Sonnet BioTherapeutics

Sonnet BioTherapeutics Holdings, Inc., a clinical stage oncology-focused biotechnology company, develops platform for biologic medicines of single or bispecific action. The company develops fully human albumin binding technology, which utilizes human single chain antibodies fragment that binds to and hitch-hikes on human serum albumin for transport to target tissues. Its lead candidate is SON-1010, a fully human version of interleukin 12 for the treatment non-small cell lung cancer, and head and neck cancer. The company is also developing SON-080, a fully human version of interleukin 6 for chemotherapy-induced peripheral neuropathy and diabetic peripheral neuropathy. It has a license agreement with New Life Therapeutics PTE, LTD. to develop and commercialize pharmaceutical preparations containing a specific recombinant human interleukin 6. Sonnet BioTherapeutics Holdings, Inc. is based in Princeton, New Jersey.

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Sonnet BioTherapeutics Holdings, Inc. is a clinical stage biotechnology company, which engages in the innovation of biologic medicines. Its Fully Human Albumin Binding (FHAB) technology utilizes a single chain antibody fragment that binds to and hitch-hikes on human serum albumin for transport to target tissues. Its pipeline focuses on cytokines, a class of cell signaling peptides that, among other important functions, serve as potent immunomodulatory agents. The company was founded by Pankaj Mohan and John K. Cini in 2011 and is headquartered in Princeton, NJ.

PRINCETON, NJ, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the next CEO Corner segment has been published on the Company's website .

Sonnet BioTherapeutics Announces Release of the Next CEO Corner Segment

Continued progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC)

Sonnet BioTherapeutics Reports Fiscal Year 2024 Financial Results and Provides Corporate Update

PRINCETON, NJ, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that it has entered into a definitive agreement with institutional investors for the purchase and sale of an aggregate of 1,085,325 shares of its common stock (or common stock equivalents in lieu thereof) (the “Registered Direct Shares”) and warrants to purchase up to an aggregate of 1,085,325 shares of common stock (the “Registered Direct Warrants”), in a registered direct offering. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold in the registered direct offering together with one common warrant at a combined offering price of $2.23, priced at-the-market under the rules of the Nasdaq Stock Market. The Registered Direct Warrants will have an exercise price of $2.10 per share, are immediately exercisable and will expire five years from the date of issuance. The Company has also entered into a definitive agreement with an existing investor, in a concurrent private placement, for the purchase and sale of an aggregate of 673,000 shares of its common stock (or common stock equivalents in lieu thereof) (the “PIPE Shares”) and warrants to purchase up to an aggregate of 673,000 shares of common stock (the “PIPE Warrants”). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold in the private placement offering together with one common warrant at a combined offering price of $2.23, priced at-the-market under the rules of the Nasdaq Stock Market. The PIPE Warrants will have an exercise price of $2.10 per share, are immediately exercisable and will expire five years from the date of issuance.

Sonnet BioTherapeutics Announces $3.9 Million Registered Direct Offering and Concurrent Private Placement Priced At-The-Market Under Nasdaq Rules

The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level

Sonnet BioTherapeutics Announces Topline Safety Data Following Successful Completion of SON-1010 Monotherapy Dose Escalation in Phase 1 SB101 Trial

Pankaj Mohan, CEO of Sonnet discusses what this publication means in a Virtual Investor “What This Means” segment; access here

Sonnet BioTherapeutics Announces Publication Detailing the Discovery and Development of SON-1010, an Albumin-Binding IL-12 Fusion Protein, Demonstrating Its Mechanism of Action

Drs. Pankaj Mohan, CEO of Sonnet, and John Cini, CSO of Sonnet, discuss the Company's recent issuance of a U.S. patent covering a variant of IL-18 incorporated into two novel immunotherapeutic drug candidates, SON-1400 and SON-1411

Sonnet BioTherapeutics Releases Virtual Investor ‘”What this Means” Segment

PRINCETON, NJ, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet”) (NASDAQ: SONN), a clinical-stage company developing innovative targeted immunotherapeutic drugs, today announced the pricing of an underwritten public offering of 1,111,111 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and common warrants to purchase up to an aggregate of 2,222,222 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one common warrant at a combined offering price of $4.50, priced at-the-market under the rules of the Nasdaq Stock Market, for total gross proceeds of approximately $5.0 million, before underwriting discounts and commissions and offering expenses payable by Sonnet. Each common warrant is exercisable for two shares of common stock at an exercise price of $4.50 per share for a period of five years from the date of issuance. The offering is expected to close on or about November 7, 2024, subject to the satisfaction or waiver of customary closing conditions.

