Continued progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC) Executed licensing agreement to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN) Multiple value-driving milestones expected throughout calendar year 2025 as well as pipeline expansion opportunities across the solid tumor market Total annual... Read More

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... Read More

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 Stable disease (SD) at four months post-initiation of dosing was seen in 10 of 21 (48%) evaluable monotherapy patients, and importantly included one patient dosed at the MTD who had a partial response (PR) by RESIST criteria (a 45% decrease from baseline) Together,... Read More

Pankaj Mohan, CEO of Sonnet discusses what this publication means in a Virtual Investor “What This Means” segment; access here PRINCETON, NJ, Dec. 04, 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 publication of extensive discovery, development and preclinical data... Read More

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 Watch the “What this Means” segment here PRINCETON, NJ, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet”) (NASDAQ: SONN), a clinical-stage company... Read More

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... Read More

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) IL-18 has significant importance for cancer immune-oncology and combination with IL-12 on Sonnet’s F H AB platform which Sonnet believes could present an important oncology possibility The lock-and-load... Read More

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... Read More

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 Alkem to fund, develop and commercialize SON-080 for the treatment of DPN in India and commercialize SON-080 for the treatment of Chemotherapy Induced Neuropathy (CIPN) and Autonomic Neuropathy in India The estimated... Read More

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... Read More

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. The reverse... Read More

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. As part of the event, Pankaj Mohan, Founder and Chief Executive Officer of Sonnet... Read More

Preclinical data has demonstrated the potential of SON-1210, the first albumin-binding bifunctional IL-12/IL-15 fusion protein, for solid tumor immunotherapy An Innovative Immuno Oncology Consortium (“IIOC”) led by Oncology experts funded by the Sarcoma Oncology Center will conduct an investigator-initiated Phase 1/2a study of SON-1210 in pancreatic cancer, an indication with significant unmet medical need Company management... Read More

Ongoing progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC) Partnership efforts to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN) underway Granted composition of matter patent in key territory – the United States – covering SON-1210 and its application in high-value solid tumor indications with... Read More

Data indicates that SON-080 was well-tolerated at both doses, with no evidence of a pro-inflammatory cytokine response Pain and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo controls Sonnet intends to seek a partnership to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic... Read More

PRINCETON, N.J., June 20, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the “Company” or “Sonnet”), a clinical-stage company developing targeted immunotherapeutic drugs, announced today the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,828,500 shares of common stock, issued by Sonnet in October 2023 (the... Read More

Sonnet discovered and characterized a modified version of Interleukin-18 (IL-18 Binding Protein Resistant or IL-18 BPR ) that exhibits wild-type binding to the IL-18 receptor (IL-18Rc), coupled with undetectable binding to the inhibitory IL-18 Binding Protein (IL-18BP) IL-18 BPR was linked to Sonnet’s proprietary tumor targeting F H AB platform, with or without single-chain wild-type IL-12 The bifunctional SON-1411 molecule... Read More

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-F H AB) dosed in combination with atezolizumab (Tecentriq ® ) will be... Read More

PRINCETON, NJ / ACCESSWIRE / May 22, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that its Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value. Sonnet has engaged Chardan Capital Markets, LLC ("Chardan") to act... Read More

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... Read More

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... Read More

Minneapolis, Minnesota--(Newsfile Corp. - May 3, 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 Founder and Chief Executive Officer, Richard Kenney, M.D., Chief Medical... Read More

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... Read More

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... Read More

PRINCETON, NJ / ACCESSWIRE / February 29, 2024 / Sonnet BioTherapeutics Holdings, Inc. , (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, announced today the publication of clinical data on SON-1010 in Frontiers in Immunology . SON-1010, Sonnet's lead proprietary monofunctional compound, combines the company's fully-human albumin-binding (F H AB) construct with single-chain... Read More

