Product Development - NeOnc is developing two lead products: NEO100, which is in Phase IIa trials, and NEO212, which has received IND approval and is set to begin clinical trials in Q4 2023[22][26]. - The Phase IIa trial for NEO100 has expanded eligibility to include patients with recurrent Grade III IDH1/2 mutant astrocytomas, increasing the potential enrollment pool significantly[24]. - NEO212 has established a recommended Phase 2 dose of 610 mg, with preliminary observations suggesting anti-tumor activity in heavily pretreated patients[27]. - The ongoing Phase IIa trials aim to confirm dosing requirements and assess the drug's performance in a larger patient population[52]. - The company is also conducting a Phase I/II trial for oral NEO212, targeting various solid tumors with brain metastases[69]. - NEO212 has received FDA approval for oral administration in 2023, enabling Phase I/IIa clinical trials focusing on patients with intracranial malignancies[79]. Clinical Trial Results - In the Phase I trial of NEO100, 21% of patients showed radiographic responses, exceeding the historical response rates of <8% for recurrent high-grade gliomas[25]. - NEO100's Phase I trial demonstrated that 37% of patients were alive two years after treatment, compared to an average life expectancy of six months for recurrent glioblastoma patients[35]. - In a Phase I trial, 25% of patients with recurrent glioblastoma survived for at least 4 years, indicating preliminary signs of activity for NEO100[41][44]. - Among 12 patients in the Phase I trial, 55% survived more than one year, and 33% survived over two years[44]. - The Phase IIa study for NEO100 includes 25 patients with recurrent glioblastoma and aims to evaluate progression-free survival at six months[53][54]. - In a Phase I clinical trial, intranasal NEO100 demonstrated a progression-free survival (PFS-6) rate of 33% and an overall survival (OS-12) rate of 55% among 12 patients[100]. - The ongoing Phase 1/2a study of intranasal NEO100 has enrolled 25 patients, with 24% showing radiographic responses and 44% achieving progression-free survival at six months[103]. Drug Delivery Methods - NEO100 is being investigated for its potential to bypass the blood-brain barrier (BBB) for drug delivery, with proof of concept observed in animal models but not yet in humans[40]. - NEO100's intranasal delivery method allows for convenient administration at home, avoiding invasive procedures[51]. - NEO100's intranasal delivery method allows for direct brain access, potentially avoiding the blood-brain barrier and reducing systemic side effects[86]. - The company is exploring three drug delivery pathways using NEO100, with intranasal delivery being the only one currently in clinical testing[83]. - Intra-arterial delivery of NEO100 demonstrated the ability to open the blood-brain barrier, allowing therapeutic agents to enter the brain in mouse models[119]. Market Potential - The global CNS treatment market is projected to grow at a CAGR of 8.6% to reach $267.6 billion by 2034, while the brain tumor drug market is expected to grow at a CAGR of 9.8% to reach $4.6 billion by 2032[91]. - The GBM drug market is anticipated to grow at a CAGR of 9.8% to $4.4 billion by 2023, driven by an increasing geriatric population and rising incidence rates[92]. - The average life expectancy for patients with newly-diagnosed glioblastoma is currently only 15 months, highlighting the urgent need for effective treatments like NEO212[137]. Regulatory and Compliance - The company has no commercial products or sales infrastructure, and must conduct clinical trials to obtain regulatory approvals[28]. - The FDA regulates the approval process for new drug products, requiring substantial time and financial resources for compliance with testing and manufacturing standards[183][184]. - The company must submit a new drug application (NDA) to the FDA, which includes evidence of safety and efficacy from clinical trials, before marketing any new drug product[189]. - The FDA requires extensive monitoring and auditing of clinical activities, with annual progress reports detailing clinical trial results submitted to the FDA[192]. - Manufacturers must comply with cGMP regulations, including quality control and assurance, to maintain product safety and efficacy[216]. Intellectual Property - The company holds exclusive rights to 28 issued patents and 14 pending patent applications in the U.S., with a total of 65 issued patents and 28 pending applications internationally[147]. - The company has filed multiple patent applications for its product candidates, including NEO100 and NEO212, with expiration dates ranging from 2031 to 2038[150]. - The company is responsible for all reasonable patent expenses incurred by USC for filing, prosecution, and maintenance of the licensed patents[157]. - The patent prosecution process is complex and may require narrowing claims, which could limit the scope of patent protection[153]. Financial Obligations - The company has a litigation settlement payable of $4 million to OEP, which is recorded in the consolidated balance sheets as of December 31, 2025 and 2024[169]. - The company has settled a dispute with Fox Infused for $600,000, payable within 5 business days of the closing date of the initial public offering, with accumulated interest of 10% per annum for any default[179]. - The company must pay USC $230,000 by March 31, 2024, to satisfy prior unpaid sublicense issue royalties and annual maintenance royalties due for sublicensees[166]. Competitive Landscape - The competitive landscape for CNS treatments includes established players like Pfizer, Roche, and Novartis, as well as emerging therapies such as gene therapies and biologics[138][141]. - The company is investigating additional proprietary chemotherapy agents that have shown positive effects in laboratory tests for various cancers, including NEO212 for brain cancer[149]. Future Strategies - Future growth strategies include potential commercial launch of NEO100 following FDA approval and exploration of pediatric indications for NEO100[149]. - The company aims to change the cancer therapeutic landscape by developing novel drug delivery methods combined with new drug candidates[94].

