RankAlpha logo
Back to Rankings

NTHI

NeOncF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
14
Stored
Transcripts
0
Recent loaded
Latest report
2026-08-17
Investor release

Document history

Earnings documents stored for NTHI.

12 shown
Investor releaseQuarter not tagged2026-08-17

NeOnc Technologies Holdings Inc (NTHI) (Q2 2026) Earnings Call Highlights: First Annual Meeting ...

GuruFocus.com
This article first appeared on GuruFocus. Revenue: No revenue figures were discussed during the call. Earnings: No earnings figures were discussed during the call. Margins: No margin figures were discussed during the call. Cash Flow: No cash flow figures were discussed during the call. Expenses: No expense figures were discussed during the call. Same-Store Sales: No same-store sales figures were discussed during the call. Store Locations: No store location changes were discussed during the call. Outstanding Shares: 25,931,865 shares of common stock were outstanding as of the June 15, 2026 record date. Equity Incentive Plan: Proposal approved to increase shares available for grants by an additional 1 million shares, with annual increases beginning January 1, 2027, through January 1, 2033, equal to 20% of total common stock outstanding. Warning! GuruFocus has detected 1 Warning Sign with NTHI. Is NTHI fairly valued? Test your thesis with our free DCF calculator. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Successfully held its first annual meeting of stockholders, marking a key milestone as a public company. All proposed resolutions were approved by stockholders, including the election of two Class 1 directors. Stockholders ratified the appointment of CBIS CPAs PC as the independent registered public accounting firm for fiscal year 2026. The company received sufficient votes for all proposals, avoiding the need for an adjournment. The meeting was conducted efficiently with no outstanding questions, indicating smooth operations. The transcript is primarily procedural and lacks substantive discussion on business performance or strategy. No financial results or operational updates were provided during the meeting. The company's equity incentive plan amendment increases share dilution by up to 1 million shares plus annual increases. The meeting did not address any forward-looking guidance or pipeline developments. There were no questions from stockholders, which may indicate limited engagement or concerns. Q: What were the key proposals voted on during the 2026 Annual Meeting of Stockholders?A: Amir Heshmatpour (CEO, Executive Chairman, and President) presented four proposals: the election of two Class 1 directors (Victoria Medvec, Ph.D., and Steve Giannotta, MD) for three-year…Read full document

This article first appeared on GuruFocus. Revenue: No revenue figures were discussed during the call. Earnings: No earnings figures were discussed during the call. Margins: No margin figures were discussed during the call. Cash Flow: No cash flow figures were discussed during the call. Expenses: No expense figures were discussed during the call. Same-Store Sales: No same-store sales figures were discussed during the call. Store Locations: No store location changes were discussed during the call. Outstanding Shares: 25,931,865 shares of common stock were outstanding as of the June 15, 2026 record date. Equity Incentive Plan: Proposal approved to increase shares available for grants by an additional 1 million shares, with annual increases beginning January 1, 2027, through January 1, 2033, equal to 20% of total common stock outstanding. Warning! GuruFocus has detected 1 Warning Sign with NTHI. Is NTHI fairly valued? Test your thesis with our free DCF calculator. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Successfully held its first annual meeting of stockholders, marking a key milestone as a public company. All proposed resolutions were approved by stockholders, including the election of two Class 1 directors. Stockholders ratified the appointment of CBIS CPAs PC as the independent registered public accounting firm for fiscal year 2026. The company received sufficient votes for all proposals, avoiding the need for an adjournment. The meeting was conducted efficiently with no outstanding questions, indicating smooth operations. The transcript is primarily procedural and lacks substantive discussion on business performance or strategy. No financial results or operational updates were provided during the meeting. The company's equity incentive plan amendment increases share dilution by up to 1 million shares plus annual increases. The meeting did not address any forward-looking guidance or pipeline developments. There were no questions from stockholders, which may indicate limited engagement or concerns. Q: What were the key proposals voted on during the 2026 Annual Meeting of Stockholders?A: Amir Heshmatpour (CEO, Executive Chairman, and President) presented four proposals: the election of two Class 1 directors (Victoria Medvec, Ph.D., and Steve Giannotta, MD) for three-year terms, an amendment to the 2023 Equity Incentive Plan to increase shares by 1 million and add annual increases, the ratification of CBIS CPAs PC as the independent auditor for fiscal year 2026, and a proposal for adjournment if necessary. All proposals were approved by the majority of shares present. Q: Who were the newly elected directors, and what is their term?A: Keithly Garnett (CFO) reported that Victoria Medvec, Ph.D., and Steve Giannotta, MD, were duly elected as Class 1 directors, serving three-year terms expiring at the Annual Meeting in 2029. Q: What was the outcome of the vote on the Equity Incentive Plan amendment?A: Keithly Garnett (CFO) confirmed that the amendment to the 2023 Equity Incentive Plan was approved by the affirmative vote of the majority of shares present or represented by proxy. The amendment increases the share pool by 1 million shares and incorporates annual increases starting January 1, 2027, through 2033, equal to 20% of the total shares outstanding. Q: Was the appointment of the independent registered public accounting firm ratified?A: Yes, Keithly Garnett (CFO) stated that the appointment of CBIS CPAs PC as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, was ratified by the affirmative vote of the majority of shares present. Q: What was the record date and quorum status for the meeting?A: Keithly Garnett (CFO) noted that June 15, 2026, was set as the record date. As of that date, there were 25,931,865 outstanding shares of common stock entitled to vote. A quorum was declared present, as a majority of the outstanding shares were represented in person or by proxy. Q: Were there any questions submitted by stockholders during the meeting?A: Amir Heshmatpour (CEO) and Keithly Garnett (CFO) confirmed that no questions were submitted online during the meeting, allowing the meeting to adjourn promptly after the formal business was concluded. Q: What is the next step following the meeting's conclusion?A: Amir Heshmatpour (CEO) stated that the company will file a Form 8-K with the SEC to report the final voting results on the matters voted on during the meeting. Q: Who were the key corporate participants present at the meeting?A: The meeting was led by Amir Heshmatpour (CEO, Executive Chairman, and President) and Keithly Garnett (CFO), who served as the inspector of elections. Other attendees included Dr. Thomas Chin (Chief Medical Officer), Dr. Josh Nieman (Chief Scientific Officer), and David Choi (Chief Accounting Officer). For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-12

