Sonnet Biotherapeutc Hldng Inc Stock Price, News & Analysis

Sonnet BioTherapeutics (NASDAQ: SONN) has entered a clinical collaboration agreement with the Sarcoma Oncology Center to conduct a Phase 1/2a study of SON-1210, their bifunctional IL-12/IL-15 fusion protein, in combination with chemotherapy for pancreatic cancer treatment. The study, led by Dr. Sant Chawla and funded by the Sarcoma Oncology Center, aims to address a significant unmet medical need. Preclinical data has shown SON-1210's potential in solid tumor immunotherapy. The collaboration leverages Sonnet's Fully Human Albumin Binding (FHAB®) platform and targets pancreatic cancer, which has increased expression of FcRn and GP60 receptors, and the SPARC complex. SON-1210 has demonstrated increased immune activity and persistence in preclinical models, with no overt toxicity in IND-enabling studies.

Sonnet BioTherapeutics (NASDAQ: SONN) reported Q3 FY2024 results and provided a corporate update. Key highlights include:

1. Ongoing progress with SON-1010 clinical trials for solid tumors and Platinum-Resistant Ovarian Cancer (PROC).

2. Efforts to initiate Phase 2 trial of SON-080 in Diabetic Peripheral Neuropathy (DPN).

3. U.S. patent granted for SON-1210 composition of matter.

4. Encouraging data from SON-080 Phase 1b/2a trial in Chemotherapy-Induced Peripheral Neuropathy (CIPN).

5. $3.6 million cash on hand as of June 30, 2024, sufficient to fund operations into November 2024.

6. R&D expenses decreased to $1.7 million, while G&A expenses increased to $1.8 million for Q3.

Sonnet BioTherapeutics (NASDAQ:SONN) reported encouraging data from its Phase 1b/2a clinical trial of SON-080 for Chemotherapy-Induced Peripheral Neuropathy (CIPN). The study showed that SON-080 was well-tolerated at both 20 µg and 60 µg doses, with no evidence of pro-inflammatory cytokine response. Pain and quality of life survey results suggest potential rapid improvement of peripheral neuropathy symptoms and post-dosing durability compared to placebo. Sonnet intends to seek a partnership to initiate a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN), a larger, high-value indication with unmet medical need. The company believes this data bridges the historical safety database and is foundational for advancing SON-080 to Phase 2, evaluating its neuroprotective and neuro-regenerative effects in DPN.

Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage company, has announced the exercise of certain outstanding warrants resulting in gross proceeds of $3.4 million. The agreement involves the immediate exercise of warrants for 2,828,500 shares at a reduced price of $1.20 per share, effective June 21, 2024. Ladenburg Thalmann & Co. Inc. is the exclusive placement agent. In return for immediate exercise, Sonnet will issue new unregistered warrants for 5,657,000 shares at $1.55 per share, exercisable immediately and valid for five years. Additional adjustments include reduced exercise prices for other outstanding warrants and an extension of their terms. The funds will be used for R&D, clinical trials, working capital, and general corporate purposes.

Sonnet BioTherapeutics (NASDAQ:SONN) announced the development of two new immunotherapeutic drug candidates, SON-1411 and SON-1400, utilizing a modified IL-18 variant. SON-1411 combines IL-18BPR with IL-12 via Sonnet’s FHAB platform, while SON-1400 solely integrates IL-18BPR with FHAB. These candidates exhibit high bioactivity and target tumor environments more effectively, mitigating the inhibitory effects of IL-18BP. SON-1411 and SON-1400 were produced in CHO cells and E. coli, respectively, and show promising in vitro results for cancer treatment by enhancing immune response against tumors. The new IL-18 variant maintains receptor binding while avoiding IL-18BP inhibition, showcasing potential for broad oncological and cell-based therapies.

Sonnet BioTherapeutics (NASDAQ: SONN) announced the presentation of its SB221 study at the ASCO 2024 Annual Meeting. The study focuses on SON-1010, a recombinant human Interleukin-12 linked to Sonnet's albumin binding domain, in combination with atezolizumab (Tecentriq®). This Phase 1b/2a trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SON-1010 administered subcutaneously, alone or with a fixed dose of atezolizumab. The poster session is scheduled for June 3, 2024, from 9:00 AM to 12:00 PM CDT in Hall A, as part of the Gynecologic Cancer session. The study targets patients with platinum-resistant ovarian cancer.

Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage company, announced on May 22, 2024, that its Board of Directors is exploring strategic alternatives to maximize stockholder value. The company has engaged Chardan Capital Markets as its financial advisor to assist with assessing options such as partnerships, joint ventures, acquisitions, mergers, and other strategic transactions.

There is no set timetable for this review, and no decisions have been made regarding the strategic alternatives. Sonnet emphasizes that there is no guarantee that the evaluation will result in any definitive transactions, changes, or outcomes favorable to the company or its shareholders.

Sonnet BioTherapeutics (NASDAQ:SONN) has announced updated clinical data for its drug candidate SON-1010, used as a monotherapy or in combination with atezolizumab (Tecentriq®). The trials have enrolled a total of 61 subjects with dose escalation continuing in SB101 and SB221 trials. SON-1010 showed no dose-limiting toxicities and revealed a 10-fold extended half-life compared to rhIL-12, prolonging IFNγ responses without cytokine release syndrome. Clinical benefits were observed in 35% of evaluable patients with advanced solid tumors. Both trials reported stable disease in 60% of patients at the first follow-up scan. Sonnet is increasing the target dose of SON-1010 to enhance efficacy.

SON-1010 was also tested in a Phase 1 trial (SB102) in healthy volunteers, showing a consistent safety profile. Sonnet’s Chief Medical Officer, Dr. Richard Kenney, emphasized the clean data generated for pharmacokinetic and pharmacodynamic analyses. The combination of SON-1010 with atezolizumab may benefit from turning 'cold' tumors 'hot,' upregulating PD-L1. The company plans to further test the drug in higher doses later this year and expects more updates early next year.

Sonnet BioTherapeutics (NASDAQ:SONN) reported its FY 2024 Q2 and year-to-date business and earnings update. Key highlights include the publication of Phase 1 data showing the safety and tolerability of SON-1010 in Frontiers in Immunology and early safety data from the Phase 1b/2a trial of SON-080 for CIPN. The company received $4.3 million from New Jersey’s tax program. Financials show $3.8 million in cash and reduced R&D and administrative expenses, reflecting cost-saving measures. New partnerships and further development of SON-080 for diabetic peripheral neuropathy are planned.