Financial Performance - Total assets increased to $3,836,434 as of March 31, 2025, compared to $2,771,030 as of September 30, 2024, representing a 38.4% growth[10] - Collaboration revenue for the six months ended March 31, 2025, was $1,000,000, a decrease from $18,626 in the same period of 2024[12] - Total operating expenses for the three months ended March 31, 2025, were $4,229,420, up 9.3% from $3,868,561 in the same period of 2024[12] - Net loss for the three months ended March 31, 2025, was $(3,491,122), compared to a net income of $365,425 for the same period in 2024[12] - For the six months ended March 31, 2025, Sonnet reported a net loss of $6.65 million, compared to a net loss of $803,084 for the same period in 2024, indicating a significant increase in losses[16] - Net cash used in operating activities for the six months ended March 31, 2025, was $5.38 million, up from $2.37 million in the prior year, reflecting increased operational expenditures[16] - The company reported a net loss of $3.49 million for the three months ended March 31, 2025, compared to a net income of $0.37 million for the same period in 2024[50] - Basic net loss per share for the three months ended March 31, 2025, was $(0.89), while for the same period in 2024, it was $0.63[50] - Net loss for the six months ended March 31, 2025, was $6.7 million, compared to a net loss of $0.8 million for the same period in 2024, indicating a substantial increase in operational losses[157] Cash and Liquidity - Cash balance increased significantly to $2,059,284 as of March 31, 2025, from $149,456 as of September 30, 2024[10] - The company had cash of $2.06 million at the end of the period, down from $3.79 million at the end of the same period in 2024, highlighting liquidity challenges[16] - The company reported a net increase in cash of $1.9 million for the six months ended March 31, 2025, compared to $1.5 million in 2024, primarily due to financing activities[159] - The company expects to continue incurring significant operational expenses and net losses in the upcoming 12 months and beyond, with cash of $2.1 million projected to fund operations into July 2025[157][158] Research and Development - The FDA accepted the IND for the Phase 1b/Phase 2a study (SB221) of SON-1010 in combination with atezolizumab in August 2023, with interim data reported in April 2025[20] - The company is advancing SON-080 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and has put the SB211 study on hold pending partnering activity[23] - Sonnet's lead asset, SON-1010, is in clinical development for solid tumors, with interim safety data reported in March 2025 following successful dose escalation[19] - The company is pursuing clinical development of its lead asset, SON-1010, for solid tumor indications, including ovarian cancer, with FDA clearance received for its IND application in March 2022[19] - A collaboration agreement with Roche was announced in January 2023 to evaluate SON-1010 in combination with atezolizumab for platinum-resistant ovarian cancer[20] - The Phase 1 SB101 clinical study of SON-1010 has been expanded to evaluate its effect in combination with trabectedin, following successful monotherapy dose escalation[102] - The Data Safety Monitoring Board cleared the Phase 1b/2a study of SON-080 for Chemotherapy-Induced Peripheral Neuropathy, with initial safety data announced following the review[23] - SON-1210 is being developed for solid tumors, with a Phase 1b/2a study in pancreatic cancer initiated through a collaboration with the Sarcoma Oncology Center[24] Expenses and Liabilities - General and administrative expenses for the six months ended March 31, 2025, were $4,307,859, compared to $2,354,728 in the same period of 2024, reflecting an increase of 83.5%[12] - Total operating expenses increased to $8,078,842 for the six months ended March 31, 2025, from $5,166,058 in 2024, representing a 56.5% increase[12] - As of March 31, 2025, accrued expenses and other current liabilities totaled $1,338,552, an increase from $942,489 on September 30, 2024, with significant increases in research and development expenses from $617,545 to $956,083[57] - The company has incurred recurring losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern[27] Financing Activities - The company raised net proceeds of $3.9 million from a public offering on October 26, 2023, through the issuance of 163,281 shares and pre-funded warrants[77] - The committed equity facility allows the company to sell up to $25.0 million in common stock, with $24.8 million available as of March 31, 2025[78] - During the six months ended March 31, 2025, the company sold 98,846 shares under the Purchase Agreement for net proceeds of approximately $0.1 million[78] - The company closed a public offering on November 7, 2024, raising net proceeds of $4.2 million through the issuance of 155,000 shares and pre-funded warrants[79] - A registered direct offering on December 10, 2024, raised approximately $3.4 million from the issuance of 768,000 shares and pre-funded warrants[83] - The company recorded share-based compensation expense of $60,395 for the three months ended March 31, 2025[90] Collaboration Agreements - The Company has entered into multiple collaboration agreements, including the New Life Agreement in May 2021 and the Alkem Agreement in October 2024, which may include various revenue components[42] - The New Life Agreement generated $1.0 million in non-refundable upfront cash payments, fully recognized as collaboration revenue by December 31, 2023[70] - The Alkem Agreement includes $1.0 million in upfront payments and up to an additional $1.0 million in milestone payments, with royalties in the low double digits on net sales of the product in India[72] - As of March 31, 2025, the company has an outstanding balance of $0.5 million related to the Alkem Agreement included in accounts receivable[75] Intellectual Property and Regulatory - The European Patent Office granted a patent covering the FHAB technology, effective until February 20, 2038, enhancing the company's intellectual property portfolio[126] - The company is currently evaluating the impact of new accounting standards issued by the FASB, including ASU 2023-07 and ASU 2023-09, which will affect future financial disclosures[53][54] Miscellaneous - The company has employment agreements that provide for severance and continuation of benefits in the event of termination, including provisions for stock options upon a change in control[69] - The company has no minimum purchase commitments in contracts with CROs and CMOs, allowing for flexibility in operational expenditures[175]