NeOnc Technologies Reports Positive Topline Phase 2a Results for Intranasal NEO100 in Recurrent IDH1-Mutant High-Grade Glioma

GlobeNewswire
Company to request a Type B meeting with the FDA to align on a registrational path in a setting with no approved targeted therapy — Study met its primary endpoint: six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047) — Median overall survival of 26.09 months; 86.7% of patients alive at six months — Five of 24 patients remain on treatment, with one partial response ongoing beyond 114 days — No major toxicities reported across the cohort; adverse events predominantly low-grade — Company to host investor conference call and webcast today at 8:30 a.m. Eastern TimeCALABASAS, Calif., Aug. 12, 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 positive topline results from the Phase 2a portion of NEO100-01, an open-label study of intranasal NEO100™ (purified perillyl alcohol) in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint. Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047). “These results represent an important milestone for NeOnc and, more importantly, a source of hope for patients with recurrent high-grade glioma who currently have very limited treatment options. NEO100 met the study’s primary endpoint, demonstrated encouraging survival outcomes, and was administered intranasally by patients at home with no major toxicities reported. We believe these findings support the potential of our intranasal delivery platform to address one of the greatest challenges in treating brain cancer - the blood-brain barrier. Our priority now is to engage with the FDA and align on the most efficient path toward a registrational study,” said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer. Secondary survival endpoints were supportive. Median overall survival was 26.09 months, with 12 deaths among 24 patients. Overall survival was 86.7% at six months (95% CI: 64.3-95.5), 60.9% (95% CI: 36.4-78.4) at 12 months and 54.1% (95% CI: 29.5-73.4) at 24…Read full document

Company to request a Type B meeting with the FDA to align on a registrational path in a setting with no approved targeted therapy — Study met its primary endpoint: six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047) — Median overall survival of 26.09 months; 86.7% of patients alive at six months — Five of 24 patients remain on treatment, with one partial response ongoing beyond 114 days — No major toxicities reported across the cohort; adverse events predominantly low-grade — Company to host investor conference call and webcast today at 8:30 a.m. Eastern TimeCALABASAS, Calif., Aug. 12, 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 positive topline results from the Phase 2a portion of NEO100-01, an open-label study of intranasal NEO100™ (purified perillyl alcohol) in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint. Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047). “These results represent an important milestone for NeOnc and, more importantly, a source of hope for patients with recurrent high-grade glioma who currently have very limited treatment options. NEO100 met the study’s primary endpoint, demonstrated encouraging survival outcomes, and was administered intranasally by patients at home with no major toxicities reported. We believe these findings support the potential of our intranasal delivery platform to address one of the greatest challenges in treating brain cancer - the blood-brain barrier. Our priority now is to engage with the FDA and align on the most efficient path toward a registrational study,” said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer. Secondary survival endpoints were supportive. Median overall survival was 26.09 months, with 12 deaths among 24 patients. Overall survival was 86.7% at six months (95% CI: 64.3-95.5), 60.9% (95% CI: 36.4-78.4) at 12 months and 54.1% (95% CI: 29.5-73.4) at 24 months. “We believe that these results are a powerful validation of the science behind NEO100,” said Thomas C. Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. “We set out to reach the brain directly, delivering therapy through the nose and along the olfactory pathway rather than forcing a drug past the blood-brain barrier, and what we are seeing in Phase 2a is what our biology predicted and what we saw in Phase 1, where every long-term survivor carried an IDH1 mutation. We believe that survival of this duration in twice-treated, high-grade disease, achieved with a therapy patients take at home and with no major toxicity, is the kind of result that justifies a much larger study.” Evidence of durable disease control was observed across the cohort. Five of 24 patients remain on active treatment. One patient has remained progression-free for approximately 19 months. A second patient achieved a partial response sustained for 114 days through the end of Cycle 8 and remains on treatment in response. Objective response rate was 8.3% (two of 24 patients) by RANO 2.0. “In recurrent high-grade glioma, the outcome that matters is how long a patient can hold the disease at bay and still live their life,” said Josh Neman, PhD, Chief Clinical Officer of NeOnc. “Five of our 24 patients remain on therapy, one progression-free approaching 19 months and another in an ongoing response approaching four months, and they are taking this treatment at home rather than in an infusion chair. Durability and tolerability together are rare at recurrence, and we believe that combination is what these data point to. We look forward to discussing the findings with the FDA.” The data suggests that NEO100 was well tolerated. No major toxicities were reported across the cohort, and adverse events to date have been predominantly low-grade. The tolerability profile is consistent with the Phase 1 portion of the study, in which the data suggested that NEO100 was well tolerated at all dose levels, with no severe or dose-limiting toxicities observed. The absence of significant toxicity is notable in a population receiving continuous therapy (several patients have now remained on daily intranasal dosing for well over a year) and reflects a delivery route designed to reach the brain without systemic cytotoxic exposure. NEO100-01 is directed at a population that existing IDH-targeted therapies do not serve. Approved and late-stage IDH-targeted agents for glioma have been developed in the front-line setting for lower-grade disease, typically Grade 2, non-enhancing tumors in patients who have undergone surgery but have not yet received radiation or chemotherapy. NEO100-01 enrolled the opposite population: patients with Grade III and Grade IV IDH1-mutant tumors that have recurred or progressed after radiation and temozolomide. There is no approved targeted therapy for these patients. Approximately 90% of high-grade glioma patients recur within six to nine months of maximal therapy, and at recurrence, surgery is often not repeatable and systemic agents face rapid resistance and cumulative toxicity. NEO100 is administered intranasally by the patient at home, four times daily, in 28-day cycles, a delivery route designed to reach the brain directly while avoiding systemic cytotoxic exposure. NeOnc intends to request a Type B meeting with the U.S. Food and Drug Administration to align on a registrational development path for NEO100 in recurrent IDH1-mutant high-grade glioma. Additional pre-specified analyses including the Grade III versus Grade IV subgroup analysis, pharmacokinetics, and quality-of-life measures are ongoing and will be reported separately. The Company expects to present the full Phase 2a dataset, including detailed safety, at a future medical meeting. Conference Call and Webcast NeOnc will host an investor conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss these results, followed by a question and answer session. The live webcast can be accessed at https://www.webcaster5.com/Webcast/Page/3151/54410 or by visiting https://investors.neonc.com. A replay will be available at https://investors.neonc.com shortly following the conclusion of the call. About the NEO100-01 Phase 2a study NEO100-01 is an open-label, multi-center Phase 1/2a study of intranasal NEO100 in patients with radiographically confirmed progression of, or recurrence of, primary or secondary Grade IV glioma or Grade III astrocytoma harboring an IDH1 mutation. All patients had previously failed radiation or combined temozolomide and radiation. The Phase 2a portion enrolled 24 patients of a planned 28 at the recommended Phase 2 dose of 1,152 mg/day, self-administered intranasally four times daily in 28-day cycles until progression, death, or withdrawal. The primary endpoint is the progression-free survival rate at six months. Secondary endpoints include objective response rate by RANO 2.0 criteria, progression-free survival, overall survival, safety and tolerability, pharmacokinetics, and quality of life. All MRI scans were read by an independent central reviewer. Biostatistical analysis was conducted by Anova Enterprises, Inc. Efficacy results are reported for the intent-to-treat population. Response and progression were assessed using RANO 2.0 criteria. About NEO100 NEO100™ is a patented, ultra-pure pharmaceutical-grade formulation of perillyl alcohol, a naturally occurring monoterpene found in citrus and peppermint oils, produced through a proprietary crystalline synthesis process. Administered intranasally using a commercial nasal mask and nebulizer, NEO100 is designed to deliver therapy directly to the brain along olfactory and trigeminal pathways, bypassing the blood-brain barrier and avoiding first-pass metabolism and systemic toxicity. Data from preclinical studies suggests that NEO100 may transiently and reversibly open the blood-brain barrier, enabling brain entry of otherwise impermeable therapeutics. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of NEO100, the interpretation and significance of the Phase 2a results, plans to engage with the FDA, the design and timing of future clinical trials, and the Company's development strategy. These statements are based on management's current expectations and are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Such risks include, but are not limited to: the Phase 2a study was a single-arm, open-label study of 24 patients that did not reach its planned enrollment of 28 patients and was not powered as a confirmatory trial; results were not compared against a randomized control arm, and comparisons to historical data are inherently limited by differences in patient population, era, and assessment criteria; the primary efficacy analysis presented reflects RANO 2.0 criteria and Kaplan-Meier estimation, and results differ under the response criteria and estimation method specified in the study protocol; early-phase results frequently fail to replicate in larger, controlled studies; safety and tolerability findings in a 24-patient, open-label study may not predict the safety profile observed in larger or longer-duration studies, and additional adverse events may emerge with broader exposure; the FDA may not agree with the Company's proposed registrational path, endpoints, or analytical methods; and additional pre-specified analyses remain ongoing. Additional risks are described in the Company's filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement except as required by law. “NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc. Contacts Company Contact:[email protected] Investor Contact:Jon NugentJon Nugent [email protected] This press release was published by a CLEAR® Verified individual.

