduct all clinical trials it believes appropriate to obtain regulatory approval of SON-080 in India for the treatment of DPN. Subsequent to the partnership established with Alkem, preparations are being made to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need....SON-080 Upcoming Milestone: H2 Calendar Year 2025: Initiation of Phase 2 Trial."

New P2 trial • Diabetic Neuropathy

Sonnet BioTherapeutics Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "SON-1010 Upcoming Milestones: Phase 1: Solid Tumors (Monotherapy)​: 2H 2024; Safety Data​; 1H 2025: Topline Efficacy Data​; Phase 1b/2a: PROC (Combo with Atezolizumab)​; Phase 1b/2a: PROC (Combo with Atezolizumab)​; 2H 2024: Additional Safety Data​; 2H 2025: RP2D & Topline Efficacy Data...Seeking partnership to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need."

P1 data • P1/2 data • Trial status • CNS Disorders • Gynecologic Cancers • Oncology • Ovarian Cancer • Pain • Solid Tumor

Sonnet BioTherapeutics Reports Encouraging Data from Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) That Support Advancement into Phase 2 Study (GlobeNewswire) - "The Phase 1b data demonstrated SON-080 was well-tolerated at both 20 µg and 60 µg/dose, which was about 10-fold lower than the maximum tolerated dose (MTD) for IL-6 that was established in previous clinical evaluations. Injection site erythema was the most prominent treatment-related adverse event irrespective of the dose of SON-080, and was transient and mild in all but one case at each dose, where it was moderate....The Quality-of-Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a validated survey designed to assess cancer patients’ experience of symptoms and functional limitations related to CIPN, was used as the primary indicator of response."

P1 data • Pain • Peripheral Neuropathic Pain

SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: Sonnet BioTherapeutics | Phase classification: P1b/2a ➔ P1/2 | N=60 ➔ 9 | Trial completion date: Oct 2023 ➔ Mar 2024 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Mar 2024; Lack of Enrollment

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Pain

Sonnet BioTherapeutics to Present Preclinical Data on SON-080 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at the AACR 2024 Annual Meeting (ACCESSWIRE) - "Sonnet BioTherapeutics Holdings, Inc...announced today that preclinical data and clinical trial design from the study of SON-080 (recombinant human Interleukin-6 or rhIL-6) in CIPN will be presented in a poster session at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 5-10, in San Diego, California."

Clinical protocol • Preclinical • Oncology

Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective (Yahoo Finance) - "Sonnet BioTherapeutics Holdings, Inc...announced today that the first Phase 1b/2a clinical trial of SON-080 was cleared to proceed to Phase 2 after review by the independent DSMB. This study (SB211, NCT05435742) is being conducted at two sites in Australia in patients with persistent CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6), which required confirmation of safety before continued development in Phase 2. Many drugs cause peripheral nerve damage; patients with CIPN experience discomfort that can result in persistent, unbearable pain that may limit chemo­therapeutic treatment....The protocol required DSMB to review the unblinded safety and tolerability of SON-080 in the first nine patients in SB211."

DSMB • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2024 First Quarter Business and Earnings Update (Yahoo Finance) - "Enrollment has finished in the Phase 1b safety portion of the SB211 study of SON-080...in patients with persistent CIPN. A safety update from this trial is expected during the first quarter of 2024."

P1/2 data • Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business and Financial Update (Yahoo Finance) - "SON-080 (low-dose IL-6): Enrollment of the first portion of the SB211 study in CIPN is nearing completion, which should position the DSMB to complete its review of the preliminary safety data during the first calendar quarter of 2024."

DSMB • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business Overview (Yahoo Finance) - "Sonnet is working to complete enrollment in the SON-080 trial in chemotherapy-induced peripheral neuropathy (CIPN) and continues to expect early safety data prior to the 2023 calendar year end."

P1/2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2023 Third Quarter Business and Earnings Update (Issuer Direct) - "'We are starting our combination study using SON-1010 with atezolizumab in Australia and are working to enroll several cohorts by the end of this year'....The DSMB overseeing the study is expected to meet during the third calendar quarter of 2023. Following the completion of the DSMB review, we anticipate announcing initial safety data from the CIPN study and will consider initiating a Phase 2 study in DPN....Research and development expenses were $2.4 million for the three months ended June 30, 2023, compared to $5.6 million for the three months ended June 30, 2022. The decrease of $3.2 million was primarily due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as a decrease in share-based compensation expense."

Commercial • New trial • P2 data • Diabetic Neuropathy • Oncology

Sonnet BioTherapeutics Announces Presentations at the 2023 Cytokine-Based Drug Development Summit and Provides Preliminary Update on the SON-080 Study in Chemotherapy-Induced Peripheral Neuropathy (BioSpace) - P1/2 | N=60 | NCT05435742 | Sponsor: Sonnet BioTherapeutics | "Sonnet BioTherapeutics Holdings, Inc...announced today that John Cini, PhD, Chief Scientific Officer and Co-Founder, and Richard Kenney, MD, Chief Medical Officer, will be featured speakers at the 4th Annual Cytokine-Based Drug Development Summit in Boston, Massachusetts, June 27-29....As of June 22, 2023, seven patients have been enrolled. While the groups remain blinded, doses have been tolerated well with some mild-to-moderate transient injection site reactions. As the protocol requires a total of nine patients to be dosed for at least two weeks before a safety review by the Data Safety Monitoring Board (DSMB), we expect the DSMB to meet during the third quarter of 2023. Following the completion of the DSMB review, we anticipate announcing the initial safety data."

DSMB • Enrollment status • P1/2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2022 Business and Financial Update (Yahoo News) - "Research and development expenses were $21.4 million for the year ended September 30, 2022, compared to $16.6 million for the year ended September 30, 2021. The increase of $4.8 million was primarily due...preparation for a Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN..."