PRINCETON, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeting the tumor microenvironment (TME), today announced it will present at the 6th Annual Cytokine-Based Drug Development Summit being held May 15-16, 2025 in Boston, MA. Details of the presentation are as follows: Title: Managing Toxicity Caused by The Over Expression of Cytokines to Widen the Therapeutic WindowSes ...

- Raghu Rao, Interim Chief Executive Officer and Dr. Richard Kenney, Chief Medical Officer, of Sonnet discuss the recently announced safety data related to SON-1010 - Watch the "What This Means" video here PRINCETON, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeted to the tumor microenvironment (TME), today announced that members of the Sonnet management team partici ...

- Raghu Rao, Interim Chief Executive Officer and Dr. Richard Kenney, Chief Medical Officer, of Sonnet discuss the recently announced safety data related to SON-1010 - Watch the "What This Means" video here PRINCETON, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeted to the tumor microenvironment (TME), today announced that members of the Sonnet management team partici ...

Core Insights - The SB221 study demonstrated positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC), allowing the study to advance to the expansion phase [1][5][6] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg, with no dose-limiting toxicity or cytokine release syndrome observed [1][2][3] - A partial response (PR) was noted in one patient, with a 44% decrease in tumor size and a significant reduction in the CA 125 biomarker [1][3][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 combined with atezolizumab, with a focus on establishing the MTD [2][8] - A total of 19 subjects were treated during the dose escalation phase, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with only one serious adverse event (Grade 2 pneumonitis) reported [3][5] Clinical Implications - The results indicate that SON-1010 may be particularly effective in treating immunologically 'cold' tumors, such as ovarian cancer, by enhancing the immune response [4][7] - The study's findings suggest a potential synergistic effect when SON-1010 is used in combination with immune checkpoint inhibitors [5][6] - The safety profile observed in this trial is promising, especially given the historical safety concerns associated with rhIL-12 therapies [5][6] Future Directions - The SB221 trial will proceed to a Phase 2a randomized comparison with standard care for PROC patients [1][8] - Sonnet BioTherapeutics is seeking partnership opportunities to support the later stages of SON-1010's development [6][11]

Core Insights - The SB221 study demonstrates positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC) [1][5] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg without dose-limiting toxicity or cytokine release syndrome [1][3] - The study showed a partial response (PR) in one patient and stable disease (SD) in 33% of evaluable patients at four months [1][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 with atezolizumab, focusing on establishing the MTD [2][8] - A total of 19 subjects were treated, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with no significant toxicity observed [3][5] Clinical Implications - The results indicate that SON-1010 may enhance the efficacy of immune checkpoint inhibitors (ICIs) in treating 'cold' tumors like ovarian cancer [4][5] - The study's findings are encouraging given the historical safety concerns associated with rhIL-12, suggesting a potential for improved tumor control [5][6] - The ongoing trial will assess longer-term safety and tumor responses, with a focus on expanding the dataset for efficacy evaluation [6][8] Company Overview - Sonnet BioTherapeutics is focused on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform [10][11] - SON-1010 is designed to deliver IL-12 to tumor tissues, potentially improving the safety and efficacy profile of immunomodulators [7][10] - The company is also exploring partnerships to support the later stages of SON-1010's development [6][11]

Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeted to the tumor microenvironment (TME) [1] - The company utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs, which enhances the safety and efficacy of immune-modulating biologic drugs [2] Lead Programs - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain types of sarcoma, and ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [2] - The second program, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors, with an upcoming investigator-initiated Phase 1/2a study for pancreatic cancer in collaboration with the Sarcoma Oncology Center [2]

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]