Investor releaseQuarter not tagged2026-08-12

NeOnc Technologies shares jump after positive Phase 2a glioma results

InvestorsHub
NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) shares climbed 11.7% after the biotechnology company announced positive topline results from a Phase 2a study evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. The trial achieved its primary endpoint, with six-month progression-free survival reaching 48.9%. That compared with a pre-specified standard-of-care benchmark of 20%, with the result achieving statistical significance at p = 0.0047. Median overall survival reached 26.09 months, while 86.7% of participants were alive six months after starting treatment. The Phase 2a study enrolled 24 patients with Grade III or Grade IV IDH1-mutant tumours that had returned or progressed following treatment with radiation and temozolomide. Five participants remain on active treatment, including one patient who has remained progression-free for approximately 19 months. The objective response rate was 8.3%, with two of the 24 patients achieving a response to treatment. The progression-free survival results provided the main positive catalyst for NeOnc shares, given the limited treatment options currently available for patients with recurrent high-grade disease. No major toxicities were reported among patients participating in the study, with adverse events predominantly classified as low grade. NEO100 is administered intranasally, allowing patients to take the treatment at home four times per day in 28-day treatment cycles. The combination of the efficacy findings and tolerability profile provides NeOnc with additional clinical evidence as it considers the next stage of development for the programme. Following the positive Phase 2a results, NeOnc intends to request a Type B meeting with the U.S. Food and Drug Administration. The company plans to use the meeting to seek alignment with the regulator on a potential registrational development pathway for NEO100 in recurrent IDH1-mutant high-grade glioma. There is currently no approved targeted therapy specifically for this treatment setting. Existing approved IDH-targeted therapies have been developed for lower-grade disease in the front-line setting rather than recurrent high-grade tumours. NeOnc expects to present the complete Phase 2a dataset at a future medical conference, including more detailed information about the treatment’s safety profile. Additional pre-specified analyses are also…Read full document

NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) shares climbed 11.7% after the biotechnology company announced positive topline results from a Phase 2a study evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. The trial achieved its primary endpoint, with six-month progression-free survival reaching 48.9%. That compared with a pre-specified standard-of-care benchmark of 20%, with the result achieving statistical significance at p = 0.0047. Median overall survival reached 26.09 months, while 86.7% of participants were alive six months after starting treatment. The Phase 2a study enrolled 24 patients with Grade III or Grade IV IDH1-mutant tumours that had returned or progressed following treatment with radiation and temozolomide. Five participants remain on active treatment, including one patient who has remained progression-free for approximately 19 months. The objective response rate was 8.3%, with two of the 24 patients achieving a response to treatment. The progression-free survival results provided the main positive catalyst for NeOnc shares, given the limited treatment options currently available for patients with recurrent high-grade disease. No major toxicities were reported among patients participating in the study, with adverse events predominantly classified as low grade. NEO100 is administered intranasally, allowing patients to take the treatment at home four times per day in 28-day treatment cycles. The combination of the efficacy findings and tolerability profile provides NeOnc with additional clinical evidence as it considers the next stage of development for the programme. Following the positive Phase 2a results, NeOnc intends to request a Type B meeting with the U.S. Food and Drug Administration. The company plans to use the meeting to seek alignment with the regulator on a potential registrational development pathway for NEO100 in recurrent IDH1-mutant high-grade glioma. There is currently no approved targeted therapy specifically for this treatment setting. Existing approved IDH-targeted therapies have been developed for lower-grade disease in the front-line setting rather than recurrent high-grade tumours. NeOnc expects to present the complete Phase 2a dataset at a future medical conference, including more detailed information about the treatment’s safety profile. Additional pre-specified analyses are also continuing, including evaluations of patient subgroups, pharmacokinetics and quality-of-life outcomes. The planned FDA discussions will represent the next significant step for the NEO100 programme as NeOnc explores a potential path towards a registrational study. NeOnc Technologies Holdings stock price

Investor releaseQuarter not tagged2026-08-10

NeOnc Reports Second Quarter 2026 Financial Results and Confirms August 12 Topline Phase 2a NEO100 Data Readout

Stocktwits
CALABASAS, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for central nervous system cancers, today announced financial results for the second quarter ended June 30, 2026, highlighted recent clinical and regulatory progress across its NEO100 and NEO212 programs, and confirmed that topline results from its fully enrolled Phase 2a NEO100 study will be presented on August 12, 2026. Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer, commented: See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox “The second quarter positioned NeOnc for an important period of clinical execution. We completed the topline analysis of our fully enrolled Phase 2a NEO100 study in recurrent IDH1-mutant high-grade glioma and look forward to presenting the results to investors on August 12. This is one of the most important clinical milestones in NeOnc’s history. “At the same time, we secured UAE IND approvals for both NEO100 and NEO212, expanding our international clinical development pathway alongside our ongoing programs in the United States. The breadth of the NEO100 authorization is particularly meaningful, covering three adult and pediatric clinical programs ranging from Phase 1 through Phase 2. “Our increased research and development investment reflects tangible clinical progress, including the addition of trial sites, expanded drug-product manufacturing, patient recruitment, pediatric development and completion of the NEO100 data analysis. Importantly, general and administrative expenses declined year over year as we continued directing resources toward the advancement of our clinical portfolio. “We also strengthened our Board with the appointment of Nasim Shomali, whose strategic, financial and operating experience will support NeOnc as we advance our programs through their next stages of development. “Looking ahead, we look forward to presenting topline results from the Phase 2a study of NEO100 in recurrent IDH1-mutant high-grade glioma on August 12, 2026. This readout represents one of the most important clinical milestones in NeOnc’s history, and we look forward to discussing the results with our shareholders.” Second Quarter and…Read full document

