Core Viewpoint - Sonnet BioTherapeutics Holdings, Inc. announced the passing of its founder and CEO, Pankaj Mohan, and appointed Raghu Rao as Interim CEO while promoting Stephen McAndrew to President and Chief Business Officer [1][2] Company Overview - Sonnet is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeting the tumor microenvironment (TME) [1][3] - The company utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for creating targeted biologic drugs [3] Leadership Transition - The Board of Directors has unanimously approved the appointment of Raghu Rao as Interim CEO and Stephen McAndrew as President and Chief Business Officer [1][2] - The Board plans to initiate a search for a permanent CEO [1] Product Development - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain sarcomas, and ovarian cancer [4] - SON-1010 is currently being evaluated in a Phase 1/2a study in collaboration with Roche for platinum-resistant ovarian cancer [4] - The company is also developing a second program, SON-1210 (IL12-FHAB-IL15), for pancreatic cancer in collaboration with the Sarcoma Oncology Center [4]

Core Insights - SON-1010 is being evaluated as a combination therapy with trabectedin (Yondelis) for advanced soft tissue sarcoma, showing potential for immune mechanism synergies and enhanced progression-free survival [1][2] - The initial safety review indicated no unexpected toxicities in early dosing, allowing for full enrollment of up to 18 patients [1][2] - SON-1010 monotherapy demonstrated clinical benefit in 83% of patients at the maximum tolerated dose, including a confirmed partial response in a patient with clear cell sarcoma [1][2] Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs [1][8] - The company utilizes the Fully Human Albumin Binding (FHAB) platform to enhance the safety and efficacy of its drug candidates, including SON-1010 [6][8] - SON-1010 is designed to deliver interleukin-12 to local tumor tissue, potentially converting 'cold' tumors to 'hot' tumors and stimulating immune responses [6][8] Clinical Trial Details - The Phase 1 SB101 trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010, with a maximum tolerated dose established at 1200 ng/kg [7] - The trial includes an expansion cohort for patients with unresectable, metastatic leiomyosarcoma or liposarcoma, with a goal to assess the combination therapy's effectiveness [3][5] - The study has treated 7 patients so far, with plans to enroll up to 18 patients in total [3][7] Market Opportunity - The global market opportunity for trabectedin is estimated at $2.1 billion, highlighting significant unmet medical needs in the treatment of sarcomas [1][5] - The combination of SON-1010 and trabectedin is positioned for potential advancement into larger Phase 2 studies, which could establish a new treatment paradigm for soft tissue sarcomas [5][9]

Core Insights - Sonnet BioTherapeutics Holdings, Inc. has received a Notice of Allowance from the USPTO for a second patent related to its modified version of Interleukin-18 (IL-18), which enhances its effectiveness by binding to the IL-18 receptor while avoiding the inhibitory IL-18 Binding Protein [1][2] - The allowed patent covers various amino acid substitutions in the IL-18 protein, potentially opening up licensing opportunities independent of Sonnet's FHAB platform [1][2] - The company is developing two novel drug candidates, SON-1411 and SON-1400, which utilize the FHAB platform to enhance the therapeutic efficacy of IL-18 and IL-12 in oncology [1][4] Company Overview - Sonnet is focused on developing targeted biologic drugs using its proprietary Fully Human Albumin Binding (FHAB) technology, which aims to improve the safety and efficacy of immune-modulating biologic drugs [4] - The lead program, SON-1010, is in clinical development for advanced solid tumors and is being evaluated in combination with Roche's atezolizumab [4] - The company is also advancing SON-080 for Chemotherapy-Induced Peripheral Neuropathy and has entered a licensing agreement with Alkem Laboratories for its development in India [5] Product Details - SON-1411 is a bifunctional fusion protein combining IL-18 and IL-12, designed to enhance immune responses against tumors by stimulating IFNγ production [3][4] - The FHAB technology allows for targeted delivery to tumor and lymphatic tissues, potentially improving the therapeutic window for various cancer treatments [4][5] - SON-1400 is a monofunctional fusion protein that also utilizes the FHAB platform to extend the half-life and biological activity of IL-18 [1][2]

Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs, utilizing a proprietary platform known as FHAB (Fully Human Albumin-Binding) [4] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, enhancing the safety and efficacy of immune-modulating biologic drugs [4] Product Development - The lead program, SON-1010 (IL-12-FHAB), is in development for advanced solid tumors, certain sarcomas, and platinum-resistant ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [5] - A second product candidate, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors in partnership with the Innovative Immuno-Oncology Consortium, with plans to initiate a Phase 1/2a study for pancreatic ductal adenocarcinoma [5] - The SON-080 program, a low dose of rhIL-6, is in development for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, showing promising results in a Phase 1b/2a trial and is advancing to a Phase 2 study in India under a license agreement with Alkem Laboratories [6] Recent Events - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented key reasons for investment interest in Sonnet for 2025 [2][3]

Core Insights - Sonnet BioTherapeutics is advancing its proprietary Antibody Drug Conjugate (ADC) platform designed to address technical challenges associated with ADCs, aiming to enhance value for cancer patients [2][3] - The initial proof-of-concept ADC construct, SON-5010, demonstrated similar efficacy to Kadcyla and trastuzumab-MMAE in preclinical studies, indicating its potential in cancer treatment [1][3] ADC Platform Development - The ADC platform utilizes a flexible payload capacity and controllable drug-antibody ratios (DAR), allowing for the creation of various ADC candidates [2][3] - The platform is differentiated by its stable structural integrity, extended conjugation site flexibility, and potential for enhanced tumor penetration [2][3] SON-5010 Details - SON-5010 is produced through a two-step process involving the expression and purification of targeting scaffold and payload domains, followed by chemical linkage [2][3] - In vivo comparisons showed that SON-5010 achieved similar tumor reduction activity to Kadcyla without detectable toxicity in a mouse model [3] Strategic Partnerships and Future Plans - The company is seeking value-driven discovery partnerships to further develop its ADC candidates [2][3] - Sonnet plans to continue global prosecution of its intellectual property related to the ADC platform while exploring collaboration opportunities [3] Company Overview - Sonnet BioTherapeutics focuses on oncology and has developed the FHAB (Fully Human Albumin-Binding) technology for targeted biologic drugs [5] - The lead program, SON-1010, is in development for advanced solid tumors and is being evaluated in a Phase 1/2a study in combination with Roche's atezolizumab [5]

Core Insights - Sonnet BioTherapeutics Holdings, Inc. announced that its abstract has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) IO Conference, highlighting its focus on targeted immunotherapeutic drugs [1] Company Overview - Sonnet is an oncology-focused biotechnology company that utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs [2] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, aiming to enhance the safety and efficacy of immune-modulating biologic drugs [2] - The lead program, SON-1010 (IL-12-FHAB), is in development for advanced solid tumors, certain sarcomas, and platinum-resistant ovarian cancer, currently evaluated in a Phase 1/2a study in collaboration with Roche [2] - The second product candidate, SON-1210 (IL12-FHAB-IL15), is being developed for solid tumors in partnership with the Innovative Immuno-Oncology Consortium, with plans for a Phase 1/2a study for pancreatic ductal adenocarcinoma [2] - The SON-080 program, focusing on low-dose rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, has shown promising results in a Phase 1b/2a clinical trial and is advancing into a Phase 2 study in India under a license agreement with Alkem Laboratories [2]

