NTHI

CALABASAS, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company advancing two Phase 2 programs in central nervous system (CNS) cancers, today announced financial results for the first quarter ended March 31, 2026, and provided an update on recent operational achievements and upcoming milestones. Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented: “The first quarter of 2026 marked a transformational period for NeOnc as we advanced both of our lead clinical programs toward important regulatory and value-creation milestones. We successfully completed the Phase 1 dose-escalation portion of NEO212 and established 610 mg as the recommended Phase 2 dose. Importantly, we observed encouraging early signs of clinical activity and potential durable disease stabilization in heavily pretreated recurrent GBM and brain metastasis patients, despite the study being primarily designed to evaluate safety. We are now preparing to request a Type B End-of-Phase 1 meeting with the FDA to align on the design of a potentially pivotal registrational Phase 2 study and evaluate potential pathways toward accelerated regulatory review. For NEO100, our fully enrolled Phase 2a study in recurrent IDH1-mutant high-grade glioma continues progressing toward an anticipated interim data readout later this year. Previously reported results, including a 24% radiographic remission rate, 44% six-month progression-free survival, and the absence of significant toxicity, continue to reinforce our confidence in the therapeutic potential of NEO100 as we approach this important milestone. Operationally, we strengthened our balance sheet through a PIPE financing anchored by a $10 million commitment from Cinctive Capital, expanded our executive leadership team with the appointment of David Choi as Chief Accounting Officer, and continued advancing our Middle East strategic initiatives through NuroMENA. We believe the anticipated FDA engagement for NEO212 and the upcoming NEO100 interim data readout position NeOnc for what could become one of the most significant periods of clinical and strategic inflection in the Company’s history. My conviction in NeOnc’s long-term opportunity and clinical direction is reflected in my recent open-market purchase of more than $500,0...

Insider buying indicates management's conviction in undervalued shares ahead of multiple near-term catalysts: NEO100: interim data readout - expected within ~4 months NEO212: expects Type B End-of-Phase FDA meeting to align on a potential pivotal, registrational Phase 2 study - within the next 4 weeks CALABASAS, Calif., April 14, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (“NTHI” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced that Chairman and CEO Amir Heshmatpour has purchased approximately $300,000 worth of NTHI stock in the last week, demonstrating management's confidence in the Company's undervalued shares, ahead of multiple near-term catalysts which include: NEO100 - interim data readout - expected within ~4 months NEO212 - Type B End-of-Phase FDA meeting to align on a potential pivotal, registrational Phase 2 study – expected within the next 4 weeks The company is also providing additional context regarding the year-over-year change in operating expenses reflected in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed on March 31, 2026. For the fiscal year ended December 31, 2025, the Company reported a net loss of approximately $62 million, of which roughly 73% was attributable to non-cash stock-based compensation and one-time listing-related advisory fees, resulting in normalized ongoing cash operating expenses of approximately $10.1 million for the year. Specifically, the $45.2 million in non-cash and non-recurring charges consisted of approximately $35.6 million in stock-based compensation associated with the 2023 Equity Plan and approximately $9.6 million in one-time advisory fees related to the Company's public listing. The stock-based compensation charge covers a three-year period and includes awards granted to employees, executives, and key contributors as part of the Company's long-term incentive and retention strategy. This expense does not consume cash and does not reduce the Company's liquidity. The $9.6 million in listing-related advisory fees is a cash expense but is non-recurring in nature and is not expected to continue in future periods. The normalized cash operating expenses figure referenced above is a non-GAAP measure presented to help investors evaluate the Company's underly...