CALABASAS, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for central nervous system cancers, today announced financial results for the second quarter ended June 30, 2026, highlighted recent clinical and regulatory progress across its NEO100 and NEO212 programs, and confirmed that topline results from its fully enrolled Phase 2a NEO100 study will be presented on August 12, 2026. Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer, commented: See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox “The second quarter positioned NeOnc for an important period of clinical execution. We completed the topline analysis of our fully enrolled Phase 2a NEO100 study in recurrent IDH1-mutant high-grade glioma and look forward to presenting the results to investors on August 12. This is one of the most important clinical milestones in NeOnc’s history. “At the same time, we secured UAE IND approvals for both NEO100 and NEO212, expanding our international clinical development pathway alongside our ongoing programs in the United States. The breadth of the NEO100 authorization is particularly meaningful, covering three adult and pediatric clinical programs ranging from Phase 1 through Phase 2. “Our increased research and development investment reflects tangible clinical progress, including the addition of trial sites, expanded drug-product manufacturing, patient recruitment, pediatric development and completion of the NEO100 data analysis. Importantly, general and administrative expenses declined year over year as we continued directing resources toward the advancement of our clinical portfolio. “We also strengthened our Board with the appointment of Nasim Shomali, whose strategic, financial and operating experience will support NeOnc as we advance our programs through their next stages of development. “Looking ahead, we look forward to presenting topline results from the Phase 2a study of NEO100 in recurrent IDH1-mutant high-grade glioma on August 12, 2026. This readout represents one of the most important clinical milestones in NeOnc’s history, and we look forward to discussing the results with our shareholders.” Second Quarter and Recent Highlights Clinical and Regulatory Milestones NEO100 UAE IND Approval: In June, the Company received UAE IND approval for NEO100, covering all three NEO100 programs across adult Phase 1 through Phase 2, as well as pediatric studies. The authorization extends NeOnc’s UAE footprint beyond NEO212 and complements ongoing U.S. development, where NEO100 holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations. NEO212 UAE IND Approval: Also in June, the Company secured UAE IND approval for NEO212, enabling Phase 2 evaluation of the Company’s oral perillyl alcohol-temozolomide conjugate in the United Arab Emirates. The clearance follows completion of the Phase 1 dose-escalation study and supports the continued clinical development of NEO212 in the United Arab Emirates. FDA Feedback on NEO212 Development Program: In July, the Company received written feedback from the FDA regarding the continued development of NEO212, including its chemistry, manufacturing and controls program and the proposed transition from a capsule to a tablet formulation. NeOnc subsequently engaged with the FDA to discuss the next stage of clinical development. The Company is incorporating the FDA’s written feedback and meeting discussion into its proposed Phase 2 development strategy and expects to receive the official meeting minutes in August 2026. NEO100 Phase 2a Topline Analysis Completed: The Company completed the topline analysis of its fully enrolled Phase 2a study evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. NeOnc will present the results during an investor conference call and webcast on August 12, 2026. Strengthening Leadership and Capital Position Board Appointment: In July, the Company appointed Nasim Shomali to its Board of Directors, effective July 1, 2026. Ms. Shomali brings more than a decade of experience advising large organizations on corporate strategy, operating models and financial planning, grounded in formal training in biomedical engineering and finance. Cash Position and Financial Flexibility: As of June 30, 2026, the Company had cash and cash equivalents of approximately $2.0 million. The Company also maintained an undrawn $10.0 million line of credit with HCWG, a related party, providing additional access to capital to support ongoing operations and clinical development, subject to the terms of the facility. Capital Resources: The Company maintains access to several capital sources, including its equity purchase facility with Mast Hill Fund, LP, its $300 million shelf registration statement and its at-the-market offering program with BTIG, LLC and Alliance Global Partners. No shares were sold under either the Mast Hill facility or the ATM program during the second quarter of 2026. As of June 30, 2026, approximately $44.5 million remained available under the Mast Hill facility, subject to the terms, conditions and volume limitations of the agreement. Upcoming Investor Conference Call The Company will host an investor conference call and webcast on Wednesday, August 12, 2026, at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss topline Phase 2a results for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma. A live webcast will be available at https://www.webcaster5.com/Webcast/Page/3151/54410 or https://investors.neonc.com, where a replay will be archived shortly following the conclusion of the call. Financial Results for Q2 2026 G&A expenses: General and administrative expenses decreased to $0.9 million from $1.0 million in Q2 2025, reflecting lower D&O insurance premiums and reduced advertising, marketing and travel expenses, partially offset by increased business development costs. The year-over-year decrease reflects the Company’s continued focus on controlling corporate expenses while directing resources toward clinical development. R&D expenses: Research and development expenses were $2.6 million, compared with $0.7 million in Q2 2025. The increase reflects NeOnc’s continued investment in clinical execution, including the addition of clinical trial sites, expanded drug-product manufacturing, NEO212 patient recruitment, initiation of the NEO100-03 pediatric trial, and completion of data-lock and analysis activities for the NEO100 Phase 2a study. Net loss: Net loss was $14.2 million, or $(0.58) per diluted share, compared with $5.7 million, or $(0.30) per diluted share, in Q2 2025. Approximately $5.7 million, or 40%, of the Company’s $14.1 million in total operating expenses consisted of noncash stock-based compensation. Excluding this noncash expense, total operating expenses were approximately $8.4 million. A reconciliation of this non-GAAP measure is provided below. Cash used in operations: Net cash used in operating activities was $11,756,954 for the six months ended June 30, 2026, compared to $10,964,226 for the same period in 2025. The difference between cash used in operations and the net loss of $23,059,976 for the six-month period primarily reflects non-cash charges, including $8,384,311 of stock-based compensation. Reconciliation of GAAP Total Operating Expenses to Non-GAAP Total Operating Expenses Excluding Stock-Based Compensation (unaudited) 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s lead programs include NEO100™, which is being evaluated in multiple Phase 1 and Phase 2 clinical studies, and NEO212™, which has completed Phase 1 dose escalation and is advancing toward Phase 2 development. NEO100 has received FDA Fast Track, Orphan Drug and Rare Pediatric Disease designations. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com Important Cautions Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Please refer to the “Risk Factors” section of our quarterly and annual reports on Form 10-Q and Form 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in those reports and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, which outline important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact:[email protected] Investor Contact:Jon NugentJon Nugent [email protected] Source: NeOnc Technologies Holdings, Inc. 2026 GlobeNewswire, Inc., source Press Releases Stocktwits PR Desk has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Why Is KEEL Stock Rising Overnight Despite Missing Q2 Estimates? RIOT Stock Jumps Overnight After Report Names Anthropic As ‘Mystery’ Cloud Customer RUM Q2 Revenue Jumps 60% — CEO Targets Quake AI’s $3B Opportunity

Investor releaseQuarter not tagged2026-08-10

NeOnc Technologies to Host Investor Conference Call to Discuss Topline Phase 2a Results for Intranasal NEO100 in Recurrent IDH1-Mutant High-Grade Glioma

Stocktwits
Call to be held Wednesday, August 12, 2026 at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time CALABASAS, Calif., Aug. 10, 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 that it will host an investor conference call and webcast on Wednesday, August 12, 2026, at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox During the call, members of the NeOnc management team will present topline results from the Phase 2a portion of the NEO100-01 clinical trial, an open-label study of intranasal NEO100™, the Company’s proprietary formulation of purified perillyl alcohol, in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The discussion will include efficacy and safety observations from the Phase 2a portion of the NEO100-01 clinical trial and planned regulatory next steps. A question and answer session will follow the presentation. Featured Participants: Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer Thomas C. Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer Josh Neman, PhD, Chief Clinical Officer Keithly Garnett, Chief Financial Officer Conference Call Details: Date: Wednesday, August 12, 2026 Time: 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time Webcast: A live webcast can be accessed at: https://www.webcaster5.com/Webcast/Page/3151/54410 or by visiting https://investors.neonc.com Replay: A replay of the webcast will be available at https://investors.neonc.com shortly following the conclusion of the call. 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…Read full document

