Core Viewpoint - Sonnet BioTherapeutics Holdings, Inc. has appointed Stephen J. McAndrew, Ph.D., as Chief Business Officer, effective February 17, 2025, to enhance its business development and partnering strategy as the company progresses its clinical initiatives [1][3]. Company Overview - Sonnet is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs, utilizing its proprietary FHAB (Fully Human Albumin-Binding) technology to optimize the safety and efficacy of biologic drugs [6]. - The FHAB platform allows for the development of modular, plug-and-play constructs for various therapeutic classes, including cytokines, peptides, antibodies, and vaccines [6]. Leadership Appointment - Dr. McAndrew brings over 30 years of experience in business development and transactional agreements in the biopharmaceutical sector, having previously served as Vice President and Senior Vice President of Business Development at Sonnet [2][4]. - His role will focus on establishing key partnerships and driving the company's strategy forward, particularly in relation to the clinical development of its FHAB assets [4]. Clinical Programs - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for solid tumors and ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [7]. - The company is also advancing SON-1210 (IL12-FHAB-IL15) for pancreatic cancer and SON-080 for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, with promising results from earlier trials [7][8]. Previous Experience of Dr. McAndrew - Prior to joining Sonnet, Dr. McAndrew held senior roles at Oncobiologics, Inc. and Bristol-Myers Squibb Company, where he was responsible for business development, licensing, and revenue growth strategies [2][4]. Educational Background - Dr. McAndrew holds a Ph.D. in Cellular and Molecular Biology, a Master's in Molecular Genetics, and a Bachelor's in Science, showcasing a strong academic foundation relevant to his role [5].

Financial Performance - For the fiscal first quarter ended December 31, 2024, Sonnet reported a net loss of $3.2 million, or $1.56 per basic and diluted share, compared to a net loss of $1.2 million, or $2.46 per basic and diluted share for the same period in 2023[16]. - As of December 31, 2024, Sonnet had cash and cash equivalents of $4.9 million[17]. - The company closed a registered direct offering and concurrent private placement for aggregate gross proceeds of $3.9 million in December 2024[7]. Clinical Trials and Developments - In the Phase 1 SB101 trial, 71% of the 24 patients dosed had stable disease at the first follow-up CT, with 48% remaining stable at four months, indicating clinical benefit from SON-1010[5]. - The maximum tolerated dose (MTD) for SON-1010 was established at 1200 ng/kg, with a cohort size increased to 6 patients for enhanced assessment of pharmacokinetics and pharmacodynamics[4]. - Enrollment for the new cohort evaluating SON-1010 in combination with trabectedin is underway and expected to be completed in H1 calendar year 2025[6]. - SON-1210, a bifunctional interleukin therapy, is expected to initiate clinical trials with the first patient dosed in H1 calendar year 2025[1]. - The company plans to submit the IND for SON-1210 in Q1 calendar year 2025[20]. Business Development - The company has initiated a licensing partnership in India for SON-080 in October 2024, focusing on advancing business development opportunities[3]. Leadership Changes - A leadership reorganization has been announced, promoting Dr. Stephen McAndrew to Chief Business Officer and appointing Mr. Donald Griffith as the new Chief Financial Officer[18].

Core Insights - Sonnet BioTherapeutics has made significant progress in its clinical trials, particularly with SON-1010, showing a 45% reduction in tumor size in some patients and a 48% stable disease rate at four months post-treatment [2][6][18] - The company is expanding its clinical programs, including a new cohort for SON-1010 in combination with trabectedin and ongoing trials with Atezolizumab for platinum-resistant ovarian cancer [4][7][9] - Financial results indicate a net loss of $3.2 million for the first quarter of fiscal year 2025, with cash and cash equivalents of $4.9 million as of December 31, 2024 [18] Clinical Trials Update - SON-1010 has completed monotherapy dose escalation in the Phase 1 SB101 trial, establishing a maximum tolerated dose (MTD) of 1200 ng/kg [4][5] - The trial reported that 71% of patients had stable disease at the first follow-up, with one patient achieving a partial response [6][7] - A new cohort is being added to evaluate SON-1010 in combination with trabectedin, with topline safety data expected in H2 2025 [7][14] Upcoming Milestones - SON-1210, a bifunctional interleukin therapy, is expected to initiate clinical trials in H1 2025, with the first patient dosed [12][15] - The company anticipates additional safety data from the Phase 1b/2a trial with Atezolizumab in Q1 2025 and topline efficacy data in H2 2025 [14] Licensing and Partnerships - A licensing agreement with Alkem Laboratories was established for SON-080 in India, focusing on the treatment of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy [16][22] - The company is enhancing its leadership team to focus on business development opportunities, with a recent reorganization [19] Financial Overview - For the fiscal first quarter ended December 31, 2024, Sonnet reported a net loss of $3.2 million, compared to a net loss of $1.2 million in the same quarter of the previous year [18] - The company closed a registered direct offering and private placement for gross proceeds of $3.9 million in December 2024 [5]

European Patent Office (EPO) grants EU Patent No. EP3583125 B1 covering the Company’s Fully Human Albumin Binding (FHAB®) domain fusion proteins In addition to the U.S. and EU, Sonnet’s global IP coveragenow extends to China, Japan, Russia and New Zealand Management releases “What This Means” segment discussing the newly granted EU patent; Access here PRINCETON, NJ, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company de ...

