Sonnet BioTherapuetics(SONN)
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Sonnet BioTherapuetics(SONN) - 2025 Q4 - Annual Report
2025-12-16 21:45
Technology and Development - The company has a proprietary FHAB® technology platform designed to enhance drug accumulation in tumors and extend the duration of activity in the body, with a U.S. patent received in June 2021[13]. - The proprietary FHAB technology allows for the production of compounds with extended serum half-lives and improved tissue accumulation compared to naked recombinant cytokines[44]. - Preclinical studies indicated that mIL12-FHAB achieved a 30-to-50-fold increase in tumor reduction compared to standalone mIL-12 in mouse models[53]. - Biodistribution studies indicated that mIL12-FHAB had 2.5-4.7 times higher tumor accumulation compared to mIL-12, suggesting enhanced targeting[63]. - The company is exploring amino acid modifications to IL-18 to enhance its therapeutic potential against cancer[110]. Clinical Trials and Programs - The lead asset, SON-1010, is in clinical development for solid tumors, with a completed non-human primate toxicity study and FDA clearance for the IND application in March 2022[16]. - In the Phase 1 SB101 trial, clinical benefit was observed in 48% of patients overall and 83% at the highest dose of 1200 ng/kg, with one patient showing a partial response[20]. - The company has dosed 103 patients and healthy volunteers with SON-1010 across three Phase 1 studies, with no dose-limiting toxicity reported[22]. - A collaboration with Roche for the clinical evaluation of SON-1010 in combination with atezolizumab is ongoing, with an expansion cohort added to the study[18]. - The SON-080 program for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN) has been initiated, with a Phase 1b/2a trial started in October 2022[24]. - The SB211 study for SON-080 confirmed tolerability in initial patients, allowing progression to Phase 2 trials for neuropathy indications[24]. - The SON-1210 program, targeting solid tumors, has completed IND-enabling toxicology studies and is prepared for commercial development pending partnership activity[18]. - Phase 1 clinical trial for SON-1210 in solid tumors is expected to report topline efficacy data in H2 2025[28]. - The Phase 1b/2a trial of SON-1010 in combination with atezolizumab is ongoing, with no dose-limiting toxicities reported to date[72]. - The Sarcoma Oncology Center will conduct a Phase 1b/2a study of SON-1210 in pancreatic cancer, a significant unmet medical need[127]. Financials and Funding - The company reported net losses of approximately $16.0 million and $7.4 million for the fiscal years ended September 30, 2025 and 2024, respectively[205]. - As of September 30, 2025, the company had an accumulated deficit of approximately $133.7 million[205]. - The company has not yet commercialized any products or generated revenue from product sales[206]. - The company anticipates increased expenses as it continues to develop and conduct clinical trials for its product candidates[207]. - In the fourth quarter of 2025, holders exercised warrants to purchase 3,744,624 shares, generating gross proceeds of $11.2 million[191]. - In July 2025, the Company raised $2.0 million through a private placement of zero-interest convertible notes, convertible into 1,730,104 shares at $1.156 per share[192]. - The company raised an aggregate of $5.5 million in a private placement of Series 5 Convertible Preferred Stock, convertible at $1.25 per share[193]. - The November 2024 underwritten public offering generated net proceeds of approximately $4.2 million after deducting underwriting discounts and commissions[197]. - The company received a notice from Nasdaq on May 30, 2025, indicating non-compliance with the minimum stockholders' equity requirement of $2.5 million[198]. Partnerships and Collaborations - The company has entered into a licensing agreement with Alkem Laboratories for the development and commercialization of SON-080 in India[25]. - The Alkem Agreement, executed in October 2024, includes a $1.0 million upfront payment and potential milestone payments totaling up to $1.0 million for the commercialization of SON-080 in India[98]. - The New Life Agreement allows for the out-licensing of SON-080 for DPN in 10 ASEAN countries, with potential milestone payments totaling up to $19.0 million and royalties ranging from 12% to 30% on commercial sales[99]. - A collaboration agreement with Janssen Pharmaceuticals was announced to evaluate the efficacy of SON-1010, SON-1210, and SON-1410 in combination with Janssen's proprietary cell therapy assets[123]. Regulatory and Compliance - The company is subject to extensive government regulations regarding the research, development, and marketing of pharmaceutical products[143]. - The FDA typically inspects manufacturing facilities for compliance with cGMP requirements before approving a BLA[154]. - The FDA has 60 days for an initial review of a BLA submission, with a standard application review period of 12 months and 6 months for priority reviews[155]. - Orphan drug designation provides tax credits and market exclusivity for 7 years post-approval for products intended for rare diseases affecting fewer than 200,000 individuals in the U.S.