Core Insights - NeOnc Technologies Holdings, Inc. has appointed David Choi as Chief Accounting Officer to oversee accounting, financial reporting, internal controls, and corporate governance as the company advances its clinical-stage biotechnology platform and expands globally [1][2] Company Overview - NeOnc Technologies is a clinical-stage life sciences company focused on developing and commercializing central nervous system therapeutics, particularly targeting challenges in overcoming the blood-brain barrier [5] - The company's NEO™ drug development platform has produced a portfolio of novel drug candidates with patent protections extending to 2038, including proprietary chemotherapy agents that have shown positive effects in laboratory tests and clinical trials for malignant gliomas [5] - NeOnc's therapeutics, NEO100™ and NEO212™, are currently in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status [5] Leadership Appointment - David Choi brings over a decade of experience in accounting, financial reporting, and internal controls for public and private companies, having previously served as a Director at Blythe Global Advisors [2][3] - His expertise includes technical accounting matters, SEC reporting, and SOX compliance, which are crucial as NeOnc accelerates its clinical trials and prepares for corporate growth [2][3] - Choi is a Certified Public Accountant (CPA) with a Master of Professional Accountancy and a Bachelor of Arts in Business Economics with a minor in Accounting from the University of California, Irvine [4]

Core Insights - NeOnc Technologies Holdings, Inc. is a clinical-stage CNS oncology company focused on developing therapies to improve drug delivery to the brain, specifically targeting the blood-brain barrier (BBB) [1] - The company's lead program, NEO212, is a next-generation version of temozolomide (TMZ) aimed at addressing limitations in current treatments for brain cancer, particularly in glioblastoma [1] - NeOnc's platform includes additional programs like NEO100, which utilizes intranasal delivery methods to enhance drug penetration in the CNS [1] Company Developments - NEO212 has completed Phase 1 dose escalation in recurrent glioblastoma, establishing a Recommended Phase 2 Dose of 610 mg, with early signs of disease control observed [6] - NEO100 has shown promising Phase 2 data, indicating radiographic responses and improved progression-free survival compared to historical benchmarks [6] - NeOnc recently completed a successful PIPE offering, adding a gross $16.0 million to its balance sheet, enhancing its financial position for further development [1]

Core Viewpoint - NeOnc Technologies Holdings, Inc. has announced promising data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, a novel oral bio-conjugated therapy for central nervous system cancers, indicating early signs of clinical efficacy and establishing a Recommended Phase 2 Dose (RP2D) of 610 mg [1][2][5]. Group 1: Clinical Trial Progress - The Phase 1 dose-escalation portion of the NEO212-01 clinical trial reached Maximum Tolerated Dose (MTD) at Cohort 5 (810 mg) after a second Dose-Limiting Toxicity, leading to the establishment of the RP2D at 610 mg [2]. - The Phase 2a metastasis cohort will start with a dose of 400 mg [2]. - Early signs of clinical efficacy were observed, including indications of lasting disease control in heavily pretreated patients with recurrent glioblastoma and brain metastases [3][4]. Group 2: Therapeutic Potential - The emergence of measurable anti-tumor activity in Phase 1 supports the therapeutic potential of NEO212 and the transition into Phase 2 [4]. - NEO212 is designed to overcome MGMT-mediated resistance, a key limitation of the current standard of care, temozolomide (TMZ) [9][10]. - The bio-conjugated oral formulation of TMZ aims to enhance therapeutic performance while maintaining the practicality of oral administration [8]. Group 3: Regulatory and Development Plans - NeOnc plans to request a Type B (End-of-Phase 1) FDA meeting to discuss safety, pharmacokinetics, preliminary efficacy, and potential Accelerated Approval pathways [6]. - The company is preparing for a pivotal registrational Phase 2 study, contingent on FDA feedback and approval [8]. - The determination of the RP2D at 610 mg is seen as a significant achievement, allowing NeOnc to proceed with efficacy studies for patients in need of new oral therapies [11].

Core Insights - NeOnc Technologies Holdings, Inc. will host an investor conference call and webcast on March 4, 2026, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time to discuss initial data from the Phase 1 dose-escalation portion of the NEO212-01 clinical trial [1][2] Company Overview - NeOnc is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system (CNS) cancers, utilizing its proprietary NEO™ drug development platform [3] - The company has a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038, including NEO100™ and NEO212™, which are currently in Phase II human clinical trials under FDA Fast-Track and Investigational New Drug (IND) status [3] Clinical Trial Update - The upcoming conference call will provide updates on the Phase 1 dose-escalation portion of the NEO212-01 clinical trial, including safety and toxicity data, dose-escalation observations, pharmacokinetic findings, and planned regulatory next steps [2][3]

As filed with the Securities and Exchange Commission on February 6, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 2834 92-1954864 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NeOnc Technologies Holdings, Inc. (Exact name of registrant as specified in its charter) Identification Number) 23975 ...