Live webcast on Wednesday, January 29th at 2:40 PM ET PRINCETON, NJ, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced that Pankaj Mohan, Ph.D., Chief Executive Officer of Sonnet will present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar being held on January 29, 2025. Conference Details: Conference: LIVE! with Webull Corporate Connec ...

SON-1010, after receipt of data suggesting clinical benefit when administered as a monotherapy in patients with advanced solid tumors, enters combination evaluation with trabectedin (Yondelis®) with the potential to improve trabectedin’s therapeutic window in soft-tissue sarcoma patients Combined mechanisms have the potential to enhance progression-free survival (PFS) in some of the largest cohorts of patients with soft-tissue sarcoma Topline safety data of the combination of SON-1010 with trabectedin is e ...

Financial Performance - Total annual operating expenses reduced by approximately 37% compared to fiscal year 2023[2] - Total operating expenses decreased to $11,868,097 from $18,940,422 year-over-year[22] - Net loss for the period was $7,437,232, a reduction from the previous year's loss of $18,832,694[22] - Net loss per share, basic and diluted, improved to $(11.35) from $(145.13) year-over-year[22] - Loss from operations was $(11,849,471), an improvement from $(18,792,617) year-over-year[22] Research and Development - Research and development expenses were $5.7 million for the year ended September 30, 2024, down from $11.8 million for the year ended September 30, 2023[14] - Research and development expenses were $5,737,252, down from $11,814,690[22] - The company completed enrollment and dose escalation in the Phase 1 SB101 clinical trial of SON-1010, with 24 subjects enrolled to date[6] - Upcoming milestones include topline efficacy data for SON-1010 in H1 calendar year 2025 and additional safety data for SON-1210 in Q1 calendar year 2025[10] Funding and Financial Support - Approximately 43% of total annual operating expenses in fiscal year 2024 were covered by non-dilutive funding from the New Jersey Tax Certificate Transfer and Australia R&D Tax Incentive Programs[2] - The company received preliminary approval for the sale of tax credits from the New Jersey Technology Business Tax Certificate Transfer Program[5] - As of September 30, 2024, cash on hand was $0.1 million, with additional funding expected to extend operations into July 2025[13] Assets and Revenue - Total assets decreased to $2.77 million as of September 30, 2024, from $5.43 million as of September 30, 2023[20] - Collaboration revenue for the year ended September 30, 2024, was $18,626, compared to $147,805 in the previous year[22] Expenses Breakdown - General and administrative expenses decreased to $6.1 million for the year ended September 30, 2024, from $7.1 million for the year ended September 30, 2023[14] - General and administrative expenses decreased to $6,130,845 from $7,125,732[22] Shareholder Information - Weighted average shares outstanding, basic and diluted, increased to 655,240 from 129,760[22] Other Income and Gains - Foreign exchange gain was $84,293, compared to a loss of $(40,077) in the previous year[22] - Other income amounted to $4,327,946, with no comparable figure from the previous year[22] Licensing and Collaboration - A licensing agreement was executed with Alkem Laboratories for the development and commercialization of SON-080 for DPN in India[12]

Continued progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC)  Executed licensing agreement to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN) Multiple value-driving milestones expected throughout calendar year 2025 as well as pipeline expansion opportunities across the solid tumor market Total annual operating expenses reduced by an approximate 37% as compared to fiscal year 2023 Appr ...

Both novel bifunctional (SON-1411) and monofunctional (SON-1400) fusion proteins exhibit wild-type binding to the IL-18 receptor (IL-18Rc), coupled with undetectable binding to the inhibitory IL-18 binding protein (IL-18BP) IL-18 has significant importance for cancer immune-oncology and combination with IL-12 on Sonnet’s FHAB platform which Sonnet believes could present an important oncology possibility The lock-and-load flexibility of the FHAB platform offers the bifunctional payload capability of adding a ...

PRINCETON, NJ, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced it has received preliminary approval for a tax credit from the New Jersey Technology Business Tax Certificate Transfer Program administered by the New Jersey Economic Development Authority (NJEDA). Sonnet received approval of its application to sell up to $8,143,144 of its New Jersey State net ...