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) (clinicaltrials.gov) - P1b/2a | N=60 | Recruiting | Sponsor: Sonnet BioTherapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2022 ➔ Oct 2022

Enrollment open • Trial initiation date • Pain

Sonnet BioTherapeutics Provides Fiscal Year 2022 Third Quarter Business and Earnings Update (Sonnet BioTherapeutics Press Release) - "Sonnet BioTherapeutics Holdings, Inc...announced today its financial results for the three months ended June 30, 2022 and provided a business update....Initiated a Phase 1b/2a clinical trial of SON-080; this new study (SB211) will be conducted at multiple sites in Australia in patients with persistent chemotherapy-induced peripheral neuropathy (CIPN); initial safety data from this study are expected during the first half of 2023...Research and development expenses were $5.6 million for the three months ended June 30, 2022, compared to $3.9 million for the three months ended June 30, 2021. The increase of $1.8 million was primarily due to increased expenditures for the development of the cell lines for IL12-FHAB, IL12-FHAB-IL15 and SON-080 in connection with the initiation of a Phase 1 clinical trial for SON-1010 and preparation for a Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN..."

Commercial • P1/2 data • Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Announces Clinical Trial of SON-080 in Patients with Persistent Chemotherapy-Induced Peripheral Neuropathy (Yahoo News) - "Sonnet BioTherapeutics Holdings, Inc...announced today that a Phase 1b/2a clinical trial of SON-080 has been authorized to begin. This new study (SB211) will be conducted at multiple sites in Australia in patients with persistent chemotherapy-induced peripheral neuropathy (CIPN)....This study is a Phase 1b/2a double-blind, randomized controlled trial that is designed to demonstrate safety in patients with CIPN for at least 3 months, compared with prior efforts to develop IL-6 at higher doses for other indications, to give additional pharmacokinetic (PK) and pharmacodynamic (PD) data at these doses and to show a preliminary indication of efficacy..."

Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2022 First Quarter Business and Earnings Update (Yahoo News) - "Sonnet BioTherapeutics Holdings, Inc...announced today its financial results for the three months ended December 31, 2021 and provided a business update....Completed preparations for cGMP manufacturing of SON-080, initiated manufacturing in January, and on track for clinical study initiation in 2Q22....Research and development expenses were $4.3 million for the three months ended December 31, 2021, compared to $3.9 million for the three months ended December 31, 2020. The increase of $0.4 million was primarily due to the development of the cell lines for...SON-080..."

Commercial • Financing • New trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics Provides Fiscal Year 2021 Business and Financial Update (BioSpace) - "Sonnet BioTherapeutics Holdings, Inc...announced today its financial results for the fiscal year ended September 30th, 2021 and provided a business update....Sonnet intends to file for an ex-US Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN during the first half of 2022. Pursuant to the license agreement the Company entered with New Life Therapeutics Pte., Ltd of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN with the objective of initiating an ex-US pilot efficacy study in the second half of 2022....Research and development expenses were $16.6 million for the year ended September 30, 2021, compared to $9.9 million for the year ended September 30, 2020. The increase of $6.8 million was primarily due to the development of the cell lines for IL12-FHAB, IL12-FHAB-IL15 and SON-080..."

Commercial • New P1/2 trial • CNS Disorders • Neuralgia • 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

"$SONN Sonnet BioTherapeutics Announces the Successful Completion of a Non-human Primate Toxicology Study of SON-080 https://t.co/XHMwYeC4qU" (@stock_titan)

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

Sonnet BioTherapeutics Holdings, Inc.’s acquisition of Relief Therapeutics SA (Global Legal Chronicle) - "RELIEF THERAPEUTICS Holding SA...announced the closing of the binding Share Exchange Agreement ('SEA') for the acquisition by Sonnet BioTherapeutics, Inc., now a subsidiary of Sonnet BioTherapeutics Holdings, Inc....signed August 12, 2019....Together with its proprietary pipeline of preclinical-stage assets, Sonnet will pursue the funding of Atexakin Alfa acquired together with Relief SA....Sonnet is positioning Atexakin Alfa to rapidly enter clinical trial which aim is to confirm safety and tolerability as well as to provide preliminary insights into efficacy for CIPN."

Financing • M&A • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Sonnet BioTherapeutics holdings announces merger closing (Yahoo Finance) - "Sonnet BioTherapuetics Holdings, Inc....today announced that its merger with Sonnet BioTherapeutics, Inc. ('Sonnet') closed April 1, 2020....In addition, immediately prior to the merger, Sonnet completed its acquisition of the global development rights for Atexakin Alfa...from Relief Therapeutics SA ('Relief'), through the issuance of shares of Sonnet....The Company will pursue the clinical development of SON-080 for the treatment of Peripheral Neuropathies focusing primarily on Chemotherapy-Induced Peripheral Neuropathy (CIPN)."

M&A

Relief Therapeutics holding SA announces the closing of its share exchange agreement with Sonnet Biotherapeutics, Inc. for the divestment of its wholly-owned subsidiary Relief Therapeutics SA (Yahoo Finance) - "RELIEF THERAPEUTICS Holding SA...announces the closing of the binding Share Exchange Agreement ('SEA') for the acquisition by Sonnet BioTherapeutics, Inc. ...a subsidiary of Relief Holding signed August 12, 2019; Sonnet will pursue its already initiated commitment to fund the clinical development of Relief SA’s asset, Atexakin Alfa (low dose formulation of Interleukin-6, IL-6, now 'SON-080'), for the treatment of Peripheral Neuropathies focusing primarily on Chemotherapy-Induced Peripheral Neuropathy (CIPN)."

Financing