[168]. - The accelerated approval pathway allows for products to be approved based on surrogate endpoints that predict clinical benefit, particularly for serious conditions[160]. Intellectual Property - The company has secured intellectual property protection for its proprietary manufacturing processes and formulations[34]. - The company has five issued patents and has filed applications in nine other major markets, with potential expiration dates ranging from 2038 to 2041[138]. - The company has received multiple patents for its Albumin Binding Domain Fusion Proteins, with U.S. Patent No. 11,028,166 issued on June 8, 2021, and estimated to expire on March 26, 2039[139]. - The company was granted U.S. Patent No. 12,006,361 on June 11, 2024, covering its product candidate SON-1210, a bifunctional version of IL-12 and IL-15[140]. Market Potential and Competition - The prevalence of diabetic peripheral neuropathy (DPN) is estimated to affect 50%-80% of the diabetic population, with projections indicating over 350 million people with diabetes by 2030[83]. - Current treatments for DPN primarily address pain, leaving significant unmet medical needs, which presents high commercial market potential for SON-080[85]. - The company faces significant competition from large pharmaceutical and biotechnology firms, which may have greater financial resources and expertise[119].
Recent Market Activity: Analysis of Top Losers
Financial Modeling Prep· 2025-12-03 00:00
Core Insights - Several companies have experienced significant stock price declines due to various factors, including company-specific developments and broader market trends [1] Company Summaries - **Black Hawk Acquisition Corporation (NASDAQ:BKHAR)**: The stock price dropped to $0.86, a decrease of approximately 43%. The decline is attributed to the inherent volatility of SPACs, although no specific events were disclosed [2][9] - **Fly-E Group, Inc. (NASDAQ:FLYE)**: The stock price decreased to $9.85, a decline of around 37.6%. This drop may be linked to market reactions regarding the company's financial health and ongoing investigations into potential claims on behalf of long-term shareholders [3][9] - **Janux Therapeutics, Inc. (NASDAQ:JANX)**: The stock price halved to $16.87, reflecting a 50.35% decrease. This significant decline is likely related to updated interim data from its clinical trial for JANX007, impacting investor confidence [4][9] - **Medicus Pharma Ltd. (NASDAQ:MDCXW)**: The stock price fell dramatically by 59.31% to $1.01. The volatility may be connected to developments in its therapeutic assets or regulatory milestones, though specific news is lacking [5] - **Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN)**: The stock price decreased to $1.39, a 55% drop. The decline may be due to setbacks in clinical development, despite recent approval of a business combination that could positively influence the company [6] Industry Observations - The significant price movements in these companies are influenced by factors such as clinical trial results, regulatory actions, financial health, and market sentiment. Biotech firms often experience volatility due to the high-risk nature of drug development, while companies in rapidly evolving sectors like electric mobility are affected by market trends and operational updates [7]
Hyperliquid Strategies Inc and Sonnet BioTherapeutics Holdings, Inc. Announce Closing of Business Combination
Globenewswire· 2025-12-02 21:30
Core Viewpoint - Hyperliquid Strategies Inc has completed a business combination with Sonnet BioTherapeutics Holdings, allowing it to operate as a digital asset treasury reserve company and begin trading on Nasdaq under the ticker "PURR" on December 3, 2025 [1][2]. Company Overview - Hyperliquid Strategies Inc (HSI) will focus on maximizing shareholder value by accumulating HYPE, the native token of Hyperliquid, a high-performance blockchain designed for all finance [6]. - HSI aims to provide capital-efficient access to the HYPE token for U.S. and institutional investors, generating compounding shareholder returns [6]. - The company is positioned to become the largest HYPE-focused digital asset treasury vehicle, capitalizing on Hyperliquid's rapid growth [6]. Business Combination Details - The business combination involved a five-for-one exchange ratio for shares received by Sonnet shareholders and Rorschach members [3]. - David Schamis will serve as the CEO of HSI, with a board of directors that includes notable figures such as Bob Diamond and Eric Rosengren [3]. Market Position and Strategy - HSI's digital asset treasury strategy allows U.S. equity investors to gain exposure to the HYPE token through a highly liquid listing [4]. - The Hyperliquid blockchain is recognized as a leading platform for perpetual futures and spot trading, processing billions in daily trading volume [5]. - The company aims to attract substantial trading volumes from a growing community of traders and developers [5]. Legal and Advisory Support - Chardan acted as the sole placement agent and exclusive financial advisor to Rorschach for the transaction [5]. - Legal counsel for HSI was provided by Greenberg Traurig, LLP, while Lowenstein Sandler LLP served as legal counsel to Sonnet [5].