Successfully raised approximately $4.55 million in gross proceeds through an underwritten public offering Extensive preclinical data on SON-1210 published in Frontiers in Immunology Received approval and executed agreement to sell New Jersey state net operating losses (NOLs) for expected net proceeds of $4.3 million Enrollment of the Phase 1b portion of the SON-080 trial in chemotherapy-induced peripheral neuropathy (CIPN)... Read More

PRINCETON, NJ / ACCESSWIRE / December 21, 2023 / Sonnet BioTherapeutics Holdings, Inc. , (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, announced today the publication of extensive preclinical data on SON-1210 in Frontiers in Immunology . SON-1210, Sonnet's lead proprietary bifunctional compound, combines the company's F H AB construct with a novel single-chain IL-12 and fully... Read More

PRINCETON, NJ / ACCESSWIRE / December 14, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs focused on oncology, announced today its financial results for the fiscal year ended September 30 th , 2023 and provided a business update. "Sonnet has had a very productive year, exemplified by important achievements across... Read More

Following the recent completion of a $4.55 million financing, Sonnet projects cash runway into the calendar year third quarter of 2024 The company is focused on its business development initiatives and anticipates being able to provide an update in the next few quarters The company continues to advance its therapeutic pipeline with the initiation of the SB221 study with SON-1010 in platinum-resistant ovarian cancer (PROC);... Read More

PRINCETON, NJ / ACCESSWIRE / October 25, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("we," "us," "our," "Sonnet" or the "Company"), a clinical-stage company developing innovative targeted biologic drugs, today announced the pricing of an underwritten public offering of 2,843,750 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor... Read More

PRINCETON, NJ / ACCESSWIRE / October 17, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that previously announced interim data from the SB101 clinical trial of the company's proprietary Fully Human AlbuminBinding (F H AB) candidate, SON-1010 (IL12- F H AB), will be presented by Dr. Sant Chawla,... Read More

Two independent radiolabeling studies showed a 2.5- to 4.7-fold increase in tumor tissue with mIL12-F H AB, the mouse version of SON‑1010, compared with mIL-12 alone Accumulation was observed in tumors compared to normal mice, and was expectedly transient in liver and kidney The model shows that the F H AB technology provides tumor targeting and retention, as well as extended half-life, that importantly complements results... Read More

PRINCETON, NJ / ACCESSWIRE / September 19, 2023 / Sonnet BioTherapeutics Holdings, Inc. , (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs, announced today that it has received formal notice from the Listing Qualifications staff of The Nasdaq Stock Market indicating that Sonnet has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). To... Read More

PRINCETON, NJ / ACCESSWIRE / August 31, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that it will effect a 1-for-22 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on Friday, September 1, 2023. The reverse stock... Read More

An IND was required to conduct the SB221 study of platinum-resistant ovarian cancer (PROC) with the combination of Sonnet's SON-1010 and Roche's atezolizumab (Tecentriq ® ) in the US As part of the overall design of the program, the clinical trial was initiated at several sites in Australia after HREC regulatory approval and TGA notification The IND acceptance by FDA allows for a global clinical effort, with the possibility... Read More

Combination study of SON-1010 with Roche's atezolizumab (Tecentriq®) has been initiated in Australia First SON-1010 Phase 1 study has been completed and comparison of the human pharmacokinetic data supports targeting of tumor tissue Early safety data from the SON-080 trial in CIPN is expected after the study's Data Safety Monitoring Board (DSMB) convenes, prior to calendar year end Collaboration with Janssen,where in vitro... Read More

PRINCETON, NJ / ACCESSWIRE / July 31, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that Pankaj Mohan, PhD, Founder and Chief Executive Officer, Jay Cross, Chief Financial Officer, and Richard Kenney, MD, Chief Medical Officer, will be presenting a corporate overview at the BTIG Virtual... Read More

PRINCETON, NJ / ACCESSWIRE / June 28, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of an aggregate of 5,000,000 shares of its common stock (or common stock equivalents in lieu... Read More

