{"success":true,"data":{"pressRelease":{"id":"155415","rtpr_id":"nGNX1n8Bnh-20260929","ticker":"NTHI","exchange":"NASDAQ","all_tickers":["NTHI"],"title":"NeOnc’s Powerful Brain Cancer Pipeline Advances","author":"Globe Newswire","published_at":"2026-09-29T12:52:25.101Z","article_body":"DALLAS, Sept. 29, 2026 (GLOBE NEWSWIRE) -- (www.InvestorsTape.com) -- NeOnc\nTechnologies Holdings (NASDAQ: NTHI) is heading toward another potentially\nimportant regulatory milestone, with the U.S. Food and Drug Administration\nscheduled to meet with the company on November 17, 2026, for an in-person\nEnd-of-Phase 1 Type B meeting concerning NEO212, its oral perillyl\nalcohol-temozolomide conjugate being developed for aggressive central nervous\nsystem cancers.\n\nNeOnc plans to seek agency feedback on the proposed patient population, Phase\n2 trial design, endpoints, dose selection and the evidence that could\nultimately support a future marketing application. The company also intends to\ndiscuss potential registrational strategies and whether a future study could\npotentially support an accelerated-approval pathway.\n\nNEO212 enters that discussion with a completed Phase 1 dose-escalation program\nand a defined recommended Phase 2 dose of 610 mg, following dose escalation to\na protocol-defined maximum tolerated dose of 810 mg. The company has reported\nearly signals of potential activity in heavily pretreated patients, including\na patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma who\nexperienced approximately a 60% tumor reduction and 21 months of disease\ncontrol. Another heavily pretreated patient with lung cancer metastatic to the\nbrain experienced stable disease for approximately 16 months. These\nobservations remain individual-patient findings rather than controlled\nevidence of efficacy, making the design and outcome of larger studies\ncritical. NeOnc has also secured UAE IND authorization for NEO212, creating an\ninternational clinical-development pathway alongside its U.S. regulatory\ndiscussions.\n\nNeOnc CEO Amir Heshmatpour summarized the immediate objective: “This meeting\nwill help us understand FDA’s feedback on the population, study design and\nendpoints for the next stage of development.” The November meeting follows\nFDA written feedback earlier this year concerning NEO212’s chemistry,\nmanufacturing and controls program and the planned transition from a capsule\nto a tablet formulation. That makes the upcoming discussion potentially\nimportant not only for clinical strategy, but also for clarifying the\npractical development path toward a larger study.\n\nThe NEO212 story is unfolding alongside meaningful progress from NeOnc’s\nlead program, NEO100. In August, the company reported topline Phase 2a results\nin recurrent or progressive Grade III and Grade IV IDH1-mutant glioma, with\nsix-month progression-free survival of 48.9% versus a prespecified 20%\nbenchmark (p=0.0047) and median overall survival of 26.09 months. NeOnc also\nreported that 86.7% of patients were alive at six months, five of 24 patients\nremained on treatment at the data cutoff, and one partial response remained\nongoing beyond 114 days. The company said it plans to request an FDA Type B\nmeeting to discuss a potential registrational pathway in this setting.\n\nThe company has also been building its financial position around those\nclinical catalysts. In September, NeOnc completed a $15 million registered\ndirect offering priced at $4.20 per share, alongside warrants with a $4.20\nexercise price. The financing involved new and existing healthcare-focused\ninstitutional investors, with proceeds designated for working capital, general\ncorporate purposes and the redemption of Series A convertible preferred stock.\nDays later, NeOnc announced that it had redeemed all 6,000 outstanding Series\nA preferred shares for $6 million in cash, stating that the transaction\neliminated the related potential dilution without issuing common shares in the\nredemption.\n\nThere has also been notable insider activity. NeOnc reported in September that\nits executives had made approximately $629,000 in open-market purchases\nfollowing the positive NEO100 Phase 2a results, including CEO Amir\nHeshmatpour's purchase of an additional 35,000 shares for approximately\n$115,400 and 111,000 shares purchased by Heshmatpour since the August clinical\nreadout. These purchases are factual disclosures of insider transactions and\ndo not establish future clinical or market performance.