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NeOnc Technologies to Showcase Progress on Addressing Brain Cancer to 63 Million TV Households on “Health Uncensored with Dr. Drew” on the Lifetime Network on September 25, premiering nationwide at 8:00 a.m. ET/PT
Globenewswire· 2025-09-22 13:00
Core Insights - NeOnc Technologies Holdings, Inc. is set to be featured on "Health Uncensored" hosted by Dr. Drew Pinsky, airing on September 25, 2025, which will provide significant national exposure to the company's innovative therapies for CNS cancers [1][10] - The episode will include discussions on NeOnc's NEO™ platform technology, which aims to overcome the Blood-Brain Barrier, and a patient testimonial highlighting the potential impact of NeOnc's drug candidates [2][3] Company Overview - NeOnc Technologies is a clinical-stage biotechnology company focused on developing therapies for central nervous system cancers, particularly malignant gliomas, utilizing its proprietary NEO™ drug development platform [6] - The company has two lead drug candidates, NEO100™ and NEO212™, currently in Phase II and Phase I clinical trials, respectively, both advancing under FDA Fast-Track status [4][6] Recent Developments - NeOnc has secured a $50 million strategic partnership with Quazar Investment to launch a clinical trials platform in the GCC & MENA regions, enhancing its global presence [12] - The company received FDA authorization to proceed with the Phase II clinical trial of NEO212, a first-in-class oral chemotherapy candidate for brain cancer [12] - NeOnc is nearing full enrollment for its NEO100-01 Phase 2a trial, with top-line data expected in early 2026, and the final patient cohort in the NEO212 Phase I trial is on track for completion in 2025 [12] - The company has been added to the Russell Microcap® Index, increasing visibility among institutional investors [12] - NeOnc received $2.5 million in non-dilutive grants from the NIH to advance its NEO212 program, indicating strong external validation of its scientific approach [12]
NeOnc Technologies Receives FDA Authorization to Proceed with Phase II Clinical Trial of NEO212 – A First-in-Class Oral Chemical Conjugated Chemotherapy Candidate for Brain Cancer
Globenewswire· 2025-09-10 13:00
Core Insights - NeOnc Technologies Holdings, Inc. has received FDA authorization to advance its NEO212-01 clinical trial into Phase IIa/IIb, marking a significant milestone for the company [1][6] - NEO212 is an innovative oral chemotherapy drug that combines Temozolomide with a proprietary molecule, NEO100, aimed at improving treatment outcomes for CNS cancers [3][4] - The Phase II trial will expand patient enrollment across leading U.S. cancer centers, with plans to activate a broad network of premier institutions [5] Company Overview - NeOnc Technologies Holdings, Inc. is a multi-Phase II clinical-stage biopharmaceutical company focused on developing novel therapies for central nervous system cancers and other challenging malignancies [7][9] - The company's portfolio includes NEO100 and NEO212, which are backed by proprietary intellectual property and clinical programs [9] Clinical Development Strategy - The NEO212-01 Phase II trial will build on the successful completion of the Phase I dose-escalation study, which demonstrated safe administration of NEO212 at doses up to 810 mg daily [2] - Patient enrollment for the Phase II trial is expected to begin before the end of 2025, with independent review of the recommended Phase II dose currently ongoing [2] Leadership Commentary - Company leadership emphasizes that the advancement to Phase II represents years of innovation and aims to redefine treatment outcomes for brain cancer patients [6] - The mission of the company is to provide hope to brain cancer patients and their families, with NEO212 embodying this vision of combining science and compassion [6]
NeOnc Technologies Closes Strategic Acquisition of Advanced AI and 3D Bioprinting IP, Appointing World-Renowned Scientist Dr. Ishwar K. Puri to its Board
Globenewswire· 2025-08-25 13:00
Core Insights - NeOnc Technologies Holdings, Inc. has successfully acquired an intellectual property portfolio that enhances its capabilities in drug discovery for CNS cancers [1][2][3] - The acquisition includes advanced technologies such as AI, 3D bioprinting, and quantum modeling, which will improve the efficiency and accuracy of therapeutic candidate screening [2][5] - The transaction was valued at $3.5 million, comprising $500,000 in cash and $3 million in common stock [3] Company Developments - The newly acquired technology allows for the creation of patient-derived 3D brain tumor models, facilitating high-throughput screening of drug candidates [2] - NeOnc's integration of this technology into its R&D operations is expected to support its strategic partnership with Quazar Investment Group for advancing clinical trials in the GCC region [3] - Dr. Ishwar K. Puri has joined NeOnc's Board of Directors, bringing significant expertise in research and innovation [4][5] Strategic Implications - The acquisition is seen as a transformative milestone for NeOnc, enabling faster and more humane drug development processes [5] - The technology is anticipated to reduce reliance on animal testing and expand potential applications beyond brain cancer to other neurological diseases [5] - NeOnc's NEO™ drug development platform, which includes NEO100™ and NEO212™, is currently in Phase II clinical trials and has received FDA Fast-Track status [6]