CALABASAS, Calif., April 01, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced financial results for the quarter and year ended December 31, 2025, and provided an update on recent operational achievements and upcoming milestones. Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented: “Q4 2025 and early 2026 marked important inflection points for NeOnc. We completed NEO212’s Phase 1 dose escalation and established a recommended Phase 2 dose of 610 mg, with early signs of possible anti-tumor activity in heavily pretreated patients. In parallel, the NEO100 Phase 2a study in recurrent IDH1-mutant high-grade glioma is fully enrolled. Updated Phase 1/2a data suggested a 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity. We also strengthened the balance sheet through a PIPE financing anchored by Cinctive Capital’s $10 million commitment, expanded the leadership team, and advanced our Middle East strategy through NuroMENA. Looking ahead, we plan to hold a Type B End-of-Phase 1 FDA meeting for NEO212. We also expect a preliminary NEO100 Phase 2a data readout in approximately five months. We believe these near-term catalysts position NeOnc to deliver value-creating milestones for shareholders in the months ahead.” Fourth Quarter and Recent Highlights Clinical Milestones & Data NEO212 — Phase 1 Complete, RP2D Set at 610 mg: Early signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and brain metastasis patients, observed even within the safety-focused phase The company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study Exploring an Accelerated Approval pathway First oral bio-conjugated temozolomide asset is mechanistically differentiated by its potential ability to overcome MGMT-mediated TMZ resistance. NEO100 — Phase 2a Fully Enrolled: Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade glioma, with an interim data readout expected in ~5 months (approximately August 2026). Updated NEO100 Clinical Results Show Possible Durable Effi...

CALABASAS, Calif., March 04, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, the Company’s novel oral bio-conjugated therapy and will host a conference call to discuss the data today at 9:00am ET. NeOnc has formally notified the FDA that the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial has reached Maximum Tolerated Dose (MTD) at Cohort 5 (810 mg, Days 1–5, 28-day cycle) following a second Dose-Limiting Toxicity. In accordance with protocol-defined stopping rules, dose escalation has been halted, no further patients will be enrolled at 810 mg, and the Recommended Phase 2 Dose (RP2D) has been set at 610 mg (Cohort 4). For the Phase 2a metastasis cohort, the starting dose will be 400 mg (Cohort 3). Notably, although Phase 1 was mainly designed to assess safety, tolerability, and identify the MTD, promising signs of clinical efficacy appeared during this phase of the study. These efficacy signs—including indications of lasting disease control in heavily pretreated patients with recurrent GBM and brain metastases—were observed within the dose-escalation groups. The emergence of measurable anti-tumor activity in Phase 1 offers early clinical confirmation of NEO212’s therapeutic potential and supports the Company’s progress into the Phase 2 segment of the trial. “These early efficacy signals, observed even within a dose-escalation safety study, provide meaningful clinical validation of NEO212’s therapeutic potential,” said Amir Heshmatpour, Chairman and CEO of NTHI. “With RP2D now established, we believe NeOnc is entering Phase 2 with positive clinical momentum and a clear development pathway.” The transition into Phase 2 will focus on further assessing efficacy at the RP2D in specific expansion cohorts, aiming to generate strong clinical data to support potential accelerated development pathways in recurrent CNS cancers. Importantly, this represents the first clinical readout of NeOnc’s bioconjugated temozolomide (TMZ) platform in an oral formulation, demonstrating NeOnc’s drug-engineering capabilities beyond its established intranasal delivery platform. The data...

CALABASAS, Calif., Feb. 27, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced today announced that it 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. During the call, members of the NeOnc management team and independent members of the Company’s Scientific Advisory Board (SAB) will present initial data from the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial, evaluating NeOnc’s proprietary bioconjugated temozolomide (TMZ) platform in an oral formulation for patients with CNS malignancies. The discussion will include an update 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. Featured Participants: Dr. Henry S. Friedman, MD – Deputy Director, Preston Robert Tisch Brain Tumor Center, Duke University; Independent Member, NTHI Scientific Advisory Board Dr. Alexandra Miller, MD – Chief Neuro-oncology, Brain Tumor Program, NYU Langone Health; Independent Member, NTHI Scientific Advisory Board NTHI Management Team: Amir Heshmatpour – Chief Executive Officer, Executive Chairman and President Dr. Thomas C. Chen, MD, PhD – Chief Medical Officer and Chief Scientific Officer Dr. Josh Neman, PhD – Chief Clinical Officer Keithly Garnett – Chief Financial Officer Conference Call Details: Date: March 4, 2026 Time: 6:00 a.m. PT / 9:00 a.m. ET Webcast: A live webcast can be accessed at: https://www.webcaster5.com/Webcast/Page/3151/53708 or by visiting https://investors.neonc.com ABOUT NEONC TECHNOLOGIES HOLDINGS, INC. NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancer...