\n\nWall Street has added another layer to the story. Roth Capital analyst\nJonathan Aschoff initiated coverage of NeOnc in September with a reported $20\nprice target, while the research firm identified potential pivotal-trial\nstarts for NEO100 and NEO212 as future development milestones. That is an\nanalyst view rather than a company forecast or regulatory determination.\n\nFor NTHI, the November 17 FDA meeting now sits at the center of a broader\nsequence of catalysts: regulatory feedback for NEO212, continued advancement\nof NEO100 following its Phase 2a readout, potential registrational\ndiscussions, international development in the UAE and further financing and\nclinical execution.\n\nFor investors tracking the CNS biotech space, that makes November 17 a date\nwith potentially significant implications for the company's development\nroadmap heading into 2027.\n\nAbout InvestorsTape.com\n\nAt InvestorsTape.com, our mission is simple: deliver financial news that cuts\nthrough the noise and shines a spotlight on the companies, innovations, and\nmarket forces shaping the next decade of growth. In a landscape dominated by\nhigh-frequency headlines and fleeting narratives, we bring clarity, depth, and\nbalance to the stories that matter, helping investors discover high-potential\ncompanies and evaluate emerging opportunities with confidence.\n\nContact\nbenh@investorstape.com\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including statements that may regard NeOnc\nTechnologies Holdings’ future revenue, growth trajectory, profitability\noutlook, expansion plans, strategic partnerships, potential regulatory\napprovals, and other projections, plans, and objectives. Forward-looking\nstatements are subject to risks and uncertainties that may cause actual\nresults to differ materially from those expressed or implied, including market\nconditions, timing of venue openings, execution risks, operational\nperformance, competition, regulatory matters, and general economic conditions.\nReaders should not place undue reliance on these statements, which speak only\nas of the date made.\n\nGeneral Disclaimer:\n\nInvestorsTape.com has been compensated for press and editorial coverage of\nNeOnc Technologies Holdings and further disclosure information is available\nhere\n(https://www.globenewswire.com/Tracker?data=rv07sOOdRJ4rt2s9tGr_gdewP_wynzNStXAfCL4iEB7OhTnTrD1VNirPK3fi1ZisyHSwAyH2cNyjC8SibzQmSX2M6NAcKsKhbBbwTAp8XZQ=).\nThis communication is provided for informational and journalistic purposes\nonly and reflects the independent editorial views of InvestorsTape.com.\n\nThis editorial discusses investigational therapy and clinical-trial results\nand is not medical advice or a recommendation to buy or sell securities.\n\nThis publication is protected speech under the First Amendment of the United\nStates Constitution. Nothing herein constitutes an offer, solicitation, or\nrecommendation to buy or sell any security, nor should it be construed as\ninvestment advice. Investing in securities involves risk, including the\npossible loss of principal. Readers are encouraged to conduct their own due\ndiligence and consult with a qualified financial advisor before making any\ninvestment decision.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a37d67da-256c-465b-a500-1ae7bd540f2a)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX1n8Bnh-20260929","title":"NeOnc’s Powerful Brain Cancer Pipeline Advances","author":"Globe Newswire","ticker":"NTHI","created":"2026-09-29T12:52:25.101Z","tickers":["NTHI"],"exchange":"NASDAQ","article_body":"DALLAS, Sept. 29, 2026 (GLOBE NEWSWIRE) -- (www.InvestorsTape.com) -- NeOnc\nTechnologies Holdings (NASDAQ: NTHI) is heading toward another potentially\nimportant regulatory milestone, with the U.S. Food and Drug Administration\nscheduled to meet with the company on November 17, 2026, for an in-person\nEnd-of-Phase 1 Type B meeting concerning NEO212, its oral perillyl\nalcohol-temozolomide conjugate being developed for aggressive central nervous\nsystem cancers.\n\nNeOnc plans to seek agency feedback on the proposed patient population, Phase\n2 trial design, endpoints, dose selection and the evidence that could\nultimately support a future marketing application. The company also intends to\ndiscuss potential registrational strategies and whether a future study could\npotentially support an accelerated-approval pathway.