Sonnet BioTherapeutics 宣布其股东已正式批准与 Hyperliquid ...
Xin Lang Cai Jing· 2025-12-02 14:55
Group 1 - Sonnet BioTherapeutics has received formal approval from its shareholders for a business combination with Hyperliquid Strategies Inc and Rorschach I LLC [1] - The transaction has been submitted via Form S-4, and plans to have Hyperliquid Strategies listed on NASDAQ post-completion [1] - Hyperliquid Strategies has previously submitted an S-1 filing to raise up to $1 billion, which may be used for the acquisition of HYPE tokens [1]
Sonnet BioTherapeutics Holdings, Inc. Announces Stockholder Approval of Proposed Business Combination with Hyperliquid Strategies Inc
Globenewswire· 2025-12-02 14:17
Group 1 - Sonnet BioTherapeutics Holdings, Inc. announced that its stockholders approved the proposed business combination with Hyperliquid Strategies Inc and Rorschach I LLC at a special meeting [1] - The final voting results for the special meeting will be filed in a Form 8-K with the U.S. Securities and Exchange Commission [1] Group 2 - Sonnet BioTherapeutics is an oncology-focused biotechnology company that utilizes a proprietary platform known as FHAB (Fully Human Albumin Binding) for developing biologic drugs [2] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, enhancing the safety and efficacy of immune modulating biologic drugs [2] - FHAB serves as a modular construct for various large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines [2]
Biotech Momentum Builds In After-Hours Trading As BioAtla, Entero, And Sonnet Climb
RTTNews· 2025-12-01 03:29
Core Insights - Several small-cap biotech and healthcare stocks experienced significant gains in after-hours trading on November 28, 2025, despite a lack of new news [1] Company Summaries - **BioAtla Inc. (BCAB)**: Shares surged 13.94% to $1.03 after closing at $0.9040, up 6.27%. The increase may be linked to financing agreements announced on November 21, including a $7.5 million advance and a Standby Equity Purchase Agreement allowing for the sale of up to $15 million in common stock at a 3% discount [2] - **Metagenomi Inc. (MGX)**: Stock rose 5.71% to $1.85 after a 3.55% gain to $1.75 during regular trading. The movement appears driven by investor sentiment or technical factors, with no new corporate updates [3] - **PAVmed Inc. (PAVM)**: Advanced 5.72% to $0.3900, recovering from a slight decline earlier in the day. The company reported a GAAP net loss of $6.3 million, or $(0.29) per share, with revenue dropping sharply to $5,000 from $996,000 year-over-year [4] - **Precision BioSciences, Inc. (DTIL)**: Gained 2.94% to $5.60, building on a 6.46% rise to $5.44. The company is set to present Phase 1 data from its ELIMINATE-B trial at the Hep-DART 2025 meeting, which may be boosting investor optimism [5] - **Reviva Pharmaceuticals Holdings, Inc. (RVPH)**: Edged up 2.04% to $0.57 after a 7.66% gain to $0.5625. The company narrowed its quarterly net loss to $4.0 million, or $0.06 per share, compared to $8.4 million, or $0.25 per share, in the prior year [6] - **Sonnet BioTherapeutics Holdings, Inc. (SONN)**: Rose 5.11% to $3.91, recovering from a 10.47% decline earlier in the day. The company adjourned a special meeting to allow more time for voting on a proposed combination with Hyperliquid Strategies Inc. and Rorschach I LLC, with over 95% of shares voting in favor [7] - **Entero Therapeutics, Inc. (ENTO)**: Gained 3.68% to $3.10 after a 5.28% rise to $2.99. The company announced a rebranding to GridAI Technologies Corp., effective December 1, 2025, following its acquisition of GRID AI Corp. The new ticker symbol "GRDX" will debut on the Nasdaq Capital Market [8]
Sonnet BioTherapeutics Holdings, Inc. Announces Adjournment of Special Meeting
Globenewswire· 2025-11-18 14:00