Financial Performance - Total assets increased to $7,182,027 as of December 31, 2024, compared to $2,771,030 as of September 30, 2024, representing a growth of 159%[12] - Collaboration revenue for the three months ended December 31, 2024, was $1,000,000, a significant increase from $18,626 in the same period of 2023[14] - Total operating expenses rose to $3,849,422 for the three months ended December 31, 2024, compared to $1,297,497 in the prior year, marking an increase of 196%[14] - Net loss for the three months ended December 31, 2024, was $3,160,706, compared to a net loss of $1,168,509 for the same period in 2023, reflecting a 170% increase in losses[14] - Cash at the end of the period increased to $4,861,503 from $149,456 at the beginning of the period, indicating a net increase of $4,712,047[18] - The company recorded total liabilities of $3,145,458 as of December 31, 2024, compared to $3,256,769 as of September 30, 2024, showing a decrease of approximately 3.4%[12] - For the three months ended December 31, 2024, the net loss was $3.16 million, compared to a net loss of $1.17 million for the same period in 2023, representing a 170% increase in losses[18] - Net cash used in operating activities was $2.91 million for Q4 2024, slightly improved from $3.09 million in Q4 2023[18] - The company raised $7.71 million from the issuance of common stock in Q4 2024, compared to $3.84 million in Q4 2023, indicating a 101% increase in financing activities[18] - Cash at the end of the period was $4.86 million, up from $3.02 million at the end of Q4 2023, reflecting a 61% increase in cash reserves[18] Shareholder Information - The company reported a weighted average of 2,022,818 shares outstanding for the three months ended December 31, 2024, compared to 474,699 shares in the same period of 2023[14] - The number of shares outstanding increased to 3,007,431 as of December 31, 2024, from 650,284 at the end of September 2024[12][16] - The weighted-average number of shares for diluted net loss per share remains the same as for basic net loss per share due to the anti-dilutive effect of dilutive securities[51] - The Company has a total of 5,161,565 potentially dilutive securities excluded from the computation of diluted shares as of December 31, 2024, compared to 805,931 in 2023[54] - As of December 31, 2024, the Company had a total of 5,789,600 outstanding warrants[91] Clinical Development - The company initiated a U.S. clinical trial (SB101) for its lead asset SON-1010 in oncology patients with solid tumors in Q2 2022[21] - Sonnet BioTherapeutics received FDA clearance for its Investigational New Drug (IND) application for SON-1010 in March 2022, allowing clinical development to proceed[21] - The company created a wholly-owned Australian subsidiary for conducting clinical trials, with an Australian study (SB102) of SON-1010 initiated in Q3 2022[21] - In January 2023, Sonnet announced a collaboration with Roche to evaluate SON-1010 with atezolizumab for platinum-resistant ovarian cancer, with the trial approved in June 2023[22] - Sonnet expanded its Phase 1 SB101 clinical study of SON-1010 in January 2025 to include a new cohort with trabectedin, which was approved as a second-line treatment in early 2024[23] - The Data Safety Monitoring Board cleared the Phase 1b/2a study of SON-080 in chemotherapy-induced peripheral neuropathy to proceed to Part 2 in early 2024[26] - Sonnet entered into a License Agreement with Alkem Laboratories in October 2024 to develop SON-080 for diabetic peripheral neuropathy in India[26] - SON-1210, a lead bifunctional construct, is being developed for solid tumors, with a Phase 1b/2a study in pancreatic cancer initiated by the Sarcoma Oncology Center[27] - SON-080 is advancing in clinical trials for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, with a Phase 1b/2a study approved in Q3 2022[26] Financing and Capital Structure - The Company has a committed equity facility allowing it to sell up to $25.0 million in common stock, with $24.9 million available as of December 31, 2024[84] - The Company closed a public offering on October 26, 2023, raising net proceeds of $3.9 million through the sale of 163,281 shares and warrants[81] - A subsequent public offering on November 7, 2024, generated net proceeds of $4.2 million from the sale of 155,000 shares and warrants[85] - The Company raised approximately $3.5 million from a registered direct and PIPE offering completed on December 10, 2024[90] - The Company recorded a contract asset of $0.5 million related to the Alkem Agreement, representing unbilled collaboration revenue[80] - The New Life Agreement generated $1.0 million in non-refundable upfront cash payments, fully recognized by December 31, 2023[72] - Under the Alkem Agreement, the Company will receive $1.0 million in upfront payments and up to an additional $1.0 million in milestone payments, along with low double-digit royalties on net sales in India[75] Expenses and Liabilities - Total accrued expenses and other current liabilities as of December 31, 2024, amounted to $1,394,520, an increase from $942,489 as of September 30, 2024, with research and development expenses rising to $969,684 from $617,545[59] - The company has contingent milestone payments totaling $3.8 million to XOMA upon achieving certain development milestones related to product commercialization[61] - The company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, with additional contingent milestone payments of up to $1.0 million based on evaluation and development milestones[70] - The company has a one-time fee obligation of $1.5 million or 5% of the first upfront payment received from a third-party partnership under the SOC Agreement for the development of SON-1210[67] - The Company incurred $12,000 in license fees under the Brink Agreement during the three months ended December 31, 2024 and 2023[65] Management and Governance - The company appointed Donald Griffith as Chief Financial Officer effective February 21, 2025, following the resignation of Jay Cross[100] - Stephen McAndrew was appointed as Chief Business Officer, with an annual base salary of $330,000 and eligibility for a performance-based cash bonus of up to 35%[101]

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]