\n\nNEO212 enters that discussion with a completed Phase 1 dose-escalation program\nand a defined recommended Phase 2 dose of 610 mg, following dose escalation to\na protocol-defined maximum tolerated dose of 810 mg. The company has reported\nearly signals of potential activity in heavily pretreated patients, including\na patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma who\nexperienced approximately a 60% tumor reduction and 21 months of disease\ncontrol. Another heavily pretreated patient with lung cancer metastatic to the\nbrain experienced stable disease for approximately 16 months. These\nobservations remain individual-patient findings rather than controlled\nevidence of efficacy, making the design and outcome of larger studies\ncritical. NeOnc has also secured UAE IND authorization for NEO212, creating an\ninternational clinical-development pathway alongside its U.S. regulatory\ndiscussions.\n\nNeOnc CEO Amir Heshmatpour summarized the immediate objective: “This meeting\nwill help us understand FDA’s feedback on the population, study design and\nendpoints for the next stage of development.” The November meeting follows\nFDA written feedback earlier this year concerning NEO212’s chemistry,\nmanufacturing and controls program and the planned transition from a capsule\nto a tablet formulation. That makes the upcoming discussion potentially\nimportant not only for clinical strategy, but also for clarifying the\npractical development path toward a larger study.\n\nThe NEO212 story is unfolding alongside meaningful progress from NeOnc’s\nlead program, NEO100. In August, the company reported topline Phase 2a results\nin recurrent or progressive Grade III and Grade IV IDH1-mutant glioma, with\nsix-month progression-free survival of 48.9% versus a prespecified 20%\nbenchmark (p=0.0047) and median overall survival of 26.09 months. NeOnc also\nreported that 86.7% of patients were alive at six months, five of 24 patients\nremained on treatment at the data cutoff, and one partial response remained\nongoing beyond 114 days. The company said it plans to request an FDA Type B\nmeeting to discuss a potential registrational pathway in this setting.\n\nThe company has also been building its financial position around those\nclinical catalysts. In September, NeOnc completed a $15 million registered\ndirect offering priced at $4.20 per share, alongside warrants with a $4.20\nexercise price. The financing involved new and existing healthcare-focused\ninstitutional investors, with proceeds designated for working capital, general\ncorporate purposes and the redemption of Series A convertible preferred stock.\nDays later, NeOnc announced that it had redeemed all 6,000 outstanding Series\nA preferred shares for $6 million in cash, stating that the transaction\neliminated the related potential dilution without issuing common shares in the\nredemption.\n\nThere has also been notable insider activity. NeOnc reported in September that\nits executives had made approximately $629,000 in open-market purchases\nfollowing the positive NEO100 Phase 2a results, including CEO Amir\nHeshmatpour's purchase of an additional 35,000 shares for approximately\n$115,400 and 111,000 shares purchased by Heshmatpour since the August clinical\nreadout. These purchases are factual disclosures of insider transactions and\ndo not establish future clinical or market performance.\n\nWall Street has added another layer to the story. Roth Capital analyst\nJonathan Aschoff initiated coverage of NeOnc in September with a reported $20\nprice target, while the research firm identified potential pivotal-trial\nstarts for NEO100 and NEO212 as future development milestones. That is an\nanalyst view rather than a company forecast or regulatory determination.\n\nFor NTHI, the November 17 FDA meeting now sits at the center of a broader\nsequence of catalysts: regulatory feedback for NEO212, continued advancement\nof NEO100 following its Phase 2a readout, potential registrational\ndiscussions, international development in the UAE and further financing and\nclinical execution.\n\nFor investors tracking the CNS biotech space, that makes November 17 a date\nwith potentially significant implications for the company's development\nroadmap heading into 2027.