Core Viewpoint - Sonnet BioTherapeutics Holdings, Inc. has adjourned its special meeting of stockholders to allow additional time for stockholders to vote on the proposed business combination with Hyperliquid Strategies Inc and Rorschach I LLC, with over 95% of the votes cast in favor of the proposal [1][2][3] Company Overview - Sonnet BioTherapeutics Holdings, Inc. is an oncology-focused biotechnology company that utilizes a proprietary platform known as FHAB (Fully Human Albumin Binding) for developing biologic drugs aimed at targeting tumor and lymphatic tissues [6] Business Combination Details - The adjourned special meeting will take place on December 2, 2025, at 9:00 a.m. Eastern Time, with the record date set for October 20, 2025 [4] - The Board of Directors unanimously recommends that stockholders vote in favor of all proposals on the agenda [4] Shareholder Engagement - The company aims to solicit additional votes to meet the required threshold for transaction approval, which necessitates a majority of all outstanding shares [2][3]
Evaluation of SON-1010 Using a Patient-Derived Tumoroid Platform to Support an Ongoing Phase 1 Study in Patients with Sarcoma
Newsfilter· 2025-10-15 14:03
Core Insights - Sonnet BioTherapeutics is collaborating with Spanios to conduct a non-clinical study using patient-derived tumoroid platforms to evaluate the efficacy of SON-1010 in treating soft tissue sarcoma, aiming to accelerate the development of therapies for rare cancers [1][2]. Company Overview - Sonnet BioTherapeutics is an oncology-focused biotechnology company that develops targeted biologic drugs using its proprietary FHAB platform, which utilizes a fully human single chain antibody fragment for targeted delivery to tumor microenvironments [3]. - Spanios is dedicated to accelerating the discovery and development of oncology drugs for rare cancers, utilizing its COMPASS platform to recreate human solid tumors and their microenvironments, thus improving predictive accuracy in preclinical research [4]. Technology and Methodology - The study employs Spanios' COMPASS platform, which closely replicates the tumor microenvironment and physiological conditions, enhancing the understanding of SON-1010's efficacy against cancer cells [2]. - The innovative approach of using patient-derived tumoroids allows for more accurate predictions regarding the clinical performance of SON-1010 therapy compared to traditional animal models [2][4]. Collaboration Goals - The collaboration aims to combine the expertise and resources of both companies to advance therapeutic research for solid tumors, ultimately providing new treatment options for patients with limited alternatives [4].
Evaluation of SON-1010 Using a Patient-Derived Tumoroid Platform to Support an Ongoing Phase 1 Study in Patients with Sarcoma
Globenewswire· 2025-10-15 14:03
Core Insights - Sonnet BioTherapeutics is collaborating with Spanios to conduct a non-clinical study using patient-derived tumoroid platforms to evaluate the effect of SON-1010 in soft tissue sarcoma, aiming to accelerate treatment development for rare cancers [1][2]. Company Overview - Sonnet BioTherapeutics is an oncology-focused biotechnology company that develops targeted biologic drugs using its proprietary FHAB platform, which utilizes a fully human single chain antibody fragment for targeted delivery to tumor microenvironments [3]. - Spanios is dedicated to accelerating the discovery and development of oncology drugs for rare cancers, utilizing its COMPASS platform to recreate human solid tumors and their microenvironments, thus improving predictive accuracy in preclinical research [4]. Technology and Methodology - The study employs Spanios' COMPASS platform, which replicates the tumor microenvironment with physiological oxygenation, enhancing the understanding of SON-1010's efficacy against cancer cells [2]. - The innovative approach of using patient-derived tumoroids allows for more accurate predictions regarding the clinical performance of SON-1010 therapy compared to traditional animal models [2][4]. Leadership Insights - Raghu Rao, Interim CEO of Sonnet, emphasized the potential of the tumoroid platform for rapid evaluation of new drugs across various solid tumors [3]. - Bhuvanesh Dave, Co-Founder and CEO of Spanios, expressed excitement about the collaboration, highlighting the combined expertise aimed at advancing therapeutic research for solid tumors [4].
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CoinMarketCap· 2025-09-25 10:26
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