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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 Holdings, Inc. (NASDAQ: SONN) has announced a 1-for-8 reverse stock split of its outstanding common stock, effective for trading on September 30, 2024. This move aims to increase the per share trading price to meet Nasdaq's $1.00 minimum bid price requirement. The company's stock will continue trading under the symbol 'SONN' with a new CUSIP number. The reverse split will reduce the number of shares outstanding from approximately 5.2 million to 650,300.
Key points:
- Par value remains $0.0001 per share
- Authorized number of shares unchanged
- No fractional shares issued; cash payments for fractional entitlements
- Applies to outstanding warrants and stock options with adjusted exercise prices
- Stockholders approved the split on September 12, 2024
- Board of directors approved the 1-for-8 ratio on September 23, 2024
Sonnet BioTherapeutics (NASDAQ: SONN) has completed enrollment and initiated dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) for advanced solid tumors. The study enrolled 24 subjects, with topline safety data expected in Q4 2024. SON-1010 is a targeted immune activation cancer therapy designed to turn 'cold' tumors 'hot'. Key points:
- No dose-limiting toxicities reported to date
- Majority of adverse events mild and transient
- One patient with endometrial sarcoma showed stable disease for almost 2 years
- Controlled induction of interferon gamma observed
- No indication of potential for cytokine release syndrome
Sonnet BioTherapeutics Holdings (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, has announced its participation in the Virtual Investor Closing Bell Series on September 9, 2024, at 4:00 PM ET. The event will feature:
- A corporate overview and business outlook by CEO Pankaj Mohan
- A moderated discussion with live Q&A opportunities
- Pre-submission of questions via email to sonn@jtcir.com
The live video webcast will be available on the company's website, with a replay accessible for 90 days following the event. This presentation offers investors a chance to gain insights into Sonnet's latest developments and future plans in the field of immunotherapy.
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.
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