\n\nAbout InvestorsTape.com\n\nAt InvestorsTape.com, our mission is simple: deliver financial news that cuts\nthrough the noise and shines a spotlight on the companies, innovations, and\nmarket forces shaping the next decade of growth. In a landscape dominated by\nhigh-frequency headlines and fleeting narratives, we bring clarity, depth, and\nbalance to the stories that matter, helping investors discover high-potential\ncompanies and evaluate emerging opportunities with confidence.\n\nContact\nbenh@investorstape.com\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including statements that may regard NeOnc\nTechnologies Holdings’ future revenue, growth trajectory, profitability\noutlook, expansion plans, strategic partnerships, potential regulatory\napprovals, and other projections, plans, and objectives. Forward-looking\nstatements are subject to risks and uncertainties that may cause actual\nresults to differ materially from those expressed or implied, including market\nconditions, timing of venue openings, execution risks, operational\nperformance, competition, regulatory matters, and general economic conditions.\nReaders should not place undue reliance on these statements, which speak only\nas of the date made.\n\nGeneral Disclaimer:\n\nInvestorsTape.com has been compensated for press and editorial coverage of\nNeOnc Technologies Holdings and further disclosure information is available\nhere\n(https://www.globenewswire.com/Tracker?data=rv07sOOdRJ4rt2s9tGr_gdewP_wynzNStXAfCL4iEB7OhTnTrD1VNirPK3fi1ZisyHSwAyH2cNyjC8SibzQmSX2M6NAcKsKhbBbwTAp8XZQ=).\nThis communication is provided for informational and journalistic purposes\nonly and reflects the independent editorial views of InvestorsTape.com.\n\nThis editorial discusses investigational therapy and clinical-trial results\nand is not medical advice or a recommendation to buy or sell securities.\n\nThis publication is protected speech under the First Amendment of the United\nStates Constitution. Nothing herein constitutes an offer, solicitation, or\nrecommendation to buy or sell any security, nor should it be construed as\ninvestment advice. Investing in securities involves risk, including the\npossible loss of principal. Readers are encouraged to conduct their own due\ndiligence and consult with a qualified financial advisor before making any\ninvestment decision.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a37d67da-256c-465b-a500-1ae7bd540f2a)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-29T12:52:25.137746919Z","server_sent_at_ms":1790686345137},"received_at":"2026-09-29T12:52:25.189Z","source_url":null},"analysis":{"id":"144142","press_release_id":"155415","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Publisher (InvestorsTape.com) discloses it was compensated for coverage of NeOnc — promotional content, not issuer disclosure","Clinical efficacy signals are individual-patient anecdotes, not controlled data","Recently completed $15M dilutive offering with warrants at $4.20"],"eventType":"clinical_trial","narrative":"NeOnc Technologies has an FDA End-of-Phase 1 Type B meeting scheduled for November 17, 2026, to discuss NEO212's proposed Phase 2 design, endpoints, dose selection and potential accelerated-approval strategy for aggressive CNS cancers.\n\nNEO212 completed Phase 1 with a recommended Phase 2 dose of 610 mg, supported by individual-patient signals (including ~60% tumor reduction in a recurrent glioblastoma patient) that are not controlled efficacy evidence. Lead program NEO100 previously beat its prespecified benchmark with 48.9% six-month progression-free survival versus 20% in recurrent IDH1-mutant glioma.\n\nThe company recently raised $15 million at $4.20 per share, redeemed all Series A preferred shares for $6 million, and reported roughly $629,000 in insider open-market purchases.\n\nNote this is paid third-party editorial coverage from InvestorsTape.com, not an issuer disclosure; the November meeting outcome is the real catalyst.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Paid promotional recap — flag Nov 17 FDA meeting as a watch-date but discount the coverage."