Call to be held Wednesday, August 12, 2026 at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time CALABASAS, Calif., Aug. 10, 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 that it will host an investor conference call and webcast on Wednesday, August 12, 2026, at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox During the call, members of the NeOnc management team will present topline results from the Phase 2a portion of the NEO100-01 clinical trial, an open-label study of intranasal NEO100™, the Company’s proprietary formulation of purified perillyl alcohol, in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The discussion will include efficacy and safety observations from the Phase 2a portion of the NEO100-01 clinical trial and planned regulatory next steps. A question and answer session will follow the presentation. Featured Participants: Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer Thomas C. Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer Josh Neman, PhD, Chief Clinical Officer Keithly Garnett, Chief Financial Officer Conference Call Details: Date: Wednesday, August 12, 2026 Time: 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time Webcast: A live webcast can be accessed at: https://www.webcaster5.com/Webcast/Page/3151/54410 or by visiting https://investors.neonc.com Replay: A replay of the webcast will be available at https://investors.neonc.com shortly following the conclusion of the call. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com. Important Cautions Regarding Forward-Looking Statements This press release contains "forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as "may,” "will,” "should,” "intend,” "expect,” "plan,” "budget,” "forecast,” "anticipate,” "believe,” "estimate,” "predict,” "potential,” "continue,” "evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Advertisement Please refer to the "Risk Factors” section of our quarterly and annual reports on Form 10-Q and Form 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in those reports and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, which outline important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. "NEO100” and "NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: Jon Nugent Jon Nugent Communications [email protected] 205-566-3026 This press release was published by a CLEAR® Verified individual. Note: This article has been published automatically by sourcing from Access Newswire. The Stocktwits editorial team did not edit this article. Stocktwits PR Desk has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Why Is KEEL Stock Rising Overnight Despite Missing Q2 Estimates? RIOT Stock Jumps Overnight After Report Names Anthropic As ‘Mystery’ Cloud Customer RUM Q2 Revenue Jumps 60% — CEO Targets Quake AI’s $3B Opportunity

Investor releaseQuarter not tagged2026-05-18

NeOnc Provides Business Update and Reports Q1 2026 Financial Results

GlobeNewswire
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…Read full document

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 $500,000 of NTHI shares.” First Quarter and Recent Highlights Clinical Milestones & Data NEO212 — Phase 1 Complete, Recommended Phase 2 Dose (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 NEO100 — Phase 2a Fully Enrolled: Phase 2a trial for IDH1-mutant recurrent high-grade glioma, with an interim data readout expected in approximately August 2026. Strengthening Leadership & Securing Growth Capital PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities. Cash Position: As of March 31, 2026, the Company had cash and cash equivalents of $138,601, which together with the PIPE proceeds and undrawn line of credit, is expected to fund planned operations into September 2026. Undrawn Line of Credit: The Company also maintains a $10 million undrawn line of credit, providing additional financial flexibility and access to capital to support ongoing clinical development and operational initiatives. Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions. Corporate & Investor Outreach Featured in New to The Street segments on Bloomberg Television and Fox Business Hosted investor calls and a key opinion leader (KOL) conference call presenting clinical data updates Financial Results for Q1 2026 G&A expenses: $488,709 vs. $849,485 in Q1 2025, reflecting less marketing, rent, travel, and Middle East partnership-related costs in 2026. R&D expenses: $1,286,336 vs. $998,222 in Q1 2025, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of the NEO100-3 study, and overall patient recruitment activity. Net loss: $8.8 million or $(0.38) per diluted share, compared to $32.3 million or $(1.78) per diluted share in Q1 2025. The year-over-year improvement reflects the significant reduction in non-cash stock-based compensation and listing-related advisory fees recognized in Q1 2025 in connection with the Company's public listing. Approximately 31% of the Q1 2026 net loss reflects $2.7 million of non-cash stock-based compensation, resulting in normalized cash operating expenses of approximately $6.1 million for the quarter (~$24.4 million annualized). Normalized cash operating expenses is a non-GAAP measure; a reconciliation is provided below. Reconciliation of GAAP Net Loss to Non-GAAP Normalized Cash Operating Expenses (unaudited) 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com. Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Please refer to the “Risk Factors” section of our Quarterly and Annual reports on Form 10-Q and 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, which outline important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials; announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data; and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact:[email protected] Investor Contact:James CarbonaraHayden IR(646)[email protected]

Investor releaseQuarter not tagged2026-04-14

NeOnc Technologies Holdings, Inc. Announces ~ $300,000 in Insider Purchases of NTHI Stock by Chairman and CEO; Company Provides Context on 2025 Financial Results

GlobeNewswire
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…Read full document

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 underlying operational cost structure. Subsequent to year‑end, the Company completed a private placement financing during the first quarter of 2026, raising gross proceeds of approximately $13.0 million. The Company used a portion of the proceeds to strengthen its balance sheet by repaying outstanding short‑term convertible debt and satisfying certain accrued obligations. Management believes this financing, combined with ongoing expense management initiatives, positions the Company to continue advancing key clinical milestones. “In 2025, we advanced our clinical programs while completing our transition to a public company,” said Keithly Garnett, Chief Financial Officer of NeOnc Technologies Inc. “While reported net loss reflects significant non‑cash and listing‑related charges, our focus remains on disciplined capital allocation and advancing NEO100 and NEO212 through important clinical inflection points. Following our first quarter 2026 financing, we are prioritizing efficient deployment of capital toward value‑creating milestones.” NeOnc remains focused on efficiently deploying capital to achieve key clinical milestones and drive long-term shareholder value. Key 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 Type B End-of-Phase FDA meeting to align on a potential pivotal, registrational Phase 2 study - within the next 4 weeks 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 ~4 months (approximately August 2026). Updated NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas: Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100 Suggested a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies 44% six-month progression-free survival (vs. 21–31% historical benchmarks) 36% of patients (9/25) alive ≥18 months post-treatment initiation No significant toxicity even under prolonged chronic dosing Reinforces NEO100's potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma. NEO100 & Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against primary and metastatic brain tumors, pointing toward a potential combination approach. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com. Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Please refer to the “Risk Factors” section of our Quarterly and annual reports on Form 10-Q and 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

Investor releaseQuarter not tagged2026-04-01

NeOnc Provides Business Update and Reports Q4 2025 Financial Results

GlobeNewswire
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…Read full document