NeOnc Technologies Holdings Inc(NTHI) - 2025 Q2 - Quarterly Results
2025-08-22 21:00
[Introduction and Agreement Overview](index=1&type=section&id=Introduction%20and%20Agreement%20Overview) This section details the parties, effective date, and purpose of the Share Exchange Agreement [Agreement Parties and Effective Date](index=1&type=section&id=Agreement%20Parties%20and%20Effective%20Date) This Share Exchange Agreement, effective August 18, 2025, is between NeOnc Technologies Holdings, Inc and the members of JandB Holdings, LLC - The Share Exchange Agreement is effective as of **August 18, 2025**[2](index=2&type=chunk) - Parties involved are **NeOnc Technologies Holdings, Inc.** (Company) and the members of **JandB Holdings, LLC** (Members)[2](index=2&type=chunk) [Recitals and Purpose of Exchange](index=1&type=section&id=Recitals%20and%20Purpose%20of%20Exchange) The Members collectively own 100% of JandB Holdings, LLC and intend to exchange their interest for 120,000 shares of Company common stock - Members collectively own **100% of the membership interest** in JandB Holdings, LLC[4](index=4&type=chunk) Exchange Share Details | Item | Value | | :--- | :--- | | Number of Exchange Shares | 120,000 | | Agreed Per Share Value | $25 | [Terms of Exchange](index=1&type=section&id=Terms%20of%20Exchange) This section outlines the authorization, issuance, and closing procedures for the share exchange [Authorization and Issuance of Exchange Shares](index=1&type=section&id=Authorization%20and%20Issuance%20of%20Exchange%20Shares) The Company has authorized the issuance of Exchange Shares to Members in return for their Membership Interest in JandB Holdings, LLC - The Company has authorized the issuance of Exchange Shares to the Members[6](index=6&type=chunk) - Members will surrender, transfer, and assign their Membership Interest in JandB Holdings, LLC to the Company in exchange for the Company's issuance of Exchange Shares[7](index=7&type=chunk) [Closing and Delivery Procedures](index=1&type=section&id=Closing%20and%20Delivery%20Procedures) The closing will occur remotely via electronic signatures, with Members delivering transfer acknowledgments and the Company delivering share statements - The closing of the Exchange will take place remotely by the exchange of electronic signatures[8](index=8&type=chunk) - Members are required to deliver an acknowledgment and transfer of membership interests to the Company[9](index=9&type=chunk) - The Company will deliver a statement from its transfer agent representing the Exchange Shares to the Members[9](index=9&type=chunk) [Representations and Warranties](index=2&type=section&id=Representations%20and%20Warranties) This section contains the formal declarations and guarantees made by both the Company and the Members [Company Representations and Warranties](index=2&type=section&id=Company%20Representations%20and%20Warranties) The Company represents it is in good standing, has corporate power to execute the agreement, and that shares will be validly issued - The Company is a duly organized, validly existing, and in good standing corporation under **Delaware law**[10](index=10&type=chunk) - All necessary corporate actions for the agreement and issuance of Exchange Shares have been taken[11](index=11&type=chunk) - The Exchange Shares, when issued, will be **duly and validly issued, fully paid, nonassessable**, and free of Company-imposed liens[12](index=12&type=chunk) [Members' Representations and Warranties](index=2&type=section&id=Members%27%20Representations%20and%20Warranties) Members represent they have authority, are accredited investors, understand the shares are unregistered, and have consulted their own advisors - Members have the necessary power and authority to execute and deliver this Agreement[13](index=13&type=chunk) - Members understand that the Exchange Shares have not been registered under the Securities Act of 1933 and are **accredited investors** as defined in Rule 501(a) of Regulation D[14](index=14&type=chunk) - Members have had a reasonable opportunity to consult with their own legal, tax, and financial advisors and are relying solely on such advisors[15](index=15&type=chunk) [Investment and Sophistication](index=2&type=section&id=Investment%20and%20Sophistication) Members affirm their sophistication, possession of adequate information, and independent decision-making without reliance on the Company's advice - Members are **sophisticated