},"keyFigures":{"drugName":"NEO212","phaseOfTrial":"End-of-Phase 1","customDimensions":{"offering_price":"$4.20","fda_meeting_date":"November 17, 2026","insider_purchases":"approximately $629,000","offering_proceeds":"$15 million","neo100_6mo_pfs_pct":"48.9%","analyst_price_target":"$20","preferred_redemption":"$6 million","max_tolerated_dose_mg":810,"neo100_6mo_pfs_pvalue":"0.0047","patients_alive_6mo_pct":"86.7%","neo100_median_os_months":"26.09","recommended_phase2_dose_mg":610,"neo100_6mo_pfs_benchmark_pct":"20%"}},"quotedText":"This meeting will help us understand FDA’s feedback on the population, study design and endpoints for the next stage of development.","namedEntities":{"people":[{"name":"Amir Heshmatpour","role":"CEO"},{"name":"Jonathan Aschoff","role":"analyst, Roth Capital"}],"products":["NEO212","NEO100"],"companies":[{"name":"NeOnc Technologies Holdings","ticker":"NTHI","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Roth Capital","relationship":"analyst coverage"},{"name":"InvestorsTape.com","relationship":"compensated publisher of this release"}],"dollarAmounts":[{"amount":"$15 million","context":"September registered direct offering proceeds"},{"amount":"$4.20","context":"per-share offering price and warrant exercise price"},{"amount":"$6 million","context":"cash redemption of 6,000 Series A preferred shares"},{"amount":"$629,000","context":"approximate executive open-market share purchases"},{"amount":"$115,400","context":"CEO purchase of 35,000 additional shares"},{"amount":"$20","context":"Roth Capital price target"}]},"materialImpact":{"score":2,"reasoning":"Third-party (paid) editorial coverage recapping an upcoming Nov 17, 2026 FDA End-of-Phase 1 meeting for NEO212 and prior NEO100 Phase 2a data. No new clinical or regulatory result is disclosed; the event itself is a scheduled meeting, not an outcome."},"tickerRelevance":{"others":[],"primary":"NTHI"},"globalImportance":22,"audienceRelevance":20,"eventTypeSecondary":["regulatory"],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"scheduled regulatory meeting preview in paid coverage","issuerAuthored":false,"promotionalContent":true}},"event_type":"clinical_trial","event_type_secondary":["regulatory"],"sentiment":"bullish","material_impact_score":2,"narrative":"NeOnc Technologies has an FDA End-of-Phase 1 Type B meeting scheduled for November 17, 2026, to discuss NEO212's proposed Phase 2 design, endpoints, dose selection and potential accelerated-approval strategy for aggressive CNS cancers.\n\nNEO212 completed Phase 1 with a recommended Phase 2 dose of 610 mg, supported by individual-patient signals (including ~60% tumor reduction in a recurrent glioblastoma patient) that are not controlled efficacy evidence. Lead program NEO100 previously beat its prespecified benchmark with 48.9% six-month progression-free survival versus 20% in recurrent IDH1-mutant glioma.\n\nThe company recently raised $15 million at $4.20 per share, redeemed all Series A preferred shares for $6 million, and reported roughly $629,000 in insider open-market purchases.\n\nNote this is paid third-party editorial coverage from InvestorsTape.com, not an issuer disclosure; the November meeting outcome is the real catalyst.","key_figures":{"drugName":"NEO212","phaseOfTrial":"End-of-Phase 1","customDimensions":{"offering_price":"$4.20","fda_meeting_date":"November 17, 2026","insider_purchases":"approximately $629,000","offering_proceeds":"$15 million","neo100_6mo_pfs_pct":"48.9%","analyst_price_target":"$20","preferred_redemption":"$6 million","max_tolerated_dose_mg":810,"neo100_6mo_pfs_pvalue":"0.0047","patients_alive_6mo_pct":"86.7%","neo100_median_os_months":"26.09","recommended_phase2_dose_mg":610,"neo100_6mo_pfs_benchmark_pct":"20%"}},"named_entities":{"people":[{"name":"Amir Heshmatpour","role":"CEO"},{"name":"Jonathan Aschoff","role":"analyst, Roth Capital"}],"products":["NEO212","NEO100"],"companies":[{"name":"NeOnc Technologies Holdings","ticker":"NTHI","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Roth Capital","relationship":"analyst coverage"},{"name":"InvestorsTape.com","relationship":"compensated publisher of this release"}],"dollarAmounts":[{"amount":"$15 million","context":"September registered direct offering proceeds"},{"amount":"$4.20","context":"per-share offering price and warrant exercise price"},{"amount":"$6 million","context":"cash redemption of 6,000 Series A preferred shares"},{"amount":"$629,000","context":"approximate executive open-market share purchases"},{"amount":"$115,400","context":"CEO purchase of 35,000 additional shares"},{"amount":"$20","context":"Roth Capital price target"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-29T12:52:33.946Z","global_importance":22,"audience_relevance":20,"importance_components":{"tickerTier":"small-cap","eventGravity":"scheduled regulatory meeting preview in paid coverage","issuerAuthored":false,"promotionalContent":true}},"durationMs":8692,"modelName":"glm-5.3-flashx"}}