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Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) is a clinical-stage biotechnology company based in Cranbury, New Jersey. The firm is pioneering the development of targeted immunotherapeutic drugs primarily aimed at treating cancers. Sonnet employs its proprietary FHAB (Fully Human Albumin Binding) technology, which utilizes a single-chain antibody fragment that binds to human serum albumin for targeted delivery to tumor and lymphatic tissues. This innovative platform enhances drug efficacy and safety by extending the half-life of therapeutic agents and concentrating them in the tumor microenvironment (TME).
Sonnet’s mission focuses on generating immuno-oncology candidates and advancing them to Phase II clinical assets. The company's current pipeline includes several promising products:
- SON-080 - A low-dose IL-6 aimed at treating chemotherapy-induced peripheral neuropathy (CIPN).
- SON-1210 - Combines IL-12 and IL-15 with Sonnet's FHAB for robust immune response targeting tumors.
- SON-1010 - Consists of a single-chain IL-12 linked with the albumin-binding domain for enhanced targeting and efficacy in cancer treatment.
Recent achievements include the publication of preclinical data demonstrating the efficacy of SON-1210 in reducing tumor growth in melanoma models. Additionally, the company reported positive safety and tolerability results from Phase 1 studies of SON-1010 in healthy volunteers and cancer patients.
Sonnet's collaboration with Genentech for the combination study of SON-1010 and atezolizumab (Tecentriq) in platinum-resistant ovarian cancer is a significant milestone. Financially, the company has successfully leveraged tax credits and managed its cash runway effectively, projecting operations funding into the latter part of 2024.
The company is also actively exploring strategic alternatives to maximize stockholder value, having engaged Chardan Capital Markets to assist in evaluating potential business development, partnerships, acquisitions, or mergers.
Sonnet BioTherapeutics has selected a new candidate, SON-1410 (IL18-FHAB-IL12), for development after successful comparisons in a mouse melanoma study. This candidate, integrating Interleukins 18 and 12, aims to target melanoma and renal cancers. An IND submission is expected in 2022. The study showed significant tumor reduction compared to placebo, with promising immune responses. Following a recent $30 million financing, Sonnet is focused on advancing its immuno-oncology pipeline, with manufacturing processes for SON-1410 already in progress.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced a public offering of 35,294,117 shares at a price of $0.85 per share, projected to raise approximately $30 million before expenses. Each share comes with an investor warrant for one additional share at the same price. A 30-day over-allotment option for an additional 5,294,117 shares is available to underwriters. Funds will be allocated for research, clinical trials, and general corporate purposes. The offering is expected to close around August 24, 2021.
Sonnet BioTherapeutics (NASDAQ:SONN) reported its fiscal Q3 2021 results, noting progress on its Fully Human Albumin Binding (FHAB) drug pipeline. With IND submissions for SON-1010 and SON-080 anticipated by year-end 2021, the company is focused on increasing the efficacy of targeted therapies. The financing strategy generated $15.9 million through an at-the-market sale, enhancing R&D capabilities. As of June 30, 2021, cash on hand stood at $6 million, with R&D expenses rising to $3.9 million, reflecting heightened developmental activity.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) has rescheduled its annual stockholders meeting to July 15, 2021, at 9:00 a.m. Eastern Time, to be conducted virtually. The meeting will include discussions on key proposals such as the election of directors and appointment of the independent auditing firm for the fiscal year ending September 30, 2021.
Sonnet is focused on developing innovative biologic drugs using its proprietary FHAB technology, which enhances drug efficacy through targeted delivery mechanisms.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) announced the issuance of U.S. Patent No. 11,028,166 for its Fully Human Albumin Binding (FHAB™) technology, valid until March 2039. This patent protects therapeutic fusion proteins designed for tumor targeting and extended pharmacokinetics. CEO Pankaj Mohan emphasized its significance in differentiating from competitors and validating their product pipeline.
Sonnet's FHAB platform enhances penetration and retention in tumors, showcasing potential for improved efficacy against wild type cytokines.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) announced positive results from a preclinical GLP repeat-dose study of SON-1010, a proprietary Interleukin 12 biologic, in nonhuman primates. The No Observed Adverse Event Level was over 50 times the expected human dose, with no cytokine release syndrome noted. The pharmacokinetic profile showed a half-life of approximately 40 hours, enhancing therapeutic potential. Additionally, significant increases in Interferon-γ, an anti-tumor cytokine, were recorded. These findings support the safety and efficacy of SON-1010 for future clinical trials.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) has signed a licensing agreement with New Life Therapeutics (NLT) for low-dose Interleukin 6 to treat Diabetic Peripheral Neuropathy (DPN) in ASEAN countries. The deal includes an upfront payment of $1 million and up to $20 million in milestone payments, along with royalties of 12% to 30% on net sales. NLT will manage a Phase 1b/2a clinical trial, set to begin in the second half of 2021. This partnership aims to address rising diabetes rates in the region and bring innovation to neuropathy treatment.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) provided an update on its ongoing programs. The company has completed GLP toxicity studies for SON-1010 and SON-080, with plans to initiate clinical trials in the second half of 2021. A partnership with New Life Therapeutics for SON-081 aims to advance it into clinical trials. Sonnet is actively developing several candidates, including SON-1210 and SON-2014, with IND submissions planned. Additionally, the company received a Notice of Allowance for its FHAB delivery technology patent, strengthening its intellectual property portfolio.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) has announced the appointments of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations, effective March 22, 2021. Dr. Kenney, with over 20 years of experience, will lead clinical development for Sonnet’s FHAB platform, aimed at treating challenging cancers. Dafonseca brings over 30 years of expertise in pharmaceutical development, recently managing oncology clinical operations at Merck. These strategic appointments come as the company prepares to advance its proprietary IL-12 therapeutic candidate, SON-1010, into clinical trials.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) provided a business update and financial results for Q1 FY 2021, reporting a cash balance of $2.3 million as of December 31, 2020. The company announced successful non-human primate studies for its lead therapeutic candidate, SON-1010, which demonstrated on-target activity and tolerability. Sonnet plans to file an IND for SON-1010 in the second half of 2021, alongside additional trials for SON-080 and SON-1210. The company has initiated an at-the-market offering program aiming to raise up to $15.9 million.
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