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 Efficacy in Recurrent IDH1-Mutant Gliomas: Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100 Suggested a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies 44% six-month progression-free survival (vs. 21–31% historical benchmarks) 36% of patients (9/25) alive ≥18 months post-treatment initiation No significant toxicity even under prolonged chronic dosing Reinforces NEO100's potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma. NEO100 & Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against primary and metastatic brain tumors, pointing toward a potential combination approach. Middle East Expansion (NuroMENA) Executive Chairmanship: His Highness Sheikh Nahyan bin Zayed Al Nahyan assumed the role of Executive Chairman of NuroMENA, NeOnc's UAE-based subsidiary, to advance a UAE-US partnership in brain cancer treatment. Operational Agreements: NuroMENA executed a Master Services Agreement with M42's IROS and expanded its Board of Directors. Strengthening Leadership & Securing Growth Capital PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities. Chief Executive Officer: Named Amir Heshmatpour as CEO to lead the company's next phase of clinical and corporate development. Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions. Scientific Advisory Board Expansion: Added two leading neuro-oncologists — Dr. David M. Ashley, Director of Duke's Preston Robert Tisch Brain Tumor Center, and Dr. Alexandra M. Miller, Chief of Neuro-Oncology at NYU Langone's Perlmutter Cancer Center — deepening the company's scientific bench. Investor & Media Engagement Broadcast Exposure: Featured across multiple New to The Street segments on Bloomberg Television (U.S., MENA, and Latin America) and Fox Business, increasing visibility among retail and institutional audiences. Investor Events & KOL Calls: Hosted multiple investor and key opinion leader conference calls presenting clinical data updates and participated in the New to The Street Accredited Investor Event at Hudson Yards, New York. Financial Results for Q4 2025 G&A expenses: $4,818k vs. $1,680k in Q4 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs. R&D expenses: $3,638k vs. $3,045k in Q4 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of NEO100-3, and overall patient recruitment activity. Net loss: $62.1 million or $3.20 per diluted share, compared to $11.9 million or $0.69 per diluted share in Q4 2024, primarily due to increased general and administrative expenses, as well as stock-based compensation expenses. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com. Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Please refer to the “Risk Factors” section of our Quarterly and annual reports on Form 10-Q and 10-K as filed with the Securities and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

Investor releaseQuarter not tagged2026-03-04

NeOnc Technologies Reports Phase 1 Dose-Escalation Results for Dosing and Toxicity and Determination of Recommended Phase 2 Dose for Oral NEO212; Management to Host KOL Conference Call Today at 9 a.m. ET

GlobeNewswire
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…Read full document

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 validate the Company’s ability to optimize CNS penetration and therapeutic exposure across both intranasal and oral modalities. NeOnc intends to request a Type B (End-of-Phase 1) FDA meeting to review safety, PK/PD, preliminary efficacy, RP2D justification, Phase 2 design modifications, and a potential Accelerated Approval pathway. Supporting regulatory materials, including MedWatch Form FDA 3500A and Form FDA 1571, have been submitted via eCTD, ensuring regulatory transparency and alignment as the program transitions into Phase 2 development. Mr. Heshmatpour, continued: “This clinical data readout represents a meaningful advancement relative to the historical standard of care in brain cancer, temozolomide (TMZ), originally developed by Merck (NYSE: MRK). Importantly, we have successfully engineered and clinically evaluated a bio-conjugated oral formulation of TMZ, NEO212, and have established the Recommended Phase 2 Dose (RP2D). Achieving dose confirmation is a critical milestone that substantially de-risks the program and positions us for the next stage of development. We believe NEO212 has the potential to meaningfully improve upon conventional TMZ by enhancing therapeutic performance while maintaining the practicality of oral administration. With this milestone achieved, we are preparing to engage the U.S. Food and Drug Administration to align on the design of what we anticipate will be a pivotal, registrational Phase 2 study, subject to FDA feedback and approval. If successful, this program could redefine the treatment paradigm for glioblastoma, astrocytoma, and other aggressive CNS malignancies.” NEO212 is specifically designed to overcome a key biological limitation of TMZ: MGMT-mediated resistance. Preclinical studies have shown that NEO212 effectively inactivates and promotes the degradation of O6-methylguanine-DNA methyltransferase (MGMT), a crucial DNA repair enzyme that causes TMZ resistance. Standard TMZ treatment does not significantly lower MGMT levels and remains vulnerable to MGMT-driven DNA repair in brain tumors. This mechanistic difference may be especially important for TMZ-resistant and MGMT-high recurrent glioblastoma patients, offering a strong biological reason to advance NEO212 into Phase 2 development in the post-TMZ setting. Mr. Heshmatpour added: “This marks our first clinical readout of a bio-conjugated oral oncology asset and validates the broader scientific foundation of our platform. Supported by approximately ten issued patents and patent applications across the NEO212 and NEO100 programs, we believe our intellectual property portfolio provides meaningful long-term strategic protection. Our immediate priority is regulatory engagement and disciplined execution toward a pivotal registrational pathway. We remain focused on advancing differentiated CNS therapies that can create durable clinical value for patients and sustainable long-term value for shareholders.” Founder, Dr. Thomas Chen, Vice-Chairman and Chief Medical Officer noted that, “The determination of the RP2D at 610 mg is a scientifically significant achievement. It confirms that our bio-conjugation technology allows for high-dose delivery of therapeutic agents with a manageable toxicity profile. We are now positioned to explore the efficacy of this optimized dose in our upcoming Phase 2 expansion.” Dr. Henry Friedman of Duke University emphasized the importance of this milestone, stating, “Establishing a safe and tolerable dose is the foundation of any successful oncology program. The identification of the RP2D for NEO212 allows NeOnc to proceed with confidence into efficacy studies for a patient population in desperate need of new oral therapies.” NEO212 is NeOnc’s first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ), the current standard of care for glioblastoma and other brain cancers (marketed as Temodar®), with NEO100 (a proprietary form of perillyl alcohol (POH), which is owned and patented by NeOnc). This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Examples of forward-looking statements include, among others, statements regarding whether the data validates the Company’s ability to optimize CNS penetration and therapeutic exposure across both intranasal and oral modalities and whether NEO212 has the potential to replace TMZ as the future standard of care for all brain cancers. These statements reflect our current expectations and beliefs based on information available at this time, but future events may differ materially from those anticipated. The “Risk Factors” section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2025 as filed with the Securities and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in our subsequent filings with the Securities and Exchange Commission, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the fact that results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced or published data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data and our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