Expanded Clinical Experience Demonstrates Additional Long-Term Survival and Radiographic Remission in Recurrent Grade III/IV IDH1-Mutant Astrocytoma Treated with Intranasal NEO100 CALABASAS, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced updated clinical results from its ongoing Phase 1/2a and compassionate-use experience evaluating intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma. Since the Company’s prior announcement and 8K event on November 12, 2025, an additional patient has achieved both durable long-term survival and radiographic remission, further strengthening the clinical signal observed with intranasal NEO100. With this update, the expanded clinical cohort now includes 25 patients, reinforcing the reproducibility and durability of treatment benefit. Updated results demonstrate that treatment with intranasally delivered NEO100 has resulted in significant radiographic remission in 6 of 25 patients (24%), representing 3X increase over the 8% response rates typically reported with salvage therapies in recurrent high-grade gliomas. Additionally, 44% of patients achieved six-month progression-free survival (PFS-6), exceeding historical benchmarks of 21–31% for IDH1-mutant recurrent high-grade gliomas. Importantly, 9 of 25 patients (36%) remain alive ≥18 months following initiation of NEO100, providing further evidence of meaningful long-term survival in this heavily pretreated population. No significant toxicity has been observed with intranasal administration of NEO100, even with prolonged and chronic dosing. Amir F. Heshmatpour, Executive Chairman, President & CEO of NeOnc Technologies Holdings, Inc., stated: “The addition of another patient achieving both long-term survival and radiographic remission further validates what we believe is a highly compelling and differentiated therapeutic signal. With radiographic responses now 300% higher than the rate historically reported with salvage therapies, these updated data reinforce our conviction that NEO100 may represent a meaningful advance for patients with recurrent IDH1-mutant high-grade gliomas—patients who have historically had few options. As we move to...

CALABASAS, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced financial results for the quarter ended September 30, 2025, and provided an update on recent operational achievements and upcoming milestones. Third Quarter & Recent Corporate Highlights Middle East – NuroMENA, the UAE-based subsidiary, advanced its regional partnerships by appointing His Highness Sheikh Nahyan bin Zayed Al Nahyan as Executive Chairman, signing a Master Services Agreement with M42’s IROS, and completing ADGM incorporation. The company also progressed a $50 million strategic partnership with Quazar Investment, strengthening Abu Dhabi–US collaboration in brain cancer treatment. Non-Dilutive NIH Funding – Awarded $2.5 million in STTR grants to advance NEO212 for gliomas and leukemia, underscoring strong scientific validation and external funding support. Technology Expansion – Executed an agreement to acquire an Advanced AI and 3D Bioprinting IP. Media & Market Visibility Featured on Fox Business, Bloomberg Television Interviewed on Yahoo Finance’s Trader Talk podcast discussing AI and biotech’s role in brain cancer treatment. Entered a 12-part national TV and media campaign with New to The Street, including commercials, earned media, and billboards. Interviewed live by Kenny Polcari (@Floorstocks). Index Inclusion – Joined the Russell Microcap® Index, broadening exposure to institutional investors. Strong IP Protection – Global patent portfolio spans all major pharmaceutical markets, covering the company’s core CNS oncology assets. Executive Leadership – Appointed Amir Heshmatpour as Chief Executive Officer to Drive Next Phase of Clinical and Corporate Growth Scientific Leadership - Appointed leading neuro-oncologists Dr. David M. Ashley (Duke University), Dr. Alexandra M. Miller (NYU Langone Health), and Dr. Henry S. Friedman to its Scientific Advisory Board Clinical Pipeline Progress NEO100-01 – Intranasal therapy for malignant recurrent WHO Grade 3 /4 IDH1 Astrocytoma Announced Phase 2a clinical results for NEO100 in recurrent brain cancer, showing a 21% response rate vs. <8% historical average 44% of patients achieved six-month progression-free survival vs. 21-31% in historical datasets...

Results of Clinical Trials Provide Evidence Supporting Significant Radiographic Response and Potential Long-Term Survival in Recurrent Grade III/IV IDH1-Mutant Astrocytoma Treated with Intranasal NEO100 CALABASAS, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a multi–Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers today announced updated clinical results from its current Phase 1/2a and compassionate care studies involving a cohort of 24 patients with recurrent WHO Grade III/IV isocitrate dehydrogenase 1 (IDH1)–mutant astrocytoma treated with its investigational intranasal agent, NEO100. Clinical results provided support that treatment with intranasally delivered NEO100 resulted in a significant radiographic response, confirmed by contrast-enhanced and perfusion MRI, in 5 of 24 patients (21%)—a rate that markedly exceeds the <8% response typically observed with salvage therapies for recurrent gliomas. Additionally, results indicated that 44% of patients in this Phase 2a study achieved six-month progression-free survival (PFS-6), surpassing the 21–31% benchmark reported in historical datasets for IDH1-mutant recurrent high-grade gliomas. Furthermore, 8 of 24 patients (33%) remained alive ≥18 months after initiation of NEO100, demonstrating long term survival. In addition, no significant toxicity was reported with intranasal administration of NEO100, even with prolonged, chronic intranasal administration, underscoring its potential utility as a therapeutic option for this patient population. Amir F. Heshmatpour, Executive Chairman, President & CEO of NeOnc Technologies Holdings, Inc., stated: “With these data, we believe NeOnc stands at the threshold of a true game-changer for one of medicine’s greatest unmet needs—recurrent IDH1-mutant hi grade gliomas. For the first time, we’re witnessing evidence of meaningful radiographic responses and support for durable survival in patients who previously had few, if any, options. As we approach full enrollment of the NEO100 trial—and our full data readout six months post-enrollment—we believe this may represent a potential paradigm shift in the treatment of brain cancer. The data will speak for itself—and for the patients whose lives we are determined to transform.” Mr. Heshmatpour added:...

CALABASAS, Calif. and ABU DHABI, United Arab Emirates, Aug. 19, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI), a multi–Phase 2 clinical-stage biotechnology company pioneering therapies for central nervous system (CNS) cancers, today announced financial results for the quarter ended June 30, 2025, and provided an update on recent operational achievements and upcoming milestones. Second Quarter & Recent Corporate Highlights $50 Million Strategic Partnership Secured – All contingencies finalized with Quazar Investment following incorporation of NuroMENA Holdings under Abu Dhabi Global Market (ADGM). This partnership will launch an advanced GCC & MENA clinical trials platform and expand NTHI’s global footprint. Non-Dilutive NIH Funding – Awarded $2.5 million in STTR grants to advance NEO212 for gliomas and leukemia, underscoring strong scientific validation and external funding support. Technology Expansion – Signed definitive agreement to acquire AI, 3D bioprinting, and quantum modeling IP portfolio from Dr. Ishwar K. Puri. Media & Market Visibility – Featured on Yahoo Finance’s Trader Talk podcast discussing AI and biotech’s role in brain cancer treatment. Entered a 12-part national TV and media campaign with New to The Street, including commercials, earned media, and billboards. Executive Chairman interviewed live by Kenny Polcari (@Floorstocks). Index Inclusion – Joined the Russell Microcap® Index, broadening exposure to institutional investors. Clinical Leadership – Appointed Dr. Josh Neman as Chief Clinical Officer to lead clinical strategy and translational oncology programs. Strong IP Protection – Global patent portfolio spans all major pharmaceutical markets, covering the company’s core CNS oncology assets. Clinical Pipeline Progress NEO100-01 – Intranasal therapy for malignant gliomas Full Phase 2a enrollment expected by September 2025. Top-line data readout anticipated in early 2026. NEO212 – Bio-conjugated therapy for brain cancer Final patient cohort in Phase I on track to complete dosing in 2025. NEO100-3 – Pediatric indication trial initiated with patient recruitment underway. Financial Results for Q2 2025 G&A expenses: $984K vs. $290K in Q2 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs. R&D expenses: $677K vs. $394K in Q2 2024, driven by additional NEO100 trial sites, incr...