Sonnet BioTherapeutics Announces Pricing of $5.0 Million Underwritten Public Offering Priced At-The-Market Under Nasdaq Rules

Both novel bifunctional (SON-1411) and monofunctional (SON-1400) fusion proteins exhibit wild-type binding to the IL-18 receptor (IL-18Rc), coupled with undetectable binding to the inhibitory IL-18 binding protein (IL-18BP)

Sonnet BioTherapeutics Announces Issuance of U.S. Patent Covering a Variant IL-18 Incorporated into Two Novel Immunotherapeutic Drug Candidates

PRINCETON, NJ, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced that it received notice on October 16, 2024 from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company regained compliance with the bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”) for continued listing on the Nasdaq Capital Market.

Sonnet BioTherapeutics Inc. Regains Compliance with Nasdaq

Sonnet to receive $1.0 million in upfront payment and up to an additional $1.0 million in milestone payments with a royalty in the low double digits on net sales, less certain expenses, in the India market

Sonnet BioTherapeutics Inc. Enters into Licensing Agreement with Alkem Laboratories Limited to Develop and Commercialize SON-080 for Diabetic Peripheral Neuropathy (DPN) in India

PRINCETON, NJ, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced it has received preliminary approval for a tax credit from the New Jersey Technology Business Tax Certificate Transfer Program administered by the New Jersey Economic Development Authority (NJEDA). Sonnet received approval of its application to sell up to $8,143,144 of its New Jersey State net operating losses (NOLs) and $62,810 of its New Jersey State research and development (R&D) tax credits for proceeds of up to $0.795 million through the New Jersey Technology Business Tax Certificate Transfer Program, subject to execution of such sale. Sonnet also expects to receive a $0.7 million net cash refund from the R&D Tax Incentive Program in Australia.

Sonnet BioTherapeutics to Receive Non-Dilutive Funding Through New Jersey Tax Certificate Transfer and Australia R&D Tax Incentive Programs

CEO Corner segments to include additional discussion related to press releases, events, corporate updates and pipeline progress

Sonnet BioTherapeutics Announces Launch of CEO Corner Platform

PRINCETON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”) (NASDAQ: SONN), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that it will effect a 1-for-8 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on Monday, September 30, 2024.

Sonnet BioTherapeutics Announces 1-for-8 Reverse Stock Split

SON-1010 is a targeted immune activation cancer therapy designed to turn ‘cold' tumors ‘hot' Topline safety data of SB101 Phase 1 study expected by Q4 2024 PRINCETON, NJ, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the completion of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors.

Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors

PRINCETON, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced that it will participate in the Virtual Investor Closing Bell Series on Monday, September 9, 2024, at 4:00 PM ET.

Sonnet BioTherapeutics to Participate in the Virtual Investor Closing Bell Series

Preclinical data has demonstrated the potential of SON-1210, the first albumin-binding bifunctional IL-12/IL-15 fusion protein, for solid tumor immunotherapy

Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement to Commence Investigator-Initiated and Funded Phase 1/2a Study of SON-1210 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer

Ongoing progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC)

Sonnet BioTherapeutics Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update

Watch the "What This Means" segment here FRENCHTOWN, NJ / ACCESSWIRE / July 24, 2024 / JTC Team ("JTC"), a fully integrated corporate communications and investor relations firm, today released a Virtual Investor "What This Means" segment featuring Sonnet BioTherapeutics, Inc. (Nasdaq:SONN), a clinical-stage company developing targeted immunotherapeutic drugs. As part of the "What This Means" segment, Pankaj Mohan, PhD, Founder and Chief Executive Officer, Richard Kenney, M.D.

Sonnet BioTherapeutics (NASDAQ:SONN) Participates in Virtual Investor "What This Means" Segment Hosted by JTC Team

PRINCETON, N.J., July 24, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced encouraging data from the Phase 1b portion of its Phase 1b/2a clinical trial evaluating SON-080 for the treatment of CIPN (the “SB211 study”). The SB211 study is a double-blind, randomized, controlled trial of SON-080 conducted at two sites in Australia in patients with persistent CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6) that builds upon previous work with atexakin alfa. The goal of the Phase 1b portion of the SB211 study was to confirm safety and tolerability before continued development in Phase 2. As previously announced in March 2024, a data and safety monitoring board reviewed the unblinded safety and tolerability of SON-080 in the first nine patients and concluded that the symptoms were tolerable in the initial patients and the study could proceed to Phase 2. Additionally, the Company participated in a Virtual Investor “What This Means” segment to further discuss the Phase 1b data and highlight what this means for its development program moving forward. Click here to access the segment.

Sonnet BioTherapeutics Reports Encouraging Data from Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) That Support Advancement into Phase 2 Study

PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that the SB221 study of SON-1010 (recombinant human Interleukin-12 linked to Sonnet's fully-human albumin binding domain or IL12-FHAB) dosed in combination with atezolizumab (Tecentriq®) will be presented as a ‘Trial in Progress' poster at ASCO 2024. Study SB221 (NCT05756907) is a Phase 1b/2a multicenter, dose-escalation, and proof-of-concept clinical study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered SC, either alone or in combination with a fixed dose of atezolizumab given IV. The work will be presented in a poster session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2024, to be held May 31 to June 4 in Chicago, Illinois.

Sonnet BioTherapeutics to Present SB221 as a Trial in Progress at the ASCO 2024 Annual Meeting

The SON-1010 studies have together enrolled 61 subjects, to date, as dose escalation continues in SB101 and SB221 at higher levels Patients have received up to 25 cycles of SON-1010 as monotherapy and 10 cycles of SON-1010 with atezolizumab (Tecentriq®) without dose-limiting toxicity at any dose level Cytokine data reveals about 10-fold extended half-life for SON-1010 compared with rhIL-12 that induces prolonged and controlled IFNγ responses, with no evidence of cytokine release syndrome at any dose Clinical benefit was seen at four months post-initiation of dosing in 35% of evaluable patients (8/23) with advanced solid tumors.

Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 as Monotherapy or Combined with an anti-PD-L1, along with an Increase in the Dose-Escalation Target

Published Phase 1 data of SON-1010 in Frontiers in Immunology demonstrating the safety and tolerability of the F H AB-derived Interleukin 12 in healthy volunteers Announced early safety data from the company's Phase 1b/2a clinical trial of SON-080 in patients with chemotherapy-induced peripheral neuropathy (CIPN) Received $4.3 million in net proceeds from the sale of net operating losses through the New Jersey Technology Business Tax Certificate Transfer Program Presented preclinical data and information on the clinical trial design from the study of SON-080 in CIPN in a poster session at the American Association for Cancer Research (AACR) Annual Meeting PRINCETON, NJ / ACCESSWIRE / May 14, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today its financial results for the three months and six months ended March 31, 2024 and provided a business update. "We are very excited about the progress we made during the first calendar quarter of this year with the SON-1010 and SON-080 programs, where the foundations for the compounds' safety profiles were further strengthened.

Sonnet BioTherapeutics Provides Fiscal Year 2024 Second Quarter and Year-to-Date Business and Earnings Update

PRINCETON, NJ / ACCESSWIRE / May 6, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a biopharmaceutical company developing innovative targeted biologic drugs, will be participating in the EF Hutton Annual Global Conference, which will take place on May 15, 2024 at The Plaza Hotel in New York. Pankaj Mohan, Ph.D.

Sonnet BioTherapeutics Announces Participation in the EF Hutton Annual Global Conference

PRINCETON, NJ / ACCESSWIRE / March 19, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that preclinical data and clinical trial design from the study of SON-080 (recombinant human Interleukin-6 or rhIL-6) in CIPN will be presented in a poster session at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 5-10, in San Diego, California. Presentation details: Title: Low dose interleukin-6 (SON-080) for neuropathies: Toxicology and clinical plans Session Title: Pharmacology and Pharmacogenetics Presentation Type: Poster Session Date and Time: Wednesday April 10, 2024, 9:00 AM - 12:30 PM Abstract Number: 7181 Location: Poster Section 24 Poster Board Number: 22 About Sonnet BioTherapeutics Holdings, Inc. Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional action.

Sonnet BioTherapeutics to Present Preclinical Data on SON-080 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at the AACR 2024 Annual Meeting

Safety in the Phase 1b part of Sonnet's double-blind, randomized, controlled trial of SON‑080 was reviewed by the study's Data Safety Monitoring Board (DSMB) The adverse event profile and tolerability of SON-080 was consistent with data from previous IL-6 candidates, meeting the Phase 1b safety objective Sonnet will leverage this safety data to support initiation of a Phase 2 clinical trial in Diabetic Peripheral Neuropathy (DPN), a much larger indication, after a potential partnership is put in place PRINCETON, NJ / ACCESSWIRE / March 11, 2024 / Sonnet BioTherapeutics Holdings, Inc. ("Sonnet" or the "Company"), (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the first Phase 1b/2a clinical trial of SON-080 was cleared to proceed to Phase 2 after review by the independent DSMB. This study (SB211, NCT05435742) is being conducted at two sites in Australia in patients with persistent CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6), which required confirmation of safety before continued development in Phase 2.

Sonnet BioTherapeutics Announces Early Safety Data from the Company's Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study's Initial Pre-Specified Objective

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