Investor releaseQuarter not tagged2026-02-27

NeOnc Technologies (Nasdaq: NTHI) to Host Investor Conference Call to Present Dose-Escalation Results from Full Phase 1 NEO212-01 Readout for Dosing and Toxicity

GlobeNewswire
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…Read full document

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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit https://neonc.com Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

Investor releaseQuarter not tagged2025-12-15

NeOnc Technologies Reports Updated Clinical Results

GlobeNewswire
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…Read full document

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 toward a complete data readout, the consistency and durability of these responses continue to exceed expectations.” Mr. Heshmatpour added: “We view this expanding dataset as a critical value-inflection point for NeOnc and for the neuro-oncology field, suggesting a potential shift away from purely palliative approaches toward durable disease control.” Founder, Vice-Chairman, and Chief Medical Officer Dr. Thomas Chen commented: “With each additional durable responder, the data increasingly support the hypothesis that intranasal NEO100 may be a first-in-class, CNS-penetrant metabolic therapy capable of inducing sustained radiographic remission and multi-year survival in recurrent IDH1-mutant gliomas.” Dr. Henry Friedman of Duke University emphasized the implications of these findings, stating, “The results from NEO100 signify a potential paradigm shift in the treatment of recurrent IDH1-mutant gliomas.” Key Data Highlights: Radiographic Response: 24% (6 of 25 patients) achieved significant radiographic remission confirmed by contrast-enhanced, T2-FLAIR, and perfusion MRI. This response rate exceeds the <8% typically observed with salvage therapies for recurrent gliomas. Progression-Free Survival (PFS-6): 44% of patients achieved 6-month progression-free survival (PFS-6), outperforming historical benchmarks of 21–31% for IDH1-mutant recurrent high-grade gliomas. Long Term Survival: 36% (9 of 25) demonstrated durable survival ≥18 months post-initiation of NEO100. Tolerability: No significant toxicity observed even with prolonged, chronic intranasal administration. Study Context: All patients in the combined analysis (1 compassionate-use case, 5 from Phase 1, and 18 from Phase 2a) had confirmed WHO recurrent Grade III/IV IDH1-Mutant Astrocytoma and were included in the analysis if they had been enrolled in the study for at least six months prior to data cutoff. Patients received intranasal NEO100, and results were assessed using Response Assessment in Neuro-Oncology (RANO) criteria. Collectively, these findings indicate that NEO100 could represent a first-in-class, CNS-penetrant metabolic therapy potentially inducing significant radiographic response and extending survival in patients with recurrent Grade III/IV IDH1-Mutant Astrocytoma, thereby potentially offering a major advancement over past approaches predominantly limited to palliative care. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit neonc.com. Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Examples of forward-looking statements include, among others, statements regarding whether a definitive agreement will be reached with Quazar. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated. The “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

Investor releaseQuarter not tagged2025-11-15

NeOnc Technologies Holdings Reports Third Quarter 2025 Results and Provides Operational Update

GlobeNewswire
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…Read full document

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 33% remained alive ≥18 months after initiation of NEO100, demonstrating long term survival No significant toxicity was reported Dr. Henry Friedman of Duke University emphasized the implications of these findings, stating, “The results from NEO100 signify a potential paradigm shift in the treatment of recurrent IDH1-mutant gliomas.” The findings were presented to the investment community during NeOnc’s November 12, 2025, investor conference call, which is available for replay at: https://www.webcaster5.com/Webcast/Page/3151/53234. Full Phase 2a enrollment completed Top-line data readout anticipated in May 2026 NEO212 – Bio-conjugated therapy for primary and metastatic brain tumors FDA authorization to proceed with Phase II Clinical Trial of NEO212 – a first-in-class oral chemical conjugated chemotherapy candidate for brain cancer Final patient cohort in Phase I on track to complete dosing in 2025. NEO100-3 – Pediatric brain tumor trial initiated with patient recruitment underway. Financial Results for Q3 2025 G&A expenses: $903k vs. $244k in Q3 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs. R&D expenses: $715K vs. $957k in Q3 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of NEO100-3, and overall patient recruitment activity. Net loss: $8.6 million or $0.45 per diluted share, compared to $2.2 million or $0.12 per diluted share in Q3 2024, primarily due to increased general and administrative expenses, as well as stock-based compensation expenses. Amir Heshmatpour, Executive Chairman, President & CEO of NeOnc Technologies Holdings, Inc., commented: “Q3 2025 was a defining quarter for NeOnc—one that firmly positions us at the forefront of innovation in CNS oncology. We delivered exceptional clinical progress, highlighted by highly encouraging Phase 2a data from our NEO100 program that signal a potential paradigm shift for patients battling recurrent high-grade gliomas. We also achieved a major regulatory milestone with FDA clearance to advance our second asset, NEO212, into Phase 2 trials, further strengthening the depth and momentum of our pipeline. Strategically and financially, we reinforced the foundation for long-term global growth. We secured meaningful support from the NIH and finalized a landmark $50 million commitment through our NuroMENA subsidiary—an agreement that accelerates our expansion across the Middle East and positions NeOnc as a clinical and scientific partner of choice in the region. This progress is further strengthened by the appointment of H.H. Sheikh Nahyan bin Zayed Al Nahyan as Executive Chairman of NuroMENA, whose leadership and vision bring extraordinary strategic value and elevate our international standing. With a fortified leadership team, heightened market visibility, and multiple significant clinical catalysts ahead, NeOnc enters the next stage of execution with confidence. We are advancing life-changing therapies for patients who urgently need new options, while driving meaningful value creation for our shareholders.” Upcoming Catalysts Q4 2025 – Completion of NEO212 Phase I final cohort dosing. May 2026 – NEO100-01 top-line data readout. Near-term – Closing and funding of the Quazar Investment of $50 million. 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 cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more about NeOnc and its pioneering technology, visit neonc.com. Important Cautions Regarding Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information. Examples of forward-looking statements include, among others, statements regarding the potential positive effects of NEO100. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated. The “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations. “NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc. Company Contact: [email protected] Investor Contact: James Carbonara Hayden IR (646)-755-7412 [email protected]

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook