$NTHI News

Child shows early improvement after compassionate-use intranasal NEO100; NeOnc names Abu Dhabi banking exec to board

NeOnc reported a critically ill three-year-old with an aggressive brain tumor treated under compassionate-use intranasal NEO100 is breathing without ventilator support and beginning to move his legs. The company notes this single uncontrolled case was administered outside its pediatric trial and frames the update alongside regulatory and corporate milestones — a 24‑patient Phase 2a topline for NEO100 (6‑month PFS 48.9%, median OS 26.09 months), Abu Dhabi IND pathway progress and a new board appointment — plus a $15M registered direct raise and an upcoming Nov. 17 FDA End-of-Phase‑1 meeting for NEO212.

NeOnc Reports Early Clinical Improvement in First Child Treated with NEO100 Under Compassionate Use in Abu Dhabi

NeOnc (NTHI) adds UAE banking exec to board ahead of Nov. 17 FDA End-of-Phase 1 meeting

NeOnc Technologies (NTHI) appointed Ali Alabedin, Head of Islamic Banking Group at First Abu Dhabi Bank with 30+ years of international banking experience, to its board. The hire comes as NeOnc advances brain-cancer programs—UAE INDs for NEO100 and NEO212 and encouraging topline results from a 24‑patient NEO100 Phase 2a—and prepares for an FDA End-of-Phase‑1 meeting for NEO212 on Nov. 17, 2026, so Alabedin’s institutional and cross-border finance experience could help with partnerships and capital needs. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

UAE banking leader joins NeOnc board as company advances brain-cancer programs

NeOnc (NTHI) appointed Ali Alabedin, Head of Islamic Banking Group at First Abu Dhabi Bank, to its board—an addition the company frames as strategic for multinational clinical development and financing as it expands activity in the UAE. NeOnc holds UAE IND authorizations for lead candidates NEO100 (adult Phase 1–2 and potential pediatric protocols) and NEO212 (completed Phase 1 dose escalation), reported 24‑patient NEO100 Phase 2a topline (6‑month PFS 48.9%, median OS 26.09 months), raised $15M via a registered direct, redeemed Series A preferred to eliminate dilution, and has an FDA End‑of‑Phase‑1 meeting for NEO212 scheduled for Nov. 17. Timing: Same-day dilution is possible, but the press release does not provide a firm first-dilution date.

NTHI adds Abu Dhabi banking exec to board as Abu Dhabi DoH clears IND path for NEO212

NeOnc (NTHI) appointed Ali Alabedin, a senior Abu Dhabi banking executive, to its board to bolster international finance/governance expertise as the company expands its regional footprint. The Department of Health – Abu Dhabi granted investigational new drug authorization supporting NEO212 development in the UAE (subject to ethics approvals), and NeOnc also highlighted positive topline NEO100 Phase 2a data (24 patients: 6‑month PFS 48.9% vs 20% benchmark; median OS 26.09 months). The company has an End-of-Phase 1 Type B meeting with the FDA on Nov 17 to discuss NEO212 Phase 2 design and regulatory pathway.

NTHI’s intranasal NEO100 Phase 2a shows 26.1‑month median OS in recurrent high‑grade glioma; highlighted among five 2026 cancer advances

A market roundup highlighted five oncology advances in 2026 and flagged NeOnc (NTHI) after its 24‑patient Phase 2a of intranasal NEO100 reported a median overall survival of 26.09 months from the first post‑recurrence dose, with mostly low‑grade adverse events and at‑home dosing that bypasses the blood‑brain barrier. The result is an encouraging survival signal in recurrent Grade III/IV IDH1‑mutant glioma but is non‑randomized with no concurrent control and mixed progression‑free survival findings; NeOnc plans FDA discussions on a registrational pathway and has a separate Nov. 17, 2026 EOP1 meeting for its NEO212 program.

NeOnc (NTHI) shows encouraging Phase 2a survival signal for intranasal NEO100; 2026 cancer breakthroughs roundup

NeOnc reported a 24-patient Phase 2a trial of intranasal NEO100 in recurrent high-grade IDH1‑mutant glioma showed a median overall survival of 26.09 months (60.9% at 12 months, 54.1% at 24 months) with predominantly low-grade adverse events, and the company plans to discuss a potential registrational pathway with the FDA. The article positions that finding alongside other 2026 oncology developments ranging from Revolution Medicines’ FDA approval in pancreatic cancer to positive Phase 3 results from Moderna/Merck, J&J and Genmab/AbbVie, emphasizing these represent mixed levels of evidence from exploratory signals to randomized approvals.

NTHI faces two near-term FDA Type B meetings for NEO100 (Oct) and NEO212 (Nov 17)

NeOnc (NTHI) has an anticipated FDA End-of-Phase 2 Type B discussion for intranasal NEO100 expected in October and a scheduled End-of-Phase 1 Type B meeting for oral NEO212 on Nov. 17, which could clarify trial design, endpoints, and path to pivotal studies. NEO100 reported encouraging Phase 2a results (24 patients: 6‑month PFS 48.9% vs 20% historical benchmark; median OS 26.09 months), but the dataset is small and the article noting these catalysts was a paid editorial, so outcomes remain uncertain until FDA feedback and further trials.

NTHI heads to Nov 17 FDA End-of-Phase 1 meeting; ALEC inks $1.27B Genentech deal; PCVX posts positive Phase 3 VAX-31 topline

Alector (ALEC) signed an exclusive global license with Genentech for AL050 (100M upfront, up to $1.17B in milestones) with Genentech taking development/commercialization while Alector retains its ABC brain-delivery platform. NeOnc (NTHI) has an in-person FDA End-of-Phase 1 meeting for NEO212 on Nov 17 as it prepares Phase 2 strategy (recommended Phase 2 dose 610 mg) and its intranasal program NEO100 reported a positive Phase 2a (48.9% 6-month PFS vs 20% benchmark, p=0.0047); Vaxcyte (PCVX) reported positive OPUS-1 Phase 3 topline for VAX-31 meeting immunogenicity and safety endpoints versus PCV20/PCV21.

Alpha Modus completed 3,170‑BTC PIPE for 51.62M shares + 51.62M warrants; NeOnc closed $15M RD

Alpha Modus (AMOD) completed a PIPE on Sep 30, 2026, receiving 3,170 BTC in exchange for 51.62 million Class A shares and warrants to purchase an additional 51.62 million shares exercisable at $4.36, creating immediate large dilution while adding a sizable crypto treasury (company says equity now >$200M). NeOnc Technologies (NTHI) also completed a $15 million registered direct offering in September and subsequently redeemed all outstanding Series A convertible preferred shares. Timing: Shares were issued at closing; initial share dilution has already occurred.

Four biotech catalysts: NeOnc FDA meeting, Connect COPD Phase 2 win, Valion oral Entolimod, Lilly retatrutide Phase 3 weight-loss data

Four biotech catalysts are highlighted: NeOnc (NTHI) has an in-person End-of-Phase 1 FDA meeting set for Nov 17 for NEO212 after Phase 1 dose escalation (recommended Phase 2 dose 610 mg) and also reported supportive Phase 2a NEO100 signals; Connect Biopharma (CNTB) reported positive Phase 2 Seabreeze STAT COPD topline in 159 patients showing an 81% reduction in treatment failure through Week 4 (p=0.0122) and plans to engage the FDA on a Phase 3 registrational program. Valion Bio (VBIO) completed an oral mucosal formulation for Entolimod and now needs systemic PK/exposure data, while Eli Lilly (LLY) posted strong Phase 3 TRIUMPH-2 retatrutide results (~20% mean weight loss at 80 weeks for 12 mg and meaningful A1C reductions) and plans a BLA submission in Q1 2027.

IOVA lifts 2026 guide; NTHI schedules Nov 17 FDA meeting; Summit gets $2B AstraZeneca investment ahead of Nov 14 PDUFA

This note flags three near-term biotech catalysts: Iovance (IOVA) raised 2026 revenue guidance to $410–$420M driven by stronger demand for Amtagvi and Proleukin and an expanding treatment-center network, suggesting commercial-scale execution. NeOnc (NTHI) has an End-of-Phase 1 Type B FDA meeting set for Nov 17 for NEO212 after a Phase 1 recommended Phase 2 dose and positive NEO100 Phase 2a topline signals, while Summit (SMMT) secured a $2B convertible-preferred investment and clinical collaboration with AstraZeneca and faces a Nov 14 PDUFA for ivonescimab plus chemo in EGFR‑mut NSCLC.

NTHI completed $15M registered direct at $4.20 with $4.20-strike warrants

NeOnc completed a $15.0 million registered direct offering in September at $4.20 per share, issuing roughly 3.57M shares and attached warrants with a $4.20 exercise price; proceeds were earmarked for working capital, general corporate purposes and redemption of Series A convertible preferred stock. The company also redeemed all 6,000 outstanding Series A preferred shares for $6.0M (removing that potential convertible dilution) and has a Type B FDA meeting for NEO212 scheduled for November 17, 2026 as the next clinical catalyst. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

Kodiak posts Phase 3 wins; NeOnc gets FDA meeting; DataMeds launches GLP‑1 app; KNOREX rolls out AI amid listing risk

Kodiak Sciences (KOD) reported positive pivotal Phase 3 DAYBREAK results for Zenkuda—non‑inferior to aflibercept on vision (p=0.0007), 54% of patients reached 24‑week dosing at one year and 0% intraocular inflammation—and plans a multi‑indication BLA in Q4 2026 while other late‑stage readouts (tabirafusp‑ted ALTO, KSI‑101) remain pending. NeOnc (NTHI) set an FDA End‑of‑Phase‑1 Type B meeting for NEO212 on Nov 17, 2026 after early Phase‑1 signals and a recommended Phase‑2 dose of 610 mg, and also reported a positive NEO100 Phase‑2a PFS/OS readout; DataMeds (MEDS) launched a consumer GLP‑1 telehealth/pharmacy/wearables app with NFL Alumni/Corexa partnerships; KNOREX (KNRX) is deploying conversational AI campaign tools but faces an NYSE American noncompliance notice over stockholders’ equity. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NTHI previously completed a September registered direct at $4.20 with accompanying warrants

The article notes NeOnc (NTHI) raised capital in a September registered direct offering priced at $4.20 per share that included accompanying warrants. That registered direct implies issuance and cap-table dilution occurred at the September closing. The release does not disclose unit/share counts, gross proceeds, placement agent, or warrant terms and expiries. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NeOnc (NTHI) schedules FDA End-of-Phase 1 meeting for NEO212 on Nov 17, 2026

NeOnc said it will meet with the FDA in person on Nov. 17, 2026 for an End-of-Phase 1 meeting to seek feedback on NEO212’s patient population, trial design, endpoints, dose selection and potential registrational/accelerated approval pathway. The meeting follows Phase 1 dose escalation (DLT at 810 mg; recommended Phase 2 dose 610 mg) and reported encouraging, but anecdotal, durable responses in two patients (one recurrent GBM partial response with ~60% shrinkage and 21 months disease control; one lung-to-brain metastasis with ~16 months stable disease).

NeOnc (NTHI) draws Roth $20 target after positive Phase 2a glioma data

Roth Capital initiated coverage of NeOnc (NTHI) with a Buy and $20 price target, flagging the company’s Phase 2a topline for NEO100 as the near-term catalyst and noting potential pivotal trials before end-2026 under analyst assumptions. NeOnc reported 6‑month PFS of 48.9% vs a prespecified 20% benchmark and median OS of 26.09 months in recurrent IDH1‑mutant high‑grade glioma, is planning FDA meetings to discuss a registrational pathway, has a second program (NEO212) with CMC feedback and a recommended Phase 2 dose, and recently raised about $15M with insider purchases. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NeOnc completed $15M registered direct at $4.20 with $4.20-strike warrants

NeOnc raised $15.0 million via a registered direct offering priced at $4.20 per share with accompanying warrants carrying a $4.20 exercise price. Placement agents were Roth Capital and A.G.P./Alliance Global Partners, and the deal closed in September 2026 so the new shares/warrants are on the cap table now. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NeOnc (NTHI) reports positive Phase 2a intranasal NEO100 data in IDH1‑mutant high‑grade glioma

NeOnc (NTHI) reported Phase 2a results for intranasal NEO100 in recurrent/progressive Grade III/IV IDH1‑mutant glioma: six‑month PFS 48.9% versus a prespecified 20% benchmark (p=0.0047), median OS 26.09 months, with no major toxicities and mostly low‑grade adverse events (5 of 24 patients still on treatment at cutoff). The company plans to seek a Type B FDA meeting to discuss a potential registrational pathway, but the data are from a small (n=24), single‑arm study and will need confirmation in larger, controlled trials within a challenging glioma landscape.

Paid NTHI editorial — market roundup on VKTX, NTHI, DCOY, GRML; no financing announced

24/7 Market News published a paid editorial highlighting Viking Therapeutics (VKTX), NeOnc Technologies (NTHI), Decoy Therapeutics (DCOY) and Greenland Mines (GRML) and discloses that NTHI compensated the publisher for ongoing coverage. The article provides company updates and catalyst commentary but does not announce any securities offering, financing terms, or share issuance.

NTHI redeems Series A preferred for $6M after announcing $15M registered direct

NeOnc (NTHI) redeemed all 6,000 shares of its Series A Convertible Preferred for $6.0M in cash, eliminating a potential discounted conversion and removing that overhang immediately. The move came days after the company announced a $15M registered direct offering that management said was structured to fund the redemption; dilution from the registered direct is delayed/undetermined until that offering closes. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NTHI redeems all Series A preferred for $6.0M; dilution eliminated

NeOnc Technologies redeemed all 6,000 outstanding Series A Convertible Preferred shares for cash at their $6.0 million aggregate stated value, funded with a portion of net proceeds from its $15 million registered direct offering announced Sept. 9, 2026. The redemption eliminates the potential conversion-based dilution (the Series A had been issued in June 2026 for $5.0 million and would have converted at 80% of the five-day low, subject to a $1.00 floor) and leaves no Series A Preferred outstanding. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NTHI prices ~$15M deal: ~3.57M shares + 3.57M warrants at $4.20

NeOnc (NTHI) priced an institutional financing for roughly $15 million at $4.20 per common share with accompanying five-year warrants; pre-funded warrants were offered in lieu of common shares. The deal covers about 3.57 million shares or equivalents plus warrants to purchase another ~3.57 million shares at $4.20; dilution will occur at closing (no closing date disclosed). Timing: Dilution depends on the offering closing, but the press release does not give a firm closing date.

NTHI insiders buy as NeOnc pushes NEO100 toward FDA meeting after Phase 2a readout

NeOnc's CEO bought 37,000 shares at $3.6654 (~$136k) just after the company announced a $15M registered direct at $4.20, signaling insider conviction while the financing offers potential dilution. The company reported Phase 2a topline for intranasal NEO100 in recurrent IDH1-mutant high‑grade glioma (24 patients, open‑label, single‑arm): 48.9% six‑month PFS versus a 20% prespecified benchmark and median OS of 26.09 months, and says it will request a Type B meeting with the FDA to discuss a potential registrational path. Timing: The press release does not indicate dilution today. Earliest dilution: date unknown.

NTHI: Intranasal NEO100 Phase 2a posts strong PFS; patent portfolio hints at nose‐to‐brain platform

NeOnc (NTHI) reported Phase 2a intranasal NEO100 data in recurrent IDH1‐mutant high‐grade glioma: a 24‐patient, open‐label study produced 48.9% six‐month progression‐free survival versus a 20% historical benchmark (p=0.0047) and median overall survival of 26.09 months. The company also controls a sizable USC‐origin patent portfolio covering intranasal delivery and related compounds (NEO100/NEO212), which could turn the nose‐to‐brain approach into a broader CNS delivery platform — but the dataset is small and non‐randomized, and a registrational trial with FDA alignment is required to validate the technology and commercial potential.