Sonnet BioTherapeutics Holdings, Inc. - SONN STOCK NEWS

Sonnet BioTherapeutics (NASDAQ: SONN) reported fiscal year 2024 results with significant operational improvements. The company achieved a 37% reduction in total operating expenses compared to fiscal year 2023, with 43% of expenses covered by non-dilutive funding. Key developments include progress in clinical trials for SON-1010 in solid tumors and Platinum-Resistant Ovarian Cancer, and a licensing agreement for SON-080 in Diabetic Peripheral Neuropathy.

Financial results show R&D expenses decreased to $5.7M from $11.8M, and G&A expenses reduced to $6.1M from $7.1M year-over-year. The company had $0.1M cash on hand as of September 30, 2024, but secured additional funding through stock sales and tax incentives, projecting operations funded through July 2025.

Sonnet BioTherapeutics (NASDAQ:SONN) has announced a $3.9 million financing through a combination of registered direct offering and concurrent private placement. The company is selling 1,085,325 shares in the registered direct offering and 673,000 shares in the private placement, both priced at $2.23 per share. Each share comes with one warrant exercisable at $2.10 per share with a five-year term.

The transaction, expected to close around December 10, 2024, is being facilitated by Chardan as the exclusive placement agent. The proceeds will support research and development, clinical trials, and working capital needs. The offering is conducted under an effective S-3 registration statement, with the private placement shares being offered under Section 4(a)(2) of the Securities Act.

Sonnet BioTherapeutics (NASDAQ:SONN) has announced successful topline safety data from its Phase 1 SB101 trial of SON-1010 in advanced solid tumor patients. The maximum tolerated dose was established at 1200 ng/kg, with no dose-limiting toxicity or cytokine release syndrome observed.

Key findings include stable disease in 48% (10 of 21) of evaluable monotherapy patients at four months post-treatment initiation, including one patient at the maximum dose achieving a partial response with a 45% tumor reduction. Of 24 total patients, 17 (71%) showed stable disease at first follow-up. The safety profile has been favorable, with mostly mild adverse events reported.

The company is currently seeking partnership opportunities for later-stage development while continuing patient monitoring for long-term safety and tumor responses.

Sonnet BioTherapeutics (NASDAQ: SONN) announced the publication of discovery and development data for SON-1010, their lead drug candidate, in Frontiers in Immunology. The research details their albumin-binding (FHAB®) technology combined with IL-12 for improved cancer treatment delivery.

The publication highlights the identification of molecules that bind to serum albumin across multiple species and pH ranges, leading to extended half-life and improved tumor targeting. Patents for FHAB and SON-1010 have been issued in major markets including the US, China, and Japan, expiring between 2038-2039.

The company is currently conducting a Phase 1 clinical trial of SON-1010 for advanced solid tumors, with safety data expected in Q4 2024. Additionally, SON-1010 is being evaluated in a Phase 1/2a study in combination with Roche's atezolizumab for Platinum-Resistant Ovarian Cancer.

Sonnet BioTherapeutics (NASDAQ: SONN) has released a Virtual Investor segment featuring CEO Dr. Pankaj Mohan and CSO Dr. John Cini discussing their recent U.S. patent issuance. The patent covers a variant of IL-18 incorporated into two novel immunotherapeutic drug candidates: SON-1400 (IL-18BPR-FHAB) and SON-1411 (IL-18BPR-FHAB-IL12). Both candidates contain a modified version of recombinant human interleukin-18 (IL-18BPR = Binding Protein Resistant).

Sonnet BioTherapeutics (NASDAQ: SONN) has announced the pricing of an underwritten public offering of 1,111,111 shares of common stock and common warrants. The offering includes common warrants to purchase up to 2,222,222 additional shares. Each share is being sold with one common warrant at a combined price of $4.50, for total gross proceeds of approximately $5.0 million. The common warrants are exercisable for five years at $4.50 per share. The offering is expected to close around November 7, 2024. The proceeds will be used for research and development, clinical trials, working capital, liability repayment, and general corporate purposes.

Sonnet BioTherapeutics (NASDAQ:SONN) announces the issuance of U.S. Patent No. 12,134,635, covering two novel drug candidates: SON-1411 and SON-1400. The patent, effective until June 2044, involves modified interleukin-18 (IL-18BPR) variants. Both drugs show wild-type binding to IL-18 receptor while avoiding binding to the inhibitory IL-18BP. SON-1411 is a bifunctional fusion protein combining IL-18BPR with IL-12, while SON-1400 is a monofunctional fusion protein, both linked to Sonnet's FHAB platform. The technology aims to overcome IL-18BP's inhibitory effects in cancer treatment, potentially expanding immunotherapy applications.

Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, has regained compliance with Nasdaq's bid price requirement for continued listing on the Nasdaq Capital Market. The company received notice from Nasdaq on October 16, 2024, confirming its compliance with Listing Rule 5550(a)(2).

As a result, Sonnet will be subject to a Mandatory Panel Monitor for one year from October 16, 2024. If the company falls out of compliance with the Bid Price Rule during this period, it will face stricter consequences, including potential delisting without the opportunity to provide a compliance plan or receive additional time to regain compliance.

Sonnet BioTherapeutics (NASDAQ: SONN) has entered into a licensing agreement with Alkem Laboratories for the development and commercialization of SON-080 for Diabetic Peripheral Neuropathy (DPN) in India. Sonnet will receive $1.0 million upfront and up to an additional $1.0 million in milestone payments, plus a low double-digit royalty on net sales.

Alkem will fund, develop, and commercialize SON-080 for DPN in India, as well as commercialize it for Chemotherapy Induced Neuropathy (CIPN) and Autonomic Neuropathy. The estimated market size for diabetic neuropathy in India is expected to reach $246.7 million by 2030.

SON-080, Sonnet's proprietary version of recombinant human Interleukin-6 (rhIL-6), has shown promising results in preclinical studies for both DPN and CIPN. The company recently announced encouraging data from the Phase 1b portion of its ongoing Phase 1b/2a clinical trial for CIPN treatment.