individuals** familiar with similar transactions and have adequate information about the Company's business and financial condition[16](index=16&type=chunk) - Members have made their own analysis and decision to enter into this Agreement independently and without reliance upon the Company[16](index=16&type=chunk) [JandB Assets](index=3&type=section&id=JandB%20Assets) Members warrant that JandB owns all contributed assets and U.S. Patent No. 11,788,057 free and clear of any liens or encumbrances - JandB owns all assets contributed by Members **free and clear of any lien, encumbrance, or other adverse claim**[17](index=17&type=chunk) - Upon acquisition, **U.S. Patent No. 11,788,057** will be owned free and clear of any lien, encumbrance, or other adverse claim[17](index=17&type=chunk) [Restrictions and Miscellaneous Provisions](index=3&type=section&id=Restrictions%20and%20Miscellaneous%20Provisions) This section covers share transfer restrictions and other standard contractual clauses [Limitations on Transfer and Restrictive Legends](index=3&type=section&id=Limitations%20on%20Transfer%20and%20Restrictive%20Legends) Members are restricted from transferring Exchange Shares except in compliance with securities laws, and shares will bear restrictive legends - Members will not assign, hypothecate, donate, encumber, or otherwise dispose of any interest in the Exchange Shares except in compliance with applicable securities laws[18](index=18&type=chunk) - The Exchange Shares will bear restrictive legends stating they have not been registered under the **Securities Act of 1933**[19](index=19&type=chunk) [General Provisions](index=3&type=section&id=General%20Provisions) This section outlines standard clauses including successors, governing law (Delaware), severability, entire agreement, and notice requirements - The Agreement's terms benefit and bind successors and assignees[20](index=20&type=chunk) - The Agreement is governed by the internal laws of the **State of Delaware**[21](index=21&type=chunk) - This Agreement constitutes the entire agreement among the parties and supersedes prior understandings, amendable only by written consent[25](index=25&type=chunk) [Signatures](index=5&type=section&id=Signatures) This section provides the formal execution of the agreement by all involved parties [Company Signature](index=5&type=section&id=Company%20Signature) The Agreement is executed by NeOnc Technologies Holdings, Inc., signed by its President and Executive Chairman - NeOnc Technologies Holdings, Inc. is represented by **Amir Heshmatpour**, President and Executive Chairman[29](index=29&type=chunk) [Members Signatures](index=6&type=section&id=Members%20Signatures) The Members, Ishwar Puri and Beth R. Levinson, have executed the Exchange Agreement - The Members, **Ishwar Puri** and **Beth R. Levinson**, have signed the Exchange Agreement[31](index=31&type=chunk) [Exhibit A: Acknowledgment and Transfer of Membership Interests](index=7&type=section&id=Exhibit%20A%3A%20Acknowledgment%20and%20Transfer%20of%20Membership%20Interests) This exhibit documents the formal transfer of membership interests from each Member to the Company [Ishwar Puri Transfer](index=8&type=section&id=Ishwar%20Puri%20Transfer) Ishwar Puri formally transfers his 50% membership interest in JandB Holdings, LLC to NeOnc Technologies Holdings, Inc., effective August 18, 2025 - Ishwar Puri transfers his **50% membership interest** in JandB Holdings, LLC to NeOnc Technologies Holdings, Inc[35](index=35&type=chunk) - The transfer is effective as of **August 18, 2025**, and accepted by NeOnc Technologies Holdings, Inc[36](index=36&type=chunk)[37](index=37&type=chunk) [Beth R. Levinson Transfer](index=9&type=section&id=Beth%20R.%20Levinson%20Transfer) Beth R. Levinson formally transfers her 50% membership interest in JandB Holdings, LLC to NeOnc Technologies Holdings, Inc., effective August 18, 2025 - Beth R. Levinson transfers her **50% membership interest** in JandB Holdings, LLC to NeOnc Technologies Holdings, Inc[40](index=40&type=chunk) - The transfer is effective as of **August 18, 2025**, and accepted by NeOnc Technologies Holdings, Inc[41](index=41&type=chunk)[42](index=42&type=chunk)
NeOnc Technologies Holdings Reports Second Quarter 2025 Results and Provides Operational Update
Globenewswire· 2025-08-19 13:00
Core Insights - NeOnc Technologies Holdings, Inc. reported financial results for Q2 2025, highlighting significant operational achievements and upcoming milestones in their clinical pipeline [1][4]. Clinical Pipeline Progress - NEO100-01, an intranasal therapy for malignant gliomas, and NEO212, a bio-conjugated therapy for brain cancer, are advancing with the final patient cohort in Phase I expected to complete dosing in 2025 [3]. - A pediatric indication trial, NEO100-3, has been initiated with patient recruitment currently underway [3]. Financial Results for Q2 2025 - General and administrative (G&A) expenses increased to $984K from $290K in Q2 2024, attributed to expanded marketing, rent, travel, and costs related to the Middle East partnership [7]. - Research and development (R&D) expenses rose to $677K from $394K in Q2 2024, driven by additional trial sites and increased recruitment efforts [7]. - The net loss for the quarter was $5.68 million, or $0.30 per diluted share, compared to a net loss of $4.52 million, or $0.27 per diluted share in Q2 2024 [7]. Strategic Developments - A $50 million strategic partnership with Quazar Investment has been secured, which will enhance NeOnc's clinical trials platform in the GCC & MENA regions [6]. - The company received $2.5 million in STTR grants from NIH to support the advancement of NEO212 for gliomas and leukemia [6]. - NeOnc has signed an agreement to acquire an AI, 3D bioprinting, and quantum modeling intellectual property portfolio [6]. - The company has been included in the Russell Microcap Index, increasing visibility among institutional investors [6]. Upcoming Catalysts - Full enrollment for the NEO100-01 Phase 2a trial is expected by September 2025, with top-line data readout anticipated in early 2026 [10]. - Completion of the NEO212 Phase I final cohort dosing is also expected in 2025 [10].
NeOnc Technologies Holdings Inc(NTHI) - 2025 Q2 - Quarterly Report
2025-08-18 16:57
Financial Performance - The company reported a net loss of $5,680,170 for the three months ended June 30, 2025, compared to a net loss of $4,522,006 for the same period in 2024, representing an increase in loss of $1,158,164[115]. - The company reported a net loss of $38,006,186 for the six months ended June 30, 2025, compared to a net loss of $7,460,982 in 2024, reflecting an increase in losses of 409.5%[144]. - Total operating expenses surged to $37,648,886 for the six months ended June 30, 2025, from $2,894,603 in 2024, an increase of 1,200.5%[144]. - Cash used in operating activities was $10,964,226 for the six months ended June 30, 2025, compared to $172,456 in 2024, indicating a significant increase in cash outflow[156]. - The company generated $39,990 in revenue for the six months ended June 30, 2025, down from $63,000 in 2024, a decrease of 36.6%[144]. Operating Expenses - Total operating expenses for the three months ended June 30, 2025, were $5,708,034, an increase of $4,407,914 compared to $1,300,120 in the same period of 2024[133]. - General and administrative expenses rose to $984,262 for the three months ended June 30, 2025, compared to $289,652 in 2024, marking an increase of 240.5%[136]. - Research and development expenses increased to $677,332 for the three months ended June 30, 2025, from $394,484 in 2024, reflecting an increase of $282,848[133]. - Share-based compensation expense was recorded at $3,526,076 for the three months ended June 30, 2025, with no such expense reported in the same period of 2024[133]. - Legal and professional expenses decreased to $520,364 for the three months ended June 30, 2025, from $590,984 in 2024, a decline of 11.9%[135]. Accumulated Deficit and Financial Position - The company has an accumulated deficit of $88,614,631 as of June 30, 2025[115]. - The company had cash totaling $125,039 at June 30, 2025, raising concerns about its ability to continue as a going concern[162]. Future Funding and Capital Requirements - The company plans to continue funding operations through equity and debt financing, as well as licensing income, to meet future obligations[163]. - The company expects expenses to increase due to ongoing research and development, preclinical studies, and clinical trials, necessitating substantial additional funding[165]. - Future capital requirements will depend on various factors, including the costs of conducting clinical trials and the timing of regulatory reviews[169]. - The company plans to finance operations over the next 12 months primarily through existing cash balances and proceeds from private placements[166]. - If the company raises funds through collaborations or licensing arrangements, it may have to relinquish valuable rights to technologies or future revenue streams[168]. Market and Economic Conditions - The company does not currently face significant market risk related to foreign currency exchange rates, but future fluctuations may occur due to contracts with foreign vendors[171]. - Inflation has not materially affected the company's business or financial condition during the recent reporting periods[172]. Commercialization and Operational Considerations - The company may incur significant commercialization expenses if marketing approval is obtained for product candidates[165]. - Additional debt financing may involve restrictive covenants that could limit operational flexibility[167]. - The company anticipates incurring costs associated with operating as a public company, which will impact overall funding needs[165]. Product Development - The company is developing NEO100 and NEO212, with NEO100 currently in Phase 2a trials and NEO212 having completed preclinical testing[110].
