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.

Earnings data Q2 2024

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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 / 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

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 (FHAB) construct with single-chain interleukin 12 (IL‑12).

Sonnet BioTherapeutics Announces a Publication Demonstrating Safety and Tolerability of SON-1010 in Healthy Volunteers

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) has completed PRINCETON, NJ / ACCESSWIRE / February 14, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapeutic drugs for cancer, announced today its financial results for the three months ended December 31, 2023 and provided a business update. "This last quarter set the stage for an exciting year across Sonnet's pipeline, highlighted by the progress of the combination study of SON-1010 and atezolizumab in platinum-resistant ovarian cancer (PROC), where we continue to expect safety data during the first half of 2024.

Sonnet BioTherapeutics Provides Fiscal Year 2024 First Quarter Business and Earnings Update

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 FHAB construct with a novel single-chain IL-12 and fully human Interleukin 15 (IL-15).

Sonnet BioTherapeutics Announces Publication Demonstrating Suitability of SON-1210, the First Albumin-binding Bifunctional IL-12/IL-15 Fusion Protein, for Solid Tumor Immunotherapy

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 30th, 2023 and provided a business update. "Sonnet has had a very productive year, exemplified by important achievements across our pipeline.

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business and Financial Update

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); early safety data from the SON-080 study in CIPN are expected before the end of 2023 PRINCETON, NJ / ACCESSWIRE / October 31, 2023 / Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, provided a fiscal year 2023 business overview. "As has been our objective since the company's founding, we are committed to innovating next generation cancer treatments of significant potential utility for patients and caregivers, alike," commented Pankaj Mohan, Ph.D.

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business Overview

Sonnet BioTherapeutics (NASDAQ: SONN ) stock is falling on Wednesday after the biotechnology company revealed details of a public share offering. That public stock offering has Sonnet BioTherapeutics selling 2,843,750 shares of SONN stock at a price of $1.60 each.

Why Is Sonnet BioTherapeutics (SONN) Stock Down 33% Today?

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 warrants to purchase up to an aggregate of 5,687,500 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with two investor warrants at a combined offering price of $1.60, for total gross proceeds of approximately $4.55 million, before underwriting discounts and commissions and offering expenses payable by Sonnet.

Sonnet BioTherapeutics Announces Pricing of $4.55 Million Underwritten Public Offering

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 (FHAB) candidate, SON-1010 (IL12- FHAB), will be presented by Dr. Sant Chawla, a key opinion leader in the field of sarcoma research, at the upcoming Connective Tissue Oncology Society Annual Meeting 2023, which will be held November 1‑4, in Dublin, Ireland. "We are excited to be part of Sonnet's first-in-human use of SON-1010 in the cancer setting that is being studied in the SB101 trial," said Sant Chawla, MD, Principal Investigator and Director of the Sarcoma Center in Santa Monica, California.

Sonnet BioTherapeutics Announces Abstract Accepted for Presentation by a Key Opinion Leader at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting

Two independent radiolabeling studies showed a 2.5- to 4.7-fold increase in tumor tissue with mIL12-FHAB, 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 FHAB technology provides tumor targeting and retention, as well as extended half-life, that importantly complements results from the human clinical studies PRINCETON, NJ / ACCESSWIRE / September 20, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, announced data from two radiolabeling studies that validate the tumor targeting attributes associated with albumin binding by the FHAB technology. Sonnet performed two independent in vivo proof-of-concept (POC) studies to show the biodistribution of interleukin-FHAB molecules to the tumor microenvironment (TME), using labs with expertise in radiolabeling biologics and in vivo biodistribution analysis.

Sonnet BioTherapeutics Announces Results of Biodistribution Studies Demonstrating Solid Tumor Targeting Using the FHAB Technology

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 regain compliance with the Rule, the Company's common shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved on September 15, 2023.

Sonnet BioTherapeutics Regains Nasdaq Minimum Bid Price Compliance

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.

Sonnet BioTherapeutics Announces 1-for-22 Reverse Stock Split

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Sonnet (SONN) receives FDA clearance to begin clinical development for its combination therapy of SON-1010 and Roche's atezolizumab, for the potential treatment of platinum-resistant ovarian cancer.