Core Viewpoint - NeOnc Technologies Holdings, Inc. has secured a private investment in public equity (PIPE) agreement, expected to generate approximately $16 million in gross proceeds, demonstrating institutional confidence in its biotech pipeline focused on central nervous system (CNS) cancers [1][2]. Group 1: Investment Details - The PIPE transaction involves the sale of up to 2,222,222 shares of common stock and five-year warrants to purchase an equal number of shares at an exercise price of $9.00, with a combined purchase price of $7.20 per share [1]. - Cinctive Capital Management LP led the investment with a commitment of $10 million, indicating strong institutional support for NeOnc's initiatives [2]. Group 2: Company Overview - NeOnc Technologies is a clinical-stage biopharmaceutical company focused on developing therapies for CNS cancers, utilizing its proprietary NEO™ drug development platform [4]. - The company’s key products, NEO100™ and NEO212™, are currently in Phase II clinical trials and have received FDA Fast-Track and Investigational New Drug (IND) status [4]. Group 3: Leadership Insights - Amir F. Heshmatpour, CEO of NeOnc, emphasized that the investment validates the company's technological approach and the potential of its clinical assets, which aim to overcome the blood-brain barrier [3]. - Rich Schimel, Co-Founder of Cinctive Capital, highlighted the innovative potential of NeOnc's delivery platforms and the firm's strategy to invest in small- to mid-cap biotech companies [3].

Company Overview - NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) is a clinical-stage life sciences company focused on developing therapeutics for the central nervous system that can effectively cross the blood-brain barrier [1] - The company has a pipeline of assets, prominently featuring NEO100, a patented pharmaceutical compound created through proprietary synthesis to ensure pharmaceutical-grade purity and reproducibility [1] Product Development - NeOnc's strategy involves intranasal administration to access the brain via olfactory and trigeminal pathways, providing a non-invasive delivery method aimed at improving patient adherence and enabling more direct drug delivery [1] - Positive Phase 1/2a results for NEO100 were announced in December, with a Phase 2a top-line readout expected in mid-2026 [7] Investment Insights - Stonegate Capital Partners has initiated coverage on NeOnc Technologies, viewing NTHI as a differentiated platform with favorable tolerability and multiple near-term catalysts as the program progresses towards a 2026 readout [1] - The closing and funding of the Quazar Investment is anticipated in the near term, which may provide additional support for the company's initiatives [7]

Core Viewpoint - New to The Street is a long-running business television platform that showcases emerging growth companies and market innovators, providing them with a credible platform to articulate their business models and market opportunities [2][3][6]. Group 1: Show Details - The upcoming broadcast, Show No. 712, will air tonight at 6:30 PM EST on Bloomberg Television as sponsored programming [2][7]. - Featured companies in this episode include NEONC Technologies, SAGTEC GLOBAL, FLOKI, and ZENITH Prep Academy, each providing insights into their respective industries [2][9]. Group 2: Company Overview - New to The Street has been operational for 17 years, delivering a differentiated media model that allows companies to communicate their strategies and innovations effectively [3][6]. - The platform is recognized for its long-form interviews that focus on business models, innovation, and milestones, avoiding speculation [10]. Group 3: Digital Presence - Beyond television, New to The Street has a significant digital footprint, ranking second in reach within the financial media category on YouTube, only behind The Wall Street Journal [8]. - The platform's flagship channel reaches millions of subscribers globally, extending the impact of each broadcast beyond its initial airing [8].

Core Insights - NeOnc Technologies Holdings, Inc. announced preclinical findings indicating that ultrasound enhances the therapeutic potency of NEO100, showing strong antitumor effects across various brain tumor types [1][3] Group 1: Research and Development - The study conducted at the University of Southern California (USC) utilized an AI-driven, 3D-bioprinted New Approach Methodology (NAM) to identify NEO100 as a leading sonodynamic therapy agent [2] - The NAM platform, based on NTHI-patented rapid magnetic 3D bioprinting technology, allows for the quick generation of patient-derived tumor organoids, significantly accelerating biomedical research [2] - An AI-driven neural network was employed to predict compounds likely to respond to focused ultrasound, with NEO100 consistently identified as a leading sonosensitizer [3] Group 2: Clinical Implications - Validation studies on bioprinted tumor spheroids demonstrated that NEO100, when combined with focused ultrasound, exhibited enhanced tumor-killing activity across various brain tumors, supporting its advancement into future clinical trials [3] - The integration of AI, 3D bioprinting, and ultrasound expands NEO100's commercial and clinical opportunities beyond current indications, as stated by the Executive Chairman of NTHI [4] Group 3: Company Overview - NeOnc Technologies Holdings, Inc. focuses on developing therapeutics for central nervous system cancers, with a drug development platform that includes NEO100 and NEO212, both in Phase II clinical trials [5] - The company has a patent portfolio extending to 2038, covering various drug candidates and delivery methods aimed at overcoming the blood-brain barrier [5]