NeOnc Technologies Finalizes All Contingencies for $50 Million Strategic Partnership with Quazar Investment as NuroMENA Holdings Receives ADGM Incorporation
Globenewswire· 2025-08-11 13:00
Core Insights - NeOnc Technologies Holdings, Inc. has officially incorporated NuroMENA Holdings Ltd. in Abu Dhabi, completing a $50 million cornerstone investment led by Quazar Investment [3][4][6] - This partnership aims to launch NeOnc's CNS platform in the MENA region and accelerate the development of its therapeutic pipeline, including NEO212 and NEO100 programs [4][5] Company Overview - NeOnc Technologies is a clinical-stage biotechnology company focused on therapies for CNS cancers, with a strong intellectual property portfolio and academic collaborations [7] - Quazar Investment is a strategic investment firm managing over $3.3 billion in assets, focusing on transformative investments in biotechnology and healthcare across the MENA region [8] Strategic Partnership - The incorporation of NuroMENA is seen as a significant validation of NeOnc's global vision and commitment to delivering innovative therapies [5] - Quazar Investment will have majority control of NuroMENA, facilitating joint governance and strategic alignment to enhance CNS therapies in the region [6][7]
NeOnc Technologies Featured on Yahoo Finance's Podcast Trader Talk: AI and Biotech Take on Brain Cancer
Globenewswire· 2025-08-04 13:00
Core Insights - NeOnc Technologies Holdings, Inc. is a clinical-stage biotechnology company focused on developing treatments for brain and central nervous system cancers, recently featured in a podcast discussing its innovative approaches and market achievements [1][2]. Company Overview - NeOnc Technologies is advancing transformative treatments for brain cancer through its NEO drug development platform, which includes novel drug candidates and delivery methods with patent protections extending to 2038 [2]. - The company has two therapeutics, NEO100 and NEO212, currently in Phase II human clinical trials, both under FDA Fast-Track and Investigational New Drug (IND) status [2]. - NeOnc has secured a $50 million partnership in the Middle East and successfully joined the Russell Microcap Index shortly after its IPO, indicating strong market interest and investor confidence [1]. Technological Focus - The company specializes in intranasal drug delivery methods aimed at overcoming the blood-brain barrier, a significant challenge in treating central nervous system conditions [2]. - NeOnc's partnership with USC's medical school enhances its research capabilities and clinical trial reach, further solidifying its position in the biotech industry [1]. Industry Context - The podcast discussion highlighted the potential impact of AI and quantum computing on the biotech sector, suggesting that these technologies could revolutionize drug development and treatment methodologies [1].
NeOnc Technologies Signs Definitive Agreement to Acquire AI, 3D, and Quantum Modeling IP Portfolio from Dr. Ishwar K. Puri; Appoints Him to Board of Directors
Globenewswire· 2025-07-30 13:00
Core Insights - NeOnc Technologies Holdings, Inc. has signed a definitive Letter of Intent to acquire a Delaware entity co-owned by Dr. Ishwar K. Puri and Beth R. Levinson, focusing on innovative treatments for brain cancers [1] - The transaction is valued at $3.5 million, consisting of $500,000 in cash and $3 million in NeOnc common stock priced at $25 per share [2] - Dr. Ishwar K. Puri will join NeOnc's Board of Directors, bringing extensive experience in research and innovation from his role at the University of Southern California [3][4] Company Overview - NeOnc Technologies is a clinical-stage life sciences company dedicated to developing therapeutics for central nervous system conditions, particularly targeting the blood-brain barrier [5] - The company's NEO™ drug development platform has produced novel drug candidates with patent protections extending to 2038, including NEO100™ and NEO212™, which are currently in Phase II clinical trials [5]
AI and biotech take on brain cancer
Yahoo Finance· 2025-07-29 19:36
Company Overview - NeOnc Technologies (NTHI) went public despite a tough market and joined the Russell Microcap Index shortly after its IPO [1] - NeOnc Technologies secured a $50 million partnership in the Middle East [1] - The company focuses on intranasal drug delivery for brain cancer and has a partnership with USC's medical school [1] Clinical Trials and Global Reach - NeOnc Technologies is expanding its reach through global clinical trials [1] Industry Trends - AI and quantum computing could transform the biotech industry [1] Podcast Information - Trader Talk on Yahoo Finance delivers expert analysis and actionable insights on market volatility [1] - The podcast is for informational and educational purposes only and should not be construed as investment advice [1]