Sonnet (SONN) Up as Ovarian Cancer Drug Enters Clinical Study

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 for more rapid recruitment through the addition of US trial sites PRINCETON, NJ / ACCESSWIRE / August 16, 2023 / Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the IND for SB221 (NCT05756907), the Phase 1b/2a clinical trial of SON-1010(IL12-FHAB) in combination with Roche's anti-PD-L1 checkpoint inhibitor, atezolizumab, has been accepted, and the study can begin in the US for the treatment of PROC. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab.

Sonnet BioTherapeutics Announces FDA Acceptance of the Company's IND for the SB221 Clinical Trial of SON-1010 Combined with Atezolizumab in the US

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 and in vivo efficacy of SON-1010, SON-1210, and SON-1410 are being evaluated in combination with certain Janssen cell therapy assets, remains ongoing PRINCETON, NJ / ACCESSWIRE / August 14, 2023 / 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 ended June 30, 2023 and provided a business update. "Sonnet continues to successfully forge ahead with our pipeline development," said Pankaj Mohan, Ph.D.

Sonnet BioTherapeutics Provides Fiscal Year 2023 Third Quarter Business and Earnings Update

Sonnet BioTherapeutics (NASDAQ: SONN ) stock is taking a beating on Monday after the company announced a public stock offering. Investors will note that this public stock offering comes from selling stockholders and not directly from Sonnet BioTherapeutics.

Why Is Sonnet BioTherapeutics (SONN) Stock Down 5% Today?

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 Biotechnology Conference, held August 7-8, 2023. Sonnet BioTherapeutics Fireside Chat Details: 2023 BTIG Virtual Biotechnology ConferenceDate: Monday, August 7, 2023Presentation Time: 12:00 pm ET Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the offering, the closing of the offering, the amount and anticipated use of proceeds from the offering, the timing of an IND submission, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature.

Sonnet BioTherapeutics to Present at the 2023 BTIG Virtual Biotechnology Conference

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 thereof), at a purchase price of $0.45 per share of common stock (or common stock equivalent in lieu thereof), in a registered direct offering. The Company has also agreed to issue to the investor, in a concurrent private placement, warrants to purchase up to an aggregate of 5,000,000 shares of common stock.

Sonnet BioTherapeutics Announces $2.25 Million Registered Direct Offering and Concurrent Private Placement

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 4th Annual Cytokine-Based Drug Development Summit in Boston, Massachusetts, June 27-29. Presentation details: June 27, 1:00 - 4:00 pmJohn Cini will co-lead a workshop entitled, "Examining Cytokine Biology to Develop a Specific &Effective Drug" June 29, 2:40 - 3:10 pmRichard Kenney will deliver a talk entitled, "A Tale of Two Forms of IL-12: The Benefits of Extending PK" CIPN Study (SB211) Preliminary Update In the SB211 study, patients are being randomized to one of three treatment groups that receive 20 µg SON-080, 60 µg SON-080, or a matching placebo in a blinded fashion, three times a week for 12 weeks.

Sonnet BioTherapeutics Announces Presentations at the 2023 Cytokine-Based Drug Development Summit and Provides Preliminary Update on the SON-080 Study in Chemotherapy-Induced Peripheral Neuropathy

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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 clinical-stage company developing targeted immunotherapeutic drugs, announced today that a Phase 1b/2a clinical trial of SON-1010 (IL12-FHAB) in combination with Roche's anti-PD-L1 checkpoint inhibitor, atezolizumab (Tecentriq®), has been approved to begin in Australia. The approval by the Bellberry HREC was based on scientific and ethical review of trial documentation, which included the successful completion of a study of SON-1010 monotherapy (SB102) in healthy volunteers (NCT05408572) and demonstration of continued safety in the first-in-human (FIH) dose-escalation trial in cancer (SB101).

Sonnet BioTherapeutics Announces Regulatory Approval for Initiation of a Clinical Trial of SON-1010 Combined with Atezolizumab

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