PRINCETON, NJ / ACCESSWIRE / June 23, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that John Cini, PhD, Chief Scientific Officer and Co-Founder, and Richard Kenney, MD, Chief Medical Officer, will be featured speakers at the 4 th Annual Cytokine-Based Drug Development Summit in Boston,... Read More

Clinical trial was approved by the Bellberry Human Research Ethics Committee (HREC) in Australia The combination of Sonnet's SON-1010 and Roche's atezolizumab (Tecentriq®) will be evaluated for the treatment of platinum-resistant ovarian cancer Recruitment is being initiated with dosing anticipated to begin imminently PRINCETON, NJ / ACCESSWIRE / June 20, 2022 / Sonnet BioTherapeutics Holdings, Inc ., (NASDAQ:SONN) a... Read More

Additional data presented from two clinical trials of SON-1010 in both healthy volunteers and patients with advanced solid tumors. Cytokine data reveal extended PK profile for SON-1010: Induces prolonged and controlled IFNγ response No evidence of cytokine release syndrome Clinical benefit was seen in 36% of patients (5/14) with advanced solid tumors Entered into a collaboration with Roche for the clinical evaluation of... Read More

PRINCETON, NJ / ACCESSWIRE / April 18, 2022 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the safety of SON-1010 dosing has been formally reviewed in both of the current Phase 1 clinical trials, and the Company is now enrolling the final dose cohort in the cancer trial. SON-1010 is a proprietary... Read More

PRINCETON, NJ / ACCESSWIRE / April 17, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the company will host a webcast to share data from its SB101 clinical study with SON-1010 in oncology patients ( NCT05352750 ) on Tuesday, April 18, 2023 at 5:00 pm ET. Webcast presenters will include: Richard Kenney, M.D., Chief Medical... Read More

PRINCETON, NJ / ACCESSWIRE / March 14, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that data from the company-sponsored SB101 multiple-dose clinical trial ( NCT05352750 ) of SON-1010 (IL12-F H AB) in adult patients with advanced solid tumors will be presented in a poster session at the... Read More

Data announced from two clinical trials of SON-1010 in both healthy volunteers and patients with advanced solid tumors Entered into collaboration with Janssen Biotech for the evaluation of three Sonnet pipeline compounds Successfully completed two IND-enabling toxicology studies with SON-1210 in non-human primate PRINCETON, NJ / ACCESSWIRE / February 13, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or... Read More

PRINCETON, NJ / ACCESSWIRE / February 8, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a clinical-stage company developing innovative targeted biologic drugs, today announced the pricing of an underwritten public offering of 13,888,888 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common... Read More

SON-1210 elicited no serious adverse events in repeat, subcutaneous dosing in a GLP toxicology study SON-1210 was well-tolerated using dosing levels at least 50x higher than the highest anticipated human clinical dose level Data show controlled induction of IFNg with no signs of cytokine release syndrome or off-target toxicity PRINCETON, NJ / ACCESSWIRE / February 1, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN)... Read More

24 healthy volunteers have been dosed in study SB102 to assess the safety, PK, and PD of SON-1010 without the background of prior chemotherapy PK data shows an extended half-life of SON-1010 of approximately 112 hours, compared to 12 hours for rhIL-12 Simulation of the controlled and prolonged induction of IFNg and minimal... Read More

Sonnet's lead product, SON-1010, to be evaluated in combination with Roche's atezolizumab (Tecentriq ® ) Sonnet will sponsor the clinical study in patients with platinum-resistant ovarian cancer, scheduled to commence during the second calendar quarter of 2023, and Roche will supply atezolizumab PRINCETON, NJ / ACCESSWIRE / January 9, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company... Read More

PRINCETON, NJ / ACCESSWIRE / December 15, 2022 / 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 fiscal year ended September 30 th , 2022 and provided a business update. Pankaj Mohan, Ph.D., Founder and CEO commented, "This was a defining